A Locke Lord team obtained a trial court decision in favor of Zydus Pharmaceuticals (USA) Inc. in a patent dispute relating to Tecfidera® (dimethyl fumarate delayed-release capsules) for the treatment of relapsing forms of multiple sclerosis. Tecfidera® reported sales in 2019 were approximately $3.3 billion. The U.S. District Court in Biogen Int’l GmbH, et al. v. Amneal Pharms LLC, et al. found asserted claims 1- 4, 6, 8-13 and 15-16 of U.S. Patent No. 8,399,514 invalid for lack of written description support under the principles of collateral estoppel based on a ruling of invalidity in the Northern District of West Virginia. Written description and obviousness grounds of invalidity were previously presented at trial by the Locke Lord team and others. Zydus has subsequently received final approval from FDA for its generic dimethyl fumarate delayed-release capsules. The Locke Lord team representing Zydus included: Michael J. Gaertner, Timothy F. Peterson and Jonathan B. Turpin and Andy J. Miller (all of Chicago).
Posted on October 27, 2020