The Federal Circuit, on an appeal from an inter partes reexamination proceeding, rejected the Patent Office Board of Patent Appeals and Interferences’ analysis of obviousness and objective indicia of nonobviousness in Leo Pharmaceutical Products, Ltd. v. Rea (Federal Circuit 2013).
Leo Pharmaceuticals’ patent claims under reexamination were directed to dermal compositions of a vitamin D analog, a corticosteroid, and a solvent (e.g., POP-15-SE) that are “storage stable and non-aqueous.” The claims embrace Leo’s commercial embodiment (i.e., Taclonex® ointment) for treating psoriasis. In finding the claimed compositions obvious over three references, the Board reasoned that the skilled artisan would have been motivated to combine one reference’s compositions of a corticosteroid and POP-15-SE with the vitamin D analogs of another reference’s compositions, because vitamin D would counteract the well- known, skin-thinning side effects of dermal treatments containing steroids. The third reference taught a combination of vitamin D and a corticosteroid for wound healing. The Board essentially concluded that the patent was “simply a combination of elements found in the prior art.” The Federal Circuit rejected this conclusion and noted that “[t]he inventors of the … patent recognized and solved a problem with the storage stability of certain formulations—a problem that the prior art did not recognize and a problem that was not solved for over a decade.” The court further noted that in this case “the prior art either discouraged combining vitamin D analogs and corticosteroids in a single formulation, or attempted the combination without recognizing or solving the storage stability problems associated with the combination.”
Specifically, the court pointed to scientific articles provided by Leo highlighting the problems with vitamin D stability at lower pHs, noting “[t]hese articles taught away from mixing topical vitamin D formulations with other drugs.” Even as researchers began to recognize the potential benefits of treatment with both vitamin D and corticosteroids, “nevertheless they recommended a two-drug regimen where patients applied the drugs at different times of a day or on alternating days.”
The court then focused on the experimental evidence provided by Leo showing the adverse effect of the use of various solvents, where a combination of vitamin D and corticosteroid was attempted in the references, on the stability of vitamin D and corticosteroid. The court concluded that because the art did not recognize the stability problem, there was no reason for the skilled artisan to attempt to improve upon the compositions in the art.
Finally, the court turned to the Board’s analysis of the objective indicia of nonobviousness presented by Leo, for example, the improved stability of the claimed compositions. Here the court criticized the Board’s reasoning that “the strong case of obviousness outweighs the experimental evidence and testimony about the advantages of the claimed composition.” Rather, the court noted that “consideration of the objective indicia is part of the whole obviousness analysis, not just an afterthought.” Indeed, in this case “the objective indicia of nonobviousness are crucial in avoiding the trap of hindsight when reviewing, what otherwise seems like, a combination of known elements.”