Galderma Laboratories, L.P. v Tolmar, Inc., 2013-1034 (Fed. Cir.) (12/11/13)
The proper test for obviousness is whether the claimed invention as a whole would have been obvious and not whether prior art provides the motivation to meet a critical parameter in the claims. The Federal Circuit reversed a determination of validity based on misstatement of the test for obviousness, and misapplication of the doctrines of teaching away, unexpected result, and commercial success.
Tolmar filed an Abbreviated New Drug Application ("ANDA") action seeking to market a generic version of Galderma's Differin Gel. In a bench trial, the district court ruled against Tolmar. The claims at issue included composition and method claims for treating acne using various compositions. The district court framed the obviousness inquiry as requiring Tolmar to provide motivation in the prior art to triple the concentration of adapalene, one of the components, to arrive at the claimed range. The Federal Circuit panel held that Tolmar carried no such burden. Instead, all Tolmar was required to show was that the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious. Citing KSR, the panel held that Tolmar was not required to prove obviousness by starting with a prior art embodiment and then providing motivation to alter that embodiment. According to the panel, this is particularly true where, as here, the prior art teaches a range that encompasses both the prior art embodiment and the claimed invention. In these circumstances, the burden of production falls on 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.
With respect to teaching away, the panel noted that the fact that increasing the amount of adapalene up to 0.1% generally increases side effects, does not mean that that prior art teaches away from using the claimed 0.3% concentration; that is, there is nothing in the prior art to suggest that increasing the concentration to 0.3% would be unproductive or that the side effects would be serious enough to dissuade the use of 0.3%.
As to unexpected results, the district court found that a skilled artisan would have expected that tripling the concentration of adapalene would have dramatically increased the side effects. The panel determined that, while this result may have been unexpected, unexpected results that are probative of nonobviousness are those that are different in kind and not merely in degree. Where an unexpected increase in efficacy is measured by a small percentage, as here, the result constitutes a difference in degree, not kind.
As to commercial success, the district court noted that the fact that Tolmar seeks to enter the market is precisely because Galderma's Differin has been commercially successful. But the panel pointed out that that is true in every ANDA case if not every patent case. The fact that Tolmar thinks it can make a profit selling a generic version reveals very little about the level of commercial success of the patented invention relative to the prior art.
The district court also relied on the fact that Differin quickly gained market share once it was introduced. But the panel noted this was because there were other Galderma patents blocking the introduction of competing acne drugs until 2010, long after Galderma's 0.3% adapalene composition was introduced. Commercial success is relevant in some cases because the law presumes an idea would have been successfully brought to market sooner had the idea been obvious. This rationale does not apply where the market entry by others is precluded due to blocking patents.
Accordingly, the majority of the panel reversed the district court's finding that the claims were not invalid.
Judge Newman dissented, noting that the majority gives short shrift to the presumption of validity, and fails to provide clear and convincing evidence of invalidity. Specifically, she argues that the burden of overcoming a district court's factual findings is heavy, including those relating to the secondary considerations of nonobviousness. Judge Newman is also critical of the majority's shifting of the burden of production to the patentee, and contends that the majority never required Tolmar to meet its evidentiary burden of proving invalidity by clear and convincing evidence.