Posts Tagged: "Galderma Labs v. Tolmar"

This article examines Federal Circuit case law analyzing validity challenges to method of treatment patent claims where the claims at issue are alleged to recite an inherent property of a method or molecule taught in the prior art. While Federal Circuit case law challenging method of treatment claims on inherent anticipation grounds is generally globally consistent and reasonably straightforward, the court’s inherent obviousness case law is less so.

Based on the governing Federal Circuit case law, where the patent claim at issue is directed to a specific component (such as a specific enantiomer) of a prior art mixture (such as a racemic drug material), it does not appear that there is anything to be gained by a patent challenger, from an anticipation standpoint, simply by virtue of the fact that the specific component inherently exists within that prior art mixture/composition. In other words, while a claim to such an isolated component may potentially be vulnerable to an anticipation attack, the anticipatory reference needs to specifically identify and characterize the component, and must teach how to isolate the component. Absent this sort of “slam dunk” scenario, a patent challenger’s success is likely to rise or fall with the merits of its obviousness argument(s). The critical factors in the obviousness analysis will likely be whether the claimed component was known to be responsible for the activity of the prior art mixture/composition; whether the process used to isolate the claimed component was challenging, or better yet still from the patentee’s perspective, whether the process was inventive; whether the prior art as a whole would have enabled one of ordinary skill in the art to isolate the claimed component; and whether the claimed component exhibits any unexpectedly superior properties relative to the prior art mixture/composition.