Teva, Viatris revive patent challenge on J&J's long-acting schizophrenia blockbuster Invega Sustenna

After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. patent on a lucrative Johnson & Johnson schizophrenia drug.

On Monday, the U.S. Court of Appeals for the Federal Circuit sided with Teva and Viatris’ argument that the last FDA-registered patent on Invega Sustenna, dubbed the ‘906 patent, may be invalid.

The appeals court’s decision will send the case back for consideration in New Jersey federal court, where U.S. District Judge Claire Cecchi in 2021 ruled that Teva failed to successfully challenge the patent’s validity. The ‘906 patent primarily concerns dosing regimens for Invega Sustenna, according to a recent court filing.

Viatris, which is attempting to position its generic version of Invega Sustenna apart from Teva’s, agreed to follow Cecchi’s 2021 decision in the case, Reuters reports.

J&J originally sued Teva and Mylan—now part of Viatris—for alleged patent infringement over potential generics to Invega Sustenna in 2018 and 2019, respectively, according to the news service.

In the latest appeals ruling, the three-judge panel decided that the ‘906 patent could be invalid because Invega Sustenna’s dosing regimen may have been obvious to an average person in the field.

A Teva spokesperson told Fierce Pharma Tuesday that the company is “pleased” by the latest decision, which will give it another shot to prove the invalidity of J&J’s patent. “We look forward to providing this important low-cost medication to patients as soon as possible,” she added.

Naturally, J&J sees things differently.

"Intellectual property protections enable us to continue the discovery and development of new life-changing therapies for patients, and J&J will continue defending the intellectual property of Invega Sustenna,” a J&J spokesperson said over email.

Approved back in 2006, Invega Sustenna is a once-a-month long-acting schizophrenia drug that seeks to sidestep many of the adherence hurdles that accompany daily oral antipsychotics. Since Sustenna’s original nod, J&J has secured approvals for even longer-acting versions of the product, such as Invega Trinza, which can be taken every three months, and Invega Hafyera, which only needs to be administered twice a year.

J&J has reaped blockbuster sales from its Invega franchise over the years, with the family of schizophrenia meds last year generating nearly $2.9 billion in the U.S. and $4.1 billion worldwide, according to J&J’s full-year 2023 earnings report.

Meanwhile, J&J last May beat back a separate attempt by Viatris to deploy a copycat of the every-three-months schizophrenia treatment Invega Trinza. At the time, New Jersey District Judge Evelyn Padin wrote that Viatris’ proposed generics would “induce infringement” of a patent known as ‘693, adding that Viatris’ attempts to show the patent was invalid had fallen flat.