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The Value of 'Research Tool' Patents in View of <i>Integra v. Merck</i>
On June 6, 2003, the Court of Appeals for the Federal Circuit seemingly breathed new life into research tool patents when it held that the use of patented peptides for drug discovery was not exempt from infringement under the “safe harbor” provision of 35 U.S.C. '271(e)(1). Integra Lifesciences, Ltd. v. Merck KGaA, 331 F.3d 860 (Fed. Cir. 2003). In an earlier case, Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., No. 95 Civ. 8833, 2001 WL 1512597 (S.D.N.Y 2001), a district court had ruled that the use of patented intermediates for drug screening was non-infringing, thereby implicating that the use of other research tool patents for drug discovery was likewise sheltered from infringement liability under '271(e)(1).
The Bristol-Myers district court decision had raised questions in the industry about the value and enforceability of research tool patents. The Federal Circuit's decision in Integra provides patentees with some indication that their patents can be enforced against at least pre-clinical drug discovery uses of the research tools.
However, in resurrecting research tool patents, the Federal Circuit determined that the jury's reasonable royalty damages award of $15 million was not supported by the evidence and remanded for further considerations. Accordingly, in deciding whether to litigate or license research tool patents (or to pursue patent protection in the first instance), patent owners and research tool users will want to carefully consider the value of the particular research tool patents at issue. This article reviews the Integra decision and its background, and outlines various factors that might be evaluated to provide an answer.
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