Litigation Details for Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Limited (D. Del. 2022)

Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Limited (D. Del. 2022)

Docket		Date Filed	2022-04-08
Court	District Court, D. Delaware	Date Terminated	2024-05-30
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To
Parties	VIATRIS INC.
Patents	10,525,057; 10,980,803; 11,154,553; 11,344,547; 11,400,087; 7,807,680; 8,008,032; 8,030,313; 8,338,427; 8,399,469; 8,722,679
Attorneys	Christine Dealy Haynes
Firms	Potter Anderson & Corroon LLP
Link to Docket	External link to docket

Details for Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Limited (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-04-08				External link to document
2022-04-08	144	Report and Recommendations	,469 (the “’469 patent”), 10,525,057 (the “’057 patent”), 10,980,803 (the “’803 patent”), 11,154,553…across seven patents. The seven patents are U.S. Patent Nos. 8,338,427 (the “’427 patent”), 8,399,469… (the “’553 patent”), 11,344,547 (the “’547 patent”), and 11,400,087 (the “’087 patent”). I held … patent, claims 1, 10, and 25; ’547 patent, claims 1, 7, and 16; ’087 patent, claims 1… the ’803 patent. 16 The ’803 patent is a continuation of the ’057 patent and shares	External link to document
2022-04-08	222	Notice of Service	Invalidity of The Cyp Method of Treatment Patents (U.S. Patent Nos. 10,525,057, 10,908,803, 11,154,553, 11,344,…Invalidity of The Cyp Method of Treatment Patents (U.S. Patent Nos. 10,525,057, 10,908,803, 11,154,553, 11,344,… Jonathan W. Steed Regarding Invalidity of U.S. Patent No. 8,399,469 [Highly Confidential], and Opening… 2022 30 May 2024 1:22-cv-00464 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2022-04-08	253	Notice of Service	Invalidity of the CYP Method of Treatment Patents (U.S. Patent Nos. 10,525,057, 10,908,803, 11,154,553, 11,344,…Invalidity of the CYP Method of Treatment Patents (U.S. Patent Nos. 10,525,057, 10,908,803, 11,154,553, 11,344,… Jonathan W. Steed Regarding Invalidity of U.S. Patent No. 8,399,469; 4) Expert Report of Dr. Yaning Wang… 2022 30 May 2024 1:22-cv-00464 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2022-04-08	303	Patent/Trademark Report to Commissioner of Patents	,030,313; 8,338,427; 8,399,469; 8,722,679; 10,525,057; 10,980,803; 11,154,553. (Attachments: # 1 Stipulation… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,807,680; 8,030,313… 2022 30 May 2024 1:22-cv-00464 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Limited: A Comprehensive Litigation Summary and Analysis

Case Overview

The litigation between Otsuka Pharmaceutical Co., Ltd. and Mylan Laboratories Limited, filed as Case No. 1:22-cv-00464 in the United States District Court for the District of Delaware, involves complex patent infringement claims related to the drug aripiprazole, marketed by Otsuka as Abilify.

Parties Involved

• Plaintiffs: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
• Defendants: Mylan Laboratories Limited, Viatris Inc., and Mylan Pharmaceuticals Inc.[3][5].

Nature of the Case

The case revolves around Otsuka's assertion that Mylan's submission of Abbreviated New Drug Applications (ANDAs) for generic versions of aripiprazole infringes on several of Otsuka's patents. Specifically, the patents in question cover various forms and preparations of aripiprazole, including its anhydrous crystal forms and methods for its preparation[1][4].

Patents-in-Suit

The litigation involves multiple patents, including but not limited to:

• U.S. Patent Nos. 8,017,615 (the ’615 patent)
• U.S. Patent Nos. 8,580,796 (the ’796 patent)
• U.S. Patent Nos. 8,642,760 (the ’760 patent)
• Additional patents such as U.S. Patent Nos. 8,338,427, 8,399,469, 10,525,057, 10,980,803, 11,154,553, 11,344,547, and 11,400,087[1][5].

Claims and Issues Presented

Otsuka claims that Mylan's ANDA filings for generic aripiprazole products infringe on the patents covering the low-hygroscopic forms of aripiprazole and the methods for preparing these forms. Mylan, in response, filed motions for summary judgment of non-infringement, which Otsuka contested by requesting additional discovery to evaluate the infringement claims properly[1][4].

Discovery and Sample Issues

A significant aspect of the litigation involves the production of representative samples of Mylan's aripiprazole Active Pharmaceutical Ingredient (API). Mylan produced samples on October 14, 2015, and August 15, 2016, but Otsuka objected to these samples due to non-compliance with required packaging specifications. Otsuka argued that these samples were not representative of the API Mylan intended to use in its tablet products and requested the court to deny Mylan's motion for summary judgment until a representative sample was provided[1][4].

Court Rulings and Decisions

The court sided with Otsuka, ruling that Mylan must produce a representative API sample for Otsuka to test and fairly evaluate infringement. This decision was crucial as it allowed Otsuka to proceed with its infringement claims based on accurate and representative samples of Mylan's API[1][4].

Markman Hearing and Claim Construction

The case also involved a Markman hearing to resolve claim construction disputes regarding several terms across seven patents. The court's construction of these terms is critical in determining the scope of the patents and whether Mylan's products infringe on them[5].

Current Status and Outcome

The case was filed on April 8, 2022, and was closed on May 30, 2024. The latest docket entry was on June 21, 2024. The specific outcome of the case, including any settlements or final judgments, is not detailed in the available sources, but the litigation has been ongoing with significant focus on the production of representative samples and claim construction[3].

Industry Implications

This litigation highlights the complexities and challenges in pharmaceutical patent disputes, particularly in the context of generic drug approvals. It underscores the importance of precise sample production and compliance with regulatory specifications in patent infringement cases.

Key Takeaways

• Patent Infringement Claims: Otsuka asserted that Mylan's ANDA filings infringed on several patents related to aripiprazole.
• Sample Production: The court required Mylan to produce representative API samples to facilitate accurate infringement evaluation.
• Claim Construction: The case involved a Markman hearing to resolve disputes over patent term interpretations.
• Regulatory Compliance: The litigation emphasizes the importance of adhering to packaging and sample production specifications in pharmaceutical patent cases.

Frequently Asked Questions (FAQs)

Q: What is the main issue in the Otsuka Pharmaceutical Co., Ltd. v. Mylan Laboratories Limited litigation?

A: The main issue is Otsuka's claim that Mylan's submission of ANDAs for generic aripiprazole products infringes on Otsuka's patents covering various forms and preparations of aripiprazole.

Q: Why did Otsuka object to the API samples provided by Mylan?

A: Otsuka objected because the samples were not provided in packaging that complied with required specifications, making them non-representative of the API Mylan intended to use.

Q: What was the court's decision regarding Mylan's motion for summary judgment?

A: The court ruled that Mylan must produce a representative API sample before the court would consider Mylan's motion for summary judgment.

Q: What patents are involved in this litigation?

A: The litigation involves several patents, including U.S. Patent Nos. 8,017,615, 8,580,796, 8,642,760, and others such as 8,338,427, 8,399,469, 10,525,057, 10,980,803, 11,154,553, 11,344,547, and 11,400,087.

Q: What is the significance of the Markman hearing in this case?

A: The Markman hearing is crucial for resolving claim construction disputes, which determine the scope of the patents and whether Mylan's products infringe on them.

Sources:

1. Otsuka Pharm. Co. v. Mylan Inc. | Robins Kaplan LLP - JDSupra
2. IN THE UNITED STATES DISTRICT COURT FOR THE ... - RPX Insight
3. Otsuka Pharmaceutical Co., Ltd. et al v. Mylan Laboratories Limited et al DC - RPX Insight
4. Otsuka Pharm. Co. v. Mylan Inc. - Casetext
5. Case 1:22-cv-00464-CFC-JLH Document 144 Filed 09/12/23 - govinfo.gov