On January
20, 2015, Bristol-Myers Squibb petitioned for certiorari in Bristol-Myers Squibb v. Teva Pharmaceutical,
asking whether an assessment of obviousness should "consider
post-filing evidence showing the actual differences between a patented
invention and the prior art.” The
Supreme Court denied the petition on May 4, but it remains an important issue,
particularly for the biotechnology and pharmaceutical industries. Two
concurring and two dissenting opinions followed by various combination of
Federal Circuit judges in the denial of a petition for en banc rehearing
highlight the confusion and divergence opinion among the members of that court.
In an article published in Biotechnology Law Report, I explained how the Federal Circuit panel’s ruling that
post-filing date toxicity data is not probative of nonobviousness appears to
run counter to a well-established body of Federal Circuit case law standing for
the opposite proposition, i.e., that post-filing evidence can be used to establish the nonobviousness of an invention. The
article also reviews some of the arguments made in support of the petition for
certiorari by amici representing the biotechnology and pharmaceutical sectors,
and critiques the highly divergent views of several Federal
Circuit judges who have weighed in on the issue.
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