Janssen Pharmaceuticals, Inc. v. Mylan Laboratories Ltd, decided March 28, 2025

Janssen sued Mylan for allegedly inducing patent infringement through its proposed generic drug labels for a treatment of missed doses of Janssen's schizophrenia medication, Invega Trinza. The district court found in favor of Janssen, determining that Mylan would likely induce healthcare providers to infringe Janssen's patent and that Mylan failed to prove the patent was invalid. Mylan appealed this decision, arguing against the findings of induced infringement and nonobviousness of the patent. The Court of Appeals ultimately affirmed the district court's decision, finding Mylan's arguments unpersuasive on both issues.

Case: Janssen Pharmaceuticals, Inc. v. Mylan Laboratories Ltd. Court: United States Court of Appeals for the Federal Circuit

Appeal From: United States District Court for the District of New Jersey

Disposition Date: March 28, 2025

Holding: Affirmed the district court's findings that Mylan will induce infringement of U.S. Patent No. 10,143,693 ('the '693 patent') and that Mylan failed to demonstrate the patent's invalidity for obviousness.

Note: This disposition is nonprecedential.

Main Themes and Important Ideas/Facts:

This case revolves around Janssen's U.S. Patent No. 10,143,693, which covers a specific dosing regimen for reinitiating treatment of schizophrenia or bipolar disorder patients who have missed a dose of Janssen's three-month paliperidone palmitate extended-release injectable suspension formulation (PP3M), marketed as Invega Trinza®. Mylan sought FDA approval for a generic version of Invega Trinza by filing Abbreviated New Drug Applications (ANDAs) with labels substantially identical to Janssen's. Janssen sued Mylan for patent infringement, arguing that Mylan's proposed labels would induce healthcare providers (HCPs) to infringe the '693 patent. Mylan countered that the '693 patent is invalid for obviousness.

The District Court ruled in favor of Janssen, finding that Mylan would inevitably induce infringement and that Mylan failed to prove the patent was obvious. Mylan appealed this decision to the Federal Circuit, which ultimately affirmed the District Court's findings.

Key Arguments and Findings:

I. Induced Infringement:

Mylan argued that the District Court incorrectly found that its proposed ANDA labels would induce infringement, presenting three main arguments:

• Argument 1: Lack of Specific Intent due to Dose Missage Discouragement: Mylan argued that by discouraging patients from missing doses in the first place, their labels demonstrated a lack of specific intent to encourage the patented reinitiation regimen.

• Federal Circuit's Finding: The court disagreed, stating that while the labels might discourage missed doses, they explicitly instruct HCPs on the patented reinitiation regimen to be followed when doses are missed.

• Quote: "As the district court correctly found, the fact that Mylan’s proposed ANDA labels “discourage missed doses” does not mean that the labels “discourage or make optional the practice of the [a]sserted [c]laims (or any claimed steps) in the inevitable situation that doses are missed.”"

• Key Idea: Explicit instructions in a proposed label to perform a patented method can establish the specific intent required for induced infringement, even if the label also advises against the situation requiring the method.

• Argument 2: Failure to Prove Inevitable Direct Infringement: Mylan contended that Janssen failed to prove that infringement would "inevitably" result because there was no guarantee that patients who missed a dose would return and follow through with the claimed reinitiation regimen.

• Federal Circuit's Finding: The court found no clear error in the District Court's determination that missed doses and patients returning within the 4-to-9-month window are inevitable. This finding was supported by Mylan's own expert's testimony indicating a significant percentage of patients miss doses and return within this timeframe, as well as a study on the transition from PP1M to PP3M.

• Quote: "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.”"

• Key Idea: Evidence, including expert testimony and studies, can support a finding of inevitable direct infringement when the proposed label instructs a patented method to address a likely scenario.

• Argument 3: Divided Infringement: Mylan argued that the claimed dosing regimen involves two actors (doctor and patient), leading to a divided infringement problem and thus no direct infringement that Mylan could induce.

• Federal Circuit's Finding: The court upheld the District Court's rejection of this argument, primarily on the grounds that it was untimely under local rules. The District Court also concluded on the merits that a single entity (the HCP) performs the claimed reinitiation dosing regimen. The Federal Circuit did not address the merits due to the untimeliness ruling.

• Quote: "The district court found that “Mylan’s divided infringement theory was not disclosed in its contentions, and appeared improperly for the first time in Mylan’s rebuttal expert report.”"

• Key Idea: Failure to raise defenses in a timely manner according to local rules can result in their rejection by the court.

  
  

II. Nonobviousness:

Mylan argued that the District Court erred in finding the '693 patent not obvious, primarily based on two arguments:

• Argument 1: Obviousness in View of Prior Art PP1M Regimen: Mylan argued that the claimed PP3M reinitiation regimen was obvious in light of prior art related to the one-month paliperidone palmitate formulation (PP1M). They contended that a skilled artisan would have been motivated to use PP1M to "ramp back up" to PP3M because PP1M was known to be "faster acting."

• Federal Circuit's Finding: The court sided with the District Court, which found that the prior art did not motivate a skilled artisan to use PP1M for reinitiating a patient who had already been advanced to PP3M. The District Court also found no credible evidence that PP1M reached therapeutic levels faster than PP3M.

• Quote: "There was nothing obvious, in other words, about using a non-PP3M formulation to reinitiate a patient that had been advanced to PP3M."

• Key Idea: For a patent to be obvious, the prior art must provide a motivation or suggestion for combining elements in the way claimed, and the result must be predictable. The court found a lack of such motivation in this case.

• Argument 2: Obviousness of the Four-to-Nine-Month Reinitiation Window: Mylan argued that the prior art taught the specific four-to-nine-month reinitiation window claimed in the patent.

• Federal Circuit's Finding: Because the Federal Circuit rejected Mylan's first argument regarding the motivation to use PP1M for reinitiation to PP3M, they deemed it unnecessary to address this second argument related to the specific time window.

• Key Idea: The success of an obviousness argument often depends on establishing a motivation in the prior art to arrive at the claimed invention as a whole.

  
  

Conclusion:

The Federal Circuit affirmed the District Court's decision, concluding that Mylan's proposed ANDA labels would induce infringement of Janssen's '693 patent and that Mylan failed to prove the patent invalid for obviousness. This decision reinforces the idea that pharmaceutical companies can be found to induce infringement when their generic product labels instruct HCPs to perform a patented method, even if those labels also advise against the circumstances requiring the method. Furthermore, the court upheld the District Court's assessment of nonobviousness, emphasizing the need for prior art to provide a clear motivation for the claimed invention.