Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 20cv13103, 2023 WL 3605733 (D.N.J. May 23, 2023) (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: Injectable paliperidone palmitate is indicated for the treatment of schizophrenia and other similar conditions. The reference-listed drug is administered by subcutaneous injection once every three months (“PP3M”). The ’639 patent relates to a method of treating patients that missed a treatment of PP3M. In particular, the asserted claims recite a dosing schedule, including a one-month, reinitiation dose on day 1 (“PP1M”), a second PP1M on about day 4 to day 12, and then a PP3M on about day 23 to day 37. Mylan sought to market a generic paliperidone palmitate. Janssen sued for patent infringement and the court found that Mylan’s ANDA product would infringe the valid patent claims.

Why Janssen Prevailed: The court first addressed the issue of infringement. Janssen argued that Mylan’s proposed label would induce health care professionals (“HCPs”) to induce infringement by administering the drug. In response, Mylan raised a divided infringement defense, contending that there would be no direct infringement because the reinitiation dosing regimen would be carried out by two independent actors: the patient, who missed a dose of PP3M and chose to return for treatment three times, and that patient’s HCP, who administers the claimed dosing regimen. As a threshold matter, the court found that Mylan waived its divided infringement theory because it was not properly disclosed in its contentions and appeared for the first time in Mylan’s rebuttal expert report. But even if that argument had been preserved, the court held that a single entity, the HCP, performed the claimed reinitiation dosing regimen. Mylan interpreted the claimed method as having seven, not three, steps: the patient missing a dose and returning three times for the injections (four steps), plus the injections administered by the HCP (three steps). The court rejected this interpretation, finding that the injections comprise the only three steps, and that each was administered by a HCP.

Next, the court addressed Mylan’s obviousness defense. Mylan failed to demonstrate that the claimed limitations were present in the prior art, that a POSA would have reason to combine the prior art references, and that the skilled artisan would have a reasonable expectation of success in doing so. The half-life of PP3M was not known in the prior art. But in arguing that the claimed dosing regimen was obvious, Mylan’s expert assumed that PP3M’s half-life could be extrapolated from PP3M’s dosing interval (every 3 months). The expert then extrapolated from the half-life of PP1M, 30 days (based on its dosing interval), and multiplied by three to arrive at a 90-day half-life for PP3M. Janssen’s experts argued, however, that a POSA would not have relied on simple extrapolation of PP1M data to arrive at conclusions about PP3M pharmacokinetics. The court also explained that there was no motivation or expectation of success to use PP3M without first stabilizing the patient for four or more months on PP1M. In particular, every PP3M reference Mylan relied on required patient stabilized on PP1M for at least 4 months prior to advancing to PP3M.

The court also concluded that secondary indicia supported a conclusion of non-obviousness. Trinza met a long-felt need by offering a three-month dosing interval. Further, the court found commercial success because the dosing regimen added significant “‘option value’ like an airbag or other safety feature in a vehicle; though it is not certain, or even probable, that the airbag will ever be needed, it is a significant purchase factor for many buyers.” Finally, the court concluded that there was skepticism that Trinza would provide the promised therapeutic benefit for the full 3-month dosing interval.

Finally, the court addressed Mylan’s Section 112 defenses. Mylan argued that the ’963 patent was invalid for non-enablement and lack of written description. As to enablement, the court found that the specification of the ’693 patent taught the concentration and ingredients necessary for the PP1M and PP3M formulations. Moreover, the patent specification taught the particle size range for PP1M and PP3M and provided general and specific manufacturing instructions sufficient to enable a skilled artisan to prepare the particles. The ’693 patent also described “preferred” examples. The court further explained that the patent claims were not unduly broad because they are directed to dosing regimens listing specific formulations, amounts, timing, and injection sites. Nor are “PP1M” or “PP3M” themselves unduly broad because a skilled artisan would understand the ’693 patent to limit PP1M and PP3M formulations to the specific ingredients. Finally, the court concluded that Mylan’s expert offered contradictory positions: “[h]ere his arguments in the alternative simply emphasize the contradiction between testifying, on the one hand, that the prior art makes the Asserted Claims obvious, and on the other, that they are not enabled because they are too vague.” As to written description, Mylan argued that there were no working examples of PP3M. The court disagreed and explained that the patent had sufficient written description support because the specification included information about the structural features of PP1M and PP3M, such as the ingredients, concentrations, particle size, and manufacturing information.