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. 

On May 13, 2025, the Department of Commerce’s Bureau of Industry and Security (BIS) formally rescinded the Framework for Artificial Intelligence Diffusion interim final rule published by the Biden Administration, on the basis that it stifled innovation, was overly complex, and undermined U.S. diplomatic relations.

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 USPTO has made a series of recent announcements in April that should not go unnoticed as they serve as important reminders for best practices in patent prosecution. In particular, the USPTO’s announcements address continuation applications, a new working group to mitigate fraud, and the elimination of expedited examinations for design applications.

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.

In a unanimous opinion issued by the D.C. Circuit on March 18, 2025, the Court of Appeals affirmed denial of Dr. Stephen Thaler’s application to register a copyright protection for a work created by his generative artificial intelligence system, holding that the Copyright Act requires human authorship.

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.

Senators John Cornyn(R-Texas), Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Dick Durbin (D.-Ill.) recently sponsored two bills, introduced on March 14th, that would affect patents in the pharmaceutical industry.

In a significant decision for generic drug manufacturers, the Federal Circuit recently affirmed that litigation expenses incurred in defending Hatch-Waxman patent lawsuits are deductible as ordinary and necessary business expenses under the Internal Revenue Code (IRC). The ruling in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025), resolves a key tax dispute, allowing tax deductions for these expenses in the year they are incurred rather than capitalizing them over time. This outcome provides clarity and potential tax benefits for qualifying businesses navigating the interplay of patent litigation and FDA drug approvals.

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.”

In 2023 and 2024, several U.S. states enacted extensive “Right to Repair” laws, reflecting a growing legislative focus on ensuring consumers have access to the parts and resources needed to repair their own products without relying on the product’s original manufacturer. Most recently, California, Colorado, Minnesota, New York, Massachusetts, and Oregon implemented comprehensive regulations aimed at providing consumers direct access to tools, parts, and information for the repair of various electronic devices and equipment, including digital products and agricultural machinery. As the “Right to Repair” movement continues to gain significant traction across the United States, it is critical that manufacturers understand these laws and how these laws will impact their individual businesses.

On February 27, 2025, the Court of Justice of the European Union (“CJEU”) issued a ruling about the requirements on data controllers to respond to data access requests regarding an automated decision-making system. In particular, the CJEU interpreted the meaning (under Article 15(1)(h) GDPR) of the phrase “meaningful information about the logic involved” in automated decision-making. Importantly, the ruling also separately addressed how to balance data access rights with the protection of the controller’s trade secrets, when the protection of trade secrets is invoked under Article 15(4) as a reason not to disclose a copy of personal data in an access request.

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.

On February 18, President Trump issued an Executive Order titled “Ensuring Accountability for All Agencies” that directs independent agencies (as well as Cabinet Departments and their sub-agencies) to route all “proposed and final significant regulatory” and budgetary actions through the White House and the Office of Management and Budget. If implemented to its full extent, this action will significantly strengthen the authority of the White House by weakening the political autonomy of these independent agencies. As an assertion of the President’s inherent powers under Article II of the U.S. Constitution, it also stands to weaken congressional influence over these independent agencies, both through the appropriations and confirmation processes.

On February 4, 2025, California Assemblywoman Rebecca Bauer-Kahan introduced AB 412, titled the AI Copyright Transparency Act (the “Act”), which is aimed at increasing greater transparency when copyrighted materials are used as training data for Generative AI (“GenAI”) models and systems. If passed, the Act would require developers who use copyrighted materials as part of their training dataset to disclose this use to the copyright owners.

The Federal Circuit recently issued a decision in Kroy IP Holdings, LLC v. Groupon, Inc., No. 23-1359 (Fed. Cir. Feb. 10, 2025), holding that collateral estoppel does not preclude a patentee from asserting any unadjudicated claims of a patent where other claims of the same patent were held unpatentable in an inter partes review (“IPR”) by the Patent Trial and Appeals board (“PTAB”).