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Federal Circuit Ruling Strengthens Defenses Against Enablement Attacks on Drug and Medical Device Patents

November 16, 2012

By BRUCE M. WEXLER & PAUL B. SUDENTAS

In a decision issued earlier this week, the Federal Circuit rejected an assertion of invalidity of a medical device patent for lack of enablement under 35 U.S.C. § 112, holding that human testing at the time the patent application was filed was not required. Importantly, the Court's reasoning in doing so should be an additional source of help in fending off the growing trend of generic attacks on drug and medical device patents under § 112.