When it comes to courtroom brawls, petitioning the U.S. Supreme Court is typically a last-ditch effort. Now, after justices slapped down bids to rehear two separate cases, Novartis and Sanofi have reached the end of the line in their respective legal sagas.
Novartis hoped to resurrect a key patent on its multiple sclerosis blockbuster Gilenya in a feud with China’s HEC Pharm. Sanofi, for its part, wanted the Supreme Court to revive an antitrust lawsuit against Viatris over an alleged EpiPen monopoly.
The Supreme Court rejected (PDF) both petitions on Monday.
In Novartis' case, the Swiss pharma giant first telegraphed plans to appeal to the Supreme Court in September 2022 after the U.S. Court of Appeals for the Federal Circuit rejected its bid to rehear its high-stakes Gilenya patent defense.
Back in June of that year, the appeals court overturned a prior decision in Novartis’ favor, siding with Chinese generics maker HEC. Novartis took another blow in October 2022, when the Supreme Court lifted a stay blocking Gilenya generics from launching in the U.S.
Novartis has sued numerous generic manufacturers, including HEC Pharm, over their FDA applications to crank out fingolimod—Gilenya’s generic moniker. Novartis settled with many of the companies, including India’s Aurobindo Pharma, Dr. Reddy’s Laboratories and Sun Pharmaceuticals, as well as North American generic players such as Viatris and Canada-based Apotex.
Those decisions pave the way for certain Gilenya generics to launch before a patent expiration in 2027.
Moving over to Viatris, the company—formed from the union of Mylan and Pfizer’s Upjohn established medicines unit—entered Sanofi’s crosshairs, again, in June 2021. That month, Sanofi requested a new trial to argue that Mylan blocked competition to its EpiPen competitor Auvi-Q, leveraging price hikes and steep rebates to keep hold of the U.S. epinephrine market. Sanofi made its case after a Kansas District Court ruled in Mylan’s favor back in December 2020.
Sanofi launched Auvi-Q in 2013. The French pharma argued Mylan “jacked up prices” on EpiPen in the year leading up to Auvi-Q’s launch before making payers an offer they “could not refuse” by floating deep rebates on EpiPen’s list price. But those rebates were only available if insurance plans agreed to restrict access to Auvi-Q, Sanofi claimed in a prior court filing.
The Supreme Court is currently entertaining a slew of Big Pharma bids to rehear high-stakes lawsuits. Look no further than Teva and GSK’s long-running "skinny" label feud, where the high court recently reached out to the U.S. solicitor general for her take on whether to hear the case.
Early this year, Bristol Myers Squibb and Pfizer had their own closely watches cases turned away by the Supreme Court.