Insights

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.

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.

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.

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.

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.

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 Judgment of the Brussels Court of Appeal is the latest development in the saga in Belgium where a Belgian parallel importer, PI Pharma NV, imported a generic Sandoz product from the Netherlands, repackaged and rebranded them, and placed them on the Belgian market alleging they were a Novartis’ originator product.

The United States Patent and Trademark Office (USPTO) issued a Federal Register Notice on February 13, 2024 explaining how it will analyze patent inventorship issues for inventions that utilize artificial intelligence (AI) systems. Overall, the USPTO concluded that AI-assisted inventions are not categorically unpatentable, but that a human must have made significant contributions in every aspect of the invention, and reminds applicants of their duty of candor to disclose information that could evidence that an individual may not be an inventor where her/his purported contribution was the result of an AI system. 

The Federal Circuit recently denied a petition for rehearing en banc in the much watched In re Cellect matter.  The landmark panel decision determined how obviousness-type double patenting (“ODP”) is impacted when patent term adjustment (“PTA”) is added to the term of one or more patents in a family under 35 U.S.C. § 154(b), resulting in different terms for the family member patents that would otherwise expire on the same day.

A recent Final Initial Determination (“FID”) from newly appointed Administrative Law Judge Hines confirmed the statutory authority of the International Trade Commission (“ITC” or “Commission”) to investigate the alleged importation of goods incorporating misappropriated trade secrets causing injury to a domestic industry, as held by the Federal Circuit in TianRui Grp. Co. Ltd. v. Int’l Trade Comm’n, 661 F.3d 1322 (Fed. Cir. 2011).  The ALJ also held that Complainant had proven its domestic industry had been substantially injured despite the fact that its revenue had increased during the same period.  For Crowell’s previous client alert on TianRui, see here.

The U.S. Supreme Court has granted review of an 11thCircuit ruling in the case of Nealy et al. v. Warner Chappell Music Inc. et al. The issue at hand is whether a copyright plaintiff can recover damages for acts that allegedly occurred more than three years before filing the case. Specifically, the court will examine the application of the discovery accrual rule, which determines when the clock starts ticking for the statute of limitations in copyright infringement cases. Warner Chappell Music argues that a copyright plaintiff should not be able to recover damages for acts that occurred outside the three-year statute of limitations. The company aims to establish a precedent that would limit the timeframe in which copyright plaintiffs can seek additional damages.

Sometimes we think we have an agreement—only to find out that we do not agree about the meaning of the agreement, and therefore have no agreement at all.  This is, of course, a common fact pattern in a contract dispute, but it is also something to look out for in the claim construction process.  An agreed claim construction is a far cry from an agreement as to the meaning of that construction as applied to the accused products.  We therefore have the counter-intuitive situation where an agreed construction becomes hotly disputed.  When this happens, it is a reminder that even when we agree on a construction that we think favors us, we should not assume that the opposing party, court, or jury will see it that way.

A petition for Inter Partes Review (IPR) kicks off an IPR proceeding, and is required to set forth the grounds of invalidity and how the claim terms should be construed. In the precedential opinion Axonics, Inc. v. Medtronic, Inc., the Federal Circuit held that if the patent owner proposes, or the Patent Trial and Appeal Board (PTAB) adopts, a claim construction that is different from the construction proposed by the petitioner, the petitioner should be given an opportunity to present invalidity arguments and evidence under the new construction. In responding to the new claim construction, however, the petitioner is limited to the prior art of record, and it may not rely upon new prior art references. The Federal Circuit left open whether the petitioner may rely upon different embodiments in a previously cited reference.

Pharmaceutical innovators typically seek broad patent protection for their discoveries in order to prevent others from exploiting not only the specific embodiments the innovator wishes to pursue commercially, but also functional equivalents. But what happens when the additional functional equivalents that the innovator seeks to protect are not expressly disclosed in the patent? The Supreme Court recently addressed this issue in Amgen v. Sanofi.

On June 22, 2023, U.S. Senators Thom Tillis (R-NC) and Chris Coons (D-DE) introduced the Patent Eligibility Restoration Act of 2023 (“the Bill”), aiming to restore patent eligibility to important inventions across many fields.  Essentially, the Bill is trying to eliminate judicial exceptions to patent eligibility, and provide clear guidance on determining patent eligibility, especially in areas such as medical diagnostics, biotechnology, personalized medicine, artificial intelligence, 5G, and blockchain.  The U.S. Supreme Court has established several judicial exceptions to subject matter eligible for patenting.  Although these exceptions are not enumerated in the statute, the Supreme Court has interpreted 35 U.S.C. § 101 to exclude subject matter from being patented if it falls within any of three areas:  natural phenomena, laws of nature and abstract ideas.  Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014).  These judicial exceptions frustrate many IP owners around the world, because many inventions that are eligible for patents in other countries cannot be patented in the U.S. or are ruled invalid in U.S. courts.  Moreover, supporters of this bill argue that leading-edge technologies that give U.S. industry competitive advantages over foreign companies have been difficult to patent in the U.S. under the Court’s rulings.  This legislation reportedly has a good chance to pass in this Congressional session, and companies need to be prepared for the dramatic changes if it becomes law.