The case involves Salix Pharmaceuticals, Ltd., Salix Pharmaceuticals, Inc., Bausch Health Ireland Ltd., and Alfasigma S.P.A. (collectively, “Salix”) and Norwich Pharmaceuticals Inc. (“Norwich”). Salix appealed from a final judgment of the United States District Court for the District of Delaware holding certain claims of their patents invalid as obvious. Norwich cross-appealed from an order that issued after the district court concluded that Norwich infringed certain claims of Salix's patents and had failed to prove those claims were invalid.
Salix's patents were related to the treatment of hepatic encephalopathy (“HE”) and irritable bowel syndrome with diarrhea (“IBS-D”) using a specific dosage of the drug rifaximin, and to a specific polymorphic form of rifaximin. The district court found that Norwich's Abbreviated New Drug Application (“ANDA”) for a generic version of rifaximin infringed Salix's patents, but also held certain claims of Salix's patents invalid as obvious.
On appeal, the United States Court of Appeals for the Federal Circuit affirmed the district court's decision. The court found no clear error in the district court's conclusion that a skilled artisan would have had a reasonable expectation of success in administering the claimed dosage regimen for the treatment of IBS-D. The court also affirmed the district court's conclusion that the polymorph patent claims were invalid as obvious. The court further affirmed the district court's order setting the effective approval date of Norwich's ANDA to be no earlier than the date of expiration of the last to expire of the HE patents, and the district court's denial of the motion to modify the final judgment. View "Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc." on Justia Law
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