Category: Intellectual Property

Zone of Natural Expansion Is a Shield, Not a Sword

The US Court of Appeals for the Federal Circuit upheld a Trademark Trial & Appeal Board decision to partially cancel trademarks, ruling that an opposition challenger could not use the zone of natural expansion doctrine to claim priority because the doctrine is strictly defensive. Dollar Financial Group, Inc. v. Brittex Financial, Inc., Case No. 23-1375 (Fed. Cir. Mar. 19, 2025) (Prost, Taranto, Hughes, JJ.)
Dollar Financial Group (DFG) is a loan financing and check cashing business that has used the mark MONEY MART since the 1980s. In 2012, DFG expanded and started using the mark in connection with pawn brokerage and pawn shop services. DFG registered MONEY MART for these new services in 2014. Brittex petitioned to cancel the registration on several grounds, including that the registrations were improperly issued in violation of the Lanham Act, which bars registration of a mark that “so resembles . . . a mark or trade name previously used in the United States by another and not abandoned, as to be likely, when used on or in connection with the goods of the applicant, to cause confusion, or to cause mistake, or to deceive.” 15 U.S.C. § 1052(d). Brittex has operated pawn shops under the names Money Mart Pawn and Money Mart Pawn & Jewelry since the 1990s and claimed prior common law rights to the MONEY MART mark for pawn services.
The Board ruled in favor of Brittex, finding that Brittex had priority over DFG for pawn services due to its earlier use of the mark. The Board also determined that DFG could not rely on the zone of natural expansion doctrine to establish priority because this doctrine is purely defensive and does not grant a proactive right to register a mark on an expanded line of goods or services. The Board also concluded that there was a likelihood of confusion between the marks, given their high similarity and the overlapping nature of the services provided by both parties. DFG appealed.
The Federal Circuit agreed that Brittex had established priority because it was the first to use the MONEY MART mark in connection with pawn services. The Court also rejected DFG’s zone of natural expansion argument, reiterating that the doctrine is defensive and cannot be used to establish priority offensively.
The doctrine of natural expansion, as explained in Orange Bang v. Ole Mexican Foods (TTAB 2015), states that:
[T]he first user of a mark in connection with particular goods or services possesses superior rights in the mark as against subsequent users of the same or similar mark for any goods or services which purchasers might reasonably expect to emanate from it in the normal expansion of its business under the mark.

However, the doctrine does not give the senior mark user an offensive or proactive use.
The Federal Circuit also addressed DFG’s argument regarding the doctrine of tacking, which allows trademark holders to make minor modifications to their own mark while retaining the priority position of the older mark. Tacking is generally permitted to allow trademark holders to make minor adjustments to their marks to reflect changing consumer preferences, aesthetics, and marketing styles. However, the Federal Circuit determined that DFG had forfeited this argument by failing to present it during the initial cancellation proceeding before the Board. Consequently, the Court declined to consider the tacking argument on appeal.

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original patent should be used to calculate the extension, not the reissue date. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., Case No. 23-2254 (Fed. Cir. Mar. 13, 2025) (Dyk, Mayer, Reyna, JJ.)
Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years.
The Hatch-Waxman Act provides owners of patents related to pharmaceutical products a process to extend the term of their patent rights to compensate for time lost during regulatory review of their NDAs. The act contains a clause providing that “the term of a patent . . . shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” Having been unable to market the invention covered by the patent for almost 12 years because of FDA’s regulatory review, Merck filed a PTE application for its reissue patent seeking a five-year extension (the maximum allowed under the act) based on the patent’s original issue date. The US Patent & Trademark Office (PTO) agreed and granted the five-year extension.
Between the reissue date and the PTO’s grant of the five-year extension, Aurobindo and other generic manufacturers had filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Bridion®. Merck sued for infringement. At trial, Aurobindo argued that the PTO improperly calculated the PTE by using the original issue date instead of the reissue date because only 686 days of FDA’s regulatory review occurred after the reissue date, as opposed to the almost 12 years which had passed since the initial issue date. The district court disagreed, finding that Aurobindo’s proposed construction “would undermine the purpose of the Hatch-Waxman Act.” Aurobindo appealed.
Aurobindo argued that the act’s reference to “the patent” referred to the reissue patent because that is the patent for which the patentee was seeking term extension. Merck argued that the act’s text, read in light of other patent statutes and the history of patent reissue, required the opposite conclusion (i.e., a PTE based on the original issue date).
The Federal Circuit agreed with Merck, explaining that while the language of the PTE text may be ambiguous, that ambiguity may be resolved by considering the PTE text in light of the history of the Hatch-Waxman Act and its place within the statutory scheme. The purpose of the act is “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications,” and “the statute should be liberally interpreted to achieve that end.”
Having found that the Hatch-Waxman Act contemplates PTE for patents claiming drug products for which exclusivity was delayed by FDA review, the Federal Circuit found no reason to deny Merck compensation for the PTE period calculated by the PTO based on the original patent issue date.

When “It’s Obvious” Just Isn’t Enough: Challenger’s Burden to Prove Obviousness

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s decision that a patent was not obvious because the petitioner failed to show sufficient support of obviousness based on prior art. AMP Plus, Inc. v. DMF, Inc., Case No. 23-1997 (Fed. Cir. Mar. 19, 2025) (Lourie, Bryson, Reyna, JJ.)
DMF owns a patent directed to a compact recessed lighting system designed for installation in a standard electrical junction box. In 2019, AMP, doing business as ELCO, petitioned for inter partes review of several claims of the patent on three grounds of unpatentability:

Anticipation by a prior reference
Obviousness based on a combination of two references
Further obviousness based on an additional source.

The Board found that one claim was anticipated but ruled that ELCO failed to prove unpatentability of the other claims, including the claim at issue on appeal. The claim at issue describes a system with wires connected to a driver and a first connector, coupled to a second connector that in turn is connected to the building’s electrical system. This specific connection was referred to as “Limitation M.” ELCO appealed. In that earlier appeal (2022), the Federal Circuit affirmed the Board’s ruling on all claims except the claim at issue and remanded the case back to the Board for further analysis.
On remand, the Board concluded that ELCO failed to demonstrate the unpatentability of the claim at issue because ELCO’s petition lacked a substantive analysis of Limitation M. The Board found ELCO’s argument that a prior art marine lighting system could be adapted for the claimed building use unsupported by evidence and ruled that the claim at issue was not obvious. Again, ELCO appealed.
ELCO raised two main arguments. First, it argued that the Board erred in not determining that the claim at issue was anticipated by a prior reference, as the Board had previously found another claim to be anticipated by the same reference. The Federal Circuit rejected this argument because ELCO had only challenged the claim at issue on the basis of obviousness in its original petition, not anticipation. Since the issue of anticipation was not raised in the petition, the Court determined that ELCO could not introduce this new ground of unpatentability on appeal.
Second, ELCO argued that its petition had sufficiently demonstrated the obviousness of Limitation M based on the prior references. The Federal Circuit disagreed, finding that ELCO’s petition did not adequately address the specific requirement for coupling the system to a building’s electrical infrastructure. The petition failed to discuss how the recessed lighting system would be installed in a building, and the references cited did not provide adequate support for the argument of obviousness for this particular limitation.
The Federal Circuit emphasized that it was not the Board’s responsibility to supplement the petitioner’s arguments or search for evidence to support an inadequately supported claim challenge. The Court reiterated that an obviousness analysis does not require the Board to fill gaps in the petitioner’s original filing. In this case, the Board had appropriately determined that ELCO failed to meet its burden of demonstrating the obviousness of Limitation M.

No APA Review of Commission Refusal to Issue Sua Sponte Show Cause Order

The US Court of Appeals for the Federal Circuit dismissed an appeal challenging a US International Trade Commission decision that upheld an administrative law judge’s (ALJ) order, ruling that such an order was within the Commission’s discretion and unreviewable. Realtek Semiconductor Corp. v. International Trade Commission, Case No. 23-1095 (Fed. Cir. Mar. 18, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)
DivX filed a complaint at the Commission against Realtek alleging a violation of § 1337 of the Tarriff Act. DivX later withdrew the complaint. Realtek subsequently filed a motion for sanctions against DivX, alleging certain misconduct. The ALJ denied the motion on procedural grounds. Realtek subsequently petitioned for Commission review, asking the Commission to exercise its authority to issue a sua sponte order requiring DivX to show cause explaining why it had not engaged in sanctionable conduct. The Commission decided not to review and adopted the ALJ’s order without comment.
Realtek appealed, contending that the Commission violated the Administrative Procedure Act (APA) by not issuing a sua sponte show cause order. The Commission argued that Realtek’s appeal should be dismissed, contending that the issue raised was unreviewable.
The Federal Circuit agreed with the Commission, stating that under § 701(a)(2) of the APA, decisions made by an agency are unreviewable by the Court when they are entrusted to the agency’s discretion by law. The Court explained that the sua sponte issuance of a show cause order is a decision that “may be, not must be,” entered by the ALJ or on the Commission’s initiative. Therefore, the decision not to act sua sponte is a decision that remains wholly within the agency’s discretion.
The Federal Circuit rejected Realtek’s argument that the Commission’s refusal to act was reviewable because the Commission failed to provide reasoning, and that Commission review would have allowed the Court to determine if there were “illegal shenanigans” in exercising discretion. However, the case cited by Realtek involved the review of “shenanigans” that fell within the Court’s reviewable categories, not one related to the Commission’s refusal to issue a show cause order sua sponte. The Court found no support for Realtek’s claim that discretionary agency actions under § 701(a)(2) become reviewable under the APA simply because the agency fails to provide its reasoning.

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.