Docket No. 2013-1286
RADER, MOORE, WALLACH
December 30, 2013
Brief Summary: DC finding that Athena violated California’s unfair competition law (UCL) by marketing, distributing and selling products that qualify as drugs without regulatory approval affirmed. The nationwide permanent injunction by the CA DC was vacated.
Summary: Athena appealed DC grant of SJ that it violated California’s unfair competition law (UCL) by marketing, distributing and selling products that qualify as drugs without regulatory approval. Allergan sells the FDA-approved prescription drug Latisse that contains prostaglandin for treatment of a condition affecting eyelash growth. It alleged Athena infringed its patent and violated the UCL by offering its prostaglandin-containing product RevitaLash. The FC panel first determined it had jurisdication because the DC preserved the parties “full appeal rights regarding claim construction” (“the parties were not left in the same legal position as if the ‘105 patent claim had never been filed”). It then considered whether the Federal Food, Drug, and Cosmetic Act (FDCA) (which does not allow a private right of action) impliedly pre-empted the California Health Code (CHC, which incorporates provisions of the FDCA). It was determined that the FDCA did not preempt the CHC because it could not “find a clear purpose by Congress” to do so. The FC panel then considered whether “Athena objectively intended to market past and present formulations of the product at issue to affect the structure of eyelashes-i.e., as drugs” in violation of the CHC. The DC concluded that it did because, for instance, “Athena’s founder, a physician, developed an initial formulation using a prostaglandin derivative with the intent to cause users’ eyelashes to grow longer and fuller”, “Athena’s marketing of subsequent formulations containing different derivatives continued to discuss eyelash growth”, and while “Athena’s marketing of the most recent formulation discussed eyelash appearance,…this did not negate anobjective intent to cause growth.” The FC panel agreed that there was no genuine dispute regarding Athena’s objective intent (“There is no dispute that Athena made drug-related claims about an early formulation-and it never expressly disavowed such claims as it reformulated its products.”) It pointed out that Athena’s current website included a message about a formula for “the look of renewed health, strength and beauty”, that the product was “dermatologist and ophthalmologist reviewed”, and “describes ‘improved appearance’ of eyelashes in the context of a ‘clinical study’”. The FC disagree with the DC permanent injunction on a national level, finding that the DC “abused its discretion by entering an injunction that regulates any and all out-of-state conduct” (“The FDA-and the FDA alone-has the power and the discretion to enforce the FDCA.”)