The U.S. Court of Appeals for the Federal Circuit (CAFC) yesterday affirmed a district court’s ruling that Novartis’ U.S. Patent No. 9,187,405 is not invalid and that HEC Pharm Co., Ltd. and HEC Pharm USA Inc.’s Abbreviated New Drug Application (ANDA) infringed the patent. The CAFC found no clear error in the district court’s finding that the patent’s claims did not fail the written description requirement under 35 U.S.C. § 112(a). Chief Judge Moore dissented, arguing that the district court’s analysis was inconsistent with the CAFC’s established precedent. The ‘405 patent covers methods of treating relapsing remitting multiple sclerosis (RRMS) with fingolimod (an immunomodulating medication) or a fingolimod salt “at a daily dosage of 0.5 mg without an immediately preceding loading dose.”

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