What is Next for Enablement and Written Description of Antibody Claims?
Patent – Patently-O 2024-04-23
Summary:
by Dennis Crouch
I had been following the case of Teva v. Lilly for a few years. Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. U.S. Patent Nos. 8,586,045, 9,884,907 and 9,884,908. The patents cover Teva’s drug Ajovy, and allegedly cover Lilly’s Emgality. Both drugs were approved by the FDA in September 2018. A Massachusetts jury sided with Teva and awarded $177 million in damages, including a controversial future-lost-profit award.
Although the jury sided with Teva, District Judge Allison Burroughs rejected the verdict and instead concluded that Teva’s patent claims were invalid as a matter of law for lacking both written description and enablement. The appeal is now pending with Teva is asking the Federal Circuit to reinstate the verdict. Lilly filed its own conditional cross appeal – arguing that the future lost profit award was not supported by the evidence or permitted by law. The case has direct parallels to the Supreme Court’s 2023 decision in Amgen v.