In a dispute between Switzerland-based Novartis and China's Eastern Sunshine Pharmaceutical Co LTD and other makers of generic drugs, Novartis is trying to block generic drug companies from launching its blockbuster multiple sclerosis treatment, Fingomode (Gilenya) Generic versions of the drug. recently, The U. S. Supreme Court rejected Novartis's attempt.

        Novartis asked the judge to put the lower court's ruling on hold, The ruling lifted a ban on generic versions of the drug Fingormode. 2021 years, Fingomode is Novartis's third-best-selling drug, Sales volume is 28 Billions of dollars.

        Sunbeam and more than a dozen other generic drugmakers filed lawsuits with the Food and Drug Administration (FDA) After applying for approval of a generic version of Fengomode, Novartis sued the generic drugmakers in federal District Court in Delaware, Accusing them of patent infringement.

        Novartis settled with some of the drugmakers it sued, To allow them to license a key patent in 2027 Launch a few generic versions of Fengomode before the year expires. Among the companies that settled with Novartis was India's Aurobindo Pharmaceuticals (Aurobindo Pharma Ltd) , Dr. Reddy's laboratory (Dr. Reddy's Laboratories) He Sun Pharmaceutical Co. , LTD (Sun Pharmaceutical IndustriesLtd) , Mylan Pharmaceuticals, a division of the Pennsylvania-based Hui Hui Corporation (Mylan Pharmaceuticals) And Obertek Pharmaceuticals, a privately held Canadian company (Apotex Inc. ) .

        FDA in 2010 The once-daily pill Fingomode was approved in 2000, The drug is used to treat relapsing multiple sclerosis, It is a chronic disease that affects the central nervous system. Novartis this year 9 Lunar representation, If the generic version of Fengomode is released, Expected in 2022 It will lose sales for the rest of the year 3 Billions of dollars.

        The patent-focused U. S. Court of Appeals for the Federal Circuit on 6 Monthly decision, One of Fingormode's key patents is invalid.

        Chief Justice of the United States John F．Roberts (John Roberts) in 9 month 29 Japan approved Novartis's request, Temporarily blocking the federal circuit from proceeding as planned 10 month 4 Issue an authorization on the day, Lifting a federal judge's injunction blocking the production of a generic version of the drug.

        Mr Roberts's appeal came after Novartis said it was likely to succeed in its appeal to the Supreme Court, And there will be a green light for generic drugs "Damage its interests, It is impossible to calculate damages after the fact" .

        Eastern Sunshine Medicine told the Supreme Court, Novartis makes money from Fingormode sales every day in the United States alone 380 Ten thousand dollars.

        East sunshine medicine said: "If Novartis fails to win its case at the Supreme Court, It will be withdrawn from payers and patients for each day that the requested stay is in effect 380 Ten thousand dollars. And no one can recover a single cent of Novartis's ill-gotten monopoly revenues. "

        A spokesman for Novartis said, The company will "Continue to vigorously defend the validity of the Fingormode patent" , And plans to petition the High Court for review of the Federal Circuit's decision.

(Compiled from www. usnews. com)

Reprinted from China Intellectual Property Network   translation: Rason group　proofread: Liu Peng

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