On March 28, 2025, Patterson Belknap secured another significant victory for our clients, Johnson & Johnson subsidiaries Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC, in a Hatch-Waxman patent infringement litigation regarding Mylan Laboratories’ proposed generic versions of Janssen’s Invega Trinza® product. Invega Trinza® is a once-every-three-month long-acting injectable antipsychotic medication for the treatment of patients with schizophrenia.

The U.S. Court of Appeals for the Federal Circuit rejected Mylan’s arguments that its planned Invega Trinza copy does not induce infringement of the patent covering Invega Trinza®’s dosing regimen, and that the patent is invalid as obvious. The Court of Appeals also rejected Mylan’s challenge to the lower court’s finding that physicians would directly infringe the patent in accordance with Mylan’s proposed generic label. The decision upholds a 2023 ruling from the U.S. District Court for the District of New Jersey, which found that Mylan’s proposed generic drug and associated labeling induce infringement of the patent and that Mylan failed to prove obviousness.

On July 1, 2025, the full Federal Circuit Court rejected Mylan’s request for the court to reconsider the ruling, denying the company’s bids for panel and en banc rehearing.

The firm previously successfully defended Janssen in a challenge from both Mylan and Teva Pharmaceuticals to Janssens’ long-acting injectable antipsychotic drug, Invega Sustenna®. Combined U.S. 2024 sales of Invega Sustenna® and Invega Trinza® amounted to $3.1 billion.

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