Supreme Court's January 2026 IP Docket: Hikma Leads a Small but Significant Field
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Supreme Court's January 2026 IP Docket: Hikma Leads a Small but Significant Field
"The Supreme Court has not granted certiorari in any patent cases this term and only four are still pending before the Court. But the ones that are pending include some important questions. Of the four, one stands out as the most likely candidate for certiorari: Hikma Pharmaceuticals v. Amarin Pharma, a Hatch-Waxman induced infringement case that received a supportive call-for-the-views-of-the-Solicitor-General (CVSG) response."
"Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, presents the strongest cert candidate among the pending patent petitions. The question is whether a generic drug manufacturer that fully carves out patented uses from its FDA-approved label can face induced infringement liability based solely on calling its product a "generic version" of the brand-name drug or citing publicly available information about the branded product's sales."
Four patent petitions remain pending before the Court, with Hikma Pharmaceuticals v. Amarin Pharma the leading certiorari candidate. The Hikma question asks whether a generic that carves out patented uses from its FDA-approved label can incur induced-infringement liability for calling its product a "generic version" or for citing public information about the branded product's sales. The dispute tests the Hatch-Waxman Act's skinny-label mechanism, which allows generic approvals that omit patented indications to permit marketing for unpatented uses. The case references Caraco Pharmaceutical Laboratories v. Novo Nordisk and received a call-for-the-views from the Solicitor General.
Read at Patently-O
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