WHEN DO DISCLOSED CONCENTRATION RANGES MAKE ANOTHER COMPOSITION OBVIOUS - GALDERMA v. TOLMAR

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Patent practitoners often assume that concentration ranges disclosed in a composition or method patent make a subsequent product or method that falls within those concentration ranges obvious. That is not necessarily correct.

In Galderma v. Tolmar, the patent claims covered both a composition and method for treating acne. The claims required 0.3% by weight of adapalene.

Prior art patents disclosed adapalene to treat acne in a range of 0.01%- 1.0%. Evidence showed that increasing the dose of adapalene likely increased the side effects, and that 0.1% was optimal for the treatment of acne. The Federal Circuit found the claims at issue obvious.

The district court framed the issue as whether the alleged infringer established motivation in the prior art to triple the concentration of adapalene from 0.1% to 0.3%. The Federal Circuit disagreed and framed the issue as:
[W]here 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.

Moreover, according to the Federal Circuit, there is no requirement that the alleged infringer must prove obviousness "by starting with a prior art commercial embodiment and then providing motivation to alter that commercial embodiment." That is especially so, when "the prior art teaches a range that encompasses both the prior art commercial embodiment and the claimed invention."

In addressing the first factor above, even though the prior art showed that increasing adapalene concentration from 0.03% to 0.1% increased side effects, the Federal Circuit disagreed that the prior art taught away from a further tripling of concentration to 0.3%.

The Federal Circuit pointed out that the prior art did not "discourage" the use of 0.1% adapalene. The court further pointed out that the prior art did not indicate that 0.3% would be "unproductive." And the prior art did not state that the increased side effects would be "serious enough" to discourage the use of 0.3%.

Other prior art references that taught the preferred concentration of 0.1% did not teach away from 0.3% because they did not "‘criticize, discredit, or otherwise discourage' investigation into the invention claimed." Teaching that something is optimal does not, according to the Federal Circuit, criticize, discredit, or otherwise discourage investigation.

Unexpected results relevant to nonobviousness, according to the Federal Circuit, are "different in kind and not merely in degree from the results of the prior art." Here, the expected result was a percentage increase in side effects. Even though it was "unexpected" that the side effects did not materialize in the 0.3% adapalene, the difference was only one of degree, according to the Federal Circuit.

PRACTICE POINTER:
One cannot, as often occurs, assume that a composition concentration is obvious if it falls in the prior art range of concentrations. A diligent inquiry needs to be made into whether the prior art teaches away by criticizing or discrediting. And unexpected results need to be analyzed in terms of differences in kind, not degree.

© Michael A. Shimokaji, 2014
The contents of this article represent the opinions of the author and not those of the author's law firm or clients.

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