Copyrights, Patents, and Trademarks — A Practical Guide to Intellectual Property
In today’s knowledge-driven economy, intellectual property (IP) stands as a cornerstone for innovation and business success. Understanding the nuances of copyrights, patents, and trademarks is essential for professionals across various fields. This guide delves into the legal and financial dimensions of these IP categories.
Understanding Intellectual Property
IP covers creations of the mind, ranging from inventions, literary and artistic works, and designs to symbols, names, and images used in commerce. These intangible assets are protected by law, enabling creators and businesses to control and benefit from their use.
Allan Grafman of All Media Ventures emphasizes that recognizing and safeguarding your IP is not just a legal necessity but a strategic business move.
Copyrights: Safeguarding Creative Expressions
Copyrights grant creators exclusive rights to their original works, covering a broad spectrum from literature and music to software and architecture.
Scope of Copyright Protection
Copyright protection applies to:
Literary Works: Books, articles, and poems.
Musical Works: Songs and instrumental compositions.
Artistic Works: Paintings, sculptures, and photographs.
Architectural Works: Building designs and blueprints.
Software: Computer programs and applications.
It’s crucial to note that while the expression of an idea is protected, the idea itself is not. As Patrick Reilly of Spike Dynamics explains, copyright safeguards the unique expression, not the underlying concept.
Registration and Its Benefits
While copyright protection is automatic upon creation, formal registration with the US Copyright Office offers significant advantages:
Legal Enforcement: Ability to file infringement lawsuits.
Public Record: Establishes a public claim of ownership.
Statutory Damages: Eligibility for statutory damages and attorney’s fees in litigation.
Timely registration, preferably within three months of publication, strengthens these protections.
Duration of Copyright
The length of copyright protection varies:
Individual Authors: Life of the author plus 70 years.
Corporate Works: 95 years from publication or 120 years from creation, whichever is shorter.
Understanding these timeframes is vital for managing and planning the use of creative assets.
Fair Use Doctrine
The fair use doctrine permits limited use of copyrighted material without permission for purposes such as criticism, commentary, news reporting, teaching, scholarship, or research. However, determining fair use involves a nuanced analysis of factors like purpose, nature, amount used, and market effect.
Patents: Protecting Innovations
Patents provide inventors with exclusive rights to their inventions, preventing others from making, using, or selling the invention without authorization.
Types of Patents
There are three primary categories of patents:
Utility Patents: For new and useful processes, machines, manufactures, or compositions of matter.
Design Patents: Protect new, original, and ornamental designs for manufactured articles.
Plant Patents: Granted for the invention or discovery of a distinct and new variety of plant that is asexually reproduced.
Criteria for Patentability
To secure a patent, an invention must be:
Novel: Not previously known or used by others.
Non-Obvious: Not an evident development to someone with ordinary skill in the field.
Useful: Demonstrably functional and operative.
Meeting these criteria requires thorough documentation and, often, a strategic approach to research and development.
Patent vs. Trade Secret
Businesses must decide between patenting an invention, which requires public disclosure, or maintaining it as a trade secret, which involves keeping the information confidential to gain a competitive edge. Each approach has its own legal and financial implications.
As Allan Grafman notes, choosing between patent protection and trade secrecy depends on the nature of the invention and the business strategy.
Trademarks: Building Brand Identity
Trademarks protect symbols, names, and slogans used to identify goods or services, serving as a company’s brand identity.
Importance of Trademarks
Trademarks distinguish products or services in the marketplace, helping consumers identify the source and quality. They can take various forms:
Words and Phrases: Brand names and slogans.
Logos and Symbols: Graphic representations.
Colors and Sounds: Distinctive hues or jingles associated with a brand.
Brian Landry of Saul Ewing LLP emphasizes that a strong trademark is invaluable for fostering consumer trust and loyalty.
Benefits of Trademark Registration
While common law provides some trademark protection based on use, federal registration with the US Patent and Trademark Office (USPTO) offers significant legal and financial advantages:
Nationwide Protection – Registration establishes exclusive rights across the US, unlike common law, which is limited to geographic areas of use.
Presumption of Ownership – A federally registered mark creates a legal presumption of the registrant’s ownership, making it easier to enforce rights in court.
Public Notice – The mark is listed in the USPTO database, warning potential applicants of an existing claim.
Ability to Sue in Federal Court – Owners of registered trademarks can bring infringement cases in federal court, often leading to higher monetary damages.
Stronger Legal Position – The USPTO actively prevents similar marks from being registered, reducing the risk of disputes.
David Perry of Blank Rome LLP notes that registering a trademark is an investment in your brand’s longevity, because it adds legal muscle to your ability to protect and expand your business.
How To Lose Trademark Rights
Even a federally registered trademark is not invincible. Here are some common ways businesses lose trademark protection:
Abandonment – If a trademark isn’t used for three consecutive years, it is presumed abandoned.
Genericide – A trademark can lose protection if it becomes the generic term for a product or service. Examples include:
Escalator (formerly a trademark of Otis Elevator Co.)
Aspirin (originally trademarked by Bayer)
Thermos (once a brand name but now a generic term for vacuum flasks)
Naked Licensing – If a trademark owner allows others to use the mark without proper quality control, it may lose its distinctiveness.
Failure to Renew – Trademark registrations must be maintained between the 5th and 6th year after registration, and again by every 10th anniversary.
Patrick Reilly warns that brands that don’t enforce their trademark risk losing it. Vigilant protection is key to maintaining brand integrity.
Trademarks vs. Domain Names
A common misconception is that owning a domain name (e.g., example.com) automatically grants trademark rights — it does not. A domain name is merely an internet address, while a trademark identifies and protects brand names, products, and services.
If a business secures a great domain name but does not use it as a trademark, another company could potentially claim trademark rights and force the domain to be surrendered. To avoid disputes, businesses should register both the trademark and relevant domain names.
Trademark Infringement: What To Do If Someone Uses Your Mark
If another business uses a confusingly similar trademark, it is important to determine whether legal action is necessary. This typically follows a step-by-step approach:
Investigate – Confirm when and how the infringing party is using the mark.
Send a Cease-and-Desist Letter – This formal letter notifies the infringer of your rights and requests that they stop using the mark.
Negotiate – In some cases, an agreement can be reached, such as:
Licensing the mark
Coexisting under specific conditions
File a Lawsuit – If the infringer refuses to stop, litigation may be necessary. Courts consider:
Strength of the original mark
Similarity of the marks
Similarity of the goods/services
Evidence of consumer confusion
Intent of the infringer
If successful, the trademark owner may recover damages, the infringer’s profits, and attorney’s fees.
Brian Landry adds that a proactive enforcement strategy prevents dilution and protects a brand’s value in the long run.
Patent Rights: A Barrier to Competition
Patents provide an exclusive right to inventors, allowing them to monopolize their innovations for up to 20 years. This exclusivity creates a competitive advantage, making patents highly valuable in technology, pharmaceuticals, and industrial design.
When Should a Business Patent an Invention?
Patents are most valuable when they:
Provide a technological breakthrough (e.g., new drug formulas, AI algorithms)
Offer long-term competitive advantage
Have high commercial potential
Are difficult to keep as trade secrets
Filing a patent requires disclosure of the invention, so businesses must weigh the risk of revealing confidential details. Allan Grafman notes that a trade secret may be preferable over a patent if secrecy is your priority.
Patent vs. Trade Secret
Feature
Patent Protection
Trade Secret Protection
Duration
20 years max
Indefinite (as long as secret is maintained)
Disclosure
Public (via USPTO)
Confidential
Cost
High (filing, maintenance, legal fees)
Low (no government registration)
Enforcement
Strong (lawsuits for infringement)
Weak (once disclosed, lost forever)
A trade secret (e.g., Coca-Cola formula) can last indefinitely, whereas a patent expires after 20 years, allowing competitors to use the technology.
Monetizing IP: Licensing and Assignments
Intellectual property is a financial asset that can be licensed or sold for profit.
Licensing vs. Assignment
Licensing: The IP owner retains ownership but grants usage rights for a fee (royalty payments).
Assignment: The IP owner sells all rights permanently.
Licensing is common in entertainment, technology, and pharmaceuticals, where companies profit from allowing third parties to use their patents, trademarks, or copyrighted content.
Patrick Reilly highlights that licensing can generate passive income, but owners must ensure strict contractual terms to avoid loss of control.
Conclusion: Why IP Protection Matters
Intellectual property rights drive economic growth, foster innovation, and enhance brand value. Businesses must actively protect and enforce their rights, whether securing a copyright, patenting an invention, or registering a trademark.
IP is an asset class that should be treated with the same diligence as real estate or stock portfolios. By understanding the legal and financial intricacies of intellectual property, businesses and professionals can protect their innovations, strengthen their brands, and maximize long-term value.
To learn more about this topic, view the webinar Copyrights, Patents, and Trademarks…Oh My!. The quoted remarks referenced in this article were made either during this webinar or shortly thereafter during post-webinar interviews with the panelists. Readers may also be interested in reading other articles about intellectual property protections.
This article was originally published here.
©2025. DailyDACTM, LLC d/b/a/ Financial PoiseTM. This article is subject to the disclaimers found here.
How Should a Licensing Commitment Affect the Availability of Injunctions at the ITC?
We may be about to find out, as the Commission seeks comments on exclusion orders for infringement of standard essential patents.
Governed by 19 U.S.C. § 337, the U.S. International Trade Commission (“ITC”) is empowered to investigate unfair acts in the importation of articles into the United States. The ITC can be a powerful forum for owners of U.S. patents as it may issue exclusion orders barring infringing articles from entering the United States. Although the ITC is an independent federal agency, it is natural to wonder whether the Trump administration’s policies – including, in particular its “America First Trade Policy” issued on January 20 – could affect litigation before the Commission.
While the day-to-day handling of investigations before the ITC is unlikely to be affected by the specific trade policies of a particular administration, § 337 provides for a presidential review period, during which the president can review and potentially veto an exclusion order entered by the Commission in an investigation. This power has rarely been exercised, but the history of presidential review in investigations involving standard essential patents (“SEPs”) provides an example where the policies of an administration can directly impact ITC practice.
It started in 2013 when the Obama administration overturned an ITC order that would have excluded various Apple iPhone and iPad products from the United States market. In that investigation, Samsung alleged that Apple infringed patents that had been declared essential to certain telecommunications standards, and, in overturning the import ban, the U.S. Trade Representative acting on behalf of the Obama administration cited a “Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments” jointly issued by the Department of Justice and the U.S. Patent and Trademark Office on January 8, 2013. https://www.justice.gov/d9/pages/attachments/2018/12/10/290994.pdf
The Obama-era Policy Statement cautioned that granting exclusion orders for infringement of standard essential patents – which are typically accompanied by commitments to license on terms that are fair, reasonable and non-discriminatory (“FRAND” or “F/RAND”) – may result in the patent owner engaging in “patent hold up” by demanding a higher royalty for the use of its patent than would have been possible before the standard was set, and that such behavior may harm consumers. Accordingly, the 2013 Policy Statement concluded that “[a]lthough [] an exclusion order for infringement of F/RAND-encumbered patents essential to a standard may be appropriate in some circumstances, we believe that, depending on the facts of individual cases, the public interest may preclude the issuance of an exclusion order in cases where the infringer is acting within the scope of the patent holder’s F/RAND commitment and is able, and has not refused, to license on F/RAND terms.”
During President Trump’s first term, the administration issued its own “Policy Statement on Remedies for Standard-Essential Patents Subject to Voluntary F/RAND Commitments” on December 19, 2019. https://www.justice.gov/atr/page/file/1228016/dl This 2019 Policy Statement identified “concerns that the 2013 policy statement has been misinterpreted to suggest that a unique set of legal rules should be applied in disputes concerning patents subject to a F/RAND commitment,” such that “injunctions and other exclusionary remedies should not be available in actions for infringement of standards-essential patents.” The 2019 Policy Statement warned that “such an approach would be detrimental to the carefully balanced patent system.” Accordingly, the USPTO and DOJ withdrew the 2013 Policy Statement in favor of a policy where “the existence of F/RAND or similar commitments [] may be relevant and may inform the determination of appropriate remedies,” but “the general framework for deciding these issues remain[ed] the same as in other patent cases.”
This back-and-forth continued with the Biden administration, but to a lesser extent. After soliciting written submissions and hearing a variety of views on both sides of the issues, on June 8, 2022, the Biden administration issued a “Withdrawal of 2019 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments,” which stated in a footnote that it was also not reinstating the Obama-era 2013 Policy Statement. https://www.uspto.gov/sites/default/files/documents/SEP2019-Withdrawal.pdf. Accordingly, the 2022 Withdrawal concluded that conduct by SEP holders and standards implementers should be reviewed “on a case-by-case basis to determine if either party is engaging in practices that result in the anticompetitive use of market power or other abusive processes that harm competition.”
It remains to be seen whether the USPTO, DOJ and NIST will reinstate the 2019 Policy Statement in President Trump’s second term. The policy statement put into effect during President Trump’s first term was withdrawn by President Biden, but in a way that did not reinstate the earlier Obama-era policy, and the 2022 Withdrawal does not on its face articulate any view of available remedies for infringement of standard essential patents that is inconsistent with the 2019 Policy Statement. Nevertheless, one would reasonably expect that the second Trump administration would be inclined to favor a policy where available remedies for infringement of standard essential patents would not materially differ from the remedies available for infringement of other patents.
However, earlier this month the International Trade Commission issued a notification suggesting that the Commission’s thoughts on this issue may not be so predictable. On March 4, 2025, the ITC published a Notice in the Federal Register relating to Investigation No. 337-TA-1380, which involved an allegation by Nokia that Amazon infringes certain patents declared essential to video compression standards which carry with them a commitment to license on RAND terms. The Notice indicates that the Commission has determined to review the Initial Determination of the Administrative Law Judge in its entirety, and it solicits written submissions from the parties on various issues, including the following SEP-specific questions:
When the complainant alleges that an asserted patent is a standard essential patent, subject to reasonable, and nondiscriminatory (RAND) licensing terms, is the complainant precluded from seeking an exclusion order and/or cease and desist order based on infringement of that patent? Should the Commission consider RAND licensing obligations as a legal or equitable defense (i.e., as part of its violation determination) under section 337(c), 19 U.S.C. 1337(c)) or as part of its consideration of the public interest factors under section 337(d)(1) and (f)(1)? Please discuss theories in law, equity, and the public interest, and identify which (if any) of the public interest factors of 337(d)(1) and (f)(1) preclude issuance of such an order.
In the event a violation is found, does the information regarding the parties’ RAND obligations and licensing attempts inform any particular public interest factor that the Commission should consider under section 337(d)(1) and (f)(1)? If so, please identify which factor it informs and explain why, including the relevant evidence of record. As part of its public interest analysis, should the Commission determine whether any prior license offer made by the patent holder covering the accused products is reasonable and non-discriminatory? If so, what evidence should the Commission consider in determining whether offers are reasonable and non-discriminatory based on the record of this investigation?
In addition, the March 4 Notice solicited written submissions from not just the parties, but also any interested government agencies or other interested parties on the issues of remedy and the public interest, which would seemingly include addressing the above two questions and, in general, Amazon’s argument in the case that an exclusion order would be against the public interest because it would exclude articles that practice SEPs. Such submissions were due on March 13, though approved late submissions continue to be filed, and the target date for completion of the Investigation is currently May 14, 2025.
The questions are interesting, particularly in view of the Obama administration’s directive in 2013 that “in any future cases involving SEPs that are subject to voluntary FRAND commitments, the Commission should be certain to (1) to examine thoroughly and carefully on its own initiative the public interest issues presented both at the outset of its proceeding and when determining whether a particular remedy is in the public interest and (2) seek proactively to have the parties develop a comprehensive factual record related to these issues in the proceedings before the Administrative Law Judge and during the formal remedy phase of the investigation before the Commission, including information on the standards-essential nature of the patent at issue if contested by the patent holder and the presence or absence of patent hold-up or reverse hold-up.”
Following that directive, the Commission has considered the issue in the past, and although it typically followed the 2013 Obama administration’s directive to consider the issues, it virtually always found that SEPs should not receive any type of “special treatment” at the ITC. However, based upon the Commission’s recent Notice, it appears that the Commission may be thinking more critically about the issue of defenses and exclusionary remedies for infringement of SEPs, with the history of these various Policy Statements showing that there is not a singular policy view, both from administrations with different perspectives and from parties with divergent interests. And with the target date for completion of the Nokia/Amazon Investigation just two months away and with comments having just recently been submitted, we may soon learn how the ITC intends to treat the Obama-era directive in the context of current trade policy.
The AI Workplace: A Guide on AI Policy Essentials [Podcast]
In this episode of our new podcast series, The AI Workplace, where we explore the latest advancements in integrating artificial intelligence (AI) into the workplace, Sam Sedaei (associate, Chicago) shares his insights on crafting and implementing effective AI policies. Sam, who is a member of the firm’s Cybersecurity and Privacy and Technology practice groups, discusses the rapid rise of generative AI tools and highlights their potential to boost productivity, spark innovation, and deliver valuable insights. He also addresses the critical risks associated with AI, such as inaccuracies, bias, privacy concerns, and intellectual property issues, while emphasizing the importance of legal and regulatory guidance to ensure the responsible and effective use of AI in various workplace functions. Join us for a compelling discussion on navigating the AI-driven future of work.
New Decree for Patent Linkage by the Mexican Government.
On March 6, 2025, a Decree providing guidelines about the technical collaboration between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for Protection against Health Risks (COFEPRIS) was published in the Federal Official Gazette. This Decree follows the draft published on February 12, 2025, noted in our newsletter dated February 19, 2025. https://natlawreview.com/article/draft-decree-patent-linkage-mexican-government.
In brief, the key points of the Decree under report are the following:
Establishing the rules for communications between IMPI and COFEPRIS.
Guidelines for new “forms,” which will be published on the official web site of both authorities. Up to the date of circulation of this newsletter, these “forms” have not been published yet.
The information that should be included in the Allopathic Medicines Gazette and the corresponding technical communications between COFEPRIS and IMPI.
COFEPRIS will publish a list of Marketing Authorizations (MA) Applications for generics and biosimilars. This list (with no rules on temporality and forms) will be considered as a warning to the public for purposes of detecting potential harm to patent rights.
In case of potential harm to patent rights, an opposition “form” can be filed by the patent owner or its licensee and/or sublicensee before COFEPRIS within the statutory term of 10 working days after the publication date of such list.
The communication rendered by COFEPRIS to IMPI, concerning the technical communication should attach the “opposition form”, along with the information provided by the patent owner or its licensee and/or sublicensee.
The most relevant provisions included within the decree are the publication of the list of MA applications and the “opportunity” to file an opposition by the patent owner if he considers that a patent right is affected by the MA applications.
The Decree is legally founded on certain provisions of the IP Law, Health Regulations, and the USMCA. It seems that the decree intends to comply with the provisions of the USMCA, where it is provided that if a person/company (patent owner) is directly affected by a proceeding, in this case, the MA applications, they must be given with a reasonable opportunity to present facts and arguments, prior to issuing the corresponding decision on the MA application.
In OLIVARES, we consider that the USMCA establishes the burden to the State Party to provide the corresponding notice to the patent holder who would be directly affected by the marketing authorization application proceeding, on the contrary, this Decree imposes on the patent holders the burden of identifying themselves as affected parties without being personally notified by COFEPRIS or IMPI.
In addition, it seems that the opposition opportunity will take place before COFEPRIS and not IMPI, even though IMPI is the patent office, i.e., the authority that handles the information related to the owner or its licensee and/or sublicensee, namely, those who could be directly impacted by the patent linkage mechanism. Nevertheless, it is expected that the details of this matter should be described later, through other official texts.
The guidelines provided are a step forward in the Mexican Linkage System, as it clarifies the information to be exchanged by these authorities. Nonetheless, for the reasons commented, we consider that the Decree does not observe the obligations of proper notice established in the USMCA for the Mexican Patent Linkage. This conclusion could be summarized in the sense that the legal burden, obligations, and formalities of a notice process are different from an opposition system.
The Decree will come into force within the next 60 working days of its publication; namely, it will enter into force on June 3, 2025.
At OLIVARES, we will continue to follow up on the upcoming changes and application of this Decree, and we will keep our clients closely informed on this matter, monitoring how the decree will be implemented within practice.
Regulations on the Implementation of the Anti-Foreign Sanctions Law of the People’s Republic of China – Foreign-Owned Intellectual Property Can Be Seized
On March 23, 2025, the State Council of the People’s Republic of China promulgated the Regulations on the Implementation of the Anti-Foreign Sanctions Law of the People’s Republic of China (实施〈中华人民共和国反外国制裁法〉的规定). Article 7 of the Regulations specifically allows for the seizure of intellectual property of those that “directly or indirectly participate in the drafting, decision-making, or implementation of the discriminatory restrictive measures in Article 3 of Anti-Foreign Sanctions Law.” Paragraph 2, Article 3 of the Law reads, “Where foreign nations violate international law and basic norms of international relations to contain or suppress our nation under any kind of pretext or based on the laws of those nations to employ discriminatory restrictive measures against our nation’s citizens or interfere with our nation’s internal affairs, our nation has the right to employ corresponding countermeasures.”
Article 7 of the Regulations reads:
The seizure, detention, and freezing referred to in Paragraph 2 of Article 6 of the Anti-Foreign Sanctions Law shall be implemented by the public security, finance, natural resources, transportation, customs, market supervision, financial management, intellectual property and other relevant departments of the State Council in accordance with their duties and powers.
Other types of property in Article 6, Paragraph 2 of the Anti-Foreign Sanctions Act include cash, bills, bank deposits, securities, fund shares, equity, intellectual property rights, accounts receivable and other property and property rights.
Relevant Articles of Law follow:
Article 3: The People’s Republic of China opposes hegemony and power politics and opposes any country’s interference in China’s internal affairs by any means and under any pretext.
Where foreign nations violate international law and basic norms of international relations to contain or suppress our nation under any kind of pretext or based on the laws of those nations to employ discriminatory restrictive measures against our nation’s citizens or interfere with our nation’s internal affairs, our nation has the right to employ corresponding countermeasures.
Article 4: The relevant departments of the State Council may decide to enter persons or organizations that directly or indirectly participate in the drafting, decision-making, or implementation of the discriminatory restrictive measures provided for in article 3 of this Law in a countermeasure list.
Article 5: In addition to the individuals and organizations listed on the countermeasure list in accordance with Article 4 of this Law, the relevant departments of the State Council may also decide to employ countermeasures against the following individuals and organizations:
(1) The spouses and immediate relatives of individuals listed on the countermeasure list;
(2) Senior managers or actual controllers of organizations included in the countermeasures list;
(3) Organizations in which individuals included in the countermeasure list serve as senior management;
(4) Organizations in which persons included in the countermeasure list are the actual controllers or participate in establishment and operations;
Article 6: In accordance with their respective duties and division of labor, the relevant departments of the State Council may decide to employ one or more of the following measures against the individuals and organizations provided for in Articles 4 and 5 of this Law, based on the actual situation:
(1) Not issuing visas, denying entry, canceling visas, or deportation;
(2) Sealing, seizing, or freezing movable property, real estate, and all other types of property within the [mainland] territory of our country;
(3) Prohibiting or restricting relevant transactions, cooperation, and other activities with organizations and individuals within the [mainland] territory of our country;
(4) Other necessary measures.
The full text of the Regulations is available here (Chinese only). A translation of the Anti-Foreign Sanctions Law is available from NPC Observer here.
OECD Report on Data Scraping and AI – What Companies Can Do Now as Policymakers Consider the Issues
The power of large language models (LLMs) that enables generative AI derives from vast quantities of data. Much of this data comes from scraping all forms of content from the internet. Despite the benefits, this practice raises numerous legal issues, some of which implicate IP issues. Dozens of pending lawsuits in the US alone include claims involving IP issues with data scraping. The recent OECD report titled “Intellectual Property Issues in AI Trained on Scraped Data” (Report) explores the intricate relationship between AI and IP rights, particularly focusing on data scraping practices used in AI training. It aims to provide policymakers with insights into the legal challenges posed by data scraping and potential policy approaches to address these issues. The following is an overview of the Report.
Data scraping involves the automated extraction of data from websites, databases, or social media platforms without coordination with the data host. Techniques include web scraping, web crawling, and screen scraping.
Scraping raises concerns about IP rights infringement, especially when copyrighted materials are involved. The issues can include copyright infringement, right of publicity/misuse of name, image or likeness (NIL), database rights, trademarks, trade secrets, among others. Legal disputes over data scraping to train AI are increasing worldwide. The legal issues are complicated by the variation in the relevant laws in different jurisdictions. As one example, the US has a “fair use” exception to copyright law, while the European Union (EU) has a “text and data mining” (TDM) exception. Some jurisdictions recognize sui generis (unique) rights to protect specific types of materials under IP law. For example, the EU provides sui generis database rights. Some jurisdictions, such as Japan, has proclaimed that training AI on copyrighted material will not be deemed an infringement. In the US, it is a critical issue pending in many lawsuits, with no clear answer yet. Other legal issues arise with the output of AI, including whether it is an infringement, if so, who is liable (the tool provider or the user) and whether it is copyright protectable.
The Report further notes that contracts, including website terms of service (TOS) and end user license agreements (EULAs) can help govern how data can be scraped or used as between the parties to the agreement, including specific provisions on permitted uses, attribution requirements, and liability allocations. However, it further notes that the enforceability of TOS and EULAs and their interaction with IP laws can vary significantly across jurisdictions. This further complicates matters.
As the Report notes, the term data scraping is often conflated with “data mining.” The latter refers to computational processes for identifying patterns, trends, and correlations in data. The Report highlights the inconsistencies in definitions and proposes a broad working definition for data scraping.
The Report further notes that the data scraping ecosystem includes research institutions and academia, AI data aggregators, technology companies and platform operators. AI data aggregators reportedly make scraped data available to third parties, often without clear licensing terms or clear disclosure of data provenance. This exacerbates the IP and other legal issues. Different legal issues may apply to different entities, depending on their role in the AI ecosystem.
The Report indicates that policymakers are increasingly considering codes of conduct and other forms of voluntary commitments by business to address challenges such as data scraping. It discusses various issues that should be addressed in these codes for AI data aggregators and users. Voluntary commitments are easy to adopt, but only work if uniformly adopted. Bad actors are unlikely to comply.
Another part of a potential solution includes policymakers encouraging the development of standard and widely accessible technical tools that protect IP rights, enable rights holders to control access to their data more easily, and support licensing mechanisms. Such tools can help with data access control and rights management to streamline compliance and enhance transparency.
The Report also suggests developing appropriate standard contract terms, including common terminology. However, given the cross-border nature of AI and the territorial nature of IP rights, this process would need to consider technical, legal and/or other terms that may already exist in different jurisdictions.
Lastly, the Report advocates raising awareness of data scraping legal issues by educating stakeholders about their rights and responsibilities in the AI data ecosystem. This includes informing stakeholders about legal implications and best practices for data usage in AI. This is an area where many companies that are just getting up to speed can benefit from assistance of knowledgeable legal counsel.
In summary, the Report underscores the need for coordinated international policy approaches to address the challenges posed by AI data scraping, balancing innovation with the protection of IP rights. It notes that by adopting voluntary codes of conduct, developing technical tools, and implementing standard contract terms, policymakers can promote responsible AI development while safeguarding intellectual property. However, this will not happen overnight and companies are using AI now.
In the interim, there are things that companies can do now to ensure responsible use of AI and minimize legal liability. Many companies are seeking advice from legal counsel to receive in-house legal training and responsible AI policy development. For some of the issues with training and developing AI policies see Why Companies Need AI Legal Training and Must Develop AI Policies and 5 Things Corporate Boards Need to Know About Generative AI Risk Management.
Federal Circuit Decision Could Encourage More Reissue Patents
The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S. Food and Drug Administration (FDA). The length of a PTE award depends on how much time was spent under FDA review after the patent was issued. But which issue date is used for a reissued patent? In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., the Federal Circuit decided that the earlier issue date of the original patent should be used to calculate PTE. By essentially preserving PTE awarded to original patents, this decision could encourage pharmaceutical companies to pursue reissue, especially if there are any concerns that broad original claims may not comply with the court’s recent Orange Book listing guidance.
The BRIDION® Patent And Regulatory Review Period at Issue
The patent at issue is listed in the Orange Book for Merck’s BRIDION® (sugammadex) product, which is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. The patent was first issued December 30, 2003, as U.S. Patent No. 6,670,340, and then reissued on January 28, 2014, as U.S. Patent No. RE44,733. The reissued patent amended a dependent claim to expressly recite the active ingredient of BRIDION®.
Merck applied for FDA approval of sugammadex on April 13, 2004 (four months after the ’340 patent issued), and it was approved on December 15, 2015. Thereafter, Merck sought, and the USPTO granted, the maximum five years of PTE available under § 156, using the issue date of the original ’340 patent for the PTE calculation. (If the issue date of U.S. Patent No. RE44,733 had been used, the PTE award would have been only 686 days.)
The challenge to the PTE award arose in the context of ANDA litigation brought by several companies seeking FDA approval to sell generic versions of BRIDION®. The district court agreed with the USPTO’s calculation, and on appeal the Federal Circuit did too.
The Federal Circuit Opinion
The Federal Circuit opinion was authored by Judge Dyk and joined by Judges Mayer and Reyna. As framed in the opinion, the issue on appeal was one of statutory construction—the meaning of “the patent” in §156(c):
The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued …
The Federal Circuit agreed with the USPTO that the language of §156(c) itself was ambiguous in that it is “unclear whether ‘the patent’ refers to the original or reissued patent.” Thus, the Federal Circuit considered “the broader context of the statute as a whole,” stating:
[T]he purpose of [§ 156] is clear: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.
With this purpose in mind, the opinion reasons:
That purpose applies in this case, since construing “the patent” in subsection 156(c) as the original patent compensates Merck for the period of exclusivity lost due to regulatory delay. On the other hand, Aurobindo’s construction denies Merck compensation for all but a small period of the delay. There is no reason why the Hatch-Waxman Act’s purpose would be served by disabling extensions of the unexpired term solely based on a patent holder’s decision to seek reissue …
The opinion concludes:
We thus conclude that, in the context of reissued patents, “the patent” in subsection 156(c) refers to the original patent. A reissued patent is entitled to PTE based on the original patent’s issue date where, as here, the original patent included the same claims directed to a drug product subject to FDA review.
Reissue Patents and Orange Book Listings
As discussed in this article, the Federal Circuit decision in Teva v. Amneal may have patent owners taking a second look at their Orange Book-listed patents, to assess whether they “particularly point out and distinctly claim” the specific drug approved by the FDA. For patents that disclose but do not expressly claim the approved active ingredient, seeking a reissue patent could allay Orange Book listability concerns. The PTE decision in Merck indicates that obtaining a reissued patent would not lessen PTE, providing further reason to consider the reissue process as an opportunity to strengthen a patent portfolio.
CNIPA and 6 Other Chinese Government Bodies Issue Opinions on Further Improving the Business Environment in the Field of Intellectual Property – New Trademark Law Coming?
On March 21, 2025, China’s National Intellectual Property Administration (CNIPA) and 6 other government bodies released the “Opinions of the State Intellectual Property Office, the Ministry of Education, the Ministry of Science and Technology, the State Administration for Market Regulation, the State Financial Regulatory Administration, the National Copyright Administration and the Chinese Academy of Sciences on further optimizing the business environment in the field of intellectual property” (国家知识产权局 教育部 科技部 市场监管总局 金融监管总局 国家版权局 中国科学院关于进一步优化知识产权领域营商环境的意见).
Some highlights include:
performing in-depth credit evaluation of patent and trademark agencies, and promptly disclose the evaluation results of agencies and practitioners to provide guidance for enterprises and the public to choose agencies;
standardize the standards and procedures for the identification and listing of serious untrustworthy entities in the field of intellectual property rights, and impose penalties on serious untrustworthy entities in the field of intellectual property rights in accordance with laws and regulations;
formulate licensing guidelines for standard essential patents, promote fair and reasonable licensing of standard essential patents, and prevent companies from using standard essential patents to implement monopoly behavior;
establish a special database on standard essential patents to facilitate access to information on standard essential patents;
accelerate the revision and deliberation of the new round of trademark law and its implementing regulations, strengthen the obligation to use trademarks, and further strengthen the regulation of malicious preemptive registration and other behaviors;
issue typical cases of abnormal patent applications to guide the improvement of patent quality; and
strictly restrain behaviors that disrupt market order such as vicious low-price competition.
The original text is available here. A translation follows.
To the competent departments for intellectual property, education, science and technology, market supervision, and copyright of all provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps, all regulatory bureaus of the Financial Regulatory Administration, and all units under the Chinese Academy of Sciences:
This Opinion is formulated to thoroughly implement the decisions and arrangements of the CPC Central Committee and the State Council on optimizing the business environment and the overall requirements for intellectual property work, promptly respond to the expectations of the public and business entities, continuously reduce institutional transaction costs, further strengthen policy support and service guarantees for business entities, help create a first-class business environment, and better promote high-quality development.
I. General requirements
Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we will adhere to the combination of problem-oriented and goal-oriented approaches, adhere to the dual-wheel drive of institutional innovation and digital empowerment, and work together online and offline. We will benchmark against international advanced practices and experience, take creating a first-class business environment as the main line, promote the market-oriented, law-based, internationalized and convenient development of the business environment in the field of intellectual property rights, focus on the needs of innovation and development and the concerns of business entities, further optimize the business environment in the field of intellectual property rights, better play the institutional role of intellectual property rights in stimulating innovation internally and promoting openness externally, and fully stimulate the endogenous motivation and vitality of innovation and creation of various entities.
By 2027, the marketization, legalization, internationalization and facilitation of the business environment in the field of intellectual property will be significantly improved, the overall quality of intellectual property creation, utilization efficiency, protection effectiveness, management level and service capabilities will be improved, intellectual property government services will be further optimized, the satisfaction and sense of gain of enterprises and the public will continue to increase, and the role of the business environment in the field of intellectual property in promoting high-quality development will be more prominent.
II. Improve the market-oriented mechanism of intellectual property rights and help build a high-standard market system
(I) Improve the incentive mechanism for intellectual property innovation. Improve the distribution system oriented towards increasing the value of knowledge, expand the autonomy of universities and research institutes in disposing intellectual property through transfer, licensing or investment, and promote the realization of intellectual property value. Strengthen the standardized management of service inventions, deepen the reform of empowering service scientific and technological achievements, improve the intellectual property income distribution mechanism with equal rights and obligations among units, scientific researchers and technology transfer institutions, and improve the due diligence exemption and fault tolerance mechanism for patent transformation. Promote the deep integration of industry, academia and research, strengthen guidance on the formulation of intellectual property-related clauses in industry-university-research cooperation agreements, and guide all parties to reasonably agree on the organizational form of cooperation, division of tasks, capital investment, ownership of intellectual property rights, distribution of rights and interests, risk sharing and liability for breach of contract. Support universities and research institutions in establishing intellectual property management funds and operating funds. (The Ministry of Science and Technology, the Ministry of Education, the National Intellectual Property Administration, the National Copyright Administration, and the Chinese Academy of Sciences are responsible according to their respective duties)
(II) Promote the healthy and orderly development of the intellectual property service industry. Actively promote the supervision of patent agency delegation, entrust the supervision functions of provincial patent agencies to the municipal (districts under the jurisdiction of municipalities directly under the Central Government) level, and strengthen grassroots supervision. Carry out in-depth credit evaluation of patent and trademark agencies, and promptly disclose the evaluation results of agencies and practitioners to provide guidance for enterprises and the public to choose agencies. Strengthen the standardized management of the copyright agency industry. Strengthen administrative law enforcement, credit supervision and punishment for breach of trust for illegal and irregular intellectual property agency behaviors in accordance with laws and regulations. Improve the relevant self-discipline rules for intellectual property agencies, strictly restrain behaviors that disrupt market order such as vicious low-price competition and improper promises, and maintain a good industry ecology. (The State Administration for Market Regulation, the National Intellectual Property Administration, and the National Copyright Administration are responsible for their respective duties)
(III) Improve the market-oriented pricing and trading mechanism of intellectual property rights. Improve the intellectual property value assessment standards, continuously publish patent implementation license statistics and copyright registration data, and guide patent holders to scientifically, fairly and reasonably estimate license royalties. Carry out internal assessment pilot projects for bank intellectual property pledge financing, and guide financial institutions to improve their independent assessment capabilities. Encourage innovation in financial products such as intellectual property insurance and credit guarantees, and give full play to the role of financial support for intellectual property transformation. Accelerate the establishment and improvement of the intellectual property trading market, improve the liquidity and disposal convenience of intellectual property assets, and promote standardized intellectual property transactions. (The Financial Supervision Administration, the National Intellectual Property Administration, and the National Copyright Administration are responsible for their respective duties)
(IV) Strengthen the coordinated protection of intellectual property rights. Increase the protection of original innovation of private small, medium and micro enterprises. Strengthen the administrative law enforcement protection of intellectual property rights, and crack down on intellectual property infringements in accordance with the law. Improve the linkage of intellectual property administrative adjudication and infringement rapid processing mechanisms such as the transfer of intellectual property administrative adjudication cases, assistance in investigations, and delivery of execution, as well as the rapid coordinated protection mechanism of central-local cooperation. Improve the intellectual property credit supervision system, standardize the standards and procedures for the identification of the list of serious untrustworthy entities in the field of intellectual property rights, and impose penalties on serious untrustworthy entities in the field of intellectual property rights in accordance with laws and regulations. Relying on the national enterprise credit information disclosure system, strengthen the collection and disclosure of information such as trademarks, patents, intellectual property pledge registrations, enterprise-related administrative licenses, and administrative penalties. Strengthen anti-monopoly supervision and law enforcement, prevent and stop the abuse of intellectual property rights to exclude and restrict competition, protect fair competition in the market, and promote innovation and development. (The State Administration for Market Regulation, the National Intellectual Property Administration, and the National Copyright Administration are responsible for their respective duties)
(V) Promote collaborative innovation between standards and patents. Strengthen the linkage between patent examination and standard setting, formulate policy guidelines for patents related to promotion standards, and guide innovation entities to integrate their own intellectual property rights into technical standards. Formulate licensing guidelines for standard essential patents, promote fair and reasonable licensing of standard essential patents, and prevent companies from using standard essential patents to implement monopoly behavior. Establish a special database on standard essential patents to facilitate access to information on standard essential patents. (The State Administration for Market Regulation and the National Intellectual Property Administration are responsible for their respective duties)
III. Strengthen legal protection of intellectual property rights to better support comprehensive innovation
(VI) Improve intellectual property laws and regulations. Accelerate the revision and deliberation of the new round of trademark law and its implementing regulations, strengthen the obligation to use trademarks, and further strengthen the regulation of malicious preemptive registration and other behaviors. Accelerate the revision of supporting regulations for the Copyright Law. Improve the regulations on integrated circuit layout design. Promote special legislation for geographical indications, and improve a unified geographical indication protection system that coordinates special protection with trademark protection. Guide and strengthen the construction of the local intellectual property law system. (The National Intellectual Property Administration and the National Copyright Administration are responsible for the division of responsibilities)
(VII) Improve the rules for intellectual property protection in new areas. Promote research on intellectual property protection rules in cutting-edge technology fields, and do a good job in intellectual property protection in emerging fields. Carry out pilot work on data intellectual property rights in depth, and accelerate the establishment of data intellectual property protection rules. Explore and improve open source standards and specifications, study and formulate information technology open source intellectual property compliance standards, open source community code contribution rules and standards, and improve the level of open source intellectual property protection. (The National Intellectual Property Administration and the National Copyright Administration are responsible for their respective duties)
(VIII) Innovate the diversified examination model for patents and trademarks. Comprehensively use various examination models such as priority examination to serve the key core technology research and development. According to the needs of regional development and local key industries, further expand the pre-examination field of local intellectual property protection centers to better meet the needs of innovative entities for rapid patent confirmation and pre-examination. Optimize the rapid examination model for trademark registration applications, allow rapid examination of graphic trademarks, improve the implementation of priority examination decisions in trademark rejection reviews and objection applications, and better support parties to quickly safeguard their legitimate rights and interests. Accelerate the establishment of a trademark examination collaboration evaluation mechanism to continuously improve the quality and efficiency of examinations. (The State Intellectual Property Office is responsible)
(IX) Improve the patent and trademark examination rules. Issue the “Patent Application Guidelines” and typical cases of abnormal patent applications to guide the improvement of patent quality. Deepen the agency quality monitoring and trigger-type supervision mechanism with the rectification of abnormal patent applications as the core, and achieve precise crackdowns and precise policies. Promote the establishment of a conflict resolution mechanism for corporate names, abbreviations and trademark rights, and increase regulatory efforts. On the premise of ensuring data security, promote the sharing of patent, trademark information and business entity information, deepen the coordination between trademark examination and business entity registration in the business field, explore the establishment of a registered trademark marking and disposal mechanism for the demise of the right holder, release trademark registration resources in a timely manner, and help solve the problem of difficult trademark registration. (The State Administration for Market Regulation and the National Intellectual Property Administration are responsible according to their respective duties)
(10) Improve the copyright registration system and mechanism. Promote the establishment of a unified national copyright registration system, and further standardize the registration of works, computer software copyright registration, copyright pledge registration, foreign-related copyright contract registration, copyright exclusive license use contract and transfer contract filing. Refine copyright registration standards, study and build a copyright data service information platform, improve the level of copyright registration digitization, gradually realize online copyright registration, improve copyright registration publicity query, data submission and statistical analysis systems, promote the integration of copyright registration, query, monitoring and protection, and provide better quality and convenient services for the development of related industries. (National Copyright Administration is responsible)
IV. Improving the internationalization level of intellectual property services and effectively promoting opening up
(XI) Deepen international exchanges in the field of public services. Continue to strengthen cooperation with intellectual property examination institutions of various countries and deepen the sharing of examination information. Promote cooperation on intellectual property information and data resource projects with countries and regions participating in the joint construction of the “Belt and Road”. Support qualified Technology and Innovation Support Centers (TISCs) to carry out international exchanges on public services of intellectual property information. Encourage high-level foreign institutions to provide intellectual property services in China. Deepen international cooperation on geographical indications, encourage research on foreign language versions of geographical indication-related standards, and enhance the international influence of China’s geographical indication brands. Guide and support Chinese companies to enhance the added value and competitiveness of trademark brands, improve the international operation capabilities of trademark brands, and shape a good image of Chinese trademark brands. Continue to strengthen cooperation with copyright departments of various countries to enhance the influence and voice of copyright. (The National Intellectual Property Administration and the National Copyright Administration are responsible for their respective duties)
(XII) Strengthen guidance on overseas intellectual property dispute response. Encourage local governments to set up intellectual property guidance stations in countries and regions with intensive trade exchanges. Rely on overseas intellectual property dispute response guidance sub-centers to provide enterprises with professional and efficient overseas dispute response guidance services. Organize a list of key export enterprises by industry and increase assistance in rights protection. Support insurance institutions to develop and launch more overseas intellectual property insurance products, promote the establishment of overseas intellectual property rights protection assistance funds, and help enterprises reduce rights protection costs. Timely collect and publish information on foreign intellectual property legal systems, build a database of foreign intellectual property litigation cases, conduct typical case analysis and research, and provide information support for enterprises to deal with foreign-related intellectual property disputes. Increase the cultivation of foreign-related intellectual property legal service institutions, strengthen the construction of foreign-related intellectual property legal talent teams, and enhance the professionalism and pertinence of enterprises’ overseas dispute response guidance. (The Financial Regulatory Administration, the National Intellectual Property Administration, and the National Copyright Administration are responsible for their respective duties)
V. Promote the convenience of government services for intellectual property rights and enhance the benefits to enterprises and the public
(XIII) Promote the optimization of service processes and innovation of models. Continue to reduce the processing cycle of patent and trademark changes. Under normal circumstances, changes in recorded items involving the transfer of patent rights should be reviewed within 1 month, and trademark transfers and changes should be reviewed for the first time within 40 days and 20 days respectively. Fully implement the notification and commitment process in the reduction of patent fees, improve the post-verification and risk prevention mechanism, and further facilitate business and public affairs. Relying on the resource aggregation advantages of regional government service centers and government service platforms, promote the “one form application, one set of materials, and one window acceptance” for changes in enterprise registration matters and trademark changes, explore the integrated processing of other departments’ businesses that have a strong correlation between intellectual property business and the entire life cycle of enterprises, and provide more “one-stop service for one type of affairs” services for enterprises and the public. Standardize the government service hotline of the National Intellectual Property Administration, continuously improve the hotline connection rate and the ability level of responding personnel, establish and improve the “handle complaints immediately” mechanism, better play the role of the service hotline as a window directly facing enterprises and the public, and promptly understand problems and suggestions and respond to the demands of enterprises and the public. (The State Administration for Market Regulation and the National Intellectual Property Administration are responsible according to their respective duties)
(XIV) Deepen the digital empowerment of public services. Relying on the national intellectual property protection information platform and copyright-related information platforms, build an exclusive service space for rights holders to facilitate one-click query of all patents, trademarks, copyrights, geographical indications, and integrated circuit layout design information under their names, and timely push reminders of payment deadlines, service progress and other information. Explore the application of technologies such as natural language large models to improve the intention recognition and accurate answering capabilities of online intelligent customer service, optimize intelligent question and answer, intelligent search, intelligent guidance and other services, and better guide enterprises and the public to handle affairs efficiently and conveniently. Accelerate the construction of a national intellectual property digital comprehensive public service platform, deepen data sharing and business collaboration in the fields of intellectual property and economy, science and technology, administrative law enforcement, judicial protection, market supervision, etc., further promote the sharing and application of intellectual property electronic certificates and licenses data, and realize the interoperability and mutual recognition of electronic certificates and licenses across regions and departments. (The National Intellectual Property Administration and the National Copyright Administration are responsible for their respective duties)
(XV) Optimize the public intellectual property rights service system that is convenient for the people and beneficial to enterprises. Continue to improve the public intellectual property rights service network, further enhance the service efficiency of the National Intellectual Property Rights Information Service Center (TISC) of Colleges and Universities and the National Intellectual Property Rights Information Public Service Outlets, and strengthen service support for strategic scientific and technological forces and key industries. Support public intellectual property rights service institutions to set up service stations in key industrial parks and science and technology parks to achieve full coverage of key parks for public intellectual property rights services. Issue national standards for public intellectual property rights services, and promote the non-discriminatory acceptance and handling of intellectual property rights business across the country with the same standards. Strengthen trademark and brand public services, conduct trademark information analysis and utilization, and guide and support public service institutions to increase service support for regional brand building and corporate brand development. (The National Intellectual Property Administration and the National Copyright Administration are responsible for their respective duties)
(XVI) Standardize the evaluation of services. Improve the regular government-enterprise communication mechanism, conduct an evaluation of the satisfaction of intellectual property public services, launch an online “good and bad reviews” system for intellectual property government services, and promptly publish the evaluation results to form a service evaluation mechanism that connects the entire process of evaluation, rectification, feedback, and supervision. Adhere to the orientation of high-quality development, optimize the design of evaluation indicators related to intellectual property, and do not directly include quantitative indicators such as intellectual property registration authorization, transfer transactions, etc. into the evaluation indicators, and accelerate the transformation of intellectual property work from pursuing quantity to improving quality. (The National Intellectual Property Administration and the National Copyright Administration are responsible for their respective duties)
VI. Organizational Guarantee
The National Intellectual Property Administration will work with relevant departments to strengthen work coordination, improve work mechanisms, deepen data sharing, ensure that various reform measures are fully implemented, and adopt various forms to interpret policies, guide public opinion, and summarize experiences. Focusing on the achievements of building a first-class business environment in the field of intellectual property, timely sort out and summarize, publicize and promote typical experiences and innovative practices in optimizing the business environment, and carry out various forms of publicity and reporting to create a good social atmosphere and public opinion atmosphere. All regions should implement the work well, and at the same time, in light of the actual development of the region, actively reform and innovate, and take the lead in trials to promote more breakthroughs in optimizing the business environment in the field of intellectual property.
China’s Supreme People’s Court Releases Fifth Batch of Typical Cases of Seed Industry Intellectual Property Protection
On March 19, 2025, China’s Supreme People’s Court (SPC) released the Fifth Batch of Typical Cases of Seed Industry Intellectual Property Protection By People’s Courts (人民法院种业知识产权司法保护典型案例 (第五批)). The Fifth Batch includes 15 typical cases of judicial protection of seed industry IP concluded in 2024 including 13 civil cases, 1 administrative case and 1 criminal case. While not a common law system, China uses typical cases to “guide” the lower courts and public.
The SPC provided brief explanations of the cases and relevance as follows. The original text with links to the full decisions is available here (Chinese only).
Case 1. “Gangyou 188” new rice plant variety infringement case
[Dispute over infringement of new plant variety rights between Gan XX Industrial Company and Chongqing Non XX Industrial Company and Lei XX]
Second instance: 最高人民法院（2023）最高法知民终3165号
[Basic Facts of the Case]
Gan XX Industrial Company is the exclusive licensee of the new rice plant variety “Gangyou 188”. It filed an infringement lawsuit, claiming that the “Gangyou 88” seeds produced and sold by Chongqing Non XX Industrial Company and sold by Lei XX infringed its variety rights, and requested that the two companies be ordered to stop the infringement, Chongqing Non XX Industrial Company compensate for losses and reasonable expenses totaling more than 15.14 million RMB, and Lei XX bear joint and several liability for reasonable expenses. Chongqing Non XX Industrial Company argued that it had obtained the production and operation rights of the approved variety “Gangyou 88” through legal transfer, and at the time of transfer, it had conducted authenticity appraisal of the “Gangyou 88” it used and had fulfilled its reasonable review obligations, so it should not bear compensation liability. After the administrative agency and the first instance court commissioned appraisals respectively, the alleged infringing seeds “Gangyou 88” produced and sold by Chongqing Non XX Industrial Company and sold by Lei XX were identical to the standard sample of the approved variety, and were similar to the authorized variety “Gangyou 188”. The court of first instance determined that Chongqing Non XX Industrial Company and Lei XX did not infringe the law based on the fact that the alleged infringing seed “Gangyou 88” was identical to its approved standard sample. Gan XX Industrial Company filed an appeal.
[Judgment Result]
The Supreme People’s Court held in the second instance that there are differences between variety approval and variety authorization in terms of application procedures and system purposes. Whether the alleged infringing seeds are identical to the standard samples of the approved varieties has no relevance to whether they are identical to the characteristics and properties of the authorized varieties for protection. Unless otherwise provided by laws and administrative regulations, the production, reproduction, and sale of authorized variety propagation materials without the permission of the variety right holder constitutes infringement of variety rights. If the alleged infringing seeds belong to the approved varieties, he can claim the corresponding contractual liability from the transferor based on the contractual relationship, but cannot use this to counter the infringement claim of the variety right holder. If there are multiple license transfers of the infringing approved varieties, unless there is evidence that the alleged infringer has not used the seeds, the infringement time can be calculated from the date on which he acquired the variety in principle. Based on this, the second instance changed the judgment ordering Chongqing Non XX Industrial Company and Lei XX to stop the infringement, Chongqing Non XX. Industrial Company must compensate for losses and reasonable expenses for rights protection totaling more than 5.96 million RMB, and Lei XX was responsible for reasonable expenses for rights protection of 6,288 RMB.
【Typical significance】
This case clearly stipulates that the transferee of the approved variety shall bear legal responsibility for any act that constitutes infringement of the variety rights in the production and operation of the approved variety, which not only provides strong protection for the variety rights holder, but also effectively regulates the seed industry market. This case serves as a warning to seed operators to standardize their operations throughout the entire process of variety authorization, variety approval, and variety production promotion, in order to promote awareness of variety rights protection. The second instance judgment has reference significance in clarifying the legal nature of the approved variety, clarifying the method of infringement judgment, and reasonably determining compensation.
Case 2. “Sailete” apple new plant variety temporary protection period royalties and infringement case
[Dispute between Yin XX company and You XX company regarding temporary protection period royalties and infringement of new plant variety rights]
First instance: 甘肃省兰州市中级人民法院（2023）甘01知民初9号
Second instance: 最高人民法院（2023）最高法知民终3113号
[Basic Facts of the Case]
The “Sailete” apple variety was selected and bred by a research institute company in New Zealand and obtained the plant variety rights in China. Ying XX International Company is an interested party in the variety rights of “Sailete”. They have filed a lawsuit claiming that You XX Agricultural Company has been producing, breeding, and selling “Sailete” breeding materials without permission since 2018, and has sold a large amount of apple fruits harvested from them, which constitutes infringement. They request an order to stop the infringement, to inactivate the infringing materials, and to apply punitive damages of 5 million RMB. The You XX Agricultural Company believes that its planting of fruit trees does not constitute production or reproduction, and that planting fruit trees only for the purpose of obtaining apple fruits rather than specifically cultivating seedlings and does not constitute infringement. Even if it is determined to constitute infringement, it should not be ordered to inactivate the fruit trees, let alone determine the compensation amount based on the sales volume of apple fruits. After appraisal, it was found that the branches of the “Aifei” fruit tree purchased by Yin XX company from You XX agricultural company through notarization are identical to the “Sailete” variety. You XX agricultural company did not provide evidence that its fruit trees have a legal source.
[Judgment Result]
The Lanzhou Intermediate People’s Court of Gansu Province ruled at first instance that You XX Agricultural Company should inactivate all infringing propagation materials (plants, branches, etc.), and at the same time applied double punitive damages, and ordered You XX Agricultural Company to compensate for losses, temporary protection period usage fees and reasonable expenses totaling 3.3 million RMB. You XX Agricultural Company appealed.
The Supreme People’s Court held in the second instance that in the process of planting and obtaining “Sailete” apples by You XX Agricultural Company, a large number of saplings and branches must have been propagated. Based on the evidence in this case, it can be reasonably inferred that it has been engaged in the continuous production and propagation of authorized variety propagation materials. You XX agricultural company plants saplings of the “Sailete” variety for profit, sells a large number of apple fruits, and engages in propagation behavior. Its planting behavior should be recognized as production and reproduction behavior. It not only produces and reproduces apple seedlings, but also sells apple fruits. The act of selling harvested materials is a natural extension of the production and propagation of authorized varieties of breeding materials in the chain of time and obtaining illegal benefits, and should be considered as a whole. When determining the amount of compensation, the principle of comprehensive compensation should be followed, and the profits obtained from selling harvested materials should be used as a reference for infringement profits. Inactivating the breeding materials of infringing varieties is an effective measure and a natural means to stop infringement. When determining the specific responsibility for ceasing infringement, based on the characteristics of the accused infringing variety’s long-term growth and asexual reproduction, if the infringing propagation materials are not inactivated, the infringing plants may survive for a long time and have the risk of spreading. Compared to the method of removing seedlings and replanting them, the right holder’s claim to stop infringement by inactivating the scion and grafting non infringing varieties of scions can better balance the interests of all parties and should be supported. The appeal was dismissed and the original verdict was upheld.
【Typical significance】
The holder of the variety right in this case is a New Zealand company, and the judgment shows that the People’s Court insists on equal protection in accordance with the law. This case regards the act of selling harvested materials as a natural extension of the production and reproduction of propagation materials, and when the infringer mainly obtains illegal profits by selling harvested materials, the sales profit of the harvested materials is used as the basis for determining the amount of compensation, which provides an important reference for the calculation of compensation in subsequent similar cases and further strengthens the comprehensive protection of variety right holders. The method of stopping infringement supported by this case, which is to cut off the scion of infringing propagation material and graft other non-infringing variety scions, fully considers the characteristics of perennial asexually propagated crops, fully protects the interests of variety right holders, and reasonably takes into account the recovery of agricultural production and avoidance of resource waste, and makes useful explorations for refining the forms of stopping infringement of variety rights.
Case 3. Infringement of the new variety of rose plant “Tianshan Xiangyun”
[Dispute between Xinjiang Hua XX Technology Company and a Xinjiang seedling farm regarding infringement of new plant variety rights]
Second instance: 最高人民法院（2024）最高法知民终665号
[Basic Facts of the Case]
Xinjiang Hua Technology Co., Ltd. is the owner of the variety right of the new variety of Rosaceae, “Tianshan Xiangyun”. In 2022, Xinjiang Hua Technology Co., Ltd. notarized the purchase of seedlings that infringed the variety right of “Tianshan Xiangyun” from a certain seedling farm in Xinjiang. On May 28, 2023, a certain seedling farm in Xinjiang signed a “Seedling Ordering Agreement” with a certain cultivation base in Changji, agreeing to sell 8,000 “Tianshan Xiangyun Seedlings.” Xinjiang Hua Technology Co., Ltd. filed an infringement lawsuit, claiming that the Xinjiang seedling farm had continued to infringe from 2014 to 2023, and requested that Xinjiang farm to stop the infringement and compensate for losses and reasonable expenses totaling 5 million RMB. Xinjiang Hua Technology Co., Ltd. sells “Tianshan Xiangyun” at a price of 320-360 RMB per plant, while the Xinjiang seedling farm sells it at a price of 120-160 RMB per plant. Xinjiang Hua Technology Co., Ltd. claims that the average of the difference between its sales price of “Tianshan Xiangyun” and the sales price of the Xinjiang seedling farm in is its sales profit. The Xinjiang seedling farm argued that it was a public welfare institution. Since 2014, it has been cutting branches of rose varieties such as “Tianshan Xiangyun” from municipal parks for breeding. In 2021, the 36 rose varieties cultivated will be uniformly named “Tianshan Rose.” “Tianshan Xiangyun” is only one of them. Its behavior is scientific research and development, and the seedlings it obtained were cut from municipal parks or introduced from other places. According to the principle of exhaustion of rights, it does not constitute infringement. The 2021 work summary submitted by it shows that 10,500 “Tianshan Xiangyun” cuttings were taken in 2021, and 4,000 survived. The “Origin Quarantine Certificate” of the Xinjiang seedling farm in 2022 and 2023 recorded that the number of “Tianshan Rose” including “Tianshan Xiangyun” was 20,000 and 50,000 respectively. The first instance court determined that the production, breeding and sales behavior of the Xinjiang seedling farm exceeded the scope of scientific research and had a profit-making purpose. The infringement was established and ordered it to stop the infringement and pay 200,000 RMB in compensation. Xinjiang Hua Technology Company appealed.
[Judgment Result]
The Supreme People’s Court held in the second instance that the application of the principle of exhaustion of variety rights is based on the premise that the authorized variety propagation materials are sold by the variety right holder or the entity or individual authorized by the variety right holder, and only applies to the subsequent production, propagation, and sales of the legally sold authorized variety propagation materials themselves, and does not apply to the re-propagation and sale of the sold propagation materials. The Xinjiang seedling farm failed to prove that its propagation behavior was to use the authorized variety to cultivate new varieties, and its large-scale propagation was inconsistent with the scale required for scientific research. At the same time, it engaged in sales for profit, which constituted infringement. The Xinjiang seedling farm admitted that it had cut and propagated “Tianshan Xiangyun” seedlings at the end of 2014 and is still producing and propagating it. Combined with the notarial certificates involved in the case, relevant agreements, work summaries and other evidence, it can be determined that it has continued to infringe since at least 2014 to 2023. Considering that the price of goods sold to the outside world is bound to be higher than the production cost and the Xinjiang seedling farm refused to provide relevant account books and other information, the average value of the difference between the price of “Tianshan Xiangyun” sold by Xinjiang Hua Technology Company and the sales price of Xinjiang seedling farm, that is, 200 RMB/plant, was used as the basis for determining the losses suffered by the right holder due to infringement. Based on the evidence in the case, the number of alleged infringing seedlings produced and bred by the Xinjiang seedling farm in 2021 was not less than 4,000, and in 2023 it was not less than 8,000. Based on this, selecting the average number of these two years, it can be determined that the number of alleged infringing seedlings produced and bred by the Xinjiang seedling farm from 2021 to 2023 was 6,000 plants/year. The amount of damages calculated based on these three years alone has exceeded the 3 million RMB requested by Xinjiang Hua Technology Company in appeal. Therefore, the second instance changed the judgment to fully support the amount of compensation requested by Xinjiang Hua Technology Company on appeal.
【Typical significance】
This case clearly states that the principle of exhaustion of rights does not apply to the act of re-breeding and selling the propagation materials that have been sold. The second-instance judgment supported the relevant claims of the variety right holder when the infringer refused to submit financial books and other evidence, calculated the infringement damages based on the difference between the variety right holder’s selling price and the infringer’s selling price, and significantly increased the amount of compensation, effectively protecting the rights and interests of breeding innovation entities, and has precedential significance for breaking through the difficulties of evidence and accurately determining the amount of compensation in similar infringement cases.
Case 4. “Jinjing 818” new rice plant variety infringement case
[Dispute over infringement of new plant variety rights between Jiangsu Jin XX Industrial Company and Xuzhou Agricultural Materials Company, Zhao XX and Zhao YY]
First instance: 江苏省南京市中级人民法院（2022）苏01民初2019号
Second instance: 最高人民法院（2023）最高法知民终2896号
[Basic Facts of the Case]
Jiangsu Jin XX Industrial Company is the licensee of the exclusive implementation license for the new rice plant variety “Jinjing 818”. In May 2020, a certain agricultural material company in Xuzhou was ordered to stop infringement and bear punitive compensation liability for using white bags and irregular packaging to sell infringing seeds without the permission of the “Jinjing 818” variety right holder. The company failed to comply with the above judgment, and Jiangsu Jin XX Industrial Company applied for compulsory execution. During the execution process, the court added Zhao XX, the sole shareholder and legal representative of a certain agricultural material company in Xuzhou, as the liable person. Since January 2021, Zhao XX has successively released seed supply information, contact numbers of the heads of various sales areas of a certain agricultural material company in Xuzhou, and accountant Zhao YY in WeChat group chats, and organized offline ordering activities. Starting from November 29, 2021, a farmer communicated with the sales staff of the agricultural material company in Xuzhou about the purchase of the alleged infringing seeds, and paid the deposit and the remaining amount to Zhao YY’s account. Jiangsu Jin XX Industrial Company filed a lawsuit, requesting that Xuzhou XX Agricultural Materials Company, Zhao XX, and Zhao YY stop infringing and jointly compensate for losses and reasonable expenses for rights protection totaling 3 million RMB. During the first instance trial, it was determined that the alleged infringing seeds were very similar or identical to “Jinjing 818”.
[Judgment Result]
The Nanjing Intermediate People’s Court of Jiangsu Province held at first instance that after being ordered to stop infringement in the previous case, the Xuzhou Agricultural Materials Company once again organized seed transactions through WeChat groups and committed infringement. Zhao XX, the legal representative and sole shareholder of Xuzhou Agricultural Materials Company, used WeChat groups to publish seed supply information and organized offline ordering activities, playing a key and core organizational role in seed transactions, and jointly infringed with Xuzhou Agricultural Materials Company. Zhao YY, who participated in seed sampling, collected transaction funds with his personal account after Xuzhou Agricultural Materials Company was found liable, and he, Xuzhou Agricultural Materials Company, and Zhao XX jointly infringed. The three defendants were ordered to stop the infringement, and Xuzhou Agricultural Materials Company and Zhao XX jointly compensated Jiangsu Jin XX Industrial Company for economic losses and reasonable expenses totaling 1.8 million RMB, and Zhao YY was jointly liable for 350,000 RMB of it. The three defendants appealed. The Supreme People’s Court rejected the appeal in the second instance and upheld the original judgment.
【Typical significance】
This case is a typical example of severely cracking down on hidden infringements and the persons directly responsible. In response to hidden infringements such as organizing seed transactions on online platforms, the actual controller of the company who played an organizing and decision-making role in the occurrence of the infringement and other persons who received the company’s infringement proceeds with their personal accounts and directly participated in the infringement were found to have committed joint infringements with the company, and were ordered to bear joint and several liability based on the circumstances of their infringement and the extent of their role, effectively raising the cost of infringement.
Case 5. Infringement of the new variety of the genus “Hongyunlai”
[Dispute over infringement of new plant variety rights between a Shanghai plant company and a Guangzhou agricultural science company]
Second instance: 最高人民法院（2022）最高法知民终1362号
[Basic Facts of the Case]
A plant company in Shanghai and a non-party company in Shanghai are the variety rights holders of the new fruit vine variety “Hongyunlai.” In January 2020, the plant company in Shanghai obtained “Xinhongxing” seedlings sold by the Guangzhou agricultural science company and has them notarized and stored at the Plant New Variety Testing (Shanghai) Branch Center, and sent the above two samples to a technology company in Ningbo for testing. On April 13, 2020, the technology company in Ningbo issued a “Technical Appraisal Opinion”, and the appraisal result was that the AFLP fingerprints of the two varieties were 95.08% similar, and the two varieties were highly similar. The plant company in Shanghai filed a lawsuit, requesting that the Guangzhou agricultural science company be ordered to stop infringement and compensate for losses. The first-instance judgment did not adopt the technical appraisal opinion on the grounds that the varieties involved had no national standards or industry standards for molecular marker detection, and rejected all the claims of the plant company in Shanghai. The plant company in Shanghai appealed. In the second instance, the Supreme People’s Court approved the appraisal application of the plant company in Shanghai, and with the consent of both parties, designated a testing agency to conduct the appraisal. The testing agency used the MNP labeling method to conduct testing and issued a test report stating that the genetic similarity between the tested sample and the control sample was 99.91%, and the identification results were extremely similar or the same variety.
[Judgment Result]
The Supreme People’s Court held in the second instance that the people’s courts should review whether the molecular marker detection method for plant variety identity identification is scientific and reliable. If the molecular marker detection method for a specific plant variety has not yet established a national standard or industry standard, the identification results made by qualified identification institutions and appraisers with reference to other relevant standards, if the identification method can scientifically and accurately distinguish different varieties and has sufficient scientific basis and repeatability, can be used as evidence to determine whether the alleged infringing object is identical to the authorized variety. The “MNP Marking Method for Plant Variety Identification” has been established as a national standard and can be applied to the identification of original varieties, substantially derived varieties and variety authenticity identification of rice, corn, soybeans, etc. The identity identification of pineapple varieties of the genus Pyrifera can be carried out in accordance with the “MNP Marking Method for Plant Variety Identification.” After identification, the alleged infringing seedlings “Xinhongxing” and the authorized variety “Hongyunlai” are very similar or identical varieties. The Guangzhou agricultural science company did not submit rebuttal evidence, so it can be determined that the alleged infringing seedlings are identical to the authorized variety “Hongyunlai”. The court then changed the judgment to require the Guangzhou agricultural science company to stop infringing and compensate for the losses and reasonable expenses totaling 1.075 million RMB.
【Typical significance】
This case is a typical case of exploring the use of MNP labeling for identification of specific crops for which national or industry standards for molecular marker detection have not yet been established. The second-instance judgment conducted a strict review of the identification methods and institutions of specific crops, and based on the scientific nature and repeatability of the identification methods, determined that the identification opinions can be used as evidence to determine that the alleged infringing seedlings are identical to the authorized varieties, avoiding the lack of identification standards for specific crop variety rights affecting judicial protection and relief. This case provides a precedential example for the use and judicial review of the MNP labeling method in the identification of the identity of new plant varieties.
Case 6. Infringement of the new corn plant variety “Jingnuo 6”
[Dispute over infringement of new plant variety rights between a breeding company in Beijing and a certain industrial company in Guangxi, a certain subsidiary in Shenzhen, and a certain seed store]
First instance: 广东省深圳市中级人民法院（2022）粤03民初4649号
Second instance: 最高人民法院（2023）最高法知民终1790号
[Basic Facts of the Case]
A certain scientific academy in Beijing is the owner of the variety right of the new corn plant variety “Jingnuo 6”, and a certain breeding company in Beijing is its exclusive licensee. “Jingkenuo 2000” is a hybrid corn variety produced with “Jingnuo 6” and “Bai Nuo 6” as parents. The breeding company in Beijing filed a lawsuit, requesting that a certain industrial company in Guangxi, a certain subsidiary in Shenzhen, and a certain seed store stop using “Jingnuo 6” to produce the alleged infringing seed “Shenkenuo 8” and compensate for the losses. The first instance court conducted an authenticity appraisal of the alleged infringing seeds “Shenkenuo 8” and “Jingkenuo 2000” in accordance with the law, and conducted a parent-child relationship appraisal of the alleged infringing seeds “Shenkenuo 8” and “Jingnuo 6”. The appraisal result is that the alleged infringing seeds “Shenkenuo 8” and “Jingkenuo 2000” are similar varieties, and are suspected to have a parent-child relationship with “Jingnuo 6”.
[Judgment Result]
In the first instance, the Shenzhen Intermediate People’s Court of Guangdong Province determined that the alleged infringing seed “Shenkenuo No. 8” was produced by reusing the authorized variety “Jingnuo 6” as the parent, based on the results of the authenticity identification and parent-child relationship identification in the case, and ordered the industrial company in Guangxi, the subsidiary in Shenzhen, and the seed store to stop the infringement, and ordered the industrial company in Guangxi to compensate for losses of 300,000 RMB and reasonable expenses of 50,000 RMB, the subsidiary in Shenzhen to compensate for losses of 100,000 RMB , and the seed store to compensate for losses of 20,000 RMB. The industrial company in Guangxi and a subsidiary in Shenzhen appealled.
The Supreme People’s Court held in the second instance that, when judging whether a specific hybrid is produced and propagated by repeatedly using the authorized variety as a parent, given that there is currently a lack of national standards or industry standards for the identification of the parent-offspring relationship of plant varieties, the parent-offspring relationship identification opinion made by the identification agency in reference to the variety authenticity identification standard can be used as the basis for determining the facts. The identification report in this case can serve as preliminary evidence to determine that the alleged infringing seed “Shenkenuo No. 8” repeatedly used the authorized variety “Jingnuo 6” breeding materials in the production process. At the same time, combined with the identification opinion that the hybrid “Jingkenuo 2000” produced with “Jingnuo 6” as the mother parent and the alleged infringing hybrid “Shenkenuo No. 8” are similar varieties, it can be determined that the fact that “Shenkenuo No. 8” was produced using the “Jingnuo 6” breeding materials as the parent is highly likely. The Guangxi industrial company and a subsidiary in Shenzhen failed to provide evidence to prove that the alleged infringing seeds have a legitimate parental source, so their claim of non-infringement is not supported. The court therefore ruled to dismiss the appeal and uphold the original judgment.
【Typical significance】
With the deepening of intellectual property protection in the seed industry, the protection of crop parents has become one of the key concerns of variety right holders. At present, there is no universal standard for the identification of the parent-offspring relationship of plant varieties. How to prove that the hybrid variety in question is produced using the authorized variety is a difficult problem in judicial practice. This case reasonably considers the laws of crop breeding, comprehensively analyzes the results of the parent-offspring relationship identification between the parent variety and the hybrid variety, and the authenticity identification results of the hybrid variety, and reasonably allocates the burden of proof, thereby achieving effective protection of the legitimate rights and interests of the parent variety right holders, and providing a reference for handling similar cases in judicial practice.
Case 7. Infringement of the new corn plant variety “Xianyu 508”
[Dispute over infringement of new plant variety rights between a certain industrial company in Shandong and a certain agricultural company in Shanxi and a certain distribution department in Qi County]
Second instance: 最高人民法院（2024）最高法知民终819号
[Basic Facts of the Case]
A certain industrial company in Shandong, authorized by the variety right holder, has the right to file a civil lawsuit in its own name for infringement of the variety right of “Xianyu 508”. After testing, the allegedly infringing seeds “Chenqiang 808”, “Jinongyu 885” and “Jinke 757” are very similar or identical to the authorized variety of “Xianyu 508”. The Shandong industrial company filed an infringement lawsuit, requesting that a certain agricultural company in Shanxi and a certain distribution department in Qi County stop the infringement and compensate for losses and reasonable expenses totaling 550,000 RMB. The Shandong industrial company requested to determine the amount of compensation based on the profit of the infringement of the Shanxi company, and submitted the sales data of corn seeds of “Chenqiang 808”, “Jinongyu 885” and “Jinke 757” filed on the seed industry big data platform from 2018 to 2021; and claimed to determine the production and sales quantity of infringing seeds based on the production numbers of the Shanxi company in the above-mentioned filing data. The court of first instance ordered the Shanxi agricultural company and the Qi county distribution department to stop the infringement, and ordered the Shanxi agricultural company to compensate for losses of 30,000 RMB and reasonable expenses of 16,000 RMB, and the Qi county distribution department to pay reasonable expenses of 4,000 RMB. Both the Shandong agricultural company and the Shanxi agricultural company appealed.
[Judgment Result]
The Supreme People’s Court held in the second instance that the alleged infringer registered production and operation on the seed industry big data platform as a producer, and the name of the alleged infringing seed was the same as the name of the registered variety, and the production time of the alleged infringing seed was close to the registration time of the seed industry big data platform. In principle, it can be presumed that the registered sales quantity is the production and sales quantity of the infringing seeds. Combined with the facts of this case, the names of the alleged infringing seeds “Chenqiang 808”, “Jinongyu 885” and “Jinke 757” obtained through notarization are the same as the names of the registered varieties, and the production time of the alleged infringing seeds is close to the registration time of the seed industry big data platform in 2021. It can be presumed that the seeds with the same name registered by the Shanxi agricultural company in 2021 are all “Xianyu 508” corn seeds, and the registered sales quantity can be determined as the production and sales quantity of the alleged infringing seeds, and the infringement damages can be calculated accordingly. Therefore, the Shanxi agricultural company was sentenced to compensate for losses of 370,000 RMB and reasonable expenses of 30,000 RMB.
【Typical significance】
The information system of the seed administration department stores data and information related to seed production, sales and other links. Through the reasonable use of relevant data and information, effective tracking of the infringing subject and the scale of infringement can be formed. This case clarifies the use of the registered data of the seed industry big data platform in the calculation of damages for variety rights infringement. Through comprehensive consideration of the registered data of the seed industry big data platform and the infringement involved in the case, the sales volume of infringing seeds is reasonably estimated, and the amount of infringement compensation is calculated accordingly, which effectively solves the problem of difficulty in providing evidence for variety rights holders and effectively increases the intensity of infringement compensation.
Case 8. Infringement case of new wheat plant variety “Bainong 207”
[Dispute over infringement of new plant variety rights between Hua XX Industrial Company, Feng XX Industrial Company and Tang XX Sales Department]
Second instance: 最高人民法院（2023）最高法知民终113号
[Basic Facts of the Case]
Hua XX Industrial Company is the exclusive licensee of the new plant variety “Bainong 207”. The alleged infringing seeds were purchased from Tang’s store. The packaging bag and the QR code scan screenshot show that the variety name is “Sunshine 818”, and the producer is “Feng XX Industrial Company”. The query of the QR code traceability website shows that the queried product is genuine, and the production unit also points to Feng Industrial Company. Hua Industrial Company filed a lawsuit, requesting that Feng Industrial Company and Tang’s store stop infringing and compensate for losses of 300,000 RMB. In the first instance, Hua Industrial Company submitted a “Test Report” made by a unilateral commission, intending to prove that the alleged infringing seeds are the same variety as the authorized variety “Bainong 207”. The first instance court determined that the control sample “Bainong 207” had no sample number, the source was questionable, and the test conclusion was insufficient. The production date and test date shown on the scanned QR code of the packaging bag were two years earlier than the sales date, which was inconsistent with common sense and could not prove that the alleged infringing seeds were produced by Feng Industrial Company. Therefore, the first instance judgment dismissed all the claims of Hua Industrial Company. Hua Industrial Company appealed. In the second instance, the court initiated the appraisal according to law, as the alleged infringing seeds were sealed in good condition and met the conditions for appraisal. The appraisal agency conducted an identity test on the alleged infringing seeds and the “Bainong 207” standard sample in the national standard sample library, and the test results showed that the two were the same variety.
[Judgment Result]
The Supreme People’s Court held in the second instance that the information marked on the seed packaging and label, the license or the information pointed to by the number of the “Origin Quarantine Certificate” is an important basis for identifying the production and sales entity of the alleged infringing seeds. Unless there is evidence to the contrary, the seed producer and operator information clearly marked on the packaging bag can be used to determine the identity of the production and sales entity. Therefore, in the absence of evidence to the contrary, Feng Industrial Company can be identified as the producer and seller of the alleged infringing seeds. The probative force of the inspection report issued by the appraisal agency should be reviewed from the aspects of the source of the sample, the identification method, the identification procedure and the identification qualification. The appraisal agency entrusted by the court conducted a germination test on the sample to be tested. After the successful germination determined that the seed vitality was normal, it used the molecular marker identification method for detection and issued an inspection report in accordance with the national standard, which can prove that the alleged infringing seeds are identical to the “Bai Nong 207” wheat variety. Tang’s sales department knew that it was infringing seeds but still sold them, and should bear joint and several liability. Based on this, the second instance court changed the judgment to require Feng Industrial Company and Tang Store to stop the infringement, and Feng Industrial Company to compensate for the losses and reasonable expenses for rights protection totaling 300,000 RMB, and Tang Store to bear joint and several liability within 50,000 RMB of this amount.
【Typical significance】
Accurately identifying the infringing subject is a key link in maintaining the order of the seed market and protecting the legitimate rights and interests of the variety rights holders. This case clarified the basis for identifying the producers and sellers in the variety rights infringement disputes, and highlighted the importance of making good use of the management information involved in seed supervision to achieve coordinated protection. At the same time, the second-instance judgment provided guidance on the evidence and duty of care of the appraisal applicant. According to the second-instance appraisal opinion, the infringement facts were confirmed, and the legitimate rights and interests of the variety rights holders were fully protected.
Case 9. Infringement of the new soybean plant variety “Qihuang 34”
[Dispute over infringement of new plant variety rights between Shandong Sheng XX Industrial Co., Ltd. and Qingdao Li XX Professional Cooperative and Geng XX]
First instance: 山东省青岛市中级人民法院（2024）鲁02知民初34号
[Basic Facts of the Case]
Shandong Sheng XX Industrial Company is the exclusive licensee of the new soybean plant variety “Qihuang 34”. Qingdao Li XX Professional Cooperative and its operator Geng promised to sell “Qihuang 34” soybean seeds through Douyin [TikTok] video accounts and WeChat video accounts. According to statistics, the videos released on different dates advertised that the amount of seeds produced and sold by them reached 310 tons. Shandong Sheng XX Industrial Company filed a lawsuit, requesting that Qingdao Li XX Professional Cooperative and Geng stop the infringement and jointly compensate for the loss of 300,000 RMBand reasonable expenses of 12,596 RMB.
[Judgment Result]
The Intermediate People’s Court of Qingdao City, Shandong Province held at first instance that the Qingdao Li XX Professional Cooperative and Geng XX produced and sold seeds that infringed the “Qihuang 34” soybean plant new variety rights without permission, which constituted infringement and they should bear civil liabilities such as stopping the infringement and compensating for losses. The Qingdao Li XX Professional Cooperative and Geng sold 310 tons of infringing soybean seeds through the Internet. According to the notarized purchase price of 3.5 RMB per catty by Shandong Sheng XX Industrial Company, the infringing sales amounted to 2.17 million RMB. Based on this, the first instance judgment fully supported the economic losses of 300,000 RMB claimed by Shandong Sheng XX Industrial Company, and supported the reasonable expenses of 10,000 RMB for rights protection. After the first instance judgment, neither party appealed.
【Typical significance】
This case embodies the effective use of online evidence in seed industry infringement cases. At the same time, it fully supports the rights holder’s claim for compensation based on the evidence in the case, reflecting the judicial orientation of the People’s Court to effectively strengthen the protection of seed industry intellectual property rights and increase the intensity of compensation for damages.
Case 10. Infringement of the new soybean plant variety “You6019”
[Dispute over infringement of new plant variety rights between Henan Xu XX Industrial Company and Henan Hua XX Industrial Company, Xin XX Agricultural Materials Business Department and Ming XX Agricultural Materials Business Department]
First instance: 河南省郑州市中级人民法院（2023）豫01知民初1907号
Second instance: 最高人民法院（2024）最高法知民终713号
[Basic Facts of the Case]
Henan Xu Industrial Company is the exclusive licensee of the new soybean plant variety “You 6019”. This variety passed the national variety approval in 2018 and is suitable for summer planting in Hubei, Chongqing, southern Anhui, northern Jiangxi, and southern Shaanxi. The “Zhongdou 40” soybean seeds produced by Henan Hua Industrial Company were commissioned by Xin Agricultural Materials Business Department and sold by Ming Agricultural Materials Business Department in Anxiang County, Changde City, Hunan Province, and were seized by local agricultural law enforcement departments. After testing, “Zhongdou 40” and “You 6019” are suspected to be the same variety. Henan Xu Industrial Company filed a lawsuit, requesting that Henan Hua Industrial Company, Xin Agricultural Materials Business Department, and Ming Agricultural Materials Business Department stop infringement and compensate for losses and reasonable expenses of 300,000 RMB. Henan Hua Industrial Company, Xin Agricultural Materials Business Department, and Ming Agricultural Materials Business Department argued that their sales activities occurred outside the suitable planting area for the “You 6019” variety, and Henan Xu Industrial Company had no right to claim rights and should not receive economic compensation.
[Judgment Result]
The Zhengzhou Intermediate People’s Court of Henan Province ruled at first instance that Henan Hua XX Industrial Company, Xin XX Agricultural Materials Business Department, and Ming XX Agricultural Materials Business Department should stop infringing the law and compensate for losses and reasonable expenses of RMB 150,000, RMB 10,000, and RMB 5,000 respectively. Henan Hua XX Industrial Company appealed.
The Supreme People’s Court held in the second instance that if the variety right is legal and within the effective protection period, it should be protected by law. The scope of the prohibition power of the variety right is not limited by the authorized variety suitable planting area or the approved area, and the establishment of the variety right infringement is not conditional on whether the alleged infringement is carried out in the authorized variety suitable planting area or the approved area. The production and sale of authorized variety propagation materials in non-approved areas without the permission of the variety right holder still constitutes infringement according to law. At the same time, damages, as a basic legal remedy for the right holder, should not be adversely affected by the infringement occurring in non-approved areas. On the contrary, infringement in non-approved areas not only damages the rights and interests of the variety right holder, but also may damage the interests of growers, which can be used as a factor to aggravate the infringement. Hua XX Industrial Company produced and sold the alleged infringing seeds in non-approved suitable planting areas, which constituted infringement and should bear compensation liability. At the same time, based on the same authorized variety, the same infringement and the infringing subject, the reasonable expenses incurred by the variety right holder in the administrative law enforcement procedure to maintain its variety rights can be determined as reasonable expenses in the case of infringement of new plant variety rights disputes, and they shall be supported when determining compensation liability. The court then ruled to dismiss the appeal and upheld the original judgment.
【Typical significance】
This case clarified the nature of the infringement of the production and sale of authorized varieties in non-approved areas, emphasized that the protection of variety rights is not limited by the planting area, and that the infringement may also affect the legitimate rights and interests of growers, which can be used as a factor in the aggravation of the infringement. At the same time, this case also clarified that the reasonable expenses spent by the variety right holder in the administrative law enforcement procedure to maintain its variety rights under certain circumstances can be supported as reasonable expenses in the case of infringement of new plant variety rights. The judgment in this case further strengthened the comprehensive protection of the legitimate rights and interests of variety right holders.
Case 11. Infringement of new varieties of rose plants such as “LEXTEEWS”
[Dispute over infringement of new plant variety rights between a Dutch group company, an Ai agricultural company and a Lanzhou agricultural technology company]
First instance: 甘肃省兰州市中级人民法院（2023）甘01知民初42、43、44号
[Basic Facts of the Case]
A Dutch group company is the owner of the variety rights of three new rose plant varieties, including “LEXTEEWS”. Ai Agricultural Company is an affiliated company of a Dutch group company, authorized to produce, promote and sell a series of rose varieties including “LEXTEEWS” in China, and has the right to sue for related infringements. An agricultural company in Lanzhou bred, promised to sell and sold “LEXTEEWS” and other rose varieties on a large scale in the flower industry base. The Dutch group company and Ai Agricultural Company filed three infringement lawsuits, requesting that the agricultural company in Lanzhou stop the infringement and compensate for losses and reasonable expenses totaling more than 10 million RMB.
[Judgment Result]
After the first instance of the case was filed at the Intermediate People’s Court of Lanzhou City, Gansu Province, Ai Agricultural Company immediately applied for property preservation of more than 8 million RMB in the account funds of the Lanzhou Agricultural Company. Rose planting by the Lanzhou Agricultural Company has reached a certain scale. The first instance court organized mediation between the two parties many times, promoting win-win cooperation between the two parties, and finally signed an authorization statement and cooperation framework agreement, transforming the infringement into authorized cooperation.
【Typical significance】
The People’s Court adheres to the purpose of justice for the people and the principle of equal protection, actively explores diversified dispute resolution, and ultimately mediates the case. It not only equally protects the rights of foreign variety right holders in accordance with the law, but also lays a solid foundation for future cooperation between the two parties, prompting both parties to integrate resources, give play to their respective advantages, drive industrial development, and achieve good results of win-win, multi-win and win-win results.
Case 12. Case involving a “shousi pineapple” planting contract
[Planting contract dispute between Hainan Feng Fruit Company and Ye Ding]
Second instance: 海南自由贸易港知识产权法院（2023）琼73民终328号
[Basic Facts of the Case]
On October 11, 2020, Hainan Feng Fruit Company and Ye Ding signed the “Pineapple Planting Agreement”, which stipulated that the two parties would cooperate in planting “shousi pineapples”. Ye Ding would provide pineapple seedlings and planting fertilizers for a fee, provide planting technology free of charge, and guarantee that the pineapple fruit yield would not be less than 3,000 kilograms per mu, and the cultivated pineapple seedling yield would not be less than 12,000 plants per mu; after the pineapple fruits matured, Ye Ding would repurchase all the pineapple fruits at a price not less than 3 RMB per kilogram. During the cooperation process, Hainan Feng Fruit Company filed a lawsuit on the grounds that the pineapple production and sales price did not conform to the contract agreement, requesting that Ye Ding pay a penalty of 505,008 RMB, compensate for losses of 288,985 RMB, and repurchase pineapple seedlings at market prices. Ye Ding counterclaimed and requested Hainan Feng Fruit Company to pay 115,396 RMB for seedlings and compensate for losses due to overdue payments. The court of first instance ruled that Ye Ding should compensate Hainan Feng Mou Fruit Company for the losses, and Hainan Feng Fruit Company should pay the remaining amount of seedlings to Ye Ding. Hainan Feng Fruit Company appealed to the Hainan Free Trade Port Intellectual Property Court.
[Judgment Result]
After the Hainan Free Trade Port Intellectual Property Court accepted the case, it handled the case prudently and sought diversified solutions, considering that seeds and seedlings are important raw materials for agricultural production and their quality and safety are related to farmers’ income and agricultural development. Considering that the subject matter of the case, “shousi pineapple” seedlings, is a non-major crop variety with high economic value, in order to substantially resolve the disputes and contradictions between the two parties, the court communicated with the two parties many times before and after the court, and facilitated the mediation of the two parties from multiple angles of “emotion”, “reason” and “law”. The two parties signed the mediation agreement and immediately implemented the contents of the mediation agreement on the day they received it, and the case was successfully resolved.
【Typical significance】
This case is a typical example of settling disputes in the seed industry. Based on the contract agreement and legal provisions, the trial court balanced the interests of seed users and seed suppliers, advocated that the parties eliminate differences, show mutual understanding and compromise, and achieve win-win results, thus facilitating the settlement of the case and effectively implementing the concept of justice for the people in specific cases, ensuring the safety of seed use and maintaining the healthy development of the seed industry.
Case 13. Unfair competition case involving the name of a well-known breeder
[Unfair competition dispute between a certain agricultural high-tech company and Wan Group Company and Jiangxi Wan Industrial Company]
First instance: 江西省上饶市中级人民法院（2024）赣11民初10号
Second instance: 江西省高级人民法院（2024）赣民终288号
[Basic Facts of the Case]
Before his death, Academician Yuan Longping signed the “Yuan Longping Brand Rights License Agreement” with a certain agricultural high-tech company, authorizing the company to exclusively use his name in its business activities. Wan Group Company and Jiangxi Wan Industrial Company have overlapping business scopes with a certain agricultural high-tech company. They use the words “Guo Mi Wannian Gong Yuan Longping” in the outer packaging of rice and other products and in online publicity for promotion and sales. The agricultural high-tech company filed a lawsuit, requesting that the two defendants immediately stop unfair competition and compensate the agricultural high-tech company for economic losses of 1 million RMB and reasonable expenses of 100,000 RMB for rights protection.
[Judgment Result]
The Shangrao Intermediate People’s Court of Jiangxi Province ruled at first instance that Wan Group and Jiangxi Wan Industrial Company should immediately stop the unfair competition of producing and selling packaging products with “Yuan Longping’s” name and signature, and immediately delete the promotional content that improperly uses “Yuan Longping’s” name and signature; Wan Group and Jiangxi Wan Industrial Company should compensate for the losses and reasonable expenses of rights protection totaling 50,000 RMB. Wan Group and Jiangxi Wan Industrial Company appealed.
The Jiangxi Provincial High People’s Court held in the second instance that the use of the words “Yuan Longping” in the form of inscriptions and signatures on the allegedly infringing goods was commercial use. Academician Yuan Longping’s name has a high degree of popularity and influence, and is a name with a certain influence. The agricultural high-tech company enjoys the relevant commercial use rights of the name “Yuan Longping”. Wan Group Company and Jiangxi Wan Industrial Company used the name “Yuan Longping” for product promotion and sales without obtaining legal authorization, which easily misled people into believing that their products had a specific connection with Academician Yuan Longping or the agricultural high-tech company, constituting commercial confusion. This behavior violated the principle of good faith and recognized business ethics, damaged the legitimate rights and interests of the agricultural high-tech company, and constituted unfair competition. Based on this, the second instance court ruled to dismiss the appeal and uphold the original judgment.
【Typical significance】
Academician Yuan Longping is a hybrid rice breeding expert in my country and the father of hybrid rice in the world. His name has extremely high social influence and commercial value. The judgment in this case clarifies the legal standard for the commercial use of the names of well-known breeders to constitute unfair competition, and provides guidance for adjudication of similar disputes. The judgment in this case effectively implements the principles of honesty and trustworthiness and business ethics, effectively safeguards the commercial rights and interests of the names of well-known breeders, regulates the market competition order, and helps to create a healthy and fair market environment.
Case 14. Invalidation of the new corn plant variety “FL218”
[Administrative dispute over invalidity of new plant variety rights between Guizhou Hui XX Industrial Co., Ltd. and the Plant Variety Review Committee of the Ministry of Agriculture and Rural Affairs and Hubei Kang XX Industrial Co., Ltd.]
First instance: 北京知识产权法院（2022）京73行初4665号
Second instance: 最高人民法院（2024）最高法知行终627号
[Basic Facts of the Case]
Hubei Kang XX Industrial Company is the owner of the variety right of the new corn plant variety “FL218”. Guizhou Hui XX Industrial Company filed a request for invalidation with the Plant Variety Review Committee of the Ministry of Agriculture and Rural Affairs, claiming that the variety had been mass-produced and sold before the application date, and other varieties approved for breeding with it as a parent had also been mass-produced and sold, so the variety in question did not have novelty. The Plant Variety Review Committee made an invalidation review decision, believing that the evidence in the case was insufficient to prove that the variety in question lacked novelty and specificity, and maintained the validity of the variety right in question. Guizhou Hui XX Industrial Company was dissatisfied and filed an administrative lawsuit with the Beijing Intellectual Property Court.
[Judgment Result]
The Beijing Intellectual Property Court held at first instance that “FL218” possessed novelty and specificity, and rejected the lawsuit filed by Guizhou Hui XX Industrial Co., Ltd. Guizhou Hui XX Industrial Co., Ltd. appealed.
The Supreme People’s Court held in the second instance that Guizhou Hui XX Industrial Company only requested the declaration of invalidity of the variety right on the grounds that “FL218” did not have novelty, and did not explicitly claim specificity. However, considering that Hubei Kang XX Industrial Company also agreed to review whether “FL218” had specificity during the invalidation review procedure and administrative litigation, the invalidation review decision protected the rights and interests of the variety right holder to defend, listened to the opinions of the variety right holder, and did not constitute a procedural violation. The specificity of a new plant variety refers to the obvious difference in characteristics between the propagation materials of the variety and the known varieties before the application date. The invalidation applicant needs to clarify the known varieties of the authorized variety and prove that the authorized variety is not obviously different from the known variety through evidence such as DNA identification results or field test results. The burden of proof shall be borne by the invalidation applicant. Guizhou Hui XX Industrial Company did not submit evidence to prove that the three parent varieties involved in the case were known varieties of “FL218”, nor did it have preliminary evidence to prove that “FL218” was the same variety as the three parent varieties involved in the case, and did not fulfill the burden of proof. Because it failed to prove that “FL218” did not have novelty and specificity, the appeal was dismissed and the original judgment was upheld.
【Typical significance】
This case focuses on the legality of the procedure, clarifies the scope of the procedure for invalidation of variety rights initiated upon application, the specific identification standards and the distribution of the burden of proof in the procedure for confirmation of variety rights, and provides guidance for the review and proof in the procedure for invalidation of variety rights. This case helps to standardize the procedure for reviewing the invalidation of variety rights and promote the high-quality development of the seed industry.
Case 15. Crime of infringing trade secrets involving the new rice plant variety “Tsuen U 822”
First instance: 安徽省合肥高新技术产业开发区人民法院（2023）皖0191刑初611号
[Basic Facts of the Case]
A certain high-tech company in Anhui is the owner of the new plant variety rights of “Quanyou 9311A”, “YR0822” and “Quanyou 822”. Among them, the “Quanyou 822” rice seed was developed by the company’s scientific research team. The cultivation technology and genetic information of its mother “Quan 9311A” are the company’s core secrets and have not been disclosed to the public. Strict confidentiality measures have been taken. After the trial planting of “Quanyou 822” achieved mass production, the Anhui high-tech company transferred the relevant technology to its wholly-owned subsidiary, an Anhui industrial company, which obtained the exclusive domestic production and operation rights, and the transfer contract stipulated strict confidentiality obligations for all personnel involved in the production and management of the seeds. In 2019 and 2020, a certain industrial company in Anhui signed a “Hybrid Rice Seed Production Contract” with Deng XX, the legal representative of a certain seed professional cooperative, entrusting the cooperative to produce “Tsuenyou 822” rice seeds. It clearly stipulated that the contractor should ensure that the parents will not be lost, not be bred privately, and not be used for other purposes privately, and that the seeds produced by the contract will not be lost. The contractor will bear legal responsibility for the loss of parents or private breeding. In addition, the number of mother rice parents will be issued each year based on the number of acres planted by farmers, and technicians will be stationed at the planting base to provide long-term guidance on planting, supervise production, and prevent rice seed loss. Since 2019, Deng XX, Wang XX and Huang X of a certain seed company have conspired to arrange for Huang, an employee of their cooperative, to apply for more parent “Quan 9311A” from a certain seed company in Anhui by applying more per mu, and privately bred “Quanyou 822” rice seeds outside the supervision of a certain seed company in Anhui, and handed them over to a certain seed company to sell 113,840 kilograms under a fake brand, causing a loss of 1,090,360 RMB to the certain high-tech company in Anhui. On October 11, 2023, the People’s Procuratorate of Hefei High-tech Industrial Development Zone, Anhui Province, filed a public prosecution, accusing Deng, Wang , Huang 1 and Huang 2 of obtaining the right holder’s business secrets through improper means of false reporting and fraud, violating the confidentiality obligation to use the business secrets they obtained, causing major losses to the business secret right holder, and the circumstances are serious, and they should be held criminally responsible for the crime of infringing on business secrets.
[Judgment Result]
The People’s Court of Hefei High-tech Industrial Development Zone, Anhui Province, held at first instance that Deng and Huang violated the agreement with the right holder on keeping trade secrets, privately bred rice seeds, and Wang and Huang were responsible for selling them, making illegal profits, causing major losses to the right holder of the trade secrets, and the circumstances were serious, constituting the crime of infringing trade secrets. The defendants Deng Jin, Huang , Wang Yong, and Huang were sentenced to fixed-term imprisonment ranging from ten months to one year and two months , and fined between 20,000 RMB and 200,000 RMB.
【Typical significance】
The judgment in this case uses criminal means to crack down on infringements, demonstrating the judicial system’s severe punishment of seed-related crimes. By exerting the legal deterrent power of criminal sanctions, we can effectively punish and prevent seed-related crimes, improve the protection of breeding innovation, purify the seed market, and create a good innovation environment for seed companies.
Federal Circuit Confirms Calculation of PTE for Reissue Patents Under Regulatory Review
Highlights
Calculation of patent term extension for drug products under regulatory review is based on the issue date of the original patent, not the reissue patent (if there is one), a recent court ruling said
Calculation of PTE based on the original patent’s issue date is consistent with purpose and legislative intent of Hatch Waxman Act, which is to compensate for patent exclusivity lost while patented drug products are under regulatory review
Cancellation of claims covering drug products under regulatory review in a reissue patent will result in forfeiture of any patent term extension
In Merck Sharp & Dohme B.V. et al. v. Aurobindo Pharma USA, Inc. et al, the U.S. Court of Appeals for the Federal Circuit addressed the narrow question of whether patent term extensions (PTE) for patents covering drug products that are under regulatory review pursuant to 35 U.S.C. § 156(c) is based on the issue date of the original patent or the reissue patent. The Federal Circuit sided with the district court and the patent owner, Merck, finding that the term “patent,” as used in Section § 156(c), refers to the original patent and not the reissued patent. As a result, patent term extension (PTE) is calculated based on the issue date of the original patent.
Merck’s ʼ340 patent covering sugammadex, the active ingredient in BRIDION®, was issued on Dec. 30, 2003. Merck applied for a reissue patent while sugammadex was under regulatory review, adding 12 narrower claims. The reissue patent was issued as the REʼ733 patent on Jan. 28, 2014, and sugammadex was approved by the Food and Drug Administration (FDA) on Dec. 15, 2015. The U.S. Patent and Trademark Office (PTO) granted Merck’s request for a five-year patent term extension—the maximum allowed under Section 156(c)—based on the ʼ340 patent’s original issue date.
Aurobindo, which submitted an Abbreviated New Drug Application for sugammadex, argued that the PTO should have calculated Merck’s PTE based on the issue date of Merck’s reissue patent and not the original patent (in which case Merck would only have been entitled to 686 days of PTE and not the full five years), because the original patent is “dead” upon reissue. The Federal Circuit flatly rejected this argument, relying heavily on the purpose and legislative intent underlying the Hatch Waxman Act, which was “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.”
Adopting Aurobindo’s argument, the court said, would eviscerate this purpose and compensate patent owners for only a small period of delay caused by FDA review. The Federal Circuit emphasized that Merck was entitled to the full PTE based on the original patent’s issue date because the reissue patent included all of the original claims of the ʼ340 patent that was subject to FDA review.
Takeaways
Because the Federal Circuit’s decision only applies to reissue patents with the same claims as the original patent, patent owners with drug products under regulatory review should think twice before canceling claims in a reissue application, as doing so will result in forfeiture of PTE if the canceled claims cover the drug product that is under review. However, the Federal Circuit did not address how PTE should be calculated when a reissue patent significantly modifies the scope of the original claims but does not cancel them, which remains an open question.
Federal Circuit Opens the Door to Additional Domestic Industry Investment: “Ordinary Importer” No Longer
In its recent decision in Lashify, Inc. v. International Trade Commission, the Federal Circuit opened the door for patent owners to include expanded categories of domestic investment to satisfy the economic prong of the domestic industry requirement under Section 337(a)(3)(B). App. No. 2023-1245, Opinion (Mar. 5, 2025). Post-manufacture activities that previously were not considered—like sales, marketing, warehousing, quality control, and distribution—are now likely includable as domestic industry investments for purposes of establishing a domestic industry under Section 337(a)(3)(B). This is a significant departure from International Trade Commission (ITC) precedent and will likely open the door to a greater number of ITC investigations involving foreign-manufactured articles.
One of the unique aspects of ITC practice is its requirement that the complainant prove the existence of a domestic industry in order to obtain the coveted exclusion order. This requirement involves two prongs—the technical prong, which requires the complainant prove that it practices the patent at issue; and the economic prong, which requires the complainant prove with respect to the articles protected by the patent: (A) significant investment in plant and equipment; (B) significant employment of labor or capital; or (C) substantial investment in exploitation, including engineering, research and development, or licensing. 19 U.S.C. § 1337(a)(3). The Federal Circuit’s decision in Lashify addressed the economic prong.
Since its enactment in 1988, the ITC’s interpretation of Section 337(a)(3)(B) has effectively barred domestic investments directed solely to post-manufacture activities such as sales, marketing, warehousing, quality control, and distribution from establishing the existence of a domestic industry. The ITC often referred to these activities as those of an “ordinary importer,” failing to alone meet the economic prong of the domestic industry requirement because such activities contribute nothing to the actual manufacture of the article. Where manufacture of the article occurs outside of the United States, no additional steps occur in the United States to make the article salable, and thus no cognizable domestic industry activities remain for purposes of establishing the economic prong. Over the years, this interpretation of Section 337(a)(3) has effectively required some form of domestic manufacture or assembly activity to satisfy the economic prong of the domestic industry requirement. This is likely not the case anymore.
Lashify sells artificial eyelash extensions, applicator tools and products, and lash-extension storage containers. While Lashify conducts research and development in the United States, it manufactures its products overseas and ships them to U.S. customers who purchase the products via Lashify’s website. Customers are then able to use a variety of Lashify-provided resources to apply them, such as educational videos on social media, online chats, and video-call sessions. Lashify owns patents directed to these products, including a least one utility patent directed to, for example, certain lash-fusion technology; and design patents directed to, for example, a certain storage cartridge for eyelash extensions. Lashify filed a complaint before the ITC, in which it alleged that importers of similar products were violating Section 337 by infringing these patents.
The Administrative Law Judge (“ALJ”) at the ITC denied Lashify relief under the statute, determining, inter alia, that Lashify did not satisfy the economic prong of the domestic industry requirement. In reaching this determination, the ALJ excluded expenses relating to sales, marketing, warehousing, quality control, and distribution, following decades of ITC precedent considering these investments alone insufficient to meet the economic prong of the domestic industry requirement. The ALJ reasoned that because there were “no additional steps required to make these products saleable” upon arrival into the United States, and because the quality control measures were “no more than what a normal importer would perform upon receipt,” no domestic industry existed under Section 337(a)(3)(B).
The Commission agreed to review the ALJ’s decision and affirmed. The majority agreed with the ALJ that Lashify had not satisfied the economic prong of the domestic industry requirement, reasoning that “it is well settled that sales and marketing activities alone cannot satisfy the domestic industry requirement.” The majority reached the same conclusion with respect to warehousing, quality control, and distribution.
Lashify appealed to the Federal Circuit. The Federal Circuit vacated the ITC’s determination and remanded the investigation to the ITC for redetermination of satisfaction of the economic prong of the domestic industry requirement. The Federal Circuit concluded that the ITC’s determination relied upon an incorrect interpretation of Section 337(a)(3)(B). The Federal Circuit rejected the ITC’s conclusion that Lashify’s analysis was “overinclusive and not supported” because it “included expenses related to warehousing, distribution, and quality control” as well as “sales and marketing expenses.” The Federal Circuit found no support for these categorical exclusions in the text of the statute, relying heavily on its plain text and a thorough review of the legislative history surrounding the 1988 enactment.
The Federal Circuit observed that the provision “straightforwardly states that domestic industry ‘shall be considered to exist if there is in the United States, with respect to the articles protected by the patent . . . concerned, . . . significant employment of labor and capital.’” 19 U.S.C. § 1337(a)(3)(B). Absent some limitation, the Federal Circuit concluded:
[T]he provision covers significant use of “labor” and “capital” without any limitation on the use within an enterprise to which those items are put, i.e., the enterprise function they serve. In particular, there is no carveout of employment of labor or capital for sales, marketing, warehousing, quality control, or distribution. Nor is there a suggestion that such uses, to count, must be accompanied by significant employment for other functions, such as manufacturing. The Commission’s holdings attribute limitations to clause (B) not found there.
The Federal Circuit went on to conclude that there was no other rationale for imparting a categorical limitation to Section 337(a)(3)(B), precluding reliance on these types of investments from the context of the statute or its legislative history. The Federal Circuit thus directed the ITC, on remand, to “count Lashify’s employment of labor and capital even when they are used in sales, marketing, warehousing, quality control, or distribution, and the Commission must make a factual finding of whether those qualifying expenses are significant or substantial based on ‘a holistic review of all relevant considerations.’”
The Federal Circuit’s decision in Lashify is likely to have a significant impact on ITC practice. Foremost, it is likely to make the ITC available to businesses and industries previously excluded from the venue on the basis of the foreign manufacture of the imported article. Now, foreign manufacture of the article is not likely to be a bar to a patent owner’s ability to claim significant or substantial domestic investment in labor and capital under Section 337(a)(3)(B), even when such labor and capital is devoted to activities that do not make the product saleable or amount to anything more than those post-manufacture activities performed by an ordinary importer. Companies who perform such purely post-manufacture activities—as long as such investments are significant—will have the ability to claim such activities constitute domestic investment for purposes of meeting the economic prong of the domestic industry under Section 337(a)(3)(B).
Key Considerations Before Negotiating Healthcare AI Vendor Contracts
The integration of artificial intelligence (AI) tools in healthcare is revolutionizing the industry, bringing efficiencies to the practice of medicine and benefits to patients. However, the negotiation of third-party AI tools requires a nuanced understanding of the tool’s application, implementation, risk and the contractual pressure points. Before entering the negotiation room, consider the following key insights:
I. The Expanding Role of AI in Healthcare
AI’s role in healthcare is rapidly expanding, offering a wide range of applications including real-time patient monitoring, streamlined clinical note-taking, evidence-based treatment recommendations, and population health management. Moreover, AI is transforming healthcare operations by automating staff tasks, optimizing operational and administrative processes, and providing guidance in surgical care. These technological advancements can not only improve efficiency but also enhance the quality of care provided. AI-driven customer support tools are also enhancing patient experiences by offering timely responses and personalized interactions. Even in employment recruiting, AI is being leveraged to identify and attract top talent in the healthcare sector.
With such a wide array of applications, it is crucial for stakeholders to understand the specific AI service offering when negotiating a vendor contract and implementing the new technology. This knowledge ensures that the selected AI solution aligns with the organization’s goals and can be effectively integrated into existing systems, while minimizing each party’s risk.
II. Pre-Negotiation Strategies
Healthcare AI arrangements are complex, often involving novel technologies and products, a wide range of possible applications, important data use and privacy considerations and the potential to significantly impact patient care and patient satisfaction. Further, the regulatory landscape is developing and can be expected to evolve significantly in the coming years. Vendors and customers should consider the following when approaching a negotiation:
Vendor Considerations:
Conduct a Comprehensive Assessment: Understand the problem the product is addressing, expected users, scope, proposed solutions, data involved, potential evolution, and risk level.
Engage Stakeholders: Schedule kick-off calls with the customer’s privacy, IT, compliance, and clinical or administrative teams.
Documentation: Maintain summary documentation detailing model overview, value proposition, processing activities, and privacy/security controls.
Collaborate with Sales: Develop strategies with the sales team and consider trial periods or pilot programs. Plan for the progression of these programs. For example, even if a pilot program is free, data usage terms should still apply.
Customer Considerations:
Evaluate Within AI Governance Scope: Don’t treat an AI contract like a normal tech engagement. Instead, approach this arrangement within a larger AI governance scope, including accounting for the introduction of ethical frameworks, data governance practices, monitoring and evaluation systems, and related guardrails to work in tandem with the product’s applications.
Engage Stakeholders: Collaborate with legal, privacy, IT, compliance, and other relevant stakeholders from the outset.
Consider AI-Specific Contracts: Use AI-specific riders or MSAs and review standard vendor forms to streamline negotiations.
Assess Upstream Contract Requirements: Ensure upstream requirements can be appropriately reflected downstream.
Perform vendor due diligence:As with any nascent industry, some vendors will not survive or may significantly change their focus or products, which might impact support or the long-term viability of the service. Learn about your vendor and ask questions about their financial stability, privacy and security posture.
III. AI Governance and Risk Assessment
Evaluating AI-related risk requires understanding risk across the full lifecycle of an AI product, including its model architecture, training methods, data types, model access, and specific application context. In the healthcare space, this includes understanding the impact to operations, the effect on clinical care and any other impact to patients, the amount of sensitive information involved, and the degree of visibility and/or control the organization has over the model.[1] For example, the risk is much larger with respect to AI that is used to assist clinical decision-making for diagnostics (e.g., assessing static imaging in radiology); whereas, technology used for limited administrative purposes carries a comparatively smaller risk. Here are three resources that healthcare organizations can use to evaluate and address AI-related risks:
A. HEAT Map
A HEAT map can be a helpful tool for evaluating the severity of risks associated with AI systems. It categorizes risks into different “heat” levels (e.g., informational, low, medium, high, and critical). This high-level visual representation can be particularly helpful when a healthcare organization is initially deciding whether to engage a vendor for a new AI product or platform. It can help the organization identify the risk associated with rolling out a given product and prioritize risk management strategies if it moves forward in negotiating an agreement with that vendor.
For example, both the customer and the vendor might consider (and categorize within the HEAT map) what data the vendor will require to perform its services, why the vendor needs it, who will receive the data, and what data rights the vendor might be asking for, how that data is categorized, whether any federal, state or global rules impact the acceptance of that data, and what mitigations are necessary to account for data privacy.
B. NIST AI Risk Management Framework
The National Institute of Standards and Technology (NIST) has created the NIST AI Risk Management Framework to guide organizations in identifying and managing AI-related risks.[2] This framework offers an example of a risk tiering system that can be used to understand and assess the risk profile of a given AI product, and ultimately guide organizations in the creation of risk policies and protocols, evaluation of ongoing AI rollouts, and resolution of any issues that arise. Whether healthcare organizations choose to adopt this risk tiering approach or apply their own, this framework reminds organizations of the many tools at their disposal to manage risk during the rollout of an AI tool, including data protection and retention policies, education of users, incident response protocols, auditing and assessment practices, changes to management controls, secure software development practices, and stakeholder engagement.
C. Attestations and Certifications
Attestations and certificates (e.g., HITRUST, ISO 27001, SOC-2) can also help your organization ensure compliance with industry standard security and data protection practices. Specifically, HITRUST focuses on compliance with healthcare data protection standards, reducing the risk of breaches and ensuring AI systems that handle health data are secure; ISO 27001 provides a framework for managing information security, helping organizations to safeguard AI data against unauthorized access and breaches; and SOC-2 assesses and verifies a service organization’s controls related to security, availability, processing integrity, confidentiality, and privacy, in order to ensure AI services are trustworthy. By engaging in the process to meet these certification standards, the organization will be better equipped to issue-spot potential problems and implement corrective measures. Also, these certifications can demonstrate to the public that the organization takes AI risks seriously, thereby strengthening trust and credibility amongst its patients and business partners.
IV. Contract Considerations
Once parties have assessed their organizational needs, engaged applicable stakeholders/collaborators, and reviewed their risk exposure from an AI governance perspective, they can move forward in negotiating the specific terms of the agreement. Here’s a high-level checklist of the terms and conditions that each party will want to pay careful attention to in negotiations, along with a deeper dive into the considerations surrounding data use and intellectual property (IP) issues:
A. Key Contracting Provisions:
Third-party terms
Privacy and security
Data rights
Performance and IP warranties
Service level agreements (SLAs)
Regulatory compliance
Indemnification (IP infringement, data breaches, etc.)
Limitations of liability and exclusion of damages
Insurance and audit rights
Termination rights and effects
B. Data Use and Intellectual Property Issues
When negotiating the terms and conditions related to data use, ownership, and other intellectual property (IP) issues, each party will typically aim to achieve the following objectives:
Customer Perspective:
Ensure customer will own all inputs, outputs, and derivatives of its data used in the application of the AI model;
Confirm data usage will be restricted to service-related purposes;
Confirm the customer’s right to access data stored by vendor or third-party as needed. For example, the customer might want to require that the vendor provide any relevant data and algorithms in the event of a DOJ investigation or plaintiff lawsuit;[3]
Aim for broad, protective IP liability and indemnity provisions; and
Where patient health information is involved, ensure that it is being used in compliance with HIPAA. Vendors want to train their algorithm on PHI. Unless the algorithm is only being trained for the benefit of the HIPAA-regulated entity and fits within a healthcare operations exception, a HIPAA authorization from the data subject will typically be required to train the algorithm for broader purposes.
Vendor Perspective:
Ensure vendor owns all services, products, documentation, and enhancements thereto;
Access customer data sources for training and improving machine learning models; and
Retain ownership over outputs. From the vendor’s perspective, any customer data that is inputted into the vendor’s model is modified by that model or product, resulting in the blending of information owned by both sides. One potential solution to this shared ownership issue is for the vendor to grant the customer a longstanding license to use that output.
V. Conclusion
In conclusion, negotiating contracts for AI tools in healthcare demands a comprehensive understanding of the technology, data use, risks and liabilities, among other considerations. By preparing effectively and engaging the right stakeholders and collaborators, both vendors and customers can successfully navigate these negotiations.
FOOTNOTES
[1] UC AI Council Risk Assessment Guide.
[2] NIST AI 600-1, Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (July 2024).
[3] Paul W. Grimm et al., Artificial Intelligence as Evidence, 19 Northwestern J. of Tech. and Intellectual Prop. 1, 9 (2021).
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