Leo Pharmaceutical Products, Ltd. v. Rea (726 F.3d 1346, 2013)

RADER, Chief Judge.

This appeal arises from an inter partes reexamination of U.S. Patent No. 6,753,013 (the '013 patent). The '013 patent is owned by Leo Pharmaceutical Products, Ltd. (Leo Pharmaceuticals) and challenged by third party requester Galderma R & D. While the “substantial evidence” standard of review for fact findings made by the Board of Patent Appeals and Interferences (Board) makes Leo Pharmaceutical’s burden on appeal a challenging one, after careful review, this court finds that Leo Pharmaceuticals has met that burden. Because the Board incorrectly construed the claim term “storage stable,” this court reverses the Board’s claim construction. See Ex parte Leo Pharm. Prods., Ltd., No. 2012-003165 (B.P.A.I. Apr. 30, 2012). Furthermore, because the Board incorrectly found the claimed invention would have been obvious in view of the prior art and incorrectly weighed the objective indicia of nonobviousness, this court reverses the Board’s obviousness determination.

I.

This case concerns pharmaceutical compositions for the topical treatment of certain skin conditions, e.g., psoriasis. See '013 patent col. 1, 11. 8-10, 19-25. Psoriasis can be a painful and socially debilitating disease. The prior art discloses that psoriasis is commonly treated through a combination treatment of: (1) a vitamin D analog and (2) a corticosteroid. '013 patent col. 1,11. 23-26.

The '013 patent teaches that simultaneous treatment with vitamin D and corticosteroids can heal psoriasis faster and more effectively. '013 patent col. 9, 11. 1-11. However, according to-the '013 patent, a storage stable combination of vitamin D and corticosteroids in a single formulation did not exist in the prior art. '013 patent col. 1, 11. 29-31. The '013 patent teaches that previous combination formulations were not storage stable because vitamin D and corticosteroids have divergent pH requirements for optimum stability. '013 patent col. 1, 11. 31-36. Specifically, vitamin D analogs require basic environments with a higher pH value (above 8) for optimal stability, but corticosteroids are most stable in acidic environments with a lower pH value (in the range of 4-6). '013 patent col. 1, 11. 48-53. Because of the storage stability problem, physicians had to prescribe a two-drug regimen that required patients to apply one drug in the morning and another at night. '013 patent col. 1, 11. 61-67. This two-drug regimen generated patient compliance issues.

After recognizing the storage stability problem, Leo Pharmaceuticals began testing formulations that combined vitamin D analogs and corticosteroids. In testing formulations from the prior art, Leo Pharmaceuticals found that several ingredients — including almond oil, propylene glycol, and water — did not solve the problem.