"The leading contender is Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, which asks whether a generic drug manufacturer that fully carves patented uses out of its FDA-approved label can nonetheless face induced infringement liability simply by calling its product a "generic version" of the brand-name drug or referencing publicly available information about the branded product's sales. The"
"Hikma's petition contends that allowing inducement liability based solely on generic drug labeling and reference to the brand product would effectively nullify the statutory skinny label mechanism. The Federal Circuit's approach, Hikma argues, conflicts with the Court's recognition in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012), that the Hatch-Waxman framework contemplates generics entering the market with narrower labels than the branded drug."
Six pending certiorari petitions focus on patent law and Federal Circuit procedure as the Supreme Court approaches its November and December conferences. The leading petition, Hikma Pharmaceuticals v. Amarin, asks whether a generic manufacturer that carves patented uses out of its FDA-approved label can still be liable for induced infringement by calling the product a "generic version" or referencing branded-product sales. The petition challenges a Federal Circuit decision that allowed inducement claims despite Hikma's label omitting direct references to the patented method. The Hatch-Waxman framework permits so-called skinny labels under 35 U.S.C. §271(e)(2). Hikma contends that allowing inducement liability based on labeling or reference would nullify the skinny-label mechanism and conflict with Caraco. The Supreme Court's June 23, 2025 CVSG requests the Solicitor General's view on statutory interpretation and policy implications.
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