Federal Circuit to USPTO in Leo Pharmaceutical: Secondary Considerations Are Not an Afterthought

November 11, 2013

Rebuking the USPTO’s standard practice in inter partes reexaminations of evaluating evidence of secondary considerations only after the USPTO has already found that a prima facie case of obviousness has been established, the Federal Circuit reinforced that “consideration of…objective indicia is part of the whole obviousness analysis, not just an afterthought.” Leo Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346, 1357 (Fed. Cir. 2013) (emphasis in original).

Inter partes reexamination of Leo Pharmaceutical’s U.S. Patent No. 6,753,013 was initiated by Galderma R&D, and concerned pharmaceutical compositions for the topical treatment of skin conditions such as psoriasis. The claims at issue recited a pharmaceutical composition comprising at least one vitamin D analogue selected from a given group, at least one corticosteroid, and at least one solvent selected from a given group, where the pharmaceutical composition is “storage stable and non-aqueous.” Id. at 1349-50. The “storage stable and non-aqueous” clause in the claims was added by Leo Pharmaceuticals during reexamination and reflected Leo Pharmaceutical’s finding, as reflected in the claims of the ‘013 Patent, that prior art combinations of vitamin D and corticosteroids had storage stability problems that precluded them from being administered in a single, stable formulation. The ‘013 Patent solved this problem by using the claimed group of solvents along with the vitamin D analogue and the corticosteroid, and the use of the group of solvents permitted the vitamin D analogue and the corticosteroid to coexist in a single, stable formulation.

During reexamination, the USPTO found that the claims of the ‘013 Patent were obvious in view of a combination of three references. The first reference disclosed the use of a steroid and a solvent, but not the use of vitamin D, with the teaching that the inclusion of the solvent rendered preservatives unnecessary. The second reference disclosed the use of a corticosteroid and vitamin D, but not the use of a solvent. The third reference disclosed a composition containing a steroid and a vitamin D analogue, but did not disclose the use of a solvent. However, none of the references addressed stability concerns or indicated that the use of the solvent recited in the claims of the ‘013 Patent could solve any storage stability concerns that may have been present.
Leo Pharmaceuticals attempted to counter the Board’s finding by presenting “extensive experimental evidence” that the water, alcohol, and propylene glycol found in the prior art compositions caused degradation of the vitamin D and corticosteroid compositions. Id. at 1351. Yet the Board “found that the objective indicia did not overcome a prima facie case of obviousness.” Id.

The Federal Circuit took issue with the Board’s treatment of Leo Pharmaceutical’s evidence, stating that the treatment of a patent within the context of an inter partes reexamination is different from the treatment of an application. It is typical during the prosecution of an application for an Examiner to set forth obviousness rejection that an applicant then attempts to rebut with evidence of secondary considerations. In those instances, the Examiner may evaluate whether the evidence outweighs the prima facie case of obviousness. However, the Federal Circuit distinguished that from when a rejection of a patent’s claim is pending before the Board in an inter partes proceeding where the Board has all of the evidence in front of it to begin with. In those instances, “the Board is reviewing evidence of obviousness – including objective indicia – submitted by two adversarial parties for the claims of an issued patent.” Id. at 1358 (emphasis in original). In those cases, “the Board should give the objective indicia its proper weight and place in the obviousness analysis, and not treat objective indicia of nonobviousness as an afterthought.” Id. Indeed, “[o]bjective indicia of nonobviousness play a critical role in the obviousness analysis….[and here] are crucial in avoiding the trap of hindsight when reviewing, what otherwise seems like, a combination of known elements.” Id.

The Federal Circuit’s ruling in Leo Pharmaceutical relates to inter partes reexaminations, but it appears that the ruling is also applicable to inter partes reviews (IPR). In particular, in IPRs, like inter partes reexaminations, the Board will have in front of it all objective evidence and arguments, “submitted by two adversarial parties for the claims of an issued patent.” Id. at 1358 (emphasis omitted). Thus, it appears that Leo Pharmaceutical reinforces the importance of submitting persuasive evidence of secondary considerations when preparing your position in an IPR.


Travis Ribar


Mr. Ribar practices in all areas of intellectual property law with a focus on infringement and validity, as well as on the litigation of intellectual property matters, including reexamination practice.

A former Patent Examiner at the USPTO, he also counsels and assists clients in the procurement of both U.S. and foreign patents, which includes the preparation and prosecution of patent applications.

Mr. Ribar specializes in the areas of photoresist formulations and applications, rubber compositions, plastics and adhesives, membranes, medical and drug delivery devices, display devices, semiconductor materials, food compositions, polymeric materials, and the chemical arts.