LEO Pharmaceutical Products, Ltd. v. Rea

LEO Pharmaceutical Products, Ltd. v. Rea

Federal Circuit (2013)

Fitzpatrick Successfully Appeals from Inter Partes Reexamination to Uphold Validity of Taclonex® Patent

On August 12, 2013, the Federal Circuit issued a decision in favor of Fitzpatrick’s client, LEO Pharma, reversing the determination of the Board of Patent Appeals and Interferences (“Board”) that LEO Pharma’s U.S. Patent No. 6,753,013 was obvious. The ‘013 patent claims a pharmaceutical composition containing a vitamin D analog and a corticosteroid as active ingredients and a “solvent component C” selected from among six specified groups of compounds. LEO Pharma markets an ointment product covered by the ‘013 patent under the trade name Taclonex®.

The ‘013 patent was in inter partes reexamination for six years before the Board’s decision finding the patent obvious. On appeal, the Federal Circuit applied the “substantial evidence” standard of review for fact findings made by the Board, which the Federal Circuit stated “makes Leo Pharmaceutical’s burden on appeal a challenging one.” The Federal Circuit found that LEO Pharma met that burden and reversed the Board’s obviousness determination. The Federal Circuit found that the Board had used hindsight to combine prior art references and had incorrectly weighed the objective indicia of nonobviousness. The Federal Circuit also reversed the Board’s claim construction of the term “storage stable.”

Lead Partner: William E. Solander

Other Team Members: Bruce C. Haas and Damien N. Dombrowski