Federal Circuit Clarifies the “Reasonable Expectation of Success” Required in Hatch-Waxman Obviousness Challenges

January 03, 2018

The U.S. Federal Circuit recently clarified the standard that patent challengers must satisfy when attempting to invalidate patented inventions directed to new uses for known drugs. Although designated as a nonprecedential opinion, Genzyme Corporation v. Dr. Reddy’s Laboratories, Nos. 2016-2206, 2016-2207 (Fed. Cir. Dec. 18, 2017) provides important guidance for evaluating whether, for purposes of alleged obviousness, a prior art reference’s isolated, prophetic statement about a possible new use for a drug can support a finding that a person of ordinary skill in the art (“POSITA”) would have had a “reasonable expectation of success” in combining prior art references to achieve the claimed invention.

Continue reading "Federal Circuit Clarifies the “Reasonable Expectation of Success” Required in Hatch-Waxman Obviousness Challenges".