Insights

The USPTO is actively implementing and seeking out technologies to enhance the speed, accuracy, and consistency of the examination of patent applications.

Applicants entering the U.S. national phase of an international (PCT) application have two options: enter the national stage under 35 U.S.C. §371 or file a “bypass” national application under 35 U.S.C. § 111(a). A bypass application allows applicants to file a new U.S. application that claims priority to the PCT application, treating the PCT application as a U.S. parent and bypassing the traditional national phase entry. Depending on the applicant’s goals and strategy, bypass applications can be filed as a continuation, divisional, or continuation-in-part (CIP).

Twenty years ago, the Supreme Court held that “one who distributes a device with the object of promoting its use to infringe copyright, as shown by clear expression or other affirmative steps taken to foster infringement, is liable for the resulting acts of infringement by third parties.” MGM Studios, Inc. v. Grokster, Ltd., 545 U.S. 913, 919 (2005). In the Grokster case, the Supreme Court found that peer-to-peer file sharing companies could be liable for copyright infringement for their users’ deployment of file sharing software. There, the Court found that liability was warranted because the file sharing companies knew that its users were infringing, and the companies materially contributed to that infringement.

For the past few years since its official launch, as well as getting to grips with the developing procedures and case law of the Unified Patent Court (UPC), representatives have been using the UPC’s Case Management System (CMS) in its first iteration.

On June 10, 2025, the United States Patent and Trademark Office (USPTO) published a final rule that will discontinue the Accelerated Examination program for utility applications, beginning July 10, 2025. The final rule also modifies the rules of practice to clarify the grounds for which a petition to make special may be granted and when a fee is required for such a petition. Currently, Applicants have several ways to expedite examination of their patent applications. For example, an Applicant can expedite examination of utility patent applications by either petitioning to make their application special through the Accelerated Examination program or by applying through the Prioritized Patent Examination Program (“Track One” program).

Last week, artificial intelligence companies won two significant copyright infringement lawsuits brought by copyright holders, marking an important milestone in the development of the law around AI. These decisions – Bartz v. Anthropic and Kadrey v. Meta (decided on June 23 and 25, 2025, respectively), along with a February 2025 decision in Thomson Reuters v. ROSS Intelligence – suggest that AI companies have plausible defenses to the intellectual property claims that have dogged them since generative AI technologies became widely available several years ago. Whether AI companies can, in all cases, successfully assert that their use of copyrighted content is “fair” will depend on their circumstances and further development of the law by the courts and Congress.

The U.S. Court of Appeals for the Federal Circuit has relaxed the standard and clarified the analysis for the showing of a nexus to a patented invention when patent licenses are presented as objective indicia of nonobviousness.

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.