An inherent tension exists at the nexus between IP and clinical
trials arising from the requirements for obtaining patent
protection and the disclosure requirements for registration of a
clinical trial. This tension has escalated in Australia due to a
recent court decision in which it was found that disclosure of
untested clinical trial hypotheses can invalidate a patent. As
such, patent applicants may wish to think twice before awaiting the
outcome of a planned clinical trial before seeking patent
protection.
Australia adheres to the Declaration of Helsinki, which provides
that information relating to clinical trial protocols must be
registered in a publicly accessible database before the first
participant is recruited.1 Typically, key details about
the design, conduct and administration of planned clinical trials
in Australia are registered in the Australian New Zealand Clinical
Trials Register (ANZCTR). In addition, companies may issue
announcements and press
