After handing Novartis a win in January, a U.S. appeals court has changed course in a Gilenya patent infringement lawsuit. On Tuesday, the judges revived a Chinese drugmaker’s bid to challenge the blockbuster multiple sclerosis med with its copycat.
The U.S. Court of Appeals for the Federal Circuit has found a Novartis patent on Gilenya invalid, reversing an earlier decision from January. At the time, a divided court panel shot down defendant HEC Pharm Co’s argument that the patent lacked a proper written description, scuppering the generic drugmaker’s plans to market a Gilenya copycat prior to the patent's expiration in 2027, Reuters reported.
The case revolves around Gilenya’s so-called ‘405 patent, which covers methods for treating relapsing multiple sclerosis with a specific dose of the med, court documents show. The patent calls for daily administration of Gilenya 0.5 mg, the court filing states.
Crucially, however, the patent’s specification fails to mention loading doses, which are higher or more frequent doses at the start of treatment, the court said.
“Instead, it describes administering fingolimod at regular intervals,” the court documents continue, using Gilenya’s generic name.
“Because the ‘405 patent fails to disclose the absence of a loading dose, the district court clearly erred” in its earlier decision, Chief Judge Kimberly Moore wrote in the appeals court’s latest verdict.
Still, not every judge agreed with the reversal. In a dissenting opinion, circuit judge Richard Linn argued that the panel majority applied a tougher standard to the case than it should have.
Novartis isn’t playing sitting duck, either, saying Tuesday it would file a petition to seek further review of the appeals court’s decision.
The company plans to “vigorously defend” the validity of Gilenya’s ‘405 patent, leaving “all available options” on the table,” Novartis said. That includes current plans to seek a review of the decision by the full Court of Appeals for the Federal Circuit, which the company said could take several months.
Novartis initially sued HEC in Delaware federal court after the Chinese company filed for FDA approval of its Gilenya copycat. Novartis has settled with multiple other generic drugmakers involved in the Gilenya litigation, teeing up certain generics to launch before 2027, Reuters pointed out.
Because the appeal process remains open, meanwhile, the permanent injunction against HEC is still in place, Novartis said, adding that it believes HEC is “not permitted to launch a generic version of Gilenya at this time.”
Gilenya, first approved in 2010, is Novartis’ third best-selling drug behind Cosentyx and Entresto, according to the Swiss company’s 2021 annual report. Last year, the med pulled down $2.78 billion globally.
Editor's note: This story was updated with comments from Novartis.