Introduction
The litigation between Janssen Pharmaceuticals, Inc. and Mylan Laboratories Limited revolves around patent infringement and validity issues related to Janssen's patented reinitiation regimen for the drug Invega Trinza®, a long-acting injectable antipsychotic medication used to treat schizophrenia.
Background
Janssen Pharmaceuticals, Inc., along with its affiliates Janssen Pharmaceutica NV and Janssen Research & Development LLC, initiated a Hatch-Waxman patent infringement action against Mylan Laboratories Limited. Mylan had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) to market a generic version of Invega Trinza®[3].
Patent Claims and Infringement Allegations
Janssen alleged that Mylan's proposed generic drug would infringe on its patented reinitiation regimen. This regimen is specifically designed for patients who have missed a dose of the drug, which is prescribed to be administered once every three months. The patent in question involves a dosing regimen for administering paliperidone palmitate to psychiatric patients, particularly focusing on the reinitiation dosing regimen for patients who have missed doses[2][3].
Trial and Court Findings
The case was heard in the US District Court for the District of New Jersey. After a two-week bench trial, the court ruled in favor of Janssen. The key findings were:
-
Inducement of Infringement: The court determined that Mylan's proposed drug labels "expressly instruct[ed]" healthcare providers to follow Janssen's patented reinitiation regimen for patients who missed a dose by a specified amount of time. This instruction was deemed sufficient to prove that Mylan would inevitably induce healthcare providers to infringe Janssen's patent[1][3].
-
Divided Infringement Defense: Mylan argued that there was no direct infringement because the steps of the claimed dosing regimens would be carried out by two independent actors: the patient and the healthcare provider. However, the court rejected this defense, finding that a single entity (the healthcare provider) performs the claimed reinitiation dosing regimen's steps[1].
-
Obviousness: Mylan failed to demonstrate by clear and convincing evidence that the asserted claims of Janssen's patent would have been obvious to a person of ordinary skill in the art (POSA). The court found that Mylan did not provide sufficient evidence to invalidate the patent on grounds of obviousness[1].
Expert Testimony and Evidence
The trial involved extensive expert testimony. For Janssen, experts such as Roger Sommi, a University of Missouri-Kansas City Professor of Pharmacy Practice, and Carla Mulhern, a Managing Principal of Analysis Group, testified. Mylan's experts included Dr. Steven Berger, a Board-Certified forensic and general psychiatrist, and Dr. Laird Forrest, a University of Kansas Professor of Pharmaceutical Chemistry. The court weighed the credible testimony and other evidence presented, ultimately siding with Janssen's arguments[1][3].
Commercial Success and Secondary Considerations
The court also considered secondary considerations of non-obviousness, including the commercial success of Invega Trinza®. Analysis Group's expert report and testimony by Carla Mulhern supported the argument that there was a causal nexus between the invention claimed in the patent and the commercial success of the drug[3].
Appeals and Related Litigation
Mylan's attempts to challenge the patent through other avenues, such as an inter partes review (IPR) petition, were unsuccessful. The Patent Trial and Appeal Board (PTAB) denied institution of the IPR under the NHK-Fintiv factors, citing the advanced status of parallel district court proceedings. Mylan's appeal and request for mandamus relief were also denied by the Federal Circuit, which upheld the PTAB's discretionary denial of institution[5].
Key Takeaways
- Patent Infringement: Mylan's proposed generic drug labels were found to induce infringement of Janssen's patented reinitiation regimen.
- Validity of Patent: The court upheld the validity of Janssen's patent, finding that Mylan failed to prove obviousness.
- Expert Testimony: The trial highlighted the importance of expert testimony in patent litigation.
- Commercial Success: The commercial success of Invega Trinza® was considered a secondary consideration supporting the non-obviousness of the patent.
FAQs
Q: What was the main issue in the litigation between Janssen and Mylan?
A: The main issue was whether Mylan's proposed generic version of Invega Trinza® would infringe on Janssen's patented reinitiation dosing regimen.
Q: How did the court determine inducement of infringement?
A: The court found that Mylan's proposed drug labels explicitly instructed healthcare providers to follow Janssen's patented regimen, leading to inevitable infringement.
Q: What was Mylan's defense against the infringement allegations?
A: Mylan argued a divided infringement defense, claiming that the steps of the dosing regimen would be carried out by two independent actors, but the court rejected this defense.
Q: Did Mylan challenge the validity of Janssen's patent?
A: Yes, Mylan argued that the patent was obvious, but the court found that Mylan did not provide sufficient evidence to support this claim.
Q: What role did expert testimony play in the trial?
A: Expert testimony from both sides was crucial in evaluating the technical aspects of the patent and the alleged infringement.
Citations
- Janssen Pharm. v. Mylan Labs., 20cv13103 (EP) (LDW), United States District Court, D. New Jersey, May 15, 2023.
- Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., 22-1258, U.S. Court of Appeals for the Federal Circuit, April 1, 2024.
- Janssen Pharmaceuticals Inc., et al. v. Mylan Laboratories Limited, Analysis Group.
- JANSSEN PHARMACEUTICALS, INC. et al v. MYLAN PHARMACEUTICALS INC., 3:21-cv-18609, District of New Jersey.
- Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V., 989 F.3d 1375, U.S. Court of Appeals for the Federal Circuit, February 3, 2022.
