Tuesday, June 23, 2015

Supreme Court Denies Cert in Case Involving Post-Filing Evidence in Assessing Obviousness of Pharmaceutical Inventions

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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