J&J defeats generic drugmakers in US appeal over schizophrenia treatment
The U.S. Court of Appeals for the Federal Circuit ruled that Teva and Viatris failed to demonstrate, opens new tab that the patent's innovations were obvious, blocking their path to manufacturing a cheaper generic version of J&J's blockbuster drug.
In an earlier appeal in the same case last year, the Federal Circuit had granted the drugmakers' request for U.S. District Judge Claire Cecchi in New Jersey to reconsider their case. The appeals court on Tuesday affirmed a December ruling by Cecchi that J&J's patent was valid.
Spokespeople for Teva and Viatris did not immediately respond to requests for comment on the decision. A J&J spokesperson said that the company was pleased with the ruling.
J&J sold more than $4.2 billion worth of Invega Sustenna and related drugs worldwide last year, with more than $3.1 billion in U.S. sales, according to a company report. It sued Teva and Mylan, which is now part of Viatris, for patent infringement over their proposed generic versions of the drug in 2018 and 2019, respectively.
Cecchi ruled in 2021 that Teva failed to prove a J&J patent covering a dosing regimen for Invega Sustenna was invalid. Viatris agreed to be bound by Cecchi's decision.
The Federal Circuit overturned that ruling last April and remanded the case to New Jersey. The appeals court gave Teva another chance to prove that the patent was invalid by showing that the dosing regimen would have been obvious to an ordinary person in the field.
Cecchi ruled for J&J again in December. The appeals court upheld the decision on Tuesday, agreeing with the judge that the dosing regimen was not obvious.
The case is Janssen Pharmaceuticals Inc v. Teva Pharmaceuticals USA Inc, U.S. Court of Appeals for the Federal Circuit, No. 2025-1228.
For J&J: Barbara Mullin of Patterson Belknap Webb & Tyler
For Teva and Mylan: John O'Quinn of Kirkland & Ellis
For Mylan: Deepro Mukerjee of Katten Muchin Rosenman
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Teva, Viatris win new chance to challenge J&J schizophrenia drug patent
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