ADAPT PHARMA OPERATIONS v. TEVA PHARMACEUTICALS USA, INC.

Adapt appeals the District Court’s final judgment of invalidity with respect to several patents related to methods of treating opioid overdose by intranasal administration of a naloxone (NARCAN^®).  In 2012, amidst the growing opioid addiction crisis, the FDA held a public meeting to encourage the industry to develop an intranasal naloxone product, and explained that any intranasal naloxone formulation should deliver the same amount of drug to the bloodstream as injectable formulations.  In 2015, Adapt filed a patent application that led to the patents that eventually were listed in the Orange Book as covering NARCAN^®. Teva submitted an ANDA to the FDA seeking approval to manufacture and sell a generic version of NARCAN^®, including a Paragraph IV certification asserting that the Adapt patents are invalid, unenforceable, and/or not infringed. Adapt sued Teva for infringement and before trial, Teva stipulated to infringement, and the parties agreed to try validity. Adapt argues on appeal that the district court failed to articulate a reason why a skilled artisan would have been motivated to combine the prior art references to arrive at the claimed invention. However, the district court found that a skilled artisan would have been motivated to optimize the formulation for nasal delivery relying on both the fact that the FDA explicitly provided a motivation to formulate an intranasal naloxone product by identifying a need or problem known in the industry, and testimony of both parties’ experts. The CAFC holds that this analysis was not clearly erroneous.  The CAFC also found no clear error in the district court’s finding that the prior art, as a whole, did not teach away from the claimed invention. Nor was the CAFC persuaded by Adapt’s argument that the district court committed legal error because, according to Adapt, it concluded that the asserted claims would have been obvious before considering Adapt’s evidence of objective indicia of nonobviousness.  Although acknowledging that this is a close case, with facts supporting both parties’ arguments as to their preferred outcome, the CAFC affirms the district court’s judgment that the asserted claims are invalid as obvious. Judge Newman dissents because in her view there was no teaching or suggestion in the prior art to make this combination of ingredients for use in the claimed method to achieve the described beneficial results.

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