Yesterday, the U.S. Supreme Court issued its decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, unanimously reversing the Federal Circuit and holding that Amarin failed to state a claim “more than a sheer possibility” for active inducement of patent infringement under 35 U.S.C. § 271(b) to
Supreme Court Hears Oral Argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.: Induced Infringement and “Skinny Labels” at a Crossroads
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.
Genesis Mission and New Guidance for AI-Assisted Inventions
The Federal government is accelerating AI‑enabled innovation by launching the Genesis Mission, a sweeping national initiative to accelerate scientific discovery using artificial intelligence. The goal of the Mission is to “build an integrated AI platform to harness Federal scientific datasets…to train scientific foundation models and create AI agents to test new hypotheses, automate research workflows, and accelerate scientific breakthroughs.” Under the leadership of the Assistant to the President for Science and Technology, the Department of Energy will implement the Mission.
Federal Circuit Clarifies Limits of Issue Preclusion Between IPRs and District Courts
The Federal Circuit’s recent decision last week in Inland Diamond Prods. Co. v. Cherry Optical Inc., offers an important reminder for patent litigators: a PTAB’s factual finding in an inter partes review (IPR) does not automatically bind a district court. The case underscores that issue preclusion has clear boundaries when different forums apply different standards of proof.
Federal Circuit Reverses $4.7M Verdict in Labcorp v. QIAGEN: Claim Scope and Doctrine of Equivalents in the Crosshairs
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
Impact of the Leadership in Critical Technologies Act on U.S. Artificial Intelligence, Semiconductors and Quantum Computing
On the heels of the recent reintroduction of the PERA and PREVAIL Acts of 2025, a bipartisan group of lawmakers in Congress has introduced the Leadership in Critical and Emerging Technologies (“CET”) Act. The goal of the Leadership in CET Act is to “encourage innovation by, and the leadership of, the United States with respect to critical or emerging technologies” – specifically, artificial intelligence, semiconductor design, and quantum information science.
Interesting Recent § 101 Cases – Structural Components Are Not Enough
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.
Value and Risk of Overlapping Intellectual Property Protections
A well-orchestrated intellectual property strategy requires carefully and thoughtfully leveraging copyright, trademark, and patent laws, as highlighted by a recent decision handed down by the United Sates Court of Appeals for the Federal Circuit: CeramTec GMBH v. CoorsTek Bioceramics LLC.
Litigating Patents in the ITC: When and Why Companies Take the Section 337 Route
Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences, and consumer electronics industries. With the power to block infringing products from entering the U.S., the ITC has become an increasingly attractive option for patent holders seeking swift and decisive remedies.
The Uncertain Future of Section 101: Patent Eligibility in the Wake of Recent Supreme Court (In)Action
Patent eligibility under 35 U.S.C. § 101 remains one of the most hotly contested and unpredictable areas of U.S. patent law. In the years following the Supreme Court’s landmark decisions in Alice Corp. v. CLS Bank Int’l (2014) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), lower courts, the USPTO, and the Federal Circuit have wrestled with the proper application of the two-step framework for determining whether an invention is directed to an abstract idea, law of nature, or natural phenomenon—and, if so, whether it includes an inventive concept sufficient to transform it into patent-eligible subject matter.