Off to a running start? Federal Court of Australia permits generic manufacturer to make PBS application before patent expiry
Can a manufacturer apply for Pharmaceutical Benefits Scheme (PBS) approval for a generic drug before the patent has expired? Justice Nicholas held in February in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 that the answer was “Yes”, and his Honour’s decision was recently affirmed by the Full Federal Court in read more…