Posts Tagged: "Novartis"

SCOTUS Denial of Novartis Petition for Cert Returns Focus Toward ‘Procedural Insanity’ at the Federal Circuit

On April 17, the U.S. Supreme Court denied a petition for writ of certiorari filed by pharmaceutical developer Novartis seeking to overturn a decision on rehearing by the U.S. Court of Appeals for the Federal Circuit that invalidated patent claims covering the blockbuster multiple sclerosis (MS) treatment, Gilenya. The cert denial leaves in place a CAFC decision derided by commentators as “procedural insanity” and increases the focus upon certain machinations at the appellate court bearing the fingerprints of Chief Judge Kimberly Moore.

Novartis Asks SCOTUS to Rein in CAFC and Ninth Circuit Approach to Panel Rehearing Decisions

Last week, Novartis Pharmaceuticals followed through on its  September 2022 promise that it would appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June 2022 decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case.

Novartis to Appeal CAFC’s ‘Unprecedented’ U-Turn in Ruling on Multiple Sclerosis Drug Claims to SCOTUS

Novartis Pharmaceuticals announced today that it will appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case. The CAFC in June vacated a different three-judge panel’s January opinion upholding Novartis’ U.S. Patent No. 9,187,405. In the original ruling, Chief Judge Moore had dissented from the majority; in the rehearing, Moore authored the opinion vacating the January decision, with Judge Linn dissenting.

Federal Circuit Upholds Patent Term Extension for Novartis Drug

The United States Court of Appeals for the Federal Circuit recently affirmed a district court decision finding the ‘229 patent valid, unexpired, enforceable, and infringed, and granting an injunction until February 2019. Specifically, the Federal Circuit held that the ‘229 patent’s five-year term extension pursuant to 35 U.S.C. § 156 was valid, even though it effectively extended the term of a related patent. The Court also held that the ‘229 patent was not invalid based on obviousness-type double patenting because obviousness-type double patenting cannot invalidate a patent which has received a valid term extension. Novartis AG v. Ezra Ventures LLC, No. 2017-2284, (Fed. Cir. Dec. 7, 2018) (Before Moore, Chen, and Hughes, Circuit Judges) (Opinion for the court by Chen, Circuit Judge).

Novartis acquires French radiopharmaceutical firm for oncology drug after losing patent protection for Gleevec

Novartis has agreed to acquire French radiopharmaceutical firm Advanced Accelerator Applications (AAA) in a deal which values AAA at $3.9 billion USD. The deal, funded through short- and long-term debt, adds the radioligand therapy (RDL) known as Lutathera to the Novartis pipeline. This drug, approved for use in the European Union and currently undergoing trials for approval by the U.S. Food and Drug Administration (FDA), is used in the treatment of patients suffering from neuroendocrine tumors.