Federal Court dismisses first Commonwealth damages claim against an unsuccessful pharmaceutical patentee

In an unprecedented decision, the Federal Court of Australia has considered and dismissed a claim by the Commonwealth Government for compensation from sponsors of innovator pharmaceutical products, pursuant to undertakings as to damages given in exchange for an interlocutory (preliminary) injunction restraining the launch of the first generic product: Commonwealth of Australia v Sanofi (No

Biosimilars in Australia

A ‘biosimilar medicine’ or ‘biosimilar’ is a highly similar, but not identical, version of an original biological medicine (‘reference medicine’) – a medicine comprised of large complex molecules derived in some way from a living organism.  In this sense, a biosimilar differs to some extent from a traditional small molecule “generic” medicine, which is commonly

Patent Term Extensions in Australia: under pressure but safe for now

Government responds to the Productivity Commission Report and the Courts find “Swiss-style” claims not sufficient for a PTE   The Australian Government, in its highly anticipated response to the Productivity Commission’s Report, recommended only a minor change to the legislation relating to patent term extensions (PTEs).  Almost simultaneously, in the equally eagerly-awaited decision of the

$30m for infringement of Bayer’s Australian Yasmin patent – a “small” jurisdiction with big benefits

In a recent landmark Australian Federal Court decision, Bayer v Generic Health [2017] FCA 250, Bayer was awarded $30m ($25.7m in damages plus interest) to compensate for lost revenue caused by generic product sales infringing its patent covering the oral contraceptive Yasmin (ethinylestradiol/drospirenone).  This sets a new benchmark in Australia for future damages claims against generic manufacturers.  The Court’s willingness to adequately