Posts Tagged: "Novartis"

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 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.

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 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.

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one for Allergan, which saw its overall revenues increase by 48 percent when compared to 2015’s first quarter; revenue for Allergan’s branded pharmaceutical divisions grew by 71 percent year-over-year. The company’s infectious disease division was not its most profitable and yet it saw the greatest amount of growth compared to the previous year. Teflaro entered the Allergan portfolio thanks to a series of acquisitions in the biopharma realm over the past few years. The pediatric anti-infective was first developed by Forest Laboratories, formerly of New York City, which was acquired by Actavis in February 2014 for a combination of cash and equity which reached a reported $25 billion.

Bristol-Myers Squibb was able to move on in clinical trials of its cancer drug Opvido more quickly than anticipated after kidney cancer patients who were administered the medication showed superior overall survival compared to those patients who were not on an Opvido regimen. Opvido, which has already been approved by the U.S. Food and Drug Administration for the treatment of advanced melanomas and lung cancers, is an inhibitor of the protein known as programmed cell death protein 1, or PD-1. PD-1 inhibits the response of T cell lymphocytes, making it more difficult for an immune system to target a tumor.