Leo Pharm. Prods., Ltd. v. Kappos, No. 12-1520 (Fed. Cir. 2013)Annotate this Case
Prior art concerning treatment of the skin disease, psoriasis, discloses a combination treatment of a vitamin D analog and a corticosteroid. Leo’s patent calls for simultaneous treatment with vitamin D and corticosteroids to heal psoriasis faster and more effectively; a storage-stable combination of vitamin D and corticosteroids in a single formulation did not exist in prior art because vitamin D and corticosteroids have different pH requirements for optimum stability. Because of the storage-stability problem, doctors had to prescribe a regimen that required patients to apply one drug in the morning and another at night, which caused patient compliance issues. Leo discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether, solved the storage stability problem by allowing the vitamin D analog and corticosteroid to coexist in a single pharmaceutical product. The Board of Patent Appeals rejected several claims. The Federal Circuit reversed. The Board incorrectly construed the term “storage stable,” incorrectly found the claimed invention would have been obvious in view of prior art, and incorrectly weighed the objective indicia of nonobviousness.