JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. , No. 22-1258 (Fed. Cir. 2024)
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In this case, the United States Court of Appeals for the Federal Circuit heard an appeal from the United States District Court for the District of New Jersey in a patent dispute between Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica NV (collectively "Janssen"), and Teva Pharmaceuticals USA, Inc. and Mylan Laboratories Ltd. (collectively "Teva and Mylan"). The dispute pertained to U.S. Patent No. 9,439,906, owned by Janssen, and 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. Teva and Mylan challenged the validity of the patent, arguing that the claims were obvious and indefinite.
The district court found in favor of Janssen, holding that Teva and Mylan had failed to prove that the patent was invalid on the grounds of obviousness or indefiniteness. Teva and Mylan appealed this decision.
On appeal, the Federal Circuit vacated and remanded the district court's nonobviousness determination, finding that the lower 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.
Consequently, the case was sent back to the district court for further proceedings consistent with the Federal Circuit's opinion.
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