15 July 2005
Key Points:
Exceptions to patent infringement for experimental use have recently attracted considerable attention in the pharmaceutical and legal communities in the United States and Australia.
In the United States, the recent legal focus on this issue has been as to the scope of the US statutory exception for research undertaken in order to gain regulatory approval. On 13 June 2005, in Merck KGaA v Integra LifeSciences I, Ltd[1], the United States Supreme Court unanimously reversed the decision of the United States Court of Appeals for the Federal Circuit. In doing so, the Supreme Court broadly interpreted this exception under US law so not to limit it to the clinical testing of a new drug, but also to include the use of patented drugs in preclinical studies provided there is a reasonable basis for believing that the experiments will produce the types of information relevant to an application for regulatory approval. The Court further held that there is no basis for excluding patents on research tools from this exception. The Court however left untouched the scope of the common law exemption from infringement.
In Australia, over the last 16 months, the Advisory Council on Intellectual Property ("ACIP") has undertaken a comprehensive review of whether Australia should have a general experimental use exception to patent infringement and, if so, what form that exception should take. The limited exception that currently exists for research undertaken to gain regulatory approval has been considered as part of that review. ACIP is expected to deliver its final report to the Government shortly, and that report is expected to be released to the public in the coming months.
Merck v Integra will be discussed in greater detail in the next issue of Insights as will the ACIP report if made public by that date.
[1] 2005 U.S. LEXIS 4840; 73 U.S.L.W. 4468; 18Fla. L. Weekly Fed. S 394
