Takeda Chemical v. Alphapharm (Fed. Cir. 2007).
Alphapharm filed an ANDA with the FDA — hoping to begin making generic version of Takeda’s patented diabetes treatment ACTOS. ($1.7 b annual sales). The district court found the invention nonobvious, but Alphapharm asked the CAFC to review the case under the new standards of KSR v. Teleflex. On appeal, the CAFC affirmed.
Graham Primary Law: In the 1966 case of Graham v. John Deere, the Supreme Court set forth the primary methodology for determining obviousness. That methodology requires an examination of 1) the scope and content of the prior art; 2) differences between the prior art and the claims; 3) level of ordinary skill in the pertinent art; and 4) objective evidence of nonobviousness. According the CAFC, KSR left the Graham formula intact, but added the provision that the test must be flexibly applied.
Although flexibility is required, one inflexible rule is that a prima facie obviousness rejection requires at least “some reason” that would have led a chemist to modify the prior art in a particular manner. Here, the court could find no reason for such a modification or that the modification would have been ‘obvious to try.’ – validity affirmed.
Genus-Species Unexpected Results: Judge Dyk in Concurrence indicated that two of the broader claims were likely invalid based on a rule of unexpected results for species:
In my view a species should be patentable over a genus claimed in the prior art only if unexpected results have been established.
Dyk concurred with the validity finding because the “overbreadth” argument had been waived.