Invega Trinza® (paliperidone palmitate)
Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding; Opinion by Dyk, C.J.) (Appeal from D.N.J., Padin, J.)
Drug Product and Patent(s)-in-Suit: Invega Trinza® (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 patent claims the use of Invega Trinza for treating patients who have missed a treatment of PP3M. The dosing instructions in the Invega Trinza prescribing label track the asserted claims of the ’693 patent. Specifically, the label instructs doctors that if a patient had his or her last dose between four and nine months ago, “do NOT administer the next dose ... [i]nstead, use the re-initiation regimen shown in Table 2.” Mylan filed three ANDAs seeking approval from the FDA to market generic paliperidone palmitate before expiration of the ’693 patent, and those labels are substantially identical to the Invega Trinza label. Janssen filed suit, asserting infringement and specifically that Mylan’s proposed ANDA labels will induce doctors to infringe. After a bench trial, the district court held: (i) Janssen had demonstrated that Mylan will inevitably induce doctors to infringe; and (ii) Mylan had not demonstrated that the ’693 patent is obvious or otherwise invalid. Mylan appealed and the Federal Circuit affirmed.
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. Under the subsection “Missed Dose 4 Months to 9 Months Since Last Injection,” Mylan's proposed ANDA labels instruct doctors that, if the patient received a PP3M dose four to nine months ago, “do NOT administer the next dose of [PP3M]” and goes on to say, “Instead, use the re-initiation regimen shown in Table 2” which directs doctors to perform the same administrating steps as the claimed reinitiation regimen. That Mylan’s proposed labels “discourage missed doses” does not mean that the labels discourage or make optional the practice of the asserted claims in the inevitable situation that doses are missed. Moreover, the district court found that missed doses and patients returning between 4 and 9 months after a missed dose are inevitable, meaning that infringement of the claimed reinitiation regimen would be inevitable. There was no clear error on the part of the district court in its reliance on the evidence at trial to find that Janssen carried its burden of proof to show infringement. Finally, the district court rejected Mylan’s divided-infringement argument on two grounds: (i) Mylan’s divided-infringement defense was untimely—it was not disclosed in Mylan’s contentions and appeared improperly for the first time in Mylan’s rebuttal expert report—under the governing local rules; and (ii) it was rejected on the merits, concluding that a single entity—a doctor—performs the claimed reinitiation dosing regimen. The former was not an abuse of discretion; therefore, the Federal Circuit didn’t address the latter.
With respect to the district court’s determination of non-obviousness, Mylan raised two arguments: (i) PP3M reinitiation regimen is obvious in view of the prior-art PP1M regimen; and (ii) the prior art taught the specific four-to-nine-month reinitiation window claimed in the asserted claims. Nothing in the prior art motivated a skilled artisan to use PP1M after a patient has been advanced to PP3M. That is because, according to the district court, there was no credible evidence that taught that PP1M reached therapeutic levels any faster than PP3M. “The district court also found that although the prior art showed starting a patient on PP1M to get them up to PP3M in the first place (i.e., not for reinitiation to PP3M), that prior art taught stabilizing on PP1M for at least four months before advancing to PP3M—as opposed to the asserted claim’s reinitiation dose of PP3M on about the 23rd day to about the 37th day after administering the second reinitiation loading dose of PP1M.” Therefore, on the record before the Federal Circuit, there was no clear error in the district court’s findings supporting its conclusion that Mylan failed to prove that the ’693 patent is invalid for obviousness.
