Related coverage linked through entity extraction aliases.
Jul 01, 2026
Supreme Court unanimously reversed the Federal Circuit in Hikma v. Amarin, ruling that 'skinny label' generic marketing does not induce patent infringement absent active steps to encourage it. The decision requires affirmative conduct, not mere plausible interpretations, to support inducement claims.
Jul 23, 2026
The Supreme Court will hear Hikma's appeal in the 'skinny label' patent fight over Amarin's Vascepa. The ruling could affect generic drug competition and investment in new drug indications.
Apr 22, 2026
Novartis reported 2025 sales of $54.5 billion, up 8%, while earnings per share rose 15% to $8.98. Amarin reported fiscal 2025 revenue of $213.6 million, down 6.5%, and narrowed its net loss per share to $0.09 from $0.20.
Apr 09, 2026
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
Mar 24, 2026
Legal scholars argue FDA-required drug labels should not serve as evidence in patent infringement cases against generic manufacturers. The Supreme Court will hear a case involving this "infringement by label" theory, which could clarify that regulatory compliance alone doesn't prove patent violation. This approach threatens affordable generic drug access by creating liability for companies following FDA rules.
Mar 02, 2026
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
