Leo Pharm. Prods., Ltd. v. Rea

Addressing a finding of obviousness arising out of an inter partes re-examination from the Board of Patent Appeals and Interferences (Board) at the U.S. Patent and Trademark Office (USPTO), the U.S. Court of Appeals for the Federal Circuit reversed the Board’s claim construction and obviousness determination, finding the Board incorrectly construed a claim term and, in its obviousness analysis, gave too little weight to the objective indicia of non-obviousness. Leo Pharm. Prods., Ltd. v. Rea, Case No. 12-1520 (Fed. Cir. Aug. 12, 2013) (Rader, C.J.)

The re-examined patent was directed to pharmaceutical compositions for the topical treatment of certain skin conditions—for example, psoriasis. While the prior art disclosed treating psoriasis with a combination of vitamin D and a corticosteroid at different times, the re-examined patent taught using those treatment methods simultaneously. Leo Pharmaceuticals argued that the prior art did not adequately teach using these treatment methods together with adequate storage stability. During re-examination, Leo Pharmaceuticals amended and added claims to address the stability issue by adding “storage stable.” After construction of that term using a test disclosed in the written description, the Board found the claims obvious. Leo appealed.

The Federal Circuit explained that the USPTO failed to give the claims their broadest reasonable construction consistent with the specification by limiting the definition of the term to just one accelerated stability test disclosed in the specification. The Federal Circuit found that the customary meaning of the term would include stability during a composition’s shelf life for its intended use, a broader reading.

The Federal Circuit also reversed the Board’s obviousness determination. The Federal Circuit found that the invention of the re-examined patent solved a storage-stability problem described in the prior art. That prior art discouraged the combination of vitamin D and corticosteroids as a concurrent treatment method because of the storage-stability issues, and the patent solved that problem for certain formulations.

Other prior art taught a combination of vitamin D with corticosteroids but failed to recognize the storage-stability problems. The Federal Circuit explained that the Board used impermissible hindsight when it combined that art with references solving the storage-stability problems. Because the art did not even recognize the storage-stability problems, the Federal Circuit reasoned that a person of ordinary skill in the art would have had no reason to try to improve upon the art. One of ordinary skill would not turn to prior art to solve an unknown problem.

The Federal Circuit further found that, based on the fact that one of the prior art references was published 22 years before the filing of the application for patent, one of ordinary skill would not have been motivated to make the invention. If the invention had been obvious, a skilled artisan would have achieved the invention sooner. The Federal Circuit also found that one of the pieces of prior art taught away from any of the combinations relied upon by the Board.

Finally, the Federal Circuit found that when the objective indicia were considered in concert with the entire obviousness analysis, there was a compelling case of non-obviousness. The Federal Circuit emphasized that the objective indicia are part of the whole obviousness analysis, and not just an afterthought. Here, the patent owner presented extensive evidence showing unexpected results, evidence of commercial success of an embodiment of the invention, and evidence establishing a long-felt but unresolved need for the invention due to the age of the prior art references. The Federal Circuit found this evidence to be probative of non-obviousness.