J&J's Momenta calls infringement against Viatris' Copaxone generic, but why now?

Johnson & Johnson’s Momenta Pharmaceuticals unit is crying patent infringement against Mylan—now Viatris—plus two of the generics maker’s Indian manufacturing partners, according to a new lawsuit. But the generic drug they're targeting is five years old.

The J&J drug in question is Momenta’s Glatopa, or glatiramer acetate injection, a generic formulation of Teva Pharmaceutical’s multiple sclerosis med Copaxone. Under a partnership with Sandoz, the Momenta med won an approval as the first copycat to Teva’s blockbuster MS med back in April 2015.

That first nod was for a 20-mg/mL presentation. A higher-dose, 40-mg/mL version won approval in early 2018.

In between those two approvals, Mylan scored its own nod for 20- and 40-mg generics of Copaxone. In 2017, the company said it planned to start rolling out product “immediately." Viatris, meanwhile, was born in late 2020 through the merger of Mylan and Pfizer’s Upjohn unit.

Mylan officially launched its 20- and 40-mg generics in the U.S. in October of 2017, the same month it scored FDA approval. 

In the new lawsuit, J&J and Momenta allege Mylan and its Indian manufacturing partners Natco Pharma and Gland Pharma violated two patents related to Glatopa’s production. Momenta is the exclusive holder of both patents in question, dubbed ‘489 and ‘374 in the complaint. It's not immediately clear why Momenta is bringing the lawsuit years after Mylan's approval.

For the FDA to have approved the defendant companies’ manufacturing process for glatiramer acetate, Momenta figures they must have included steps described in its patents. 

J&J's Momenta is seeking "all damages or other monetary relief" as compensation for the alleged infringement, the lawsuit states.

Momenta also wants the court to prevent Mylan, its subsidiaries and its partners from continuing to infringe by making and selling generic Copaxone in the U.S.

Natco called it "a meritless suit for a product that has been in the market for more than five years,” the company said in a regulatory filing, as quoted by Business Standard. “Mylan and Natco will strongly defend against this suit,” the Indian drugmaker added.

"J&J’s and Momenta’s unusual lawsuit, alleging infringement of two old patents nearly 5 years after Mylan launched its 20 mg/mL and 40 mg/mL Glatiramer Acetate Injection products is meritless," a Viatris spokesperson said over email. "We have strong defenses to these patents and will vigorously defend against them."

Editor's note: This story has been updated to include Viatris' statement.