Insights

Acting USPTO Director Coke Morgan Stewart issued a Director Discretionary decision on June 6, 2025, in iRhythm Technologies Inc. v. Welch Allyn Inc., IPR2025-00363, -00374, -00376, -00377, and -00378 Paper 10 (PTAB June 6, 2025). This decision granted Patent Owner’s request for discretionary denials of institution in five related IPR challenges.  It follows several recent Director decisions that have all discretionarily denied petitions for reasons other than the substantive merits of the challenges. However, this decision is the first one that relies upon “[s]ettled expectations of the parties, such as the length of time the claims have been in force,” a new consideration that was first articulated in the USPTO’s “Interim Process for PTAB Workload Management” memorandum (“Interim Memo”) dated March 26, 2025.

Acting USPTO Director Coke Morgan Stewart recently issued a Director Review decision on May 19, 2025, in Ecto World, LLC v. RAI Strategic Holdings, Inc, IPR2024-01280, Paper 13 (PTAB May 19, 2025), that was subsequently designated as precedential by the Patent Trial and Appeal Board (PTAB). The decision seeks to eliminate inconsistencies amongst PTAB panels in using its discretion to deny institution under 35 U.S.C. § 325(d). 

On Friday, May 9, 2025, the U.S. Copyright Office released the third (pre-publication) installment in a series of reports regarding the intersection of artificial intelligence (AI) and copyright law.[1]  This report addresses the legal implications of training generative AI models using copyrighted materials.[2] 

As part of the 2012 America Invents Act, statutory estoppel was included to balance the interests of patent owners and patent challengers following an inter partes review (“IPR”).  Estoppel prevents an IPR petitioner from later asserting in court that a claim “is invalid on any ground that the petitioner raised or reasonably could have raised” during the IPR.  35 U.S.C. § 315(e)(2).  As applied, estoppel prevents petitioners from later relying in district court or in ITC proceedings on most patents or printed publications – the limited bases upon which petitioner can rely in an IPR.  But a question remained, and contradictory district court decisions arose, as to whether petitioners would be estopped from relying on a prior art commercial product (known as “device art,” which could not itself have been raised in the IPR) even if a printed publication describing the product (i.e. a patent or technical manual) was available and presumably could have been raised. 

In a bipartisan show of support for American inventors and technological leadership, Senators Chris Coons (D-DE), Thom Tillis (R-NC), and Mazie Hirono (D-HI) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) held a press conference on Wednesday, May 1, 2025, to highlight growing momentum behind the Promoting and Respecting Economically Vital American Innovation Leadership Act (known as the PREVAIL Act) and the Patent Eligibility Restoration Act (known as the PERA Act).  

The Federal Circuit recently addressed a case of first impression involving AI patented technology under 35 U.S.C. § 101 to hold that “claims that do no more than apply established methods of machine learning to a new data environment” are not patent eligible. This case provides helpful guidance for patent prosecutors on how to draft claims directed to AI technology to be patent-eligible and for litigators on how to attack or defend AI patents.

In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.

On March 13, 2025, the United States Court of Appeals for the Federal Circuit issued a decision about Patent Term Extensions (PTEs) under the Hatch-Waxman Act for reissue patents. In Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254), the Court confirmed that the PTE provision under 35 U.S.C. § 156 refers to the original patent’s issue date, not the reissue patent’s issue date. Thus, the issue date of the original patent should be used when calculating the extension period.

On Wednesday, March 5, 2025, the United States Patent Trial and Appeal Board (“PTAB”) handed down the latest decision in the COVID vaccine proceedings between Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) and ModernaTX, Inc. (“Moderna”). The PTAB found all challenged claims unpatentable in two patents held by Moderna related to Moderna’s COVID-19 vaccine technology: U.S. Patent Nos. 10,702,600 (the “’600 patent”) and 10,933,127 (the “’127 patent”), both entitled “Betacoronavirus mRNA Vaccine.”

On February 28, 2025, the USPTO announced that it was rescinding a 2022 memorandum issued by former USPTO Director Kathi Vidal, entitled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” which had curtailed discretionary denials of PTAB post-grant proceedings. The February 2025 announcement directs parties to refer to PTAB precedent for guidance, including the decisions in Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) and Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020). The announcement further indicates that, to the extent any PTAB or Director Review decisions relied on the 2022 memorandum, the portions of those decisions shall not be binding or persuasive on the PTAB.

Design patents play a crucial role in protecting the aesthetic and functional aspects of electric vehicle (EV) charging stations and connectors, which are essential components in the growing EV market, and the burgeoning infrastructure supporting the same. Participants in this crowded market would be wise to protect their innovations and investments by filing for design patents directed to distinctive design elements of the products and services they offer, as part of a robust intellectual property strategy. Doing so can help such participants enhance their market position, obtain and then maintain market differentiation, and attract investors.

On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.

On November 22, 2024, World Intellectual Property Organization (WIPO) member states adopted the Riyadh Design Law Treaty (“Treaty”). This development is arguably the biggest advancement in international design law since 1999, when the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs (“the Hague Agreement”) was adopted.

Since 2020, the FCC has been working on rules for cellular communication technology that allow vehicles to share information with other vehicles, infrastructure, and safety systems (commonly known as cellular vehicle-to-everything or C-V2X).  Although the C-V2X industry continues its development at a blistering pace, some have commented that advancements in the space have been impeded because of the FCC’s delay. In a September 27, 2024 letter to the FCC, the Alliance for Automotive Innovation (“AAI”), whose membership includes both manufacturer and technology companies, once again requested that the FCC finalize rules for C-V2X technology so that innovations in the field can be made and deployed.

The Federal Circuit in Sanho Corp. v. Kaijet Technology International Limited, Inc., No. 2023-1336 (Fed. Cir. July 31, 2024) recently addressed the prior art exception of a “public disclosure” under 35 USC § 102(b)(2)(B).  Affirming a decision of the U.S. Patent Trial and Appeals Board (“PTAB”), the court held that “publicly disclosed” is only satisfied if the invention was made available to the public, and a non-confidential but otherwise private sale of an invention is not a sufficient “public disclosure”.  This case provides a cautionary tale that disclosing or selling an invention before filing a patent application is fraught with risk.

The USPTO has proposed a rule rendering a patent unenforceable if it is disclaimed over another patent that is subsequently found invalid.  The FTC filed a comment letter in support of the USPTO’s proposed rule, noting that “the proposed rule would reduce the costs incurred by potential competitors challenging weak patents or defending against assertions of patent claims that are obvious variants of a single invention.”

In its first en banc decision in six years, the Federal Circuit in LKQ Corp. v. GM Global Technology Operations LLC, No. 2021-2348 (Fed. Cir. May 21, 2024) overruled the prevailing obviousness test for design patents; abandoning the decades-old standard known as the Rosen-Durling test, and embracing a less rigid approach to assessing obviousness for design patents.  As explained below, the decision creates uncertainty as to how the obviousness of design patents should be assessed in the future.  

On April 11, 2024, the USPTO published its “Guidance on Use of Artificial Intelligence-Based Tools in Practice Before the United States” in the Federal Register (the “Guidance”). As the title suggests, the document provides additional opinions and guidance from the USPTO on the use of AI tools for prosecuting patent and trademark applications before the USPTO.

On March 25, 2024, the Federal Circuit issued a precedential opinion in Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd., a case with significant implications for the application of the safe harbor provision of 35 U.S.C. § 271(e)(1). This case involved the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd., an India-based medical device company, to San Francisco for a medical conference. According to Meril, these heart valve systems, part of Meril’s Myval System designed to treat heart disease, were never displayed or offered for sale at the conference but were instead stored in a bag in a hotel closet and later in a storage room. The Court’s decision to affirm the district court’s grant of summary judgment of noninfringement in favor of Meril brings to light the nuances of applying the safe harbor provision in patent infringement cases.

The Federal Circuit’s decision in University of South Florida Board of Trustees v. United States, 22-2248 (Fed. Cir. Feb. 9, 2024) hints at the broad scope of the federal government’s license rights under the Bayh-Dole Act.