Generics
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
13 February 2025
Latest Features
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.
Big Pharma
The long-running legal saga between the pharma giant and the NHS as well as generic drug makers has developed further, as Darren Smyth of EIP explains.
More News
29 January 2025 Complex legal battle concerns ‘skinny label’ strategy used by generic drug makers, prompting a $235 million award | Pharma giant looks for enhanced damages due to ‘wilful infringement’, while opponent wants another trial.
28 January 2025 Court cites lack of inventiveness and failure to meet reproducibility standards | Decision part of broader international litigation with mixed rulings | Generics still barred from selling products until early February.
2 January 2025 The Japanese pharma company files complaint against Lupin Pharmaceuticals | Suit alleges patent infringement over the company’s proposed generic version of a key ALS drug.
19 December 2024 Pair of generic drug makers challenged validity of patent on priority, novelty and inventive step | EPO found the patent did not introduce any new matter not originally disclosed in the pharma company’s application.
8 October 2024 A UK court upholds the patent for Astellas Pharma's life-extending prostate cancer treatment | Judgment dismisses attempts by Accord Healthcare, Sandoz, and Teva to invalidate the patent | Parallel litigation in Germany and Netherlands ongoing.
22 August 2024 Judges will not rehear safe harbour case between Edwards and Meril | Medtech company said court’s precedent ‘distorts the market’ for patented products.
22 August 2024 FTC backs FDA's proposals to streamline approval process for interchangeable biosimilars | Move aims to lower prescription drug costs and expand access to critical treatments | FTC emphasises the new guidance could create competition in the biologics market and save US healthcare billions of dollars.
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