Facing 'imminent' Gilenya generics and a $300M sales hit, Novartis takes patent fight to Supreme Court

After back-to-back setbacks in its high-stakes Gilenya patent defense, Novartis is taking its arguments all the way to the Supreme Court.

Wednesday, Novartis said it plans to petition the Supreme Court to take up the case after the U.S. Court of Appeals for the Federal Circuit rejected its bid to rehear the case.

Back in June, the appeals court overturned a prior decision in favor of the Swiss drug giant. In doing so, the court sided with Chinese generics maker HEC Pharma and found a patent on the multiple sclerosis drug is invalid, opening the prospect of early competition.

Since Gilenya is Novartis' third biggest drug by sales, the decision carries real commercial weight. If generics launch this year, Novartis expects a $300 million hit to its 2022 revenue guidance, the company said Wednesday. Novartis' effort to petition the Supreme Court could take several months, the company said.

The federal circuit's June decision reversed a January ruling surrounding Gilenya’s ‘405 patent, which covers methods for treating relapsing multiple sclerosis with a specific dose of the medicine. However, the patent doesn’t mention loading doses, which are higher or more frequent doses at the start of treatment, the court said.

The decision may affect the launch timing for other generics players, as well. With the reversal of the original decision, other generics companies might be able to launch their generics of the drug imminently, Novartis notes in its statement.

Still, Novartis said it intends to “vigorously defend” the patent’s validity and is considering “all available options.”

Gilenya brought in $2.78 billion worldwide last year, ranking third on Novartis' sales chart behind immunology drug Cosentyx and cardio medicine Entresto.