Posts Tagged: "written description requirement"

Juno Asks Supreme Court to Reconsider Denial of Petition on Section 112 Question in Light of Amgen Review

Following the denial of Juno Therapeutics’ petition to the U.S. Supreme Court earlier this month, Juno last week petitioned the High Court for rehearing, arguing that the grant of certiorari in Amgen v. Sanofi warrants reconsideration. Juno explained that the issues presented in the Amgen case “are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.” Juno is asking that the Court grant the petition for rehearing, vacate the denial of certiorari, and hold the case pending the outcome in Amgen.

Supreme Court’s Denial of Juno Therapeutics is Another Blow to the Life Science Patent Industry

On November 7, the U.S. Supreme Court issued an order list showing that it had denied the petition for writ of certiorari filed in Juno Therapeutics, Inc. v. Kite Pharma, Inc. In denying the petition, the Court refused yet again to clarify the Federal Circuit’s questionable interpretation of U.S. patent code, this time within the context of the written description requirement of 35 U.S.C. § 112, and leaves in place an appellate court ruling that many believe will be very damaging to the United States’ life sciences innovation sector.

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.

Juno Petition Asks SCOTUS to Clarify Written Description Standard

Juno Therapeutics last week petitioned the U.S. Supreme Court, asking it to review an August 2021 decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) that reversed a jury verdict for Juno and Sloan Kettering Institute for Cancer Research, wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence.

O’Malley Dissents from ‘Concerning’ CAFC Ruling that Biogen’s MS Drug Patent is Invalid

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.