This U.S. Supreme Court patent decision today will be big news for those financing early-stage life sciences companies:
Merck v. Integra, 545 U. S. ___ (2005).
In a unanimous decision, the Supreme Court has set aside the Federal Circuit’s holding — finding that “the use of patented compounds in preclinical studies is protected [under 35 U.S.C. § 271(e)(1)] as long as there is a reasonable basis for believing that the experiments will produce the types of information that are relevant” to FDA approval.
More broadly, the decision, which sets aside a prior Federal Circuit ruling, will come as no surprise to those who have read Lerner & Jaffe’s “Innovation and its Discontents”, where the authors convincingly argue that the patent specialists at the Federal Circuit have taken an overly patentholder-friendly view of intellectual property law.