Insights

For 15 years, the question “Should we file an IPR?” was easy. The answer — almost invariably — was “yes.” High institution rates, a famously skeptical U.S. Patent Trial and Appeal Board (PTAB), and minimal downside made inter partes review (IPR) a nearly reflexive tool in the litigator’s arsenal. U.S. Patent and Trademark Office (USPTO) Director Squires’ precedential decision issued May 14, 2026, in Magnolia Medical Technologies, Inc. v. Kurin, Inc. (IPR2026-00097) provides clarity to that calculus.

On April 30, 2026, USPTO Director John A. Squires issued an updated memorandum superseding the December 4, 2025, guidance on Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs). The USPTO has also created a new position — Deputy Commissioner for Patents focusing on AI Policy, Practice, and Operations — and has welcomed longtime practitioner and private-sector AI expert Barry Schindler to this role. This alert summarizes the key updates and actionable guidance for patent applicants and practitioners.

As prescription drug prices continue to soar in the United States, the Supreme Court recently heard the highly anticipated oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the first patent case at the Court since 2023. While the Justices did not seem motivated to make significant changes to the current standards for induced patent infringement, the stakes are high for brand and generic pharmaceutical companies, as each side continues to wrestle with the main dilemma that this case raises: What is the right balance between marketing skinny labels to engage in lawful generic competition and avoiding induced infringement liability?

In Constellation Designs, LLC v. LG Electronics Inc., No. 2024-1822 (Fed. Cir. Apr. 28, 2026), the U.S. Court of Appeals for the Federal Circuit distinguished between two sets of claims under a Section 101 analysis, invalidating one set as result-oriented “optimization” claims that did not recite how to achieve such optimization, but upholding the other set as patent-eligible for reciting specific configurations with defined parameters. The court also confirmed that patentees may prove infringement by combining standards-based and product-specific evidence on a limitation-by-limitation basis.

At the European Patent Office (EPO), a recent referral of case T 873/24 from the Technical Board to the Enlarged Board of Appeal may clarify whether last summer’s decision in case G 1/24 on claim interpretation may be extended to the analysis of Added Subject-Matter. Already G 1/24 is impacting the assessment of patentability at the EPO, but should this referral be allowed, G 1/24’s effect on the assessment of added matter could result in a real shake up of the EPO’s notoriously strict assessment of support. Nonetheless, a review of how we got here highlights the value of late arguments during the EPO appeal process.

[1] In a recent development, the UK Supreme Court ruled that Artificial Neural Networks (ANNs) are not excluded from patentability due to being a computer program “as such.” In doing so, the Court set out the framework of a new test for the UK Intellectual Property Office (IPO) to use when evaluating the patentability of computer. The ruling breaks down barriers to the patenting of AI algorithms in the UK and paves the way for a wider change in the UK IPO’s approach to assessing excluded subject matter.

On March 11, 2026, U.S. Patent and Trademark Office (USPTO) Director Squires issued a memorandum (2026 memo) to all Patent Trial and Appeal Board (PTAB) users titled “Additional Discretionary Institution Considerations — U.S. Manufacturing and Small Business Use of AIA Proceedings.”[1] In the 2026 memo, the director adds three new factors in determining whether to institute inter partes review (IPR) and post-grant review (PGR) proceedings.[2] The factors focus on domestic manufacturing and the use of these proceedings by small businesses.[3] The memo applies immediately to all pending IPR and PGR proceedings in which the due date for the patent owner’s discretionary brief has not yet elapsed.[4] Patent owners, petitioners with domestic manufacturing ties, and small business petitioners should take note.

Although the Supreme Court’s 2014 decision in Alice v. CLS Bank and its progeny affected the issuance and enforcement of software patents and led to a major shift in U.S. patent policy, software patents still have value today and such protection therefore should be pursued.

Nearly a decade and a half after the passage of the Leahy-Smith America Invents Act (“AIA”), the Federal Circuit finally had its first occasion to review an appeal of a derivation proceeding that was litigated before the Patent Trial and Appeal Board (“Board”) in Global Health Solutions LLC v. Selner. This case provides helpful guidance for patent litigators regarding the proper legal framework in a derivation proceeding and serves as a reminder that patent applications should be filed as soon as possible. As the facts of this case show, it is important that inventors retain documents and other evidence of the conception of their invention, as well as its communication to others, should there be any challenge to their invention.

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).

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.

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.

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.

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”).

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 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.