Janssen Pharms., Inc. v. Teva Pharms. USA, Inc

Authored by: Jeremy J. Gustrowsky

In a recent decision, the Federal Circuit provided important guidance on how courts should analyze the obviousness of pharmaceutical dosing regimen patents. The case involved Janssen’s U.S. Patent No. 9,439,906, which covers specific dosing regimens for Invega Sustenna, an injectable treatment for schizophrenia. Teva Pharmaceuticals challenged the validity of this patent, arguing that the claimed dosing regimens were obvious in light of prior art. While the district court initially sided with Janssen, the Federal Circuit found that the lower court had applied the wrong legal standards in several key respects.

A central issue was whether the patent claims required the dosing regimen to be effective for the entire patient population or just for an individual patient. The Federal Circuit clarified that the claims only required administering the regimen to “a psychiatric patient,” not to a generalized population. The district court’s focus on population-wide efficacy, therefore, was incorrect and led to an improper analysis of the prior art.

The appellate court also criticized the district court for being too rigid in its approach to obviousness. Instead of considering how a person skilled in the art might combine or modify prior art references using their knowledge and creativity, the lower court looked for explicit teachings or motivations in each reference. The Federal Circuit emphasized that obviousness should be assessed flexibly, considering the broader context and the possibility of predictable results from combining known elements.

On the issue of indefiniteness, the Federal Circuit affirmed the district court’s finding that the patent’s particle-size claims were not indefinite. The challenger had not shown that different measurement techniques would typically yield inconsistent results for the claimed formulations. Ultimately, the case was sent back to the district court for a new analysis of obviousness using the correct legal standards, but the patent survived the indefiniteness challenge.