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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.
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