Generics
20 August 2025 The Japanese pharma company has defended a key patent for a treatment that achieved record 2024 sales of over $6 billion—but a patent cliff looms.
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
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.
20 February 2025 British pharma giant says that a Federal Circuit decision could stifle competition by lowering the bar for proving patent infringement | Earlier ruling ‘nullifies a statutory mechanism for expediting access to generic drugs and breaks sharply with precedent on inducement’ says UK pharma company.
13 February 2025 The company’s Eylea treatment patent faced intense scrutiny as the US Federal Circuit heard Williams & Connolly, RMMS Legal, and McGuireWoods argue over criticality, stability, and validity.
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