• Jul 12 2019
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  • Category: CAFC Updates

Indivior markets and holds the New Drug Application (“NDA”) for Suboxone® sublingual film, an opioid addiction treatment that combines buprenorphine and the opioid antagonist naloxone. Several generic drug companies filed Abbreviated New Drug Applications (“ANDAs”) to market generic versions of Suboxone Film prior to the expiration of the patents, and Indivior then brought actions for patent infringement, accusing DRL and Watson of infringing the patents. The CAFC finds that Indivior has not shown clear error in the court’s holding that DRL employs conventional top air drying, which is insufficient to meet the drying limitation of the asserted as properly construed.   The CAFC also finds that the district court did not clearly err in its finding that Watson infringes the ’514 patent and did not abuse its discretion in denying it relief from the infringement judgment under Rule 59, noting that while Rule 59 gives a court authority to alter or amend a judgment, that authority is exercised only in limited circumstances, such as to prevent a manifest injustice. With respect to indefiniteness, Watson and Teva argue that the claims recite a physical impossibility—a flowable yet solid cast film—and are therefore indefinite, but the CAFC finds that the only sensible reading of the claim is that the cast film is made from a matrix that is flowable before drying and is not simultaneously dry and flowable. Regarding obviousness, the CAFC finds that the district court did not clearly err in finding that secondary considerations support non-obviousness. The CAFC also agrees that the district court correctly found that DRL’s product does not infringe under the doctrine of equivalents, because when a patentee discloses subject matter but does not claim it, the patentee dedicates the unclaimed subject matter to the public and cannot recapture it through the doctrine of equivalents. The CAFC therefore, affirms-in-part and vacates-in-part. Judge Mayer dissents, opining that there is no need for the court to reach the issue of infringement because the three patents are invalid as obvious.


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