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Leo Pharm. Prods. v. Rea

United States Court of Appeals for the Federal Circuit

August 12, 2013, Decided

2012-1520

Opinion

 [***1945]   [*1348]  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)1 makes Leo Pharmaceutical's burden on appeal a challenging one, after careful review, this court finds that Leo Pharmaceuticals has  [**2] 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.

This case concerns pharmaceutical compositions for the topical treatment of certain skin conditions, e.g., psoriasis. See '013 patent col. 1, ll. 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  [*1349]  analog and (2) a corticosteroid. '013 patent col. 1, ll. 23-26.

The '013 patent teaches that simultaneous treatment  [**3] with vitamin D and corticosteroids can heal psoriasis faster and more effectively. '013 patent col. 9, ll. 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, ll. 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, ll. 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, ll. 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.  [***1946]  1, ll. 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  [**4] art, Leo Pharmaceuticals found that several ingredients—including almond oil, propylene glycol, and water—did not solve the problem. See J.A. 566-68 (aqueous alcohol-based solvents); J.A. 561-63, 570 (propylene glycol and almond oil). Leo Pharmaceuticals then discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether (POP-15-SE), solved the storage stability problem by allowing the vitamin D analog and the corticosteroid to coexist in a single pharmaceutical product.

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726 F.3d 1346 *; 2013 U.S. App. LEXIS 16610 **; 107 U.S.P.Q.2D (BNA) 1943 ***; 2013 WL 4054937

LEO PHARMACEUTICAL PRODUCTS, LTD., Appellant, v. Teresa Stanek Rea, ACTING DIRECTOR, UNITED STATES PATENT AND TRADEMARK OFFICE, Appellee.

Prior History:  [**1] Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences in No. 95/000,153.

Leo Pharm. Prods. v. Kappos, 2012 U.S. App. LEXIS 26259 (Fed. Cir., Dec. 20, 2012)

Disposition: REVERSED.

CORE TERMS

vitamin, composition, corticosteroid, storage, analog, prior art, Pharmaceuticals, stability, solvent, invention, stable, combining, formulations, propylene, glycol, nonobviousness, objective indicia, teaches, degradation, discloses, artisan, almond oil, steroid, psoriasis, solve, ingredients, preparation, skin, side effect, reexamination

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Infringement Actions, Claim Interpretation, General Overview, Nonobviousness, Evidence, Fact & Law Issues, Elements & Tests, Substantial Evidence, Prior Art, US Patent & Trademark Office Proceedings, Interference Proceedings, Business & Corporate Compliance, Patent Law, Reexamination Proceedings, Graham Test, Secondary Considerations