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Guiding the Fight Against Fakes: PTO Opens Public Comment Period

The US Patent & Trademark Office (PTO) issued a notice inviting feedback from intellectual property rights holders and online marketplaces regarding proposed voluntary guidelines aimed at curbing the sale of counterfeit goods on online marketplaces. 90 Fed. Reg. 21291 (May 19, 2025). Public comments will be accepted through June 27, 2025.

The PTO will also hold a public hearing in Washington, DC, on June 5, 2025, to solicit feedback on newly drafted guidelines, which were developed by the Organization for Economic Cooperation and Development (OECD) and focus on key enforcement areas, including repeat infringers, international cooperation, transparency, public awareness, sanctions, and market surveillance. The PTO emphasized that it is working with both government and private sector partners to strengthen efforts against counterfeiting, which has become increasingly prevalent in e-commerce.

According to a recent report by the OECD and the EU Intellectual Property Office, the global trade in counterfeit goods reached $467 billion in 2021, with apparel, footwear, and leather goods constituting the most-seized items. The report identified China and Hong Kong as the top sources of counterfeit products.

The OECD’s anticounterfeiting initiative follows a three-phase approach:

  • Defining the scope of the problem and outlining a strategic response
  • Developing voluntary guidelines to combat illicit trade
  • Facilitating global dialogue among public and private stakeholders to refine and implement best practices

The PTO’s June 5 hearing marks the start of the OECD’s third phase: facilitating dialogue between public and private stakeholders. Additional hearings will be held in other countries as part of this global effort.

The hearing comes on the heels of high-profile enforcement efforts, including a recent federal court order in Illinois that extended a freeze on assets linked to overseas sellers accused of distributing counterfeit National Basketball Association merchandise.

The PTO hopes the hearing will help refine the proposed best practices and identify remaining gaps, as policymakers and industry leaders work together to combat the growing threat of illicit online trade.




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It’s a Matter of Timing: The PTO’s Latest Decisions on Discretionary Denials

Since the US Patent & Trademark Office’s (PTO) decision to rescind former Director Vidal’s memo on procedures for post-grant proceedings where there is parallel district court litigation, Current Acting Director Coke Morgan has issued four decisions regarding requests for discretionary denials:

  • Twitch Interactive, Inc. v. Razdog Holdings LLC, IPR2025-00307; 00308, Paper 18 (P.T.A.B. May 16, 2025)
  • Amazon.com v. NL Giken, Inc., IPR2025-00250; 00407, Paper 14 (P.T.A.B. May 16, 2025)
  • Arm Ltd. and Mediatek, Inc. v. Daedalus Prime LLC, IPR2025-00207, Paper 10 (P.T.A.B. May 16, 2025)
  • Ericsson and Verizon Wireless v. Procomm International, IPR2024-01455, Paper 15 (P.T.A.B. May 16, 2025).

The Director ultimately granted two of the requests and denied the other two.

In Twitch Interactive v. Razdog Holdings LLC, the PTO denied the patent owner’s request for discretionary denial. The parallel district court proceeding did not have a scheduled trial date, and the projected trial date was far beyond the PTO’s final written decision date. The petitioner also provided statistical evidence that the district court would likely issue a stay for the pending inter partes review (IPR) proceeding. Therefore, based on a holistic assessment of the evidence presented, the PTO denied the request for discretionary denial.

In Amazon.com v. NL Giken, Inc, the PTO similarly denied the patent owner’s request for discretionary denial. Here, the issue date for the PTO’s final written decision fell before the parallel district court trial date. The abundance of time between the dates ultimately led to the PTO’s denial.

In contrast, in Arm Ltd. and Mediatek, Inc. v. Daedalus Prime LLC, the PTO granted the patent owner’s request for discretionary denial. The PTO highlighted that it was unlikely that its final written decision would be issued before the start of the district court trial. There also was a lack of probative evidence that the district court would issue a stay if an IPR proceeding was instituted.

Finally, in Ericsson and Verizon Wireless v. Procomm International, the PTO granted the patent owner’s request for discretionary denial. The PTO found that the district court trial would conclude before a final written decision was issued in the IPR proceedings, because the trial date preceded the final written decision date by nine months. Moreover, there was no evidence to support any contention that the district court would issue a stay.

Practice Note: These four decisions emphasize the importance of timing between post-grant proceedings and parallel district court litigation. The PTO is more likely to grant discretionary denial if the final written decision of the post-grant proceeding is issued after the trial concludes in the parallel district court action. If a final written decision is likely to be issued before the trial begins in the parallel proceeding, the PTO is more likely to deny a request for a discretionary denial.




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Designated Informative: PTO Director Declines IPR Institution Following District Court § 101 Invalidation

The US Patent & Trademark Office (PTO) designated a recent Director Review decision as informative, signaling its significance for future proceedings. The decision emphasizes that a final district court ruling invalidating a patent weighs heavily against instituting inter partes review (IPR) under the Fintiv framework, reinforcing the agency’s stance on minimizing duplicative litigation. Hulu LLC v. Piranha Media Distribution LLC, IPR2024-01252; -01253 (PTAB Director Review Apr. 17, 2025) (Stewart, PTO Dir.)

Piranha requested Director Review of the Patent Trial & Appeal Board’s decision granting institution of two IPRs filed by Hulu. Piranha argued that the decision should be reversed and the IPRs denied institution, citing a district court final judgment invalidating the challenged claims under 35 U.S.C. § 101 issued before the institution decision was made. Hulu argued that Director Review was unwarranted.

In the district court litigation, Piranha asserted that Hulu infringed claims from two patents related to integration of advertising content into digital media streams. Hulu moved to dismiss the complaint, arguing that the asserted patents were ineligible for patenting under § 101. The district court determined that the asserted claims were directed to the abstract idea of “displaying an advertisement in exchange for access to copyrighted material, as well as the abstract idea of receiving, organizing, and displaying data,” and contained no inventive concept. The district court granted Hulu’s motion to dismiss and held the claims patent ineligible and therefore invalid under § 101.

The Director explained that since a district court had already ruled the patent claims invalid, launching separate IPRs to assess their patentability on other grounds was unnecessary. The Director noted that if the Federal Circuit overturned the district court’s decision, Hulu could still pursue its invalidity arguments during remand proceedings. Declining to institute review was the more efficient and practical path under the circumstances, the Director said.

While the Board applied the Fintiv framework in its institution decision, the Director observed that the framework does not align neatly with the facts of this case, where a final district court judgment under § 101 preceded the Board’s decision. The Director ultimately concluded that a second review proceeding was unwarranted given the claims’ current invalid status.




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PTO Accelerates Patent Issuance Timeline

The US Patent & Trademark Office (PTO) announced that it has shortened the time between the issue notification and the issue date for patents. Historically, the time between these two events averaged about three weeks. Seeking to provide earlier protection for inventions, the PTO intends to reduce that time to about two weeks. The PTO is making the move because publishing electronic grants via the PTO online platform has allowed the PTO to eliminate redundancies and reduce the time between grant notification and the issuance date. The shortened wait time has the added benefit of potentially allowing patent applicants to avoid the Quick Path Information Disclosure Statement (IDS), which attempts to streamline filing an IDS after payment of the issue fee.

Practice Note: Given the accelerated timeline, the PTO recommends that applicants file continuation applications before payment of the issue fee to ensure codependency.




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Fintiv Guidelines for Post-Grant Proceedings Involving Parallel District Court Litigation

On March 24, 2025, the US Patent & Trademark Office (PTO) released new guidance that clarifies application of the Fintiv factors when reviewing validity challenges simultaneously asserted at the Patent Trial & Appeal Board and in district court or at the US International Trade Commission.

This guidance follows the PTO’s February 28, 2025, announcement reverting to its previous guidelines for discretionary denials of petitions for post-grant proceedings where district court litigation is ongoing. That announcement rescinded the PTO’s June 21, 2022, memorandum entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” which prevented the Board from rejecting validity challenges where there was “compelling evidence of unpatentability.”

Based on the new guidance, the Board is more likely to defer to the district court or the Commission if the Commission’s projected final determination date is earlier than the deadline for the Board’s final written decision. The PTO pointed out that a patent challenger’s stipulation not to raise the same invalidity arguments in other proceedings if the PTO institutes an inter partes review or post grant review is highly relevant but not dispositive.

This change in policy increases the likelihood that the Board will grant discretionary denials in situations involving parallel district court or Commission proceedings.




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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 [...]

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PTO Reverts to Prior Post-Grant Guidelines for Cases Involving Parallel District Court Litigation

On February 28, 2025, the acting director of the US Patent & Trademark Office (PTO) announced that the agency will revert to previous guidelines for discretionary denials of petitions for post-grant proceedings where there is ongoing district court litigation.

This announcement rescinds the PTO’s June 21, 2022, memorandum entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation.” The memorandum stated that the Patent Trial & Appeal Board “will not deny institution of an IPR or PGR under Fintiv (i) when a petition presents compelling evidence of unpatentability; (ii) when a request for denial under Fintiv is based on a parallel ITC proceeding; or (iii) where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” The memorandum effectively limited the discretion granted in Fintiv, which outlined six factors for the Board to consider when making decisions on post-grant proceedings involving parallel district court litigation.

Now that the 2022 memorandum has been rescinded, parties to post-grant proceedings should refer to Board precedent, including Fintiv and Sotera Wireless v. Masimo, for guidance when there are parallel district court proceedings. In accordance with prior guidelines, the PTO’s objective is to achieve greater consistency in its decision-making processes, especially in situations where patent validity is contested both in the courts and before the Board. The PTO emphasized that any portions of future Board decisions that rely on the 2022 memorandum will not be binding or persuasive.

Practice Note: Because of this action, the Board will now enjoy greater discretion when ruling on post-grant petitions, which may result in an increase of discretionary denials.




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Assessing Inputs: Determining AI’s Role in US Intellectual Property Protections

The US Patent & Trademark Office (PTO) issued additional guidance on the contribution of artificial intelligence (AI) in its January 2025 AI Strategy. Similarly, the US Copyright Office issued part two of its “Copyright and Artificial Intelligence” report, addressing the copyrightability of AI- or partially AI-made works. Both agencies appear to be walking a fine line by accepting that AI has become increasingly pervasive while maintaining human contribution requirements for protected works and inventions.

In its published strategy, the PTO states that its vision is to unleash “America’s potential through the adoption of AI.” The strategy describes five focus areas:

  • Advancing the development of intellectual property policies that promote inclusive AI innovation and creativity.
  • Building best-in-class AI capabilities by investing in computational infrastructure, data resources, and business-driven product development.
  • Promoting the responsible use of AI within the PTO and across the broader innovation ecosystem.
  • Developing AI expertise within the PTO’s workforce.
  • Collaborating with other US government agencies, international partners, and the public on shared AI priorities.

The PTO stated that it is still evaluating the issue of AI-assisted inventions but reaffirmed its February 2024 guidance on inventorship for AI-assisted inventions. That guidance indicates that while AI-assisted inventions are not categorically unpatentable, the inventorship analysis should focus on human contributions.

Likewise, the Copyright Office discussed public comments regarding AI contributions to copyright, weighing the benefits of AI in assisting and empowering creators with disabilities against the harm to artists working to make a living. Ultimately the Copyright Office affirmed that AI, when used as a tool, can generate copyrightable works only where a human is able to determine the expressive elements contained in the work. The Copyright Office stated that creativity in the AI prompt alone is, at this state, insufficient to satisfy the human expressive input required to produce a copyrightable work.




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Rules Are Rules, Especially in Trademark Proceedings

The Commissioner for Trademarks recently issued a precedential decision terminating a reexamination proceeding for the registrant’s failure to respond within a statutory time period, where there was insufficient justification to waive the response requirement. In re Trigroup USA LLC, Reg. No. 7094794 (Jan. 24, 2025) (Gooder, Comm’r for Trademarks)

The Trademark Modernization Act of 2020 (TMA) created two new trademark proceedings: expungement and reexamination. The US Patent & Trademark Office (PTO) began accepting petitions for these proceedings in 2021. The reexamination proceeding must be filed within the first five years after the registration of a trademark and can only be filed against applications filed on the basis of use (§ 1(a)) or intent to use (§ 1(b)). The proceeding questions whether the mark was in use by a certain date:

  • In the case of a use-based application, the mark must have been in use on all the goods or services identified in the application by the filing date of the application.
  • In the case of an intent-to-use application, the mark must have been in use on all the goods or services identified in the application by either the date the Allegation of Use was filed or the deadline for filing the Statement of Use.

A party filing for reexamination must submit evidence that the mark was not in use by those relevant dates.

When the PTO institutes a reexamination proceeding, it issues an Office Action providing the registrant with the opportunity to rebut the claims of non-use. The rules require a response within three months of the Office Action issue date, and failure to respond results in the cancellation of the registration.

Here, the registrant did not respond to the Office Action, and the PTO cancelled the registration. The registrant then filed a Petition to the Director requesting reinstatement of the registration. Such a petition is required to include a response to the original Office Action. However, in this case, the registrant did not provide such a response, and on that basis the Commissioner found that the Petition should not be granted.

The Commissioner further found that even if the petition had included a complete response, it did not set forth sufficient facts to justify a late response. Trademark Rule 2.146(a)(5) permits the Director to waive any requirement of the rules that is not mandated by statute only “in an extraordinary situation, when justice requires, and no other party is injured.” 37 C.F.R. § 2.146(a)(5).

The registrant explained that it had an ongoing matter in China and the failure to respond was due to inadvertent error because it was dealing with the Chinese matter. The Commissioner found that this was not an extraordinary circumstance. The registrant also explained that cancellation of the registration would hinder its ongoing efforts in China and prevent it from manufacturing its products there. The Commissioner found that justice did not require the waiver of the PTO rules just because there would be harm to the registrant: “a party cannot be excused from the [...]

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PTO Withdraws Proposed Rule on Terminal Disclaimer Changes

The US Patent & Trademark Office (PTO) withdrew its proposed rule that suggested major changes to its terminal disclaimer practice. 89 Fed. Reg. 96152 (Dec. 4, 2024).

In May 2024, the PTO issued a Notice of Proposed Rulemaking that would have required a terminal disclaimer to include an agreement that a patent would be unenforceable if it was tied directly or indirectly to another patent having any claim invalidated or cancelled based on prior art. During the proposed rule’s 60-day comment period, the PTO received more than 300 comments from a variety of stakeholders that both supported and opposed the proposal.

The PTO issued a notice withdrawing the proposal, explaining that in light of resource constraints, it decided not to move forward.




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