The Hollowing Out of Patents on Biopharmaceutical Research Tools

Abstract:

After the seminal U.S. Supreme Court decision in Merck v. Integra, many commentators thought that the Bolar or “safe harbour” exemption in 35 U.S.C. §271(e)(1) would exempt most uses of biopharmaceutical research tools from patent infringement. After the 2008 Federal Circuit decision in Proveris v. Innovasystems, this argument was laid to rest and new life was given to the patentability of biopharmaceutical research tools. In comparison, Canadian case law suggests that the corresponding exemption in s. 55.2(1) of the Canadian Patent Act is broader and patents on such research tools may provide little, if any, value to patent holders.