Category: Intellectual Property

Even Jepson Preambles Require Written Description Support

The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well known in the prior art. In re Xencor, Inc., Case No. 24-1870 (Fed. Cir. Mar. 13, 2025) (Hughes, Stark, Schroeder, JJ.)
Xencor filed a patent application claiming a modified anti-C5 antibody treatment with certain amino acid substitutions that provide for longer serum half-lives and reduce the need for more frequent treatment. The application included:

A Jepson claim reciting, “[i]n a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising” certain amino acid substitutions, wherein the modified antibody has “increased in vivo half-life.”
A non-Jepson claim directed to “a method of treating a patient by administering an anti-C5 antibody comprising” certain amino acid substitutions, wherein the modified antibody “has increased in vivo half-life.”

The specification provided one example of an anti-C5 antibody, 5G1.1, and three high-level examples of potential uses for anti-C5 antibodies. The examiner rejected the claims for lack of written description. Xencor unsuccessfully appealed the rejection to the Patent Trial & Appeal Board. Xencor then unsuccessfully petitioned the Board for reconsideration. Xencor appealed to the Federal Circuit, which resulted in a remand to the Board’s Appeals Review Panel (ARP).
The ARP concluded that Jepson claim preambles require written description support and that the preamble language of “treating a patient” was limiting – even without the Jepson claim format – because it gave life and meaning to the claim recitations “increased in vivo half-life” and “administering.” Because the specification did not provide a representative number of species to support the broad genus of anti-C5 antibodies, a description of conditions that can successfully be treated with an anti-C5 antibody, or even a single working example describing treatment with an anti-C5 antibody with the claimed modifications, the ARP found that the claims lacked written description and that Xencor had not shown that anti-C5 antibodies were well known. Xencor again appealed, arguing that “treating a patient” was not limiting and that Jepson preambles do not require written description support.
With respect to the preamble of the method claim, the Federal Circuit noted that Xencor agreed that the “administering” portion was limiting but nonetheless argued that “treating a patient” was not. Although a preamble can be split into limiting and non-limiting parts, the Court reasoned that the preamble here could not be neatly packaged into separate portions because the phrase “treating a patient” was directly connected through the word “by” to the phrase “administering an anti-C5 antibody,” and each phrase gave meaning to the other. The Court further explained that the entire preamble provided the raison d’être of the claimed method: When a patient is treated with the modified anti-C5 antibody, the treatment lasts longer, reducing the frequency of treatments. Accordingly, the Court agreed with the ARP that the recitation “treating a patient” was limiting.
The Federal Circuit next concluded that substantial evidence supported the ARP’s determination that the specification did not provide written description support for “treating a patient.” Because the specification was not limited to treating a particular disease, “treating a patient” meant “treating all patients and all diseases.” While the specification provided three examples of classes of diseases that might benefit from the claimed treatment, the Court agreed with the ARP that this disclosure was inadequate to demonstrate possession of a method of treating any particular disease, let alone all diseases.
Finally, the Federal Circuit explained that a Jepson claim preamble requires written description support because it is used to define the claimed invention and the claim scope. The Court cautioned that a patentee cannot obviate the written description requirement by using a Jepson claim to avoid the requirement that the inventor be in possession of the claimed invention – otherwise, a patentee could obtain a Jepson claim with a preamble that recited a time machine as well known in the art without describing a time machine. To provide adequate written description for a Jepson claim, the applicant must establish that what is claimed to be well known in the art actually is well known in the art. The Court explained that the amount of disclosure necessary varies depending on the level of knowledge of the person skilled in the art, the unpredictability of the art, and the newness of the technology.
Given the large number of possible antibodies in the anti-C5 antibody genus and the limited disclosure in the specification, the Federal Circuit affirmed the ARP’s determination that the Jepson claim lacked adequate written description.

Human Authorship Required: AI Isn’t an Author Under Copyright Act

 
The US Court of Appeals for the District of Columbia upheld a district court ruling that affirmed the US Copyright Office’s (CO) denial of a copyright application for artwork created by artificial intelligence (AI), reaffirming that human authorship is necessary for copyright registration. Thaler v. Perlmutter, Case No. 23-5233 (D.C. Cir. Mar. 18, 2025) (Millett, Wilkins, Rogers, JJ.)
Stephen Thaler, PhD, created a generative AI system that he named the Creativity Machine. The machine created a picture that Thaler titled, “A Recent Entrance to Paradise.” Thaler applied to the CO for copyright registration for the artwork, listing the Creativity Machine as the author and Thaler as the copyright owner.
The CO denied Thaler’s application because “a human being did not create the work.” Thaler twice sought reconsideration of the application, which the CO denied because the work lacked human authorship. Thaler subsequently sought review in the US District Court for the District of Columbia, which affirmed the CO’s denial of registration. The district court concluded that “[h]uman authorship is a bedrock requirement of copyright.” Thaler appealed.
The DC Circuit reaffirmed that the Creativity Machine could not be considered the author of a copyrighted work. The Copyright Act of 1976 mandates that to be eligible for copyright, a work must be initially authored by a human being. The Court highlighted key provisions of the Copyright Act that only make sense if “author” is interpreted as referring to a human being. For instance:

A copyright is a property right that immediately vests in the author. Since AI cannot own property, it cannot hold copyright.
Copyright protection lasts for the author’s lifetime, but machines do not have lifespans.
Copyright is inheritable, but machines have no surviving spouses or heirs.
Transferring a copyright requires a signature, and machines cannot provide signatures.
Authors of unpublished works are protected regardless of their nationality or domicile, yet machines do not have a domicile or national identity.
Authors have intentions, but machines lack consciousness and cannot form intentions.

The DC Circuit concluded that the statutory provisions, as a whole, make human activity a necessary condition for authorship under the Copyright Act.
The DC Circuit noted that the human authorship requirement is not new, referencing multiple judicial decisions, including those from the Seventh and Ninth Circuits, where appellate courts have consistently ruled that authors must be human.
Practice Note: Only humans, not their tools, can author copyrightable works of art. Images autonomously generated are not eligible for copyright. However, works created by humans who used AI are eligible for copyright depending on the circumstances, how the AI tool operates, and to what degree the AI tool was used to create the final work. Authors whose works are assisted by AI should seek advice of counsel to determine whether their works are copyrightable.

China Releases Draft Implementation Measures for the Protection of Drug Trial Data Including Data Exclusivity for Foreign-Originated Drugs

On March 19, 2025, China’s National Medical Products Administration (NMPA) released Implementation Measures for the Protection of Drug Trial Data (Trial, Draft for Comments) (药品试验数据保护实施办法(试行，征求意见稿))and Working Procedures for the Protection of Drug Trial Data (Draft for Comments) (药品试验数据保护工作程序(征求意见稿)) that provides up to 6 years of data exclusivity of clinical trial data required to be submitted to the NMPA to prove safety and efficacy of a new drug to prevent generic drug manufacturers from relying on this data in their own applications.  In contrast, the US generally provides 5 years of exclusivity. However, for foreign-originated drugs, the Chinese data protection period will be 6 years minus the time difference between the date on which the drug’s marketing authorization application in China is accepted and the date on which the drug first obtains marketing authorization overseas. Comments are due before May 18, 2025. The original documents as well as spreadsheets to submit comments are available here (Chinese only).
A translation of the Implementation Measures follows.
Article 1 (Purpose and Basis) These Measures are formulated in accordance with the Drug Administration Law of the People’s Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China, the Drug Registration Management Measures and other relevant regulations in order to encourage drug innovation and meet the public’s demand for medicines.
Article 2 (Management Mechanism) The State Drug Administration (hereinafter referred to as the NMPA ) is responsible for the protection of drug trial data (hereinafter referred to as data protection) and is responsible for establishing a data protection system and implementing management work in accordance with the principles of fairness, openness and impartiality.
The Drug Technical Review Center of the National Drug Administration (hereinafter referred to as the Drug Review Center) is responsible for the specific implementation of data protection.
Article 3 (Definition of Concepts) Data protection means that when drugs containing new chemical ingredients and other qualified drugs (see the attached table for details) are approved for marketing, the National Medical Products Administration shall protect the test data and other data submitted by the applicant that are obtained independently and not disclosed, and grant a data protection period of no more than 6 years.
During the data protection period, if other applicants apply for drug marketing authorization or supplementary application relying on the data in the preceding paragraph without the consent of the drug marketing authorization holder (hereinafter referred to as the holder), the National Medical Products Administration will not grant permission; unless other applicants obtain the data on their own.
During the data protection period, if other applicants submit drug registration applications using data obtained by themselves, their applications shall be approved if they meet the requirements and no longer be granted the data protection period, but the data shall not be relied upon by other subsequent applicants .
Article 4 (Conditions of protected data)  Undisclosed trial data and other data refer to trial data in the complete application materials that are not disclosed in the application for drug marketing authorization for the first time in the country.
After a drug is approved, test data obtained when subsequent research work is completed in accordance with the requirements of the drug regulatory authorities will no longer be given new data protection.
Article 5 (Data Protection Related to Innovative Drugs) A six-year data protection period is granted for innovative drugs from the date of their first domestic marketing authorization.
If an original research drug that has been marketed overseas but not in China applies for marketing in China, the data protection period is 6 years minus the time difference between the date on which the drug’s marketing authorization application in China is accepted and the date on which the drug first obtains marketing authorization overseas. The data protection period is calculated from the date on which the drug obtains marketing authorization in China.
The scope of drug data protection in this clause includes all test data used in the drug marketing authorization application materials to prove the safety, efficacy and quality controllability of the drug.
For innovative drugs that have been approved for multiple indications but have the same approval number, each indication will be given data protection according to the registration category, and the scope of data protection for newly added indications will be the clinical trial data that support its marketing.
During the data protection period, the National Medical Products Administration will not approve the marketing application or supplementary application for improved new drugs, chemical generic drugs and biosimilar drugs submitted by other applicants without the consent of the holder, relying on the protected data of the holder , unless other applicants submit data obtained by themselves.
Article 6 (Protection of data related to improved new drugs) A three-year data protection period will be granted from the date of the first domestic marketing authorization for the improved new drug.
If a modified drug that has been marketed overseas but not in China applies for marketing in China, the data protection period is 3 years minus the time difference between the date on which the drug’s application for marketing authorization in China is accepted and the date on which the drug first obtains marketing authorization overseas. The data protection period is calculated from the date on which the drug obtains marketing authorization in China.
The scope of drug data protection in this clause includes new clinical trial data that demonstrates that the drug has significant clinical advantages over drugs with known active ingredients (marketed biological products), but does not include bioavailability, bioequivalence and immunogenicity data of vaccines.
During the data protection period, the National Medical Products Administration will not approve the marketing application or supplementary application for chemical generic drugs and biosimilar drugs submitted by other applicants without the holder’s consent and relying on the protected data of the holder , unless other applicants submit data obtained by themselves.
Article 7 (Data Protection Related to Generic Drugs) A three-year data protection period is granted to the first approved generic drugs (including drugs produced overseas) and biological products of original research drugs that have been marketed overseas but not in China. The data protection period is calculated from the date on which the generic drug or biological product obtains marketing authorization.
The scope of data protection for drugs in this clause includes necessary clinical trial data to support approval, but does not include bioavailability, bioequivalence and immunogenicity data of vaccines.
During the data protection period, the National Medical Products Administration will not approve the marketing application or supplementary application for chemical generic drugs and biosimilar drugs submitted by other applicants without the holder’s consent and relying on the protected data of the holder , unless other applicants submit data obtained by themselves.
Article 8 (Application and supporting documents)  If the applicant intends to apply for data protection, he/she shall submit an application for data protection at the same time as submitting the application for drug marketing authorization. If there are any questions about data protection-related issues, he/she may apply for communication.
Article 9 (Technical Review)  When conducting technical review of drug registration applications, the Center for Drug Evaluation shall confirm the scope and duration of data protection in accordance with the provisions of these Measures.
Article 10 (Granting of Protection Period and Publicity) For drugs that meet the data protection conditions, the National Medical Products Administration will mark the drug’s data protection information in the drug approval certificate.
The Center for Drug Evaluation has established a data protection column on its website to publish relevant information on drug data protection.
Article 11 (Acceptance, Review and Approval) After a drug obtains data protection, other applicants can submit drug marketing applications and supplementary applications that rely on the protected data within one year before the expiration of the data protection period . The Drug Evaluation Center will suspend the review time after completing the technical review, and the relevant drugs will be approved for marketing after the data protection period expires.
an applicant claims that the data was obtained independently when submitting a drug marketing application and a supplementary application , but it is discovered during the technical review process that the application relies on protected data of other applicants, the application will not be approved.
Article 12 (Termination of Data Protection) Data protection shall terminate if the drug approval document is revoked, suspended, or cancelled, if the holder voluntarily waives data protection, or in other circumstances prescribed by laws and regulations.
If data protection is terminated, the National Medical Products Administration will issue a notice on the termination of data protection, and the Drug Evaluation Center will update the relevant information in the data protection column based on the notice. From the date on which the National Medical Products Administration issues the notice on the termination of data protection, it can accept or approve drug registration applications submitted by other applicants that rely on the protected data.
Article 13 ( Incompliance with data protection information )  If, during the review process, it is found that the documents proving the first overseas marketing authorization for drugs submitted by the applicant in accordance with Articles 5 and 6 of these Measures do not match the actual situation , data protection will not be granted; if data protection has already been granted, the data protection will be cancelled.
Article 14 (Data Protection Procedure)  The specific working procedures for data protection will be separately formulated by the Drug Evaluation Center.
Article 15 (Effective Date)  This regulation shall come into force from now on.
Schedule 1
Chemical Drug Registration Classification and Data Protection Period

Classification
content
Data protection period

Category 1
Innovative drugs that have not been launched in the domestic or overseas markets.
6 years

Category 2
Improved new drugs that have not been marketed domestically or abroad.
3 years

Category 3
Domestic applicants copy original drugs that are marketed overseas but not in China.
3 years

Category 4
Domestic applicants copy original drugs that have been marketed domestically.
none

Category 5
Drugs that have been marketed overseas can apply for domestic marketing approval.

5.1
Original research drugs that have been marketed overseas apply for domestic marketing.
6 years – (domestic acceptance time – overseas listing time)

Improved drugs that have been marketed overseas may apply for domestic marketing approval.
3 years – (domestic acceptance time – overseas listing time)

5.2
Generic drugs that have been marketed overseas apply for domestic marketing.
3 years

Schedule 2
Registration classification and data protection period for preventive biological products

Classification
content
Data protection period

Category 1
Innovative vaccines
6 years

Category 2
Improved vaccines
3 years

Category 3
 
 

3.1 Application for listing of vaccines produced overseas and marketed overseas but not marketed domestically
6 years – (domestic acceptance time – overseas listing time)

3.2 Vaccines that have been marketed overseas but not in China can be produced and marketed in China
3 years

3.3 Vaccines already on the market in China
none

Court Rejects DTSA Claim Over Inadequate Efforts to Protect Alleged Trade Secrets

On March 13, 2025, the U.S. District Court for the Eastern District of New York dismissed a trade secret misappropriation claim under the Defend Trade Secrets Act (“DTSA”), finding that the employer failed to plead it had taken reasonable measures to maintain the secrecy of its alleged trade secrets.
In Negative, Inc. v. McNamara, 2025 U.S.P.Q.2d 448, the employer alleged that McNamara, a freelance contractor, misappropriated its trade secrets, which included customer contact and sales information, costs and pricing information for its apparel, marketing and pricing strategies, and internal business plans.  Negative alleged that it had taken reasonable secrecy measures—such as requiring “an intentional sign-in with multiple authentication factors,” limiting access to the files McNamara accessed to a “need-to-know” basis, preventing certain of the files from being downloaded or printed, terminating the access of former employees or contractors, and when Negative became aware McNamara had downloaded the information, demanding its return. 
However, the court disagreed that Negative’s measures were sufficient.  The court found that Negative had not alleged that it made any effort to communicate to McNamara that the information was confidential, nor required her to sign a confidentiality or non-disclosure agreement, or given her any formal instruction regarding the confidentiality of the materials she accessed.  The court dismissed Negative’s DTSA claim, holding that even drawing all reasonable inferences in Negative’s favor, it had failed to adequately plead it took reasonable measures to keep its information secret. 
This case underscores the importance of proactive and documented steps to protect confidential information, such as by using some combination of contractual obligations, explicit policies, and demonstrable efforts to restrict and monitor access. 

Clear Terms of Franchise Agreement Are Enforced Against Franchisee

A recent federal court decision in T&T Management, Inc. v. Choice Hotels, Inc. underscores key contractual and operational considerations for franchisors. T&T filed suit in U.S. District Court for the District of Minnesota against Choice Hotels alleging that Choice Hotels breached a geographic exclusivity agreement and misappropriated trade secrets. However, on February 27, 2025, the court granted a motion to dismiss, emphasizing the importance of clear contractual terms.
Background
T&T Management entered a franchise agreement with Country Inn & Suites by Carlson in 2011, which granted them exclusivity within a defined area for that brand. Over the years, Country Inn & Suites changed ownership twice—first acquired by Radisson and later by Choice Hotels. Choice subsequently issued a franchise license to Sunshine Fund Port Orange, LLC to operate a WoodSpring Suites hotel near T&T’s location. T&T argued that this action violated its exclusive territorial rights and also alleged that Choice misused proprietary guest data.
Holding
The court dismissed all claims against Choice Hotels and its co-defendants, holding:

No breach of contract: The exclusivity clause only applied to Country Inn & Suites properties, not other brands under Choice’s growing portfolio. The agreement explicitly allowed Choice to license other hotel brands within the protected area.
No tortious interference: Since there was no breach of contract, Sunshine’s entry into the market was lawful and did not constitute improper interference.
No trade secret misappropriation: The agreement designated the franchisor as a co-owner of guest data, permitting Choice to use and share it without violating the Defend Trade Secrets Act.

Key Takeaways

Precise Contract Drafting is Crucial: Franchisors should ensure that exclusivity clauses explicitly define their scope. This case demonstrates that a narrowly tailored exclusivity provision can limit disputes when a franchisor expands its brand portfolio.
Ownership of Guest Data Should Be Clearly Defined: Franchise agreements should specify data ownership and usage rights. Here, the court upheld the franchisor’s right to use and share guest data, reinforcing the need for clear contractual language.
Successor Franchisors Must Understand Their Obligations: When acquiring a franchise system, due diligence is essential to ensure compliance with existing agreements. Franchisors should verify whether existing exclusivity or operational restrictions carry over post-acquisition.

This case serves as a reminder that well-drafted franchise agreements can protect franchisors while limiting liability in the face of legal challenges.

First-to-File: A Game-Changer in US Patent Law

The shift in patent law from First-to-Invent to First-to-File came about over a decade ago, but still leaves many inventors scratching their heads. Is First-to-File really as simple as “first come, first served”?
This article aims to help understand First-to-File a little better. 
The United States patent system underwent a significant change with the enactment of the First-Inventor-to-File (FITF) provision of the America Invents Act, which became effective on March 16, 2013. The FITF provision transitioned the United States from a First-to-Invent system to a First-Inventor-to-File system (aka First-to-File), and has had a profound impact on inventors, determination of patent ownership, and the patent process.
First-to-Invent
Prior to implementation of the FITF provision, First-to-Invent was the standard in the United States. Under First-to-Invent, the patent (assuming an invention was patentable) was awarded to the inventor who could prove they were the first to conceive and develop the invention, regardless of who filed the patent application first. For example, if two inventors independently conceived the same invention, the one who could prove prior inventorship would be awarded the patent, even if they filed their application later. The second inventor to file would have to prove that they were the first to invent and did not unduly delay filing. Thus, the First-to-Invent system required inventors to maintain records of their invention process, including dates, sketches, and witness testimonies, in order to establish their priority in case of a dispute. 
First-Inventor-to-File
The First-Inventor-to-File system, which is now used in the United States and most other countries, awards the patent to the first inventor who files a patent application, regardless of who actually invented a device first. In the example above, the inventor who filed their patent application first would have priority, regardless of who invented it first chronologically. Since there is no burden on the first filer to prove the date of their idea conception, this First-to-File system improves speed and efficiency in the patent process. The US Patent and Trademark Office (USPTO) can process applications with fewer complications. Plus, the FITF provision better aligns with international patent practices, making it easier for US inventors to obtain patent protection in foreign jurisdictions. 
Advantages and Disadvantages
Both systems have their advantages and disadvantages. 
The First-to-Invent system was seen as more equitable to individual inventors and small businesses who may not have had the resources to file a patent application as quickly as larger companies. Larger entities might have the funds to file a patent before an individual inventor or small business could justify or afford the expense. Under First-to-Invent, the actual filing date was irrelevant, giving the smaller entity a better chance at controlling the IP. However, First-to-Invent often led to complex and costly legal battles to determine inventorship, possibly negating the fairness factor. 
The First-to-File system is simpler and more predictable, reducing legal disputes and promoting faster dissemination of knowledge and ideas. However, it can disadvantage individual inventors and small businesses who may need more time and resources to develop their invention and/or file a patent application. A better-financed party, which honestly conceived of the invention independently but later than the original inventor, could file a patent application earlier than the first inventor and control the IP. 
The FITF provision does provide for some exceptions. For example, if a later filer can prove that an earlier filer derived the claimed invention from them without authorization, the later filer can establish priority through a “derivation” proceeding. This is basically a trial or appeal to determine whether an invention was improperly derived from another, but the evidence must be substantial with a high burden of proof. Due to the difficulty of proving derivation, these proceedings are rare and considered to be a last resort compared to regular patent challenges such as interferences or post-grant reviews. 
Implications of the Change
The shift to First-to-File has had several implications for inventors and the patent system. FITF has placed much greater emphasis on patent filing strategies. Inventors must now act quickly to file a patent application as soon as they have a viable invention. Consequently, this has led to an influx of application filings, especially initially, which caused increased patent backlogs and delays in the examination process. Beneficially, the change has encouraged greater international harmonization of patent law, as most other countries already use the First-to-File system. 
Conclusion
The shift from First-to-Invent to First-to-File was a significant change in the United States patent system. While the new system offers greater clarity and efficiency, it also places a greater emphasis on speed and strategic patent filing. To adapt to this system, inventors need to be more proactive in protecting their intellectual property; they will want to consider filing on key inventions as soon as possible. Inventors may want to consider utilizing provisional patent applications, which offer a quicker, less expensive, and less formal way to establish an early filing date (i.e., priority date) and give inventors an additional 12 months to file a full formal, non-provisional patent application. 
Under FITF, procrastination on patent matters could lead to lost opportunity. With key innovations, it is probably wise to be “first come, first served.”

D.C. Circuit Denies Copyright to AI Artwork – What Humans Have and Artificial Intelligence Does Not

Can a non-human machine be an author under the Copyright Act of 1976? In a March 18, 2025 precedential opinion, a D.C. Circuit panel affirmed prior determinations from the D.C. District Court and the Copyright Office that an original artwork created solely by artificial intelligence (AI) is not eligible for copyright registration, because human authorship is required for copyright protection.
Dr. Stephen Thaler created a generative AI named DABUS (or Device for the Autonomous Bootstrapping of Unified Sentience), also referred to as the “Creativity Machine,” which made a picture that Thaler titled “A Recent Entrance to Paradise.” In the copyright registration application to the U.S. Copyright Office, Thaler listed the Creativity Machine as the artwork’s sole author and himself as just the work’s owner.
Writing for the panel, D.C. Circuit Judge Patricia A. Millett opined that “the Copyright Act requires all work to be authored in the first instance by a human being,” including those who make work for hire. The court noted the Copyright Act’s language compels human authorship as it limits the duration of a copyright to the author’s lifespan or to a period that approximates how long a human might live. “All of these statutory provisions collectively identify an ‘author’ as a human being. Machines do not have property, traditional human lifespans, family members, domiciles, nationalities, mentes reae, or signatures,” the court concluded.
In rejecting Thaler’s copyright claim of entirely autonomous AI authorship, the court did not consider whether Thaler is entitled to authorship on the basis that he made and used the Creativity Machine, because Thaler waived such argument in the underlying proceedings. The court also declined to rule on whether or when an AI creation could give rise to copyright protection. However, citing the guidance from the Copyright Office, the court noted that whether a work made with AI is registrable depends on the circumstances, particularly how the AI tool operates and how much it was used to create the final work.  In general, a string of recent rulings from the Copyright Office concerning “hybrid” AI-human works have allowed copyright registration as to the human-created portions of such works.
The D.C. Circuit’s statutory text-based analysis and holding stands in parallel with the counterpart U.S. patent doctrine that human inventorship is required for patent protection, provided in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022; Cert. denied) and reflected in the USPTO’s Inventorship Guidance for AI-Assisted Inventions issued February 12, 2024. 
Underlying the judicial rulings to require the human authorship and inventorship for copyright and patent protection is the concept that only humans can “create” art or can conceive the invention – that there is something special and important about human creativity, which is what the intellectual property law aims to protect. This underpinning of human creativity in the authorship and inventorship requirements was addressed in detail in a White Paper published last summer by Mammen and a multidisciplinary group of scholars at the University of Oxford.  The White Paper explains that creativity includes three core elements: (a) an external component (expressed ideas or made artifacts that reflect novelty, value, and surprisingness), (b) a mental component (a person’s thought process – interplay of divergent (daydreaming) thinking, convergent (task-focused), and recognition of salience (relevance)), and (c) a social context (for example, what society considers new, valuable, and surprising, and thus “creative”).   IP doctrines require all three core elements. Generative AI does not presently exhibit the equivalent of the mental component that is key to human creativity. 
In fact, as the White Paper discusses, there is some evidence that Generative AI can negatively impact even human creativity. First, using AI to produce creative products involves working in a way that emphasizes speed and instant answers, as well as becoming the passive consumer of such answers, rather than self-reflection or toggling between convergent and divergent thinking, which is key to creativity. Second, humans interacting with AIs tend to lose confidence in their own creative skills, and start to restrict the range of their own creative repertoire in favor of creating “mash-ups” of what AI provides. 
In analyzing the causal impact of generative AI on the production of short stories where some writers obtained story ideas from a large language model (LLM), Doshi and colleagues reported that access to generative AI caused stories to be more creative, better written, and more enjoyable in less creative writers, while such AI help had no effect for highly creative writers. However, the stories produced after using an LLM for just a few minutes indicated significantly reduced diversity of ideas incorporated into the stories, leading to a greater homogeneity between the stories as compared to stories written by humans alone. Thus, generative AI augmented less creative individuals’ creativity and quality of work, but decreased collective novelty and diversity among writers, suggesting degradation of collective human creativity by use of generative AI.
To be sure, the questions raised by Dr. Thaler and DABUS are testing the boundaries and rationales for existing IP doctrines.  Dr. Thaler argued that judicial opinions from the Gilded Age could not settle the question of whether computer generated works are copyrightable today.  But as reflected in the White Paper and affirmed by the courts, it is not enough merely to suggest that the outputs of Generative AI warrant IP protection because they are “just as good as” human-created outputs that are entitled to protection. Moreover, in most instances of AI-created work or invention, a human factor appears to be present to some extent, either in creating the AI, desiring certain goals and outputs, commanding the AI to generate a goal-oriented output, evaluating and selecting the AI-generated output, modifying the AI-generated output, or owning the AI for the purpose of using the AI-generated output. As the capabilities of AI continue to evolve, the border between human creativity and AI capability may blur further, posing an evolving set of challenges at the frontier of IP law. 

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.