In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior art describing dosing regimens for the same active ingredient.
The decision offers useful guidance for patent challengers and patent owners navigating obviousness analyses related to dosing limitations, particularly those directed to known pharmaceuticals.
Background
A patent claim is considered obvious if the differences between the claim and prior art would have made the claim’s subject matter obvious to a person of ordinary skill in the art at the time of the invention. 35 USC § 103. To challenge a patent on these grounds, the challenger must show that a person of ordinary skill in the relevant art would have been motivated to combine or modify the prior art to achieve the claimed invention and had a reasonable expectation of success in doing so. Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009).
Claims directed to dosing regimens for known drugs offer unique challenges to obviousness analyses, since the additional prior art surrounding the drug can increase the chances of a court finding a reasonable expectation of success. The Federal Circuit has found such patent claims to be invalid even in cases when there are fact-based differences between the claimed dosing regimen and prior art. See ImmunoGen, Inc. v. Stewart, No. 2023-1762, 2025 US App. LEXIS 5215 (Fed. Cir. 2025), covered here.
The underlying technology in Janssen concerns a formulation of paliperidone palmitate (PP), the active ingredient in Janssen Pharmaceutical’s schizophrenia drug product Invega Trinza. It comes in two different formulations, one lasting for one month (PP1M) and another lasting for three (PP3M). US Patent No. 10,143,693 (the ’693 patent) is directed to a dosing regimen for treating a patient who missed a dose of PP3M. It consists of a short series of PP1M doses over the course of about a week, followed by a dose of PP3M, after which the patient can resume regular doses of PP3M every three months.
Before the expiration of the ’693 patent, Mylan Laboratories filed three Abbreviated New Drug Applications (ANDAs) seeking approval from the United States Food and Drug Administration to market a generic version of Invega Trinza. The proposed labels were substantially identical to the Invega Trinza label, including the dosage instructions tracking the claims of the ’693 patent. Janssen then initiated the lawsuit, asserting that Mylan’s proposed ANDA labels would induce infringement of the ’693 patent. Mylan countered that the patent was invalid due to obviousness. The district court found (1) Mylan’s labels would induce infringement of the ’693 patent and (2) Mylan had failed to show the patent was obvious. In a nonprecedential decision, the Federal Circuit upheld both decisions.
Court holds Mylan’s generic would induce infringement
First, the Federal Circuit upheld the district court’s ruling that the label of Mylan’s generic would induce infringement of the ’693 patent if approved. Mylan raised three arguments in its defense. The first was that since its label discouraged missing a dose in the first place, the fact that the dosing instructions aligned with the ’693 patent claims failed to constitute infringement. Second, Mylan argued that Janssen failed to carry its burden of proof to show infringement would “inevitably” result, because they did not show that patients who missed a dose would return and follow through with the claimed reinitiation regimen. Lastly, Mylan raised a divided infringement defense, that is, the asserted claims involved two actors (a doctor and patient), which allegedly defeated Janssen’s showing of direct infringement.
The district court was not convinced by any of these arguments. The label’s warning against missing doses of PP was not enough to “discourage or make optional the practice of the asserted claims in the inevitable situation that doses are missed.” Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 20-13103, 2023 WL 3605733 at *17 (D.N.J. May 23, 2023). In response to Mylan’s second argument, Janssen’s expert presented evidence that over 50 percent of PP patients miss a dose at some point, and at least some percentage return following that missed dose. This was enough for the district court to find that missed doses of PP, and the resulting need for the dosing regimen laid out in the ’693 patent, were inevitable. Finally, the divided infringement argument was untimely under local rules. Even if it were timely, though, the district court found that, because a single agent performs the claimed dosing regimen, the divided infringement argument failed. See id. at *11– 12.
Court holds Mylan failed to show invalidity
Separate from infringement, Mylan also argued that the ’693 patent was invalid. More specifically, Mylan argued that the claimed dosage of PP3M was obvious over prior art describing PP1M. The Federal Circuit upheld the district court’s rejection of this argument.
Despite the existence of prior art describing a PP1M regimen, the district court found that nothing in it motivated a skilled artisan to use PP1M after a patient has been advanced to PP3M. Instead, the patent at issue “was the first [long-acting injectable antipsychotic] that recommended using two different long-acting injectable formulations to manage a missed dose.” Id. at *27.
Mylan argued that a skilled artisan would know that PP1M would be “faster acting” and therefore a suitable solution to reinstate a patient who had missed a dose of PP3M. Still, the district court found there was not “credible evidence that taught that PP1M reaches therapeutic levels any faster than PP3M” and pointed to Mylan’s own expert’s modeling that suggested PP1M and PP3M had identical absorption. Id. at *28.
In addition, although the prior art discussed starting a patient on PP1M as a precursor to PP3M, it also taught that the patient should be stabilized on PP1M for at least four months prior to starting PP3M – a length of time significantly shorter than that used in the ’693 patent. Because this longer period was the only timeline using PP1M in the prior art, the district court found there would have been no reason or motivation for a skilled artisan to suggest a different timeline in the wake of a patient’s missed dose. The Federal Circuit found no clear error in this reasoning and therefore upheld the ruling.
Janssen adds nuance to the obviousness analysis of dosing regimen patents
Litigants are encouraged to keep this ruling in mind when analyzing obviousness issues concerning dosing regimen patents. Though nonprecedential, the Federal Circuit’s decision highlights the importance of distinguishing dosing regimen claims from known drugs and existing dosing protocols.
Janssen also adds nuance to the recent Immunogen decision, in which the Federal Circuit found a dosing regimen obvious. In Immunogen, the claims at issue were directed to a dosing regimen for a known biologic designed to reduce toxic side effects with a precise dosage based on a patient’s weight. The Court held that since the particular side effects were known in the prior art, and a skilled artisan would know that reducing a dose generally decreases the risk of side effects, the claimed regimen was obvious over prior art disclosing the biologic itself.
In both cases, the courts considered whether dosing regimens were obvious in light of prior art disclosing the drug or biologic. However, the cases differ in the evidence used by the parties, especially in expert witness testimony. Unlike the defendant in Immunogen, the court found Mylan’s expert witness presented data that contradicted their obviousness argument. Id. at *28. And unlike the patent holder in Immunogen, Janssen was able to point to specific differences between its dosing regimen and the prior art (eg, that a patient need only spend about a week on PP1M in contrast to the four months found in the prior art). Regardless, both emphasize the importance of distinguishing dosing regimen claims from the prior art to a patent’s validity.
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