According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant),...more
The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the...more
The Federal Circuit considered its 35 U.S.C. § 112 enablement case law and found that “the enablement inquiry for claims that include functional requirements”—in this case, claims to antibodies defined by their function—“can...more
The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products. Eight of the...more
Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s...more