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 allow the case to move forward. Writing
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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” —
Back to District Court? PTAB Strategic Recalibration in Patent Litigation
For years, parallel proceedings at the Patent Trial and Appeal Board (PTAB) were the near-automatic response of a defendant in district court patent litigation. Accused infringers routinely filed petitions—especially inter partes review (IPR) petitions—challenging validity of the asserted patents at the PTAB. Given the PTAB’s technical expertise, historically favorable invalidation rates, and lower standard of
Updates on APEX-related Personal Jurisdiction Considerations Since SnapRays
Last year we discussed the implications of the Supreme Court’s choice not to review the Federal Circuit’s SnapRays decision for patent owners that rely on the Amazon Patent Evaluation Express (“APEX”) program. A recent case out of the Northern District of California illustrates the limits of the SnapRays decision.
Federal Circuit Eases Expert Admissibility Threshold
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
Supreme Court Takes Up Hikma v. Amarin: Induced Infringement and Skinny Labels in the Crosshairs
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
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
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
Patent Practitioners are Unsettled Regarding Seemingly-Settled Section 101 Jurisprudence
Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear principle has become anything but.
Although the statute itself has remained unchanged for two centuries, its interpretation has evolved dramatically through judicial
Stay Aware: Remote Employees Impact Venue Options In Patent Litigation
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