CAFC Reverses January Decision Affirming Sufficient Written Description for Negative Claim Limitation Over Judge Linn’s Dissent

Earlier today, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. granting a petition for rehearing from appellant HEC Pharm Co., Ltd. In granting HEC’s petition, the panel majority of Chief Judge Kimberly Moore, who authored the decision, and Circuit Judge Todd Hughes vacated a previous January ruling by the Federal Circuit, which had affirmed the District of Delaware’s final judgment that Novartis patent claims covering its Gilenya treatment for multiple sclerosis were not invalid for failing to satisfy the written description requirement under 35 U.S.C. § 112. Senior Circuit Judge Richard Linn authored a dissent arguing that the panel majority had improperly adopted a heightened written description standard and failed to take into account expert testimony from Novartis regarding a negative claim limitation that the district court found was supported by ample evidence.