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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 That announcement rescinded the PTO’s June 21, 2022, memorandum entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court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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New Year, New Fees: PTO Issues 2025 Fee Schedule

The US Patent & Trademark Office (PTO) issued its final rule setting and adjusting patent fees that will take effect on January 19, 2025. 89 Fed. Reg. 91898 (Nov. 20, 2024).

The final rule sets or adjusts 433 patent fees for undiscounted, small, and micro entities, including the introduction of 52 new fees. The fee adjustments are grouped into three categories:

  • Across-the-board adjustment to patent fees.
  • Adjustment to front-end fees.
  • Targeted fees.

Fees not covered by the targeted adjustments will increase by approximately 7.5%. Front-end fees to obtain a patent (i.e., filing, search, examination, and issue fees) are set to increase by an additional 2.5% on top of the 7.5% across-the-board adjustment. Targeted adjustments include increasing fees related to continuing applications, design patent applications, filing excess claims, extensions of time for provisional applications, information disclosure statement sizes, patent term adjustments, patent term extensions, requests for continued examinations, suspension of actions, terminal disclaimers, unintentional delay petitions, and Requests for Director Review of a Patent Trial & Appeal Board decision.

More information, including the new fee schedule, is available on the PTO’s website.




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Trademark Fee Increases: The TEAS Party Is Over

After a lengthy public comment and review process, the US Patent & Trademark Office (PTO) announced trademark fee increases effective January 18, 2025. The goal of PTO fee setting is to provide sufficient financial resources to facilitate the effective administration of the US intellectual property system. The PTO aspires to recover aggregate costs to:

  • Finance the PTO’s mission, strategic goals, and priorities.
  • Enable financial sustainability.
  • Promote efficient operations and filing behaviors.
  • Align fees with the costs of services provided.
  • Encourage access to the trademark system for all stakeholders.

The fees for filing a new trademark application via either the Trademark Electronic Application System (TEAS) or TEAS Plus will remain unchanged: $350 per class for a TEAS standard application and $250 per class for a TEAS Plus application for as long as TEAS remains available (and then using the Beta site discussed below). However, the PTO will institute surcharges for applications that are incomplete or contain custom identifications of goods or services. These application surcharges are intended to encourage more complete applications, which will improve examination efficiency and help reduce pendency.

Description Surcharge Insufficient information (Sections 1 and 44), per class $100 Using the free-form text box instead of the Trademark ID Manual within the Trademark Center to identify goods and services (Sections 1 and 44), per class $200 Each additional group of 1,000 characters in the free-form text box beyond the first 1,000 (Sections 1 and 44), per affected class $200

Since the World Intellectual Property Organization (WIPO) is currently unable to collect surcharges, the PTO will raise the fee for WIPO Madrid Trademark Applications to $600 per class.

The PTO will also raise the fees for post-registration filings to offset higher processing costs for these filings and continue balancing the cost of base applications.

Filing Current Fee Fee as of January 18, 2025 Section 9 registration renewal application, per class $300 $325 Section 8 declaration, per class $225 $325 Section 15 declaration, per class $200 $250 Section 71 declaration, per class $225 $325

The PTO has not increased the filing fees in connection with intent to use filings since 2002, although the time to examine such filings has increased exponentially because of the need to examine questionable specimens. Those fees are now set to increase as follows:

Description Current Fee Fee as of January 18, 2025 Amendment to allege use (AAU), per class $100 $150 Statement of use (SOU), per class $100 $150

The fees for requesting an extension of time are unchanged.

Finally, the number of petitions and protests have increased. The PTO will attempt to recover more of the cost of processing petitions and protests as follows:

Description Current Fee Fee as of January 18, 2025 Petition to the Director $250 $400 Petition to revive an application $150 $250 Letter of protest $50 $150

For further details, including a complete list of the fee increases, click here.

The PTO also announced that as of January 18, 2025, filers [...]

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A Lesson in Judicial Principles: No Dismissal After Decision

The US Court of Appeals for the Federal Circuit denied a patent owner’s motion to voluntarily dismiss the appeal following the Federal Circuit’s decision to vacate and remand the case to the Patent Trial & Appeal Board but before the mandate issued. Cisco Sys., Inc. v. K.Mizra LLC, Case No. 22-2290 (Fed. Cir. Nov. 19, 2024) (Dyk, Reyna, Stoll, JJ.)

Computer networking companies Cisco, Forescout, and Hewlett Packard filed a petition for inter partes review (IPR) to challenge the patentability of several claims of a patent owned by K.Mizra. The Board found that the petitioners failed to show that the challenged claims were unpatentable. Cisco and Hewlett Packard appealed.

After full briefing and oral argument, the Federal Circuit issued an opinion vacating the Board’s decision and remanding with further instructions. Before the Court’s mandate issued, the parties reached a settlement and moved to voluntarily dismiss the appeal without submitting a request to vacate the Federal Circuit opinion. The motions were unopposed.

The Federal Circuit stayed the issuance of the mandate while it considered the motions and invited the US Patent & Trademark Office (PTO) to comment. The PTO requested that the Federal Circuit deny the motions because it had already entered its opinion and judgment and denied rehearing. The Court agreed, declining to depart from its principle that granting a motion to dismiss the appeal at such a late stage (days before the issuance of the mandate) would result in a modification or vacatur of its judgment that was neither required nor a proper use of the judicial system.

The Federal Circuit also emphasized that appeals from the Board require additional consideration in terms of the PTO Director’s unconditional right to intervene. The Court concluded with a reminder that the parties were free to seek dismissal from the Board on remand.




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PTO Proposes Additional Audits to Put “Specimen Farms” Out to Pasture

In response to reports that some registrants use fraudulent specimens to prove continued use in commerce, the US Patent & Trademark Office (PTO) proposed an update to its post-registration audit process. Changes in Post-Registration Audit Selection for Affidavits or Declarations of Use, Continued Use, or Excusable Nonuse in Trademark Cases, 89 Fed. Reg. 85,435 (Oct. 28, 2024).

Since its institution in 2017, the PTO’s post-registration audit process has been essentially random. Pursuant to Section 8 of the Trademark Act, trademark owners are required to file documentation in the form of affidavits of continued use indicating that the marks remain in use in connection with goods or services covered by the registration. In turn, the public relies on the trademark register for notice of marks that may be available for use and registration. The PTO conducts random audits of submitted documentation to ensure its reliability.

Since encountering various filings that revealed “systemic efforts to subvert” a trademark’s use in commerce requirement, the PTO has taken steps to expand its audit program. For example, in 2019, the office amended its examination procedures to highlight “digitally created/altered or mockup specimens” that fraudulently indicate continued use in commerce. In 2021, the PTO became aware of “specimen farms,” which are websites designed to create the illusion of commerce without providing actual sales. To combat deceptive maintenance of obsolete marks, the PTO will no longer perform only randomized audits but will also conduct audits “directed” at items that show tell-tale signs of digital alteration or specimen farm website use.

The objective of the directed audit program is “to promote the accuracy and integrity” of the trademark register. This proposed policy is open for public comments on the Federal eRulemaking Portal until November 27, 2024.




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