Sign Up for PublicationsQuinn Emanuel recently secured a favorable settlement agreement in Axsome Therapeutics, Inc. v. Teva Pharmaceuticals, Inc., a patent litigation brought against Teva as a result of its submission of an abbreviated new drug application with the FDA to market a generic version of Axsome’s Auvelity® product prior to the expiration of Axsome’s patents.
In 2023, Teva sought FDA approval for a generic version of our client Axsome’s Auvelity® drug product, which a drug indicated for the treatment of major depressive disorder. Auvelity® is groundbreaking in that it treats major depressive disorder via a different metabolic pathway than typical antidepressants. As a result, it works faster than—and has fewer side effects typical of—other antidepressants. Patients—especially those who have failed prior antidepressant therapy—have been overwhelmingly thrilled with the speed and efficacy of Auvelity®.
Teva challenged Axsome’s patents covering Auvelity® in an attempt to market a generic version well before the expiration of those patents. What began as a single patent infringement lawsuit quickly expanded to five separate actions. By settlement time, the Firm was defending up to 16 patents covering Auvelity® while engaging in hard-fought discovery battles, aggressive challenges to the novelty, inventorship, and enforceability of the patents, and intense negotiations. However, the Firm was able to obtain an agreement from Teva that they would not launch their generic until 2039 in certain circumstances.
This reflects an extremely favorable outcome for the Firm’s client. It preserves Axsome’s market exclusivity through 2039. Moreover, the settlement guarantees Auvelity®’s future sales, providing a sizeable return on Axsome’s research and funding further development and studies on life-changing therapies. The Firm continues representing Axsome in patent infringement litigation related to an unrelated product, and they look forward to providing similarly stellar results for them and other clients from the Firm’s robust life sciences practice.