The US Supreme Court has recently examined the research exemption (the "Rules") provided by 35 USC s. 271(e)(1) in the case of Merck KGaA v Integra Lifesciences Limited. The Rules provide a safe harbour against infringement of a patent where such acts have been carried out "solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of a drug".
In 1996, Integra brought an action against Merck claiming that Merck's research relating to cell adhesion in cancer therapy infringed Integra's patents. Merck's defence relied on the Rules, however the US Court of Appeal for the Federal Circuit ("CAFC") construed the legislation narrowly and held that the Rules only apply to "clinical testing to supply information to the FDA," and not more general biomedical research without an immediate connection to an FDA submission. Merck appealed the decision to the US Supreme Court.
The US Supreme Court held that companies have a greater scope to use patented compounds as part of their research, than that provided by the CAFC judgement. The Supreme Court held that:
"exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information"
The Court went on to state:
"this necessarily includes pre-clinical studies of patented compounds that are appropriate for submission to the FDA and the regulatory process. There is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included."
This case concludes that use of patented compounds in pre-clinical studies are protected by the Rules, provided there is a reasonable basis to believe that the compound could be the subject of an FDA submission and the experiments will produce the type of information relevant to such submission.
The new broad approach adopted by the Supreme Court is likely to extend the scope of studies, which fall within the Rules, to include preclinical, pharmacokinetic and toxicological studies amongst others. The Supreme Court's ruling may also have significant implications on the research tool industry. Taken to an extreme the Rules could allow patented research tools to be used in the testing process without constituting infringement. The Court was however silent on the issue.
With the required implementation of Directive 2004/27/EC by 30 October 2005 throughout Europe, which provides equivalent provisions to the Rules, it remain to be seen how the broad approach taken by the US Supreme Court will compare with that to be adopted by the UK and other EU Member States.
For further information please contact Nick Beckett at [email protected] or on +44 (0) 207 367 2490 or Aasim Qureshi at [email protected] or on +44 (0) 207 367 3620.