On April 16, 2012, the U.S. Court of Appeals for the Federal Circuit (Cephalon et.al. v Mylan Pharmaceuticals et.al.) overturned a Delaware District Court’s finding that U.S. Patent Nos. 7,387,793 and 7,544,372 were obvious. The Appeals Court held that the District Court incorrectly limited its obviousness analysis to the issue of bioequivalence and further erred in not considering the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed formulation. The Appeals Court noted that though it may have been obvious to experiment with the use of the pharmacokinetic profile of the known immediate release formulation when contemplating an extended release formulation, “there was nothing to indicate that a skilled person would have had a reasonable expectation that such an experiment would succeed in being therapeutically effective.”
The Appeals Court went on to state:
This distinction is important. Where a skilled artisan merely pursues “known options” from “a finite number of identified, predictable solutions,” the resulting invention is obvious under section 103….Where however a defendant urges an obviousness finding by “merely throw[ing] metaphorical darts at a board” in hopes of arriving at a successful result, but “the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful”, courts should reject “hindsight claims of obviousness.”
In addition, the Court provided extensive comments on the burden and standard of proof for an obviousness inquiry as well as rejecting the Defendants’ allegation of invalidity based on lack of disclosure of best mode.
A copy of the decision can be found here.