Janssen Pharms., Inc. v. Mylan Labs. Ltd.
Invega Trinza(r) (paliperidone palmitate)
Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. Cir. No. Cir. Mar. 28 2025) (Circuit judges Dyk and Prost, as well as District Judge Goldberg, presided; opinion by Dyk, C.J. (Appellation from D.N.J. Padin, J.).
Drug Product and Patent(s)-in-Suit: Invega Trinza(r) (paliperidone palmitate); U.S. Patent No. 10,143,693 (“the ‘693 patent”)
Nature of the Case and Issue(s) Presented: Paliperidone palmitate is an antipsychotic used to treat schizophrenia and comes in two long-acting injectable forms: (i) one that lasts for one month (“PP1M”); and (ii) one that lasts for three months (“PP3M”). The ‘693 claims that Invega Trinza can be used to treat patients who have missed a PP3M treatment. The Invega Trinza label’s dosing instructions correspond to the patent’s asserted claims. The label specifically instructs doctors to “NOT administer the next dosage if the patient’s last dose was between four and nine month ago” and to instead use the reinitiation regimen shown in the Table 2. Mylan filed three ANDAs to obtain FDA approval to market generic paliperidone Palmitate before the expiration of patent ‘693 and these labels are virtually identical to the Invega Trinza Label. Janssen filed suit and claimed infringement, stating that Mylan’s proposed ANDA label will incite doctors to infringe. Mylan appealed and the Federal Circuit affirmed. Mylan appealed and the Federal Circuit affirmed.[i]Why Janssen Prevailed:
Mylan defended against Janssen’s claim of induced infringement with three arguments: (i) Mylan’s proposed labels specifically discourage patients from missing doses; (ii) Janssen failed to show that infringement would “inevitably” result because Janssen did not prove that patients who missed a dose would return and follow through with the claimed reinitiation regimen; and (iii) the asserted claims require two actors–a doctor and a patient–which gives rise to a divided-infringement problem, thereby defeating Janssen’s showing of direct infringement.Because Mylan’s label discourages missing doses, Mylan argued that Janssen could not show the requisite intent needed to prove induced infringement. Mylan’s proposed ANDA label instructs doctors that if a patient missed a dose of PP3M four to nine month ago, “DO NOT administer the next injection of
,” and continues, “Instead use the reinitiation regime shown in Table 2,” which directs them to perform the same administering steps as the claimed regimen. Mylan’s proposed ANDA labels do not “discourage missed doses”, but they do make the practice of asserted claims optional in the event that doses will be missed. The district court also found that missed dosages and patients returning to the clinic between 4 and nine months after a dose missed are inevitable. This means that infringement of the claimed regimen for reinitiation is inevitable. The district court did not commit a clear error in relying on the evidence presented at trial to determine that Janssen had met its burden of proving infringement. The district court rejected Mylan’s divided-infringement argument for two reasons: (i), it was untimely, as it was not disclosed in Mylan’s contentions and was improperly presented in Mylan’s rebuttal report under the governing local rules, and (ii), the argument was rejected on merits, concluding a single entity, a doctor, performs the claimed reinitiation doses regimen. The Federal Circuit did not address the second. The former was not an infringement; therefore, it did no address the latter. The prior art did not provide any reason for a skilled artisan using PP1M once a patient had been advanced to PP3M. According to the district court there was no evidence that PP1M achieved therapeutic levels faster than PP3M. The district court also found, that although the prior arts showed starting a patient with PP1M (i.e. not for reinitiation of PP3M), the prior art taught stabilizing a patient on at least PP1M before advancing to it.
