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Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.

HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, HEC) petition for rehearing of our prior decision in this case, 21 F.4th 1362 (Fed. Cir. 2022), in which we affirmed a final judgment of the United States District Court for the District of Delaware. The district court determined that claims 1–6 of U.S. Patent No. 9,187,405 are not invalid and that HEC infringes them. Because the ’405 patent fails to disclose the absence of a loading dose, the district court clearly erred in finding that the negative claim limitation “absent an immediately preceding loading dose” added during prosecution to overcome prior art satisfies the written description requirement of 35 U.S.C. § 112(a). We grant HEC’s petition for panel rehearing, vacate our prior decision, and reverse the district court’s judgment that Novartis’ claims are not invalid for inadequate written description.

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