A Newark, New Jersey, federal judge has halted an effort by Pennsylvania-based Mylan Pharmaceuticals Inc. to produce a generic version of Invega Trinza, a Janssen Pharmaceuticals Inc. drug for the treatment of schizophrenia.
The ruling by U.S. District Judge Evelyn Padin bars Mylan from producing a generic version of Invega Trinza until 2036.
That’s surely welcome news for Janssen, which generates millions in annual sales from the drug.
The ruling bars the Food and Drug Administration from approving Mylan’s abbreviated new drug application for its version of Invega Trinza.
The patent that Janssen holds for Invega Trinza has expired, but a related patent for a dosing regimen used by patients who missed a dose of the drug, known as the 693 patent, is still active.
Padin ruled that if Mylan moves forward with its generic version of the drug, health care providers would be instructed to infringe Janssen’s active patent.
Mylan sought to market a generic version of Invega Trinza by filing an abbreviated new drug application, arguing that Janssen’s 693 patent is invalid and does not deserve protection.
Mylan claimed that the 693 patent was invalid based on obviousness—meaning that a person of ordinary skill in the art could have formulated the patent’s claims using information that was publicly available before the patent’s issuance.
But after conducting a bench trial over nine days in 2022 and 2023, Padin ruled that Mylan did not demonstrate the patent was obvious or otherwise invalid.
Patterson Belknap Webb & Tyler represented Janssen, with Robinson Miller of Newark as local counsel. Barbara Mullin of Patterson Belknap served as lead counsel, and was aided by the firm’s Aron Fischer and Andrew Cohen. They declined to comment on the verdict.
Arnold B. Calmann, Katherine Ann Escanlar and Jeffrey S. Soos of Saiber in Florham Park represented Mylan. They did not respond to a reporter’s calls about the verdict.
Padin’s opinion was issued under seal on May 15 and issued in a redacted version on May 23.