Generics
18 September 2025 A UPC Court of Appeal decision establishes a new benchmark for what constitutes imminent infringement in pharmaceutical patent litigation, particularly regarding generics’ pre-launch preparations, writes Mike Gruber of Carpmaels & Ransford.
2 September 2025
Latest Features
Americas
A patent fee structure being mooted in the US could hurt the innovation economy, especially in industries like biotech and pharma—and will face backlash from businesses, writes Paul Hunter of Foley.
Europe
Supplementary Protection Certificate rules interpreted in different ways have left the EU’s generic and biosimilar industries hungry for clarity, explains Jiri Slavik of Adalvo.
Generics
While President Biden’s desire to reduce costs at the pharmacy counter is commendable, it is too blunt an instrument that would threaten innovation beyond the life sciences, argue former USPTO directors Andrei Iancu and David Kappos.
Asia
Five cases in which preliminary injunctions were granted are examined by Takanori Abe of Abe & Partners.
Biotechnology
The Australian government has made numerous claims for damages against patentees for savings forgone when an interlocutory/preliminary injunction delays a generic's launch but the patent is invalidated or there is a finding of non-infringement.
Generics
Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
Americas
Certain problems with the patent opposition process need to be addressed in order to protect patent owners, say Alejandro Luna and Luz Elena Elias of Olivares.
Africa
Government-led schemes to incentivise patents are leading to delays and prejudice against legitimate applicants. Tyron Grant of Spoor and Fisher explains how South Africa is tackling the problem.
More News
17 June 2025 Semaglutide generics set to enter the Canadian market by 2026 after Novo Nordisk failed to maintain key patent | Speculation over whether it was a mistake or calculated move in a country known for strict drug price controls.
10 June 2025 US appeals court confirms validity of Acadia's Nuplazid patents | Decision fends off generics from MSN Laboratories and Aurobindo Pharma until 2030s.
10 April 2025 Pharma giant dodges threat as US judge dismisses monopoly claims over its blockbuster cancer drug | FDA approves new treatment combo for advanced colorectal cancer.
1 April 2025 MSD, Novartis and Eli Lilly are among those whose multi-billion-dollar patents are hurtling towards expiration, writes Marisa Woutersen.
31 March 2025 With billions in revenue at stake, the pharma giant has a 27-country parallel litigation effort to protect its blockbuster blood thinner from generics. Marisa Woutersen finds Bayer’s outside litigation counsel ready for anything.
25 March 2025 Court of Appeals rules defence costs in Hatch-Waxman cases are deductible as ordinary business expenses | US IRS stands to pay tax rebate to generics manufacturer.
20 March 2025 Trio files multiple patent infringement lawsuits to protect blockbuster prostate cancer drug | Latest suits target Hetero and Aizant, following similar actions against Apotex, BDR Pharmaceuticals, and CIPLA.
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