• Expanded Rights for Preclinical Research Favor Innovator Drug Companies
  • June 21, 2005 | Author: Lisa M. Wilson
  • Law Firms: Duane Morris LLP - New York Office; Duane Morris LLP - Washington Office
  • In a unanimous decision anxiously awaited by many pharmaceutical and biotech companies, the U.S. Supreme Court reversed the Federal Circuit and held that the exemption from patent infringement granted under 35 U.S.C. §271(e)(1) extends broadly to preclinical research for any patented compound. According to the holding in Merck KGaA v. Integra LifeSciences I, Ltd., handed down on June 13, 2005, this "§271(e)(1) exemption" would protect a company that reasonably believes the compound being tested could be submitted for FDA approval and the experiments being undertaken would produce results and information relevant to such regulatory submissions. In contrast, the earlier Federal Circuit decision held that the preclinical research to identify new pharmaceutical compounds or new drugs did not fall within the §271(e)(1) exemption.

    In its ruling, the Supreme Court emphasized that the exemption does not embrace basic research performed without the intent to develop a drug, an issue the Federal Circuit did not address. Rather, the Supreme Court's guidance indicated that preclinical research on patented compounds that are not the subject of a regulatory submission or preclinical research omitted from a regulatory submission may still be exempt from infringement liability if the reasonable relationship requirement is met.

    The Supreme Court particularly focused on the statute's reasonable relation requirement, explaining that the statute, properly construed, "leaves adequate space for experimentation and failure on the road to regulatory approval" and that a reasonably related use exists

    [a]t least where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful would be appropriate to include in a submission to the FDA....

    For Merck (of Germany) and Integra, resolution of the infringement issue must await further action by the Federal Circuit since the Supreme Court declined to be a court of first review on the evidence presented at trial. Many in the industry will welcome the broad relief this case affords to innovators conducting preclinical research for new drug development. For others, especially universities and platform technology companies, this case does not settle whether §271(e)(1) exempts use of research tools from infringement as the justices, in a footnote, explicitly declined to express an opinion on such liability.

    For the full slip opinion, see:

    www.supremecourtus.gov/opinions/04pdf/03-1237.pdf