Patent Infringement

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Yesterday, the U.S. Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that could reshape the landscape of pharmaceutical patent enforcement and generic drug competition. The case concerns the scope of induced infringement liability under 35 U.S.C. § 271(b) in the context of “skinny labels” — the mechanism by which generic drug manufacturers may carve out patented indications from their FDA-approved labeling and enter the market for unpatented uses under Section viii of the Hatch-Waxman Act. A decision is expected by the end of the Supreme Court’s current term in June 2026. As we discussed in our earlier blog post on The Patent Playbook, this case squarely implicates the enforceability of method-of-use patents for later-developed drug indications, and the viability of the Section viii pathway for generic drug manufacturers.

In a decision that is quickly gaining attention, the Federal Circuit held that the district court abused its discretion by excluding both of Plaintiff’s experts and subsequently granting Defendants’ judgment as a matter of law (JMOL) of no infringement. Barry v. DePuy Synthes Companies.

The ruling is notable given the Federal Circuit’s recent en banc decision in Google v. EcoFactor, which reinforced district court’s gatekeeping authority over expert testimony. In Barry, however, the Court seems to be shifting greater responsibility back to the jury to assess expert credibility and weight.

The Supreme Court’s decision to review Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. places renewed attention on a familiar but unsettled issue in pharmaceutical patent law: how the induced infringement doctrine applies when a generic drug launches with a concededly “skinny” label, but engages in broader marketing and communications outside the FDA-approved label.

Although the case arises under the Hatch-Waxman Act, it squarely implicates the scope and enforceability of method-of-use patents, particularly for later-developed indications that often represent substantial additional investment by brand-name manufacturers.

For many patent cases, the United States District Court hearing your patent dispute can have a big impact on case strategy, budget and management, and even, to some extent, case outcomes. As we discussed earlier this year, how a patent owner approaches an alleged infringer can turn into a costly and inconvenient endeavor if forced to defend their patents in an unexpected jurisdiction. A recent case out of the District of Arizona illustrates the opposite scenario – where the activities of an accused infringer results in a suboptimal venue for that defendant.

Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of Delaware’s recent decision in Novo Nordisk v. Mylan is another reminder that the scope of method of treatment claims must be aligned with an FDA approved drug label. 

On August 11, 2025, the Federal Circuit reversed the District of Utah’s ruling that all but one of the claims in PowerBlock Holdings, Inc.’s U.S. Patent No. 7,578,771 were invalid under 35 U.S.C. § 101. PowerBlock Holdings, Inc., v. iFit, Inc. (“Appellate Op.”). In September 2023, the District Court found all but claim 19 failed the Alice test as they did not “add significantly more than the abstract idea of the end-result of an automated sectorized dumbbell. PowerBlock Holdings, Inc. v. iFit, Inc., 2023 WL 6377781, at *7 (D. Utah Sept. 29, 2023) (“Trial Op.”). The claims at issue are generally directed to an adjustable dumbbell system that uses an electric motor to couple additional weights to the dumbbell—allowing the user to increase or decrease the weight automatically. On appeal, the Federal Circuit reviewed the matter de novo.

The Federal Circuit recently reversed a $4.7M verdict in a patent lawsuit involving two patents concerning next-generation sequencing methods—U.S. Patent Nos. 10,017,810 and 10,450,597. Both patents concern DNA preparation using different types of primers: “target-specific primers” that bind to regions of interest in the genome and other primers or adaptors…

In April, the Federal Circuit issued a significant patent law ruling involving artificial intelligence. In Recentive Analytics, Inc. v. Fox Corp, the Court addressed a core question facing many AI-driven businesses: When are solutions applying machine learning to real-world problems inventive and patentable? The Federal Circuit affirmed the trial court’s dismissal of the underlying case at the pleading stage under § 101 and held that applying generic machine learning models to scheduling and programming tasks—without disclosing any technological advances to the underlying machine learning techniques—failed to meet the eligibility standards under 35 U.S.C. § 101.

Your Package Could Not Be Delivered – District of Delaware Strikes Electronic Storage Room Claims as Patent Ineligible

Judge Choe-Groves of the United States Court of International Trade granted Defendant’s Motion to Dismiss and ruled Plaintiff’s asserted electronic storage room patent invalid under § 101 of the Patent Act.

Luxer, a Delaware corporation and plaintiff in this patent infringement case, makes products related to controlling access to a package storage room. For example, the patent at issue describes systems and methods for controlling electronic locks of a storage room based on access rules and user credentials. The motivation behind these products is to offer a solution that allows a delivery carrier to drop off a package and a recipient to collect their package at any time and in a secure manner – no signature required. The Defendant, Package Concierge, Inc., offers very similar products.

Admissibility standards for patent damages experts has come under scrutiny. Previously, we highlighted the EcoFactor v. Google case regarding Google’s petition for rehearing en banc to address the admissibility of EcoFactor’s damages expert and the parties’ oral argument before the Court. On May 21, 2025, the Federal Circuit issued an 8-2 decision, ordering a new damages trial and overturned the $20 million verdict against Google. The Court found that the district court committed reversible error by allowing EcoFactor’s damages expert to testify at trial.