Last week, in a ruling that could be a boon to generic drug makers, the Federal Circuit invalidated claims covering the 0.3% concentration of Differin® (adapalene) acne gel as obvious. Galderma Labs. v. Tolmar, Inc. (Fed. Cir. Dec. 11, 2013). In doing so, the Federal Circuit set forth a potentially far-reaching rule: when a patent claims a particular concentration from a known range of concentrations, the burden of production automatically shifts to the patentee to come forth with objective evidence of non-obviousness.
Tolmar filed an ANDA for the generic version of Differin® 0.3% strength acne gel. Galderma’s patent covered acne gels containing 0.3% by weight of adapalene. Adapalene was a known compound; further, it was known that gels containing 0.01%-1.0% adapalene by weight were effective acne treatments. Galderma’s patented 0.3% concentration fell squarely within that known range.
Following a bench trial, Judge Leonard P. Stark of the District of Delaware rejected Tolmar’s obviousness defense, relying heavily on the secondary considerations of unexpected results and commercial success.
The Federal Circuit, with Judge Prost writing and Judge Bryson joining the 2-1 decision, disagreed, and began by calling this “an obviousness case that is both straightforward and potent.” It then put the burden on the patentee to identify objective evidence of non-obviousness:
[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.
In applying its new rule, the Federal Circuit made short work of Galderma’s secondary considerations. Galderma argued, for example, that compared to the known 0.1% concentration, the 0.3% concentration unexpectedly showed no increase in side-effects. But the Federal Circuit noted that this was merely a difference in degree, not kind, and brushed it aside. Galderma also cited the commercial success of Differin® 0.3%, but the Federal Circuit gave it no weight. Galderma had blocking patents in place until 2010, and further, “[t]he mere fact that generic pharmaceutical companies seek approval to market a generic version of a drug, without more, is not evidence of commercial success.”
The decision earned a vehement and lengthy dissent from Judge Newman for “foreclos[ing] patentability to a vast body of improvement patents.” Whether the effect will be quite so sweeping remains to be seen; however, patents claiming a particular concentration falling within a known range are undoubtedly weakened.