Nalpropian Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc., No. 18-1221 (Fed. Cir. 2019)Annotate this Case
Nalpropion markets Contrave® for weight management in overweight or obese adults, with three Orange Book-listed patents. The 626 patent is drawn to a method for treating overweight or obesity comprising diagnosing an individual as suffering from overweight or obesity by body mass index, administering bupropion in an amount effective to induce weight loss, and administering naltrexone in an amount effective to enhance the weight loss activity of bupropion. The 195 patent is also directed to methods of treating overweight or obesity, but the claims are drawn to specific dosages of sustained-release naltrexone and bupropion that achieve a specific dissolution profile. The 111 patent is directed to a composition of sustained-release bupropion and naltrexone for affecting weight loss. Actavis filed an abbreviated new drug application seeking to enter the market with a generic version of Contrave® before the expiration of those patents. Nalpropion alleged infringement; Actavis brought invalidity counterclaims. The district court held each claim not invalid and infringed. The Federal Circuit affirmed in part, rejecting Actavis’s argument that a claim of the 195 patent lacked adequate written description support because its claimed dissolution profile was achieved using one method but the specification discloses data obtained using another method. The court reversed with respect to the 626 patent; it would have been obvious for a person of skill to combine bupropion and naltrexone for treating overweight and obesity because both drugs were known to cause weight loss.