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Rothwell Figg Client Coherus Biosciences Wins Denial of Institution of PGR of Adalimumab Formulations Patent

March 19, 2020

On March 19, 2020, the Patent Trial and Appeal Board (PTAB) denied institution of a Post-Grant Review (PGR) in a victory for patent owner Coherus Biosciences, Inc.

Petitioners Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH sought review of all claims of Coherus Biosciences’ U.S. Patent No. 10,155,039, which claims stable aqueous formulations of adalimumab. Adalimumab is the active ingredient in Humira®. Coherus has developed a biosimilar formulation of adalimumb that has completed Phase III clinical trials.

Rothwell Figg filed a Patent Owner Preliminary Response on behalf of Coherus detailing why, contrary to petitioners’ arguments, the ’039 patent meets the requirements for written description, enablement, and definiteness. After evaluating both the petition and the Patent Owner’s Preliminary Response, the PTAB determined that the petitioner failed to demonstrate that it was “more likely than not” that any of the challenged claims are invalid.

In making this determination, the PTAB adopted the claim constructions for key terms as proposed by Coherus, and agreed with each of Coherus’s arguments for validity.

The Rothwell Figg team representing Coherus Biosciences includes Joseph Hynds, Jennifer Nock, and Aydin Harston.

The case is Fresenius Kabi USA, LLC v. Coherus Biosciences, Inc., PGR2019-00064.