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Article
Inflation Reduction Act Update: What’s Changing In Drug Pricing
The Inflation Reduction Act (IRA) continues to reshape the US drug‑pricing landscape as federal implementation accelerates and market responses evolve. In 2025, regulators advanced core IRA programs affecting Medicare negotiation, inflation rebates, and benefit redesign, while litigation, executive action, and agency rulemaking clarified, and in some cases expanded, the federal government’s role in pharmaceutical pricing and access.
United States Healthcare
M
Mintz
Article
SPCs To Keep The CJEU Busy: Four Referrals To Watch
Four pending cases before the Court of Justice of the European Union are set to clarify critical aspects of Supplementary Protection Certificate (SPC) law, addressing questions about manufacturing waivers, the definition of medicinal products, and what constitutes a "first" marketing authorisation. These referrals from Danish, German, and Czech courts involve major pharmaceutical companies and could significantly impact SPC strategy across EU member states.
United States IP
JA
J A Kemp LLP
Article
FDA Approves Lupin’s Ranibizumab Biosimilar
Lupin has secured FDA approval for RANLUSPEC, a ranibizumab biosimilar to Genentech's LUCENTIS, marking a significant development in the treatment of neovascular age-related macular degeneration and retinal vascular disorders. This approval establishes RANLUSPEC as the only interchangeable biosimilar ranibizumab available in both vials and pre-filled syringes in the United States, representing Lupin's second biosimilar to receive FDA authorization.
United States Healthcare
GP
Goodwin Procter LLP
Article
“Practically Complete”: Otsuka v. Lupin and the Chemistry of Missed Opportunity in Hatch-Waxman Litigation
A Federal Circuit case examines whether a generic drug manufacturer's process infringes a product-by-process patent claiming highly pure tolvaptan made through a specific reduction reaction. The dispute centers on proving infringement during an intermediate stage of chemical synthesis, raising questions about claim interpretation, expert testimony reliability, and the evidentiary challenges of demonstrating what occurs inside a sealed reaction chamber.
United States IP
YMF Law Tokyo
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