Teva wins Fed Circ appeal over J&J’s schizophrenia drug
Teva and co-appellant Mylan gain second chance at launching generics of Invega Sustenna, owned by J&J subsidiary Janssen | US Court of Appeals vacates a lower court’s decision to grant validity to the drug’s last remaining patent.
The US Court of Appeals has dealt a blow to Janssen, now Johnson & Johnson Innovative Medicine, after judges doubted the validity of its last remaining patent on the blockbuster drug Invega Sustenna.
The decision gives appellants Teva Pharmaceuticals and Mylan Laboratories (now part of Viatris) a fresh chance to launch their own generic versions.
In its decision delivered yesterday, April 1, the US Court of Appeals for the Federal Circuit vacated and remanded a lower court’s decision to grant validity to Janssen’s last remaining Orange Book patent for Invega Sustenna, used to treat schizophrenia in adults.
The drug is an extended-release intramuscular injectable of paliperidone palmitate which, according to a J&J report, along with related drugs exceeded $4.1 billion in sales in 2023.
After Teva and Mylan sought approval for their generic versions, Janssen promptly sued the duo (Teva in 2018, followed by Mylan in 2019) asserting various claims of its patent, US number 9,439,906.
Teva and Mylan subsequently joined forces to challenge the patent, questioning the validity of claims 2, 10, 13, and 20–21, which describe a dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia.
Of particular relevance is that Teva and Mylan had argued that all representative claims were invalid as obvious and that claims 19–21 were also invalid as indefinite.
After a bench trial, the US District Court for the District of New Jersey found in favour of Janssen, deciding that Teva had not proven invalidity on either arguments.
While Circuit judges Timothy Dyk, Sharon Prost and Todd Hughes affirmed the district court’s indefiniteness determination, they vacated and remanded its determination relating to nonobviousness.
The judges found that the district court had misinterpreted the scope of the patent claims, applied an overly rigid analysis to the assessment of obviousness, and erred in its analysis of secondary considerations.
However, the Federal Circuit upheld the district court's finding on indefiniteness, ruling that Teva and Mylan had failed to show that different measurement techniques would typically yield different particle-size measurements of paliperidone palmitate, as required to prove indefiniteness.
Counsel for Janssen was Patterson Belknap, led by Barbara Mullin, along with Andrew Cohen, Aron Fischer, and Meghan Larywon.
Teva and Mylan were represented by Kirkland & Ellis, led by John O’Quinn, with attorneys Bill Burgess, Christopher Jagoe and Jeanna Wacker representing Teva. Deepro Mukerjee of Katten Muchin also represented Mylan along with Lance Soderstrom, Jitendra Malik, Jillian Schurr and Eric Werlinger.
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