Litigation Details for JANSSEN PHARMACEUTICALS, INC. v. MYLAN LABORATORIES LIMITED (D.N.J. 2020)

JANSSEN PHARMACEUTICALS, INC. v. MYLAN LABORATORIES LIMITED (D.N.J. 2020)

Docket		Date Filed	2020-09-23
Court	District Court, D. New Jersey	Date Terminated	2023-05-23
Cause	15:1126 Patent Infringement	Assigned To	Evelyn Padin
Jury Demand	None	Referred To	Leda Dunn Wettre
Patents	10,143,693; 9,439,906
Link to Docket	External link to docket

Details for JANSSEN PHARMACEUTICALS, INC. v. MYLAN LABORATORIES LIMITED (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-09-23				External link to document
2020-09-23	148	Redacted Document	Patent-In-Suit 693 Patent U.S. Patent No. 10,143,693 Asserted Claims…obviousness-type double patenting over claims 1-16 of US Patent No. 9,439,906 (the 906 Patent) in view of Osborne… for obviousness-type double patenting over the 906 Patent (the patent that issued from the 519 Publication… and an earlier patent incorporated by reference in the 693 Patent, the 693 Patent disclosure would…24 (Berger). IV. THE 693 PATENT 19. The 693 Patent “relates to a method for treating	External link to document
2020-09-23	149	Redacted Document	of the patent-in-suit. That is why U.S. Patent No. 10,143,693 (“the ’693 patent”) thwarts … such patents. Examining the actual prosecution history of the patent reveals what the patent truly…JAMA to the patent office when prosecuting the ’693 patent. Without JAMA before the patent examiner, …this patent in the first place. Because when Janssen’s patent was rejected by the patent office…obtained the ’693 patent by telling the patent office that it was nothing like the ’906 patent because the	External link to document
2020-09-23	150	Redacted Document	Patent-In-Suit 693 Patent U.S. Patent No. 10,143,693 Asserted Claims…including Dr. Forrest’s own patents—the structural features in the 693 Patent are entirely adequate to…It is a bedrock principle of patent law that the claims of a patent define the invention to which the…there are “two elements of a simple patent case, construing the patent and determining whether infringement…) 519 Publication PTX-115 United States Patent Application Publication DTX	External link to document

JANSSEN PHARMACEUTICALS, INC. v. MYLAN LABORATORIES LIMITED: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Janssen Pharmaceuticals, Inc. and Mylan Laboratories Limited revolves around patent infringement claims related to Janssen's long-acting injectable antipsychotic medication, Invega Trinza®. Here, we delve into the key aspects of the case, including the legal arguments, court decisions, and implications.

Background

Janssen Pharmaceuticals Inc., along with its affiliates, filed a Hatch-Waxman patent infringement action against Mylan Laboratories Limited. Mylan had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) to market a generic version of Invega Trinza®, which is used to treat schizophrenia and schizoaffective disorder[1][3][4].

Patent Claims and Infringement Allegations

The dispute centered on Janssen's patented reinitiation regimen for patients who missed a dose of Invega Trinza®. Janssen alleged that Mylan's proposed generic drug would infringe on this patented regimen, which is designed to be administered once every three months. Mylan's proposed drug labels were found to essentially duplicate Janssen's labels, including the instructions for the reinitiation dosing regimen[1][3].

Court Proceedings and Decisions

The case was heard in the US District Court for the District of New Jersey. Here are the key points from the court proceedings:

Bench Trial and Evidence

The trial involved extensive testimony from experts on both sides. For Janssen, witnesses included Roger Sommi, a Professor of Pharmacy Practice, and Carla Mulhern from Analysis Group, who testified on the commercial success and validity of the patent. Mylan's witnesses included Dr. Steven Berger, a forensic and general psychiatrist, and Dr. Laird Forrest, a Professor of Pharmaceutical Chemistry[3].

Inducement of Infringement

The court found that Mylan's proposed labels explicitly instructed healthcare providers to follow Janssen's patented reinitiation regimen, leading to the conclusion that Mylan would inevitably induce infringement of Janssen's patent. The court rejected Mylan's defense of divided infringement, stating that a single entity (the healthcare provider) would perform the claimed dosing regimen's steps[3].

Obviousness and Validity

Mylan argued that Janssen's patent was obvious and therefore invalid. However, the court ruled that Mylan failed to prove by clear and convincing evidence that the asserted claims would have been obvious to a person of ordinary skill in the art. The court upheld the validity of Janssen's patent, finding no evidence to support Mylan's claims of obviousness[3].

Legal Arguments and Rulings

Divided Infringement Defense

Mylan's defense that the infringement was divided between the patient and the healthcare provider was rejected by the court. The court held that the healthcare provider, as a single entity, would perform the steps of the claimed dosing regimen, thus negating the divided infringement argument[3].

Secondary Considerations

The court also considered secondary considerations of non-obviousness, such as the commercial success of Invega Trinza® and the causal nexus between the invention and this success. Analysis Group's expert testimony supported these arguments, contributing to the court's decision in favor of Janssen[1].

Appeals and Related Proceedings

Mylan's attempts to appeal and challenge the decision through other legal avenues were unsuccessful:

Inter Partes Review (IPR) Denial

Mylan sought to initiate an IPR proceeding but was denied by the Patent Trial and Appeal Board (PTAB) under the NHK-Fintiv factors, which consider the advanced status of parallel district court proceedings. Mylan's appeal to the Federal Circuit was dismissed for lack of jurisdiction, and their request for mandamus relief was also denied[5].

Implications and Takeaways

Protection of Intellectual Property

The case highlights the importance of protecting intellectual property in the pharmaceutical industry. Janssen's success in defending its patent ensures that the company can continue to benefit from its innovative work without immediate generic competition.

Generic Drug Market

The decision affects the timeline for generic versions of Invega Trinza® to enter the market. Mylan's inability to market its generic version without infringing Janssen's patent delays the availability of a cheaper alternative, impacting both patients and healthcare providers.

Legal Precedents

The case sets precedents for future patent infringement disputes, particularly in the context of Hatch-Waxman actions and the interpretation of divided infringement defenses. It also reinforces the importance of secondary considerations in determining the validity of patents.

Key Takeaways

• Patent Infringement: Mylan's proposed generic drug was found to infringe on Janssen's patented reinitiation regimen for Invega Trinza®.
• Inducement of Infringement: Mylan's labels were deemed to induce healthcare providers to follow Janssen's patented regimen.
• Obviousness: Mylan failed to prove that Janssen's patent was obvious.
• Divided Infringement: The court rejected Mylan's divided infringement defense.
• Secondary Considerations: The commercial success of Invega Trinza® supported the validity of Janssen's patent.
• Appeals and IPR: Mylan's appeals and attempts to initiate an IPR were unsuccessful.

Frequently Asked Questions

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 infringement in this case? A: The court found that Mylan's proposed labels instructed healthcare providers to follow Janssen's patented regimen, leading to inevitable infringement.

Q: Did Mylan argue that Janssen's patent was invalid? A: Yes, Mylan argued that Janssen's patent was obvious and therefore invalid, but the court rejected this argument.

Q: What was the outcome of Mylan's appeal and IPR attempts? A: Mylan's appeal to the Federal Circuit was dismissed, and their request for mandamus relief was also denied. The PTAB denied institution of the IPR under NHK-Fintiv factors.

Q: How does this decision impact the pharmaceutical market? A: The decision delays the entry of generic versions of Invega Trinza® into the market, affecting patients and healthcare providers who might have benefited from a cheaper alternative.

Cited Sources

1. Analysis Group, "Janssen Pharmaceuticals Inc., et al. v. Mylan Laboratories Limited"
2. United States Court of Appeals for the Federal Circuit, "JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC."
3. Casetext, "Janssen Pharm. v. Mylan Labs., 20cv13103 (EP) (LDW)"
4. Justia Law, "JANSSEN PHARMACEUTICALS, INC. et al v. MYLAN LABORATORIES LIMITED et al, No. 2:2020cv13103"
5. Sterne, Kessler, Goldstein & Fox P.L.L.C., "Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V., 989 F.3d 1375"