Insights

On May 13, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a district court judgment of no infringement in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., No. 24-1641. The decision offers important guidance for patent holders and generic manufacturers on the role of industry standards in interpreting scientific terminology during claim construction, prosecution history estoppel, and the disclosure-dedication rule.

The U.S. Court of International Trade (CIT) is having a big year. While the U.S. Supreme Court’s affirmance of the CIT tariff ruling may be at the top of the headlines, the CIT is also making its mark on Hatch-Waxman pharmaceutical litigation. In late April 2026, the U.S. District Court for the District of New Jersey (DNJ) reassigned numerous Hatch-Waxman patent infringement cases involving 10 different drugs to Judge Jennifer Choe-Groves of the CIT, sitting by designation in the District of New Jersey. The cases currently assigned to Judge Choe-Groves relate to several different drug products, including LYNPARZA® (olaparib), RADICAVA ORS® (edaravone), NEXLETOL®/NEXLIZET® (bempedoic acid), ZEJULA® (niraparib), QULIPTA® (atogepant), UBRELVY® (ubrogepant), CREXONT® (carbidopa and levodopa), EVRYSDI® (risdiplam), SUFLAVE® (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), and CAPLYTA® (lumateperone).

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.

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.

In Fortress Iron, LP v. Digger Specialties, Inc., No. 24-2313 (Fed. Cir. Apr. 2, 2026), the U.S. Court of Appeals for the Federal Circuit reaffirmed what happens when a patent incorrectly lists the true inventors, and that error cannot be corrected under 35 U.S.C. § 256(b), which requires notice and a hearing for all “parties concerned.” In Fortress, the patent owner sought judicial correction to add an inventor under § 256(b), but that inventor could not be located. Because the missing inventor qualified as a “concerned” party under the statute, the lack of notice and a hearing for that inventor made correction under § 256(b) impossible, and the patents could not be saved from invalidity.

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.

The U.S. Court of Appeals for the Federal Circuit recently decided in Bd. of Trs. of Columbia Univ. v. Gen Digital Inc., No. 2024-1243 (Fed. Cir. 2026) that the district court erred in its denial of judgment as a matter of law as to damages resulting from foreign sales of downloadable software. At Columbia University's request, the jury had been instructed that “Columbia [was] entitled to damages based on sales to customers located outside of the United States if . . . the infringing product sold to those customers was made in or distributed from the United States, even if the infringing product [was] delivered to and used by the customer outside the United States.” The court concluded as a matter of law that the software sold to Gen Digital‘s (Norton) foreign customers was made outside the United States, and therefore the $94 million in foreign sales damages could not stand.

[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.

Ex parte reexamination is seeing a resurgence in popularity as a cost-effective means to challenge a patent’s validity and should be part of your patent strategy. An ex parte reexamination is a proceeding in which any party — including a patent owner or an anonymous third party — may submit prior art to request that the United States Patent and Trademark Office (USPTO) reassess an issued patent's validity. Once overshadowed by the introduction of inter partes review (IPR) and post-grant review (PGR) following the enactment of the America Invents Act in 2012, ex parte reexamination is now experiencing a significant resurgence as a strategic alternative to both proceedings. This client alert explains what is driving ex parte reexamination’s resurgence and what it means for your patent strategy.

The Court of Justice of the European Union (CJEU) recently delivered its judgment in the CeramTec case (C-17/24).

On November 4, 2025, the USPTO in Ex parte Desjardins designated as precedential an earlier Appeals Review Panel (ARP) decision overruling the Patent Trial and Appeal Board (Board), instead holding that claims directed to training a machine learning model are patent-eligible under 35 U.S.C. § 101 when they integrate a mathematical concept into a practical application that improves how the model operates. That precedential designation represents a material shift in legal precedent in the § 101 arena post-Alice, and it has already driven updates to the MPEP and examiner practice. As a result, Desjardins signals an adjustment in practice in favor of AI and software eligibility at the USPTO.

Patent claims must be clear and definite, as they set the boundaries of the patentee’s rights. Occasionally, however, claim language contains errors, such as typographical mistakes or incorrect numbering. Courts possess very limited authority to correct such errors. The United States Court of Appeals for the Federal Circuit has emphasized that judicial correction is appropriate only in rare circumstances, where (1) the error is evident from the face of the patent, and (2) the proposed correction is the sole reasonable interpretation in view of the claim language, specification, and prosecution history. See Group One, Ltd. v. Hallmark Cards, Inc., 407 F.3d 1297, 1303 (Fed. Cir. 2005) and Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003).

Design patents offer protection for the ornamental appearance of a product, focusing on aspects like its shape and surface decoration, as opposed to the functional aspects protected by utility patents. The scope of a design patent is defined by the drawings and any descriptive language within the patent itself. Recent decisions by the Federal Circuit emphasize the need for clarity in the prosecution history of a design patent in order to preserve desired scope to preserve intentional narrowing (and to avoid unintentional sacrifice of desired claim scope).

Claim construction is a key stage of most patent litigations, where the court must decide the meaning of any disputed terms in the patent claims.  Generally, claim terms are given their plain and ordinary meaning except under two circumstances: (1) when the patentee acts as its own lexicographer and sets out a definition for the term; and (2) when the patentee disavows the full scope of the term either in the specification or during prosecution.  Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).  The Federal Circuit’s recent decision in Aortic Innovations LLC v. Edwards Lifesciences Corp. highlights that patentees can act as their own lexicographers through consistent, interchangeable usage of terms across the specification, effectively defining terms by implication.

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.

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.

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.