TEVA PHARMACEUTICALS INTERNATIONAL GMBH, Appellant, v. ELI LILLY AND COMPANY, Appellee
ANDREW HIRSHFELD, PERFORMING THE FUNCTIONS AND DUTIES OF THE UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor 2020-1747, 2020-1748, 2020-1750 Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2018- 01422, IPR2018-01423, IPR2018-01425. Decided: August 16, 2021
Teva Pharmaceuticals International GmbH (“Teva”) appealed from a final written decision of the U.S. Patent and Trademark Office (“PTO”) Patent Trial and Appeal Board (“Board”) holding that the claims of three U.S. Patents are unpatentable as obvious over the cited prior art. The Federal Circuit affirmed.
Teva proposed that the Court first decide the merits of the appeal, and if not reversed or remanded, then the Court would issue a limited remand under Arthrex. The Court rejected Teva’s proposal. Teva then waived its right to a limited remand to seek rehearing by the Director.
Lilly asserted that a skilled artisan would have been motivated to combine the teachings of the references to make a humanized anti-CGRP monoclonal antibody for therapeutic use in humans. Teva argued that the Board considered whether a skilled artisan would have been motivated to make an antibody merely to study or use it. Therefore, according to Teva, the Board incorrectly discounted important safety and efficacy concerns when used for treating human disease. (more…)