ANDA filing not “willful infringement”
Executive Summary
The filing of an ANDA cannot constitute "willful infringement" under Waxman/ Hatch, a federal appeals court rules July 27. Federal Circuit reverses a Chicago judge's decision ordering Apotex to pay GlaxoSmithKline attorneys' fees in a Ceftin patent dispute (1"The Pink Sheet" June 2, 2003, p. 29). Apotex was enjoined from marketing its generic until the patents expired in July 2003...
You may also be interested in...
Generic Firms Warned Of First-To-File Risk: Willful Infringement Cases Rising
The pressure on generic companies to be first-to-file in patent challenges will lead to a "boom" in willful infringement cases against generics makers, an industry attorney maintains
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.