Litigation Details for Mitsubishi Tanabe Pharma Corporation v. Apotex Inc. (D. Del. 2017)

Mitsubishi Tanabe Pharma Corporation v. Apotex Inc. (D. Del. 2017)

Docket		Date Filed	2017-07-20
Court	District Court, D. Delaware	Date Terminated	2017-12-21
Cause	35:271 Patent Infringement	Assigned To	Gregory Moneta Sleet
Jury Demand	None	Referred To
Patents	7,943,582; 8,513,202
Link to Docket	External link to docket

Details for Mitsubishi Tanabe Pharma Corporation v. Apotex Inc. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-07-20				External link to document
2017-07-20	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,943,582; 8,513,202. (ceg) (… 21 December 2017 1:17-cv-00990 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Mitsubishi Tanabe Pharma Corporation v. Apotex Inc.: A Comprehensive Analysis of the Patent Infringement Case

Introduction to the Legal Battle

The pharmaceutical industry is no stranger to patent litigation, and the case of Mitsubishi Tanabe Pharma Corporation v. Apotex Inc. is a prime example of the complex legal battles that unfold in this sector. This high-stakes lawsuit, filed on May 3, 2024, in the US District Court for the District of Delaware, has drawn significant attention from industry observers and legal experts alike.

Background of the Parties Involved

Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation, the plaintiff in this case, is a renowned Japanese pharmaceutical company with a global presence. Known for its innovative drug development, particularly in the field of neurology and autoimmune diseases, Mitsubishi Tanabe has a vested interest in protecting its intellectual property.

Apotex Inc.

On the other side of the courtroom, we have Apotex Inc., a Canadian pharmaceutical corporation that specializes in generic medications. As one of the largest producers of generic drugs worldwide, Apotex has been involved in numerous patent disputes over the years.

The Crux of the Lawsuit

At the heart of this legal battle is an Abbreviated New Drug Application (ANDA) filed by Apotex. This application seeks approval to manufacture and market a generic version of one of Mitsubishi Tanabe's patented drugs. The specific drug in question is not explicitly mentioned in the available court documents, but it's likely to be a significant product in Mitsubishi Tanabe's portfolio.

The ANDA Process and Its Implications

The ANDA process, established under the Hatch-Waxman Act, allows generic drug manufacturers to seek FDA approval for a generic version of an existing approved drug without conducting full clinical trials. However, this process often leads to patent infringement lawsuits, as we see in this case.

"If Apotex commercially makes, uses, offers to sell, or sells the Apotex ANDA Product within the United States, or imports the Apotex ANDA Product into the United States, or induces or contributes to any such conduct during the term of the '979 patent, Apotex would infringe one or more claims of the '979 patent under 35 U.S.C. §§ 271(a), (b), and/or (c)."[1]

This quote from the court documents highlights the core of Mitsubishi Tanabe's allegations against Apotex.

The Patents at Stake

While the exact patents involved are not specified in the available information, the case revolves around at least two patents:

1. The '978 patent
2. The '979 patent

These patents likely cover either the drug's composition, its method of use, or both. The protection of these patents is crucial for Mitsubishi Tanabe to maintain its market exclusivity and recoup its research and development investments.

Legal Claims and Counterclaims

Mitsubishi Tanabe's Claims

Mitsubishi Tanabe's primary claim is patent infringement. They assert that Apotex's ANDA filing and potential future actions related to the generic drug would infringe on their patents. The company is seeking:

1. A declaratory judgment of infringement
2. A permanent injunction against Apotex
3. An order delaying the effective date of any FDA approval for Apotex's ANDA

Apotex's Defense and Counterclaims

While the specific details of Apotex's defense are not provided in the available information, it's common in such cases for the defendant to challenge the validity of the patents in question. This could involve arguments of obviousness or prior art that would render the patents invalid.

The Legal Process Unfolding

Initial Filings and Responses

The case was initiated on May 3, 2024, with Mitsubishi Tanabe filing the complaint. Apotex responded on May 24, 2024, with an answer to the complaint and counterclaims. This rapid response is typical in ANDA litigation due to the time-sensitive nature of drug approvals and market entry.

Pro Hac Vice Admissions

Both parties have sought pro hac vice admissions for attorneys from various firms. This is common in complex patent litigation cases, where specialized expertise is often required.

Scheduling and Case Management

The court has ordered the parties to prepare a joint scheduling order and provide a case description. This indicates that the case is moving into the discovery and pre-trial phases.

Potential Implications of the Case

For Mitsubishi Tanabe

If successful in their lawsuit, Mitsubishi Tanabe would maintain market exclusivity for their drug, potentially for several more years. This would allow them to continue recouping their R&D investments and maintain their market position.

For Apotex

A favorable outcome for Apotex would allow them to enter the market with their generic version of the drug, potentially capturing a significant market share and providing a more affordable option for patients.

Broader Industry Impact

The outcome of this case could have ripple effects throughout the pharmaceutical industry. It may influence how other companies approach ANDA filings and patent challenges in the future.

Similar Cases in the Pharmaceutical Industry

Novartis Pharmaceuticals Corporation v. Apotex Corporation

In a similar case, Novartis sued Apotex over patents related to their MIACALCIN® Nasal Spray. This case highlights the frequency of such disputes in the industry[6].

Wilmington Trust Securities Litigation

While not a pharmaceutical case, the Wilmington Trust Securities Litigation resulted in a $210 million settlement, demonstrating the high stakes often involved in complex corporate litigation[2].

The Role of Expert Witnesses

Expert witnesses play a crucial role in patent litigation cases. In similar cases, experts in fields such as chemistry, pharmacology, and patent law have been called upon to testify about the validity and infringement of patents.

Potential Outcomes and Settlements

While it's too early to predict the outcome of this case, there are several possible scenarios:

1. A court ruling in favor of Mitsubishi Tanabe, upholding their patents
2. A court ruling in favor of Apotex, invalidating the patents
3. A settlement between the parties, potentially involving a licensing agreement or delayed market entry for Apotex's generic version

The Importance of Patent Protection in Pharmaceuticals

This case underscores the critical role that patent protection plays in the pharmaceutical industry. Patents provide the incentive for companies to invest in costly and risky drug development by offering a period of market exclusivity.

The Future of Generic Drug Approvals

The outcome of this case could influence how generic drug companies approach ANDA filings in the future. It may also impact how innovator companies strategize their patent portfolios and litigation approaches.

Key Takeaways

1. Mitsubishi Tanabe Pharma Corporation has sued Apotex Inc. for patent infringement related to an ANDA filing.
2. The case involves at least two patents and centers on Apotex's attempt to market a generic version of a Mitsubishi Tanabe drug.
3. The outcome could have significant financial implications for both companies and broader impacts on the pharmaceutical industry.
4. Expert witnesses and specialized legal counsel play crucial roles in such complex patent litigation.
5. The case highlights the ongoing tension between innovator drug companies seeking to protect their patents and generic manufacturers aiming to enter the market.

FAQs

1. Q: What is an ANDA? A: An Abbreviated New Drug Application (ANDA) is a simplified submission process for generic drug manufacturers to obtain FDA approval for a generic version of an existing approved drug.

2. Q: How long do pharmaceutical patents typically last? A: In the United States, pharmaceutical patents generally last for 20 years from the date of filing, but the effective patent life can be shorter due to the time required for clinical trials and FDA approval.

3. Q: What is pro hac vice admission? A: Pro hac vice admission allows an out-of-state attorney to represent a client in a specific case in a jurisdiction where they are not licensed to practice.

4. Q: How common are patent infringement lawsuits in the pharmaceutical industry? A: Patent infringement lawsuits are very common in the pharmaceutical industry, particularly related to generic drug approvals, due to the high stakes involved in drug development and marketing.

5. Q: What factors does a court consider in a pharmaceutical patent infringement case? A: Courts typically consider factors such as the validity of the patent, whether the generic drug infringes on the patent claims, and any defenses raised by the generic manufacturer, such as obviousness or prior art.

Sources cited: [1] https://insight.rpxcorp.com/litigation_documents/13138500 [2] https://www.wilmingtontrustsecuritieslitigation.com/Content/Documents/Declaration%20of%20Hannah%20Ross%20and%20Joseph%20E%20White.pdf [4] https://dockets.justia.com/docket/delaware/dedce/1:2024cv00549/85695 [6] https://casetext.com/case/novartis-pharmaceuticals-corporation-v-apotex-corporation-3 [7] https://insight.rpxcorp.com/litigation/dedce-85695-mitsubishi-tanabe-pharma-v-apotex