Galderma Labs Patents Invalidated for Obviousness

Last week, on December 11, 2013, in Galderma Labs., L.P. v. Tolmar, Inc., the U.S. Court of Appeals for the Federal Circuit (Newman, Bryson, Prost*) reversed the district court’s judgment that U.S. Patents No. 7,579,377, No. 7,737,181, No. 7,834,060, No. 7,838,558, and No. 7,868,044, (the Patents) were not invalid for obviousness under 35 U.S.C. § 103. The Patents, which related to a topical medication approved for the treatment of acne marketed by Galderma Labs as Differin® Gel, were determined invalid as being obvious in light of the prior art.

The focus of the dispute was whether it was obvious to use a 0.3% adapalene composition for the treatment of acne, given that the prior art disclosed ranges from .03% to . 1%. Tolmar argued that the asserted claims are obvious “because they claim nothing more than the use of an old compound for a known purpose in a concentration that falls within a range disclosed in the prior art as preferred for that purpose.” Their evidence included a study in which a lotion containing 0.3% adapalene was used on animals to conclude that adapalene was “particularly suitable for the treatment of acne.” Other prior art also showed that products containing specifically 0.03% and 0.1% adapalene were suitable for the treatment of acne “without intolerable irritability.”

Additionally, the court noted that there was indication in the prior art that dermatologists desired acne treatments in varying concentrations, thus, argued Tolmar, there was enough motivation for those skilled in the art to select .3% concentration even though earlier studies had only disclosed the lower range.

In settling the dispute between the parties as to whether there was such motivation to select the claimed .3%, the court states as follows:

[quote align=”justify” color=”#999999″]“In these circumstances, where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected results relative to the prior art; or (3) there are other pertinent secondary considerations. . . .”[/quote]

According to the court’s majority, Galderma was unable to meet its burden of production. The court examined the prior art and concluded that while the comparable tolerability of 0.1% and 0.3% adapalene was unexpected in view of the prior art, a skilled artisan would have expected that tripling the concentration of adapalene would have resulted in a clinically significant increase in side effects, so the result does not constitute an unexpected result indicating nonobviousness.

Noteworthy, the majority concluded that several of the secondary considerations offered by Galderma were not significant. More specifically, the majority concluded that the commercial success of Differin® was of “minimal probative value.”

In a pretty detailed dissenting opinion, Justice Newman admitted that the obviousness question was a close one, and felt that the lower court’s analysis and decision should have been given closer attention. The dissenting opinion states:

[quote align=”justify” color=”#999999″]“Without doubt, the question of obviousness here presented is a close call. However, when the question is close, when it turns on findings and interpretations of biologic and medicinal evidence, when the application of law to fact invokes the policy of the patent statute to advance the useful arts, then the findings and rulings of the trial court warrant particular attention on appellate review…

My colleagues on this panel give scant attention to the district court’s analysis, instead making their own findings, and applying flawed procedural and substantive law…

My colleagues do not identify clear error in the district court’s findings; instead they distort the burdens of proof and production, ignore the applicable standard of proof and rely on their own factual determinations and creative theories of law, and eradicate the patent….

The district court ruled that there was not clear and convincing evidence of invalidity. By contrast, my colleagues announce their rule whereby a broad teaching that includes the patented invention removes the statutory presumption of validity, and without more establishes obviousness.”[/quote]

Read the Opinion here.

Saul Acherman
Attorney at