Case Overview
The litigation between Mitsubishi Tanabe Pharma Corporation and Aurobindo Pharma USA, Inc. revolves around a patent infringement dispute related to the drug canagliflozin hydrate, a type 2 diabetes therapeutic agent. The case, filed on July 7, 2017, is designated as Civil Action No. 3:17-cv-05005 in the U.S. District Court for the District of New Jersey[3][4].
Plaintiffs and Defendants
The plaintiffs in this case include:
- Mitsubishi Tanabe Pharma Corporation
- Janssen Pharmaceuticals, Inc.
- Janssen Pharmaceutica NV
- Janssen Research and Development, LLC
- CILAG GmbH International
The defendants are:
- Aurobindo Pharma USA, Inc.
- Invagen Pharmaceuticals, Inc.
- Macleods Pharmaceuticals, Ltd.
- Macleods Pharma USA, Inc.
- Other generic pharmaceutical companies such as Zydus Pharmaceuticals, Inc., Prinston Pharmaceuticals, Inc., and Sandoz, Inc.[3][4].
Nature of the Suit
The lawsuit is categorized as a "Patent - Abbreviated New Drug Application (ANDA)" case. The plaintiffs allege that the defendants' submission of ANDAs to the U.S. Food and Drug Administration (FDA) for generic versions of canagliflozin hydrate infringe on the patents held by Mitsubishi Tanabe Pharma and Janssen Pharmaceuticals[3][4].
Patents in Dispute
The patents at the center of this dispute cover the active ingredient canagliflozin, which targets the sodium-glucose cotransporter 2 (SGLT2). These patents include several U.S. patent numbers, and the plaintiffs argue that the defendants' generic versions would infringe on these patents if approved before their expiration dates[1][2].
Court Rulings and Decisions
In a significant ruling on March 22, 2021, the U.S. District Court for the District of New Jersey determined that the patents covering canagliflozin are valid and would be infringed by Zydus Pharmaceuticals, Inc. This decision also stipulated that the generic versions of canagliflozin hydrate should not be approved in the U.S. before July 14, 2027, with the possibility of an additional six-month exclusivity period based on pediatric clinical studies[1].
Defendants' Actions and Counterclaims
Several defendants, including Aurobindo Pharma USA, Inc., initially challenged the validity of the patents but later relinquished their invalidity defenses. Aurobindo, however, continued to assert counterclaims and filed multiple Paragraph IV certifications alleging that the patents were invalid and/or would not be infringed by their ANDA submissions[2][3].
Jurisdiction and Venue
The court has established jurisdiction over the defendants, including Aurobindo Pharma USA, Inc., based on their activities and assertions within the judicial district. Venue is proper in the District of New Jersey as the defendants have purposefully availed themselves of the rights, benefits, and privileges of New Jersey[5].
Current Status and Ongoing Litigation
The litigation is ongoing, with various motions and counterclaims still being addressed. The plaintiffs seek judgments that the defendants' actions infringe on the patents, as well as preliminary and permanent injunctions to prevent the defendants from marketing their generic products before the expiration of the patents[2][4].
Industry Impact
This litigation highlights the critical importance of intellectual property protection in the pharmaceutical industry. The outcome of this case can significantly impact the market availability of generic versions of canagliflozin hydrate, affecting both the financial interests of the involved companies and the accessibility of this medication for patients.
Key Takeaways
- Patent Protection: The case underscores the importance of patent protection for pharmaceutical companies and the legal measures they take to safeguard their intellectual property.
- Generic Competition: The litigation delays the entry of generic competitors into the market, potentially affecting the pricing and availability of the drug.
- Legal Precedents: The court's decisions in this case may set precedents for future patent infringement disputes in the pharmaceutical sector.
- Patient Access: The outcome can influence how soon patients can access more affordable generic versions of canagliflozin hydrate.
Frequently Asked Questions (FAQs)
Q: What is the main issue in the Mitsubishi Tanabe Pharma v. Aurobindo Pharma litigation?
A: The main issue is a patent infringement dispute over the drug canagliflozin hydrate, a type 2 diabetes therapeutic agent.
Q: Which court is handling this case?
A: The U.S. District Court for the District of New Jersey.
Q: What is the significance of the March 22, 2021, court ruling?
A: The ruling determined that the patents covering canagliflozin are valid and would be infringed by generic versions, delaying their approval until July 14, 2027.
Q: Why did some defendants relinquish their invalidity defenses?
A: Several defendants, including Aurobindo Pharma USA, Inc., initially challenged the patents but later dropped their invalidity defenses, though Aurobindo continued with other counterclaims.
Q: What are the plaintiffs seeking in terms of relief?
A: The plaintiffs seek judgments of patent infringement, preliminary and permanent injunctions, and an order to delay FDA approval of the generic versions until the patents expire.
Cited Sources
- Mitsubishi Tanabe Pharma Wins Patent Infringement Lawsuit of Canagliflozin Hydrate in the U.S. District Court - Mitsubishi Tanabe Pharma Corporation.
- Case 2:24-cv-04002 Document 1 Filed 03/19/24 - Justia Dockets.
- MITSUBISHI TANABE PHARMA CORPORATION et al v. AUROBINDO PHARMA USA, INC. et al - Justia Dockets.
- MITSUBISHI TANABE PHARMA CORPORATION et al v. AUROBINDO PHARMA USA, INC. et al - Law360.
- Case 2:23-cv-20354-MCA Document 1 Filed 09/13/23 - RPX Insight.
