Research Tool Patents — Rumours of Their Death are Greatly Exaggerated

Abstract

Using a patented drug during clinical trials is not infringement [35 U.S.C. 271(e)(1)]. Merck v Integra enlarged this ‘safe harbour’ to accommodate preclinical use of drugs and patented ‘research tools' if ‘reasonably related’ to FDA approval. The decision allowed lower courts, should they wish, to find any use of a research tool, except for exploratory research, ‘reasonably related’. But Third Wave v Stratagene, decided on 5 August 2005 by a Federal District Court, will inhibit any such judicial impulse. Research tool patents, therefore, should retain value. Users will license rather than pay to test enforceability. Accordingly, universities should seek out emerging research tools and evaluate their potential utility before and after FDA approval (for example, for quality control). Finally, the article stresses protecting tools by contract instead of by patent (for example, an exclusive, pre-publication licence to screen compound libraries).

Keywords

Merck patents preclinical FDA contracts licences

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References

Cohen Liz (2005), ‘United Kingdom: Testing times in the UK: Will clinical trials infringe?’, 12 October, www.mondaq.com.

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Hoffman David

(2004), ‘Note: A modest proposal toward improved access to biotechnology research tools by implementing a broad experimental use exception’, Cornell Law Review, Vol 89, pp 993–1028.