On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced healthcare providers to infringe the asserted claims of U.S. Patent No. 10,143,693 (“the ’693 patent”), and that Mylan did not demonstrate by clear and convincing evidence that the ’693 patent is invalid. Janssen Pharms., Inc. v. Mylan Lab’ys Ltd., No. 2023-2042, slip op. (Fed. Cir. Mar. 28, 2025).
Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica NV, and Janssen Research & Development, LLC (collectively, “Janssen”) manufacture Invega Trinza® (paliperidone palmitate) a long-acting injectable antipsychotic medication administered every three months[1] for the treatment of schizophrenia. Slip Op. at 2–3. Janssen sued Mylan for infringing the ’693 patent, which claims a dosing regimen for paliperidone palmitate. Id. at 2. Specifically, the ’693 patent covers the use of Invega Trinza® and relates to a method for treating patients who have missed a treatment of three-month paliperidone palmitate extended-release injectable suspension formulation. Id. at 3 (citations omitted). Janssen asserted that Mylan’s proposed ANDA label, which is substantially identical to the Invega Trinza® label, induced healthcare providers to infringe the asserted claims. Id. at 4. The district court held that Mylan would induce infringement and that the ’693 patent was not obvious or otherwise invalid. Id.
Induced Infringement
To prevail on a theory of induced infringement, a party must demonstrate: (1) direct infringement and (2) that the ANDA applicant has the specific intent to induce infringement. Slip Op. at 6 (citing Vanda Pharms. Inc. v. W.-Ward Pharms., 887 F.3d 1117, 1129 (Fed. Cir. 2018)). Mylan appealed whether the second prong of the test was satisfied—whether there was specific intent to induce infringement. Id. Ultimately, the Court held that specific intent existed, explaining, “because Mylan’s proposed ANDA labels explicitly instruct [healthcare providers] to reinitiate patients onto PP3M using the asserted claims’ methodology, the explicit instructions in Mylan’s proposed ANDA labels establish specific intent for the purposes of induced infringement.” Id. at 7.
The Court also found that Janssen satisfied its burden to show that direct infringement would occur. Slip Op. at 7. The Court relied on trial testimony offered by Mylan’s expert that “more than 50 percent of Invega Trinza® patients have missed a dose, including 20 to 30 percent returning for an appointment 16 or more weeks (about four months) after the missed dose.” Id. (internal quotations omitted). It also relied on other evidence, including a study and other credible testimony. Id. Thus, it was “inevitable” that there would be patients that would miss a dose. Id.
Finally, the Court rejected Mylan’s divided-infringement theory because it was untimely. Slip Op. at 8. At the district court, Mylan asserted that it could not induce infringement because the claimed dosing regimen was carried out by the patient and his healthcare provider such that no direct infringement could occur, and thus, no inducement could either. Id. This argument was rejected by the district court for two reasons: (1) on the merits (because a single healthcare provider performed the claimed dosing regimen); and (2) because it was untimely (because Mylan did not disclose this position in its contentions and advanced it for the first time during expert discovery). Id. at 8–9. The Federal Circuit affirmed the district court’s untimeliness ruling, and thus, did not address the merits of the argument. Id. at 9.
Obviousness
The Court ultimately found the ’693 patent not obvious over the prior art at issue, holding that the district court did not err in its conclusions. Slip Op. at 9–10. Mylan’s arguments that a skilled artisan would have been motivated by the prior art to use PP1M after a missed dose, in part due to PP1M’s absorption profile, after a patient had been advanced to PP3M—in other words, using two different long-acting injectable formulations to manage a missed PP3M dose—were rejected. Id. Furthermore, the district court found that the dosing regimen used to stabilize a patient on PP1M before advancing them to PP3M taught by the prior art was contrary to the regimen claimed in the ’693 patent. Id. at 10.
[1] The three-month injectable form is referred to as “PP3M,” whereas the one-month injectable form is referred to as “PP1M.”
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