Since the repeal of an exception to certain prohibitions
in the Competition and Consumer Act 2010 (Cth) (CCA) in
September 2019, industry participants have sought to manage the
legal risks of entering into patent settlement agreements in
different ways.
One option is Australian Competition and Consumer Commission
(ACCC) authorisation. The ACCC can confer
statutory immunity on certain conduct where the public benefit
outweighs the public detriment, including any lessening of
competition. In a
recent draft determination, understood to be the first of its
kind in the pharmaceutical industry, the ACCC proposes to decline
to authorise a patent settlement agreement that sought to permit
early entry for generic versions of two cancer treatment drugs. The
draft determination demonstrates that, while ACCC authorisation
remains an option, applications need to be supported with
significant evidence to satisfy the ACCC.
