Leo Pharm. Prods. Ltd. v. Rea

The Patent and Trademark Office should construe patent terms in the broadest sense that remains consistent with the patent specifications.

Opinion (Rader): Leo Pharmaceutical Products, Ltd. ("Leo") appealed from an inter partes reexamination of its Patent No. 6,753,013, which covers a treatment for skin conditions. The patent claimed a combination of a vitamin D analog and a corticosteriod, which was “storage stable.” The Board of Patent Appeals and Interferences held that the term “storage stable” meant the product would be stable after being subjected to a particular chemical stability test. It also concluded that the patent was invalid as obvious over three instances of prior art. Leo appealed both determinations. The Patent and Trademark Office should construe claims to the broadest extent that is consistent with the patent specifications. Because the Board's construction of “storage stable” was only from one disclosure from an example in the patent, and because a broader construction was possible, the court reversed the Board's construction as impermissibly narrow. The obviousness analysis is based on several factual inquires: 1) the scope and content of prior art, 2) the differences between prior art and the claims in the patent, 3) the level of ordinary skill in the art at the time of invention, and 4) objective evidence of nonobviousness. Two pieces of prior art relied on by the board related to the combination of vitamin D analogs and corticosteriods, but did not address the stability issue. The third piece of prior art related to the combination of a steroid and solvent to increase stability, but did not address the use of vitamin D analog. None of the prior art provided sufficient guidance to enable a practitioner to devise the patented compound however, and industry publications suggested a combination like the one claimed in the patent was inadvisable. The court also placed emphasis on the importance of objective factors of nonobviousness, including the fact that the third piece prior art was published 22 years before the '013 patent. Because of the lack of guidance from the prior art and the objective factors of nonobviousness, the Federal Circuit REVERSED the Board's invalidity determination.