Janssen Pharms., Inc. v. Teva Pharms. USA, Inc
Authored by: Jeremy J. Gustrowsky
In a significant decision for pharmaceutical patent holders, the Federal Circuit has affirmed the validity of Janssen Pharmaceuticals’ U.S. Patent No. 9,439,906, which covers specific dosing regimens for Invega Sustenna, a long-acting injectable antipsychotic used to treat schizophrenia. Teva Pharmaceuticals, seeking to launch a generic version, had challenged the patent on the grounds that its claims were obvious in light of prior art. However, both the district court and the Federal Circuit found that Teva failed to prove obviousness by clear and convincing evidence.
A key issue in the case was whether a legal presumption of obviousness should apply because the claimed dosing regimens overlapped with those disclosed in earlier references. The court explained that this presumption, common in cases involving overlapping numerical ranges, did not fit here. Unlike simple chemical compositions, the claimed invention was an integrated treatment regimen involving specific doses at particular times—a combination not clearly suggested by the prior art. The court found that Teva had not shown that a skilled person would have been motivated to arrive at Janssen’s specific regimen or would have reasonably expected it to work.
The court also addressed claims related to dosing for patients with renal impairment and to specific particle sizes in the injectable formulation. In each instance, the court concluded that Teva had not provided enough evidence that someone skilled in the field would have been motivated to make the necessary modifications based on existing knowledge. As a result, all challenged claims, including those dependent on the main claims, were upheld as nonobvious.
This decision underscores the importance of detailed factual findings in patent obviousness disputes, especially for pharmaceutical dosing regimens that go beyond simply selecting numbers from a range. The ruling provides reassurance to innovators that carefully crafted and clinically tested treatment protocols can withstand generic challenges if they represent more than routine experimentation.