January 8, 2019

SCOTUS declines to hear cases involving patents for cholesterol-lowering, Hep C drugs

Daily Briefing

    The Supreme Court on Monday declined to hear two separate cases centering on prescription drug patents.

    Justices deny request to hear case over patents for cholesterol-lowering drug

    The Supreme Court justices refused to hear a case regarding patents for the cholesterol-lowering drugs Repatha, owned by Amgen, and Praluent, owned by Regeneron Pharmaceuticals and Sanofi.

    Amgen in 2014 filed a lawsuit against Regeneron and Sanofi claiming Praluent had infringed on Amgen's patents for Repatha and sought to block Regeneron and Sanofi from selling Praluent on the U.S. market. A jury in 2016 agreed with Amgen that Praluent infringed on Repatha's patents, but the U.S. Court of Appeals for the Federal Circuit in 2017 ordered a new trial, setting aside the jury's verdict and nullifying a judge's ban on Praluent sales. Amgen appealed to the Supreme Court, asking the high court to overturn the 2017 ruling and reinstate the jury verdict, which would again block Praluent sales.

    The Supreme Court denied to hear the appeal, meaning the case will continue in a new trial that was ordered by the U.S. Court of Appeals for the Federal Circuit.

    Sanofi and Regeneron praised the Supreme Court's decision to not hear the case. The companies in a joint statement said, "We are confident that the law and the facts support our positions," and they look forward to the new trial, which is scheduled to begin Feb. 19.

    Amgen in a statement said it is preparing for the new trial.

    Justices refuse to hear case regarding patents for hep C treatments

    The justices on Monday also denied a request to hear a case regarding Merck's patents for a compound in blockbuster hepatitis C treatments, Reuters reports.

    The lawsuit involves a patent for a compound called sofosbuvir, the active ingredient in Gilead's blockbuster hepatitis C treatment Sovaldi, and one of two therapeutic compounds in Harvoni, another Gilead-owned breakthrough hepatitis C drug.

    Idenix Pharmaceuticals, a company Merck purchased in 2014, had a patent for sofosbuvir and in 2013 filed a lawsuit against Gilead, claiming Gilead had infringed on its patent. Idenix in the suit sought to block Gilead from launching Sovaldi. Merck took over the case once it acquired Idenix.

    A federal jury in 2016 found Gilead guilty of willingly infringing on Merck's patent for sofosbuvir and ordered Gilead to pay Merck $200 million for the violation. However, a judge later threw out the jury's verdict, ruling that Merck's patents could not be enforced because of misconduct by the company, including the use of confidential information from 2004 related to partnership discussions with Pharmasset, which Gilead purchased in 2011, and untruthful testimony from Merck's in-house lawyer about his involvement in confidential calls with Pharmasset employees.

    Merck appealed the case to the Supreme Court and asked that the high court overturn the judge's decision, the Court declined to hear the case (Wolfe [1], Reuters, 1/7; Wolfe [2], Reuters, 1/7).

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