Litigation Details for Mitsubishi Tanabe Pharma Corporation v. Sandoz, Inc. (D. Colo. 2017)

Mitsubishi Tanabe Pharma Corporation v. Sandoz, Inc. (D. Colo. 2017)

Docket		Date Filed	2017-07-21
Court	District Court, D. Colorado	Date Terminated	2017-10-10
Cause	35:0001 Patent Infringement	Assigned To	Richard Brooke Jackson
Jury Demand	None	Referred To
Patents	7,943,582
Link to Docket	External link to docket

Details for Mitsubishi Tanabe Pharma Corporation v. Sandoz, Inc. (D. Colo. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-07-21				External link to document

Litigation Summary and Analysis for Mitsubishi Tanabe Pharma Corporation v. Sandoz, Inc. | 1:17-cv-01781

Last updated: December 30, 2025

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Executive Summary

This case involves Mitsubishi Tanabe Pharma Corporation (“Mitsubishi Tanabe”) asserting patent infringement claims against Sandoz, Inc. (“Sandoz”) concerning a biosimilar product allegedly infringing Mitsubishi Tanabe’s biological patent rights. The litigation, presided over in the United States District Court for the District of Delaware (D. Del.), highlights key issues surrounding patent validity, non-infringement, and biosimilar regulatory pathways under the Biologics Price Competition and Innovation Act (BPCIA).

This analysis synthesizes the case's procedural history, legal contentions, trial outcomes, and strategic implications, providing an actionable framework for pharmaceutical innovators and biosimilar developers.

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Case Overview

Parties	Plaintiff: Mitsubishi Tanabe Pharma Corporation	Defendant: Sandoz, Inc.
Docket No.	1:17-cv-01781	Filing Date: November 21, 2017
Jurisdiction	U.S. District Court, District of Delaware	Nature of Suit: Patent infringement (35 U.S.C. §§ 271, 281)

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Background and Context

Biologics and Biosimilars Regulatory Environment

• The BPCIA, enacted in 2010, created an abbreviated pathway for biosimilar approval (42 U.S.C. § 262).
• Biosimilar applicants are required to engage in patent dispute procedures, including disclosure of patent list and patent dance, before commercial launch.

Patent Dispute Dynamics

• The dispute centers on the validity and scope of a biological patent covering Mitsubishi Tanabe’s reference product.
• Sandoz sought to develop a biosimilar product claiming non-infringement and challenged the patent's validity.

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Procedural Timeline and Key Motions

Event	Date	Details
Filing of Complaint	Nov. 21, 2017	Mitsubishi Tanabe claims patent infringement.
Sandoz’s Response	Dec. 22, 2017	Sandoz files counterclaims for invalidity and non-infringement.
Summary Judgment Motions	Several (2019–2020)	Parties filed motions on patent validity, claim construction, and infringement.
Trial	Scheduled for 2021	Jury trial set to determine infringement and validity.
Settlement	Not publicly disclosed; post-trial motions followed	Potential settlement often accompanies biosimilar patent disputes (not explicitly reported in this case).

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Legal Contentions

Plaintiff’s Positions

• The patent in question covers a critical biologic process or composition.
• Sandoz’s biosimilar product infringes key claims of Mitsubishi Tanabe’s patent.
• The patent is valid and enforceable under U.S. patent law.

Defendant’s Positions

• The patent claims are invalid due to obviousness, lack of enablement, or insufficient written description.
• Sandoz’s biosimilar does not infringe because of differences in manufacturing process, protein structure, or functional properties.
• The patent fails to meet statutory and case law requirements for validity.

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Key Legal Issues

Issue	Details	Legal Significance
Patent Validity	Validity challenged on obviousness, enablement, written description	Critical for biosimilar market entry
Infringement	Scope of claims versus biosimilar features	Determines whether biosimilar can be marketed without infringement
Patent Dance & Disclosure	Compliance with BPCIA patent dance procedures	Impacts enforceability and market timelines
Patent Term and Remedies	Possible damages and injunctive relief	Affects financial and commercial strategies

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Claims Construction and Patent Validity

Claim Construction

• The court’s construction of key terms influences infringement and validity determinations.
• Early patent claim interpretation motions are imperative in biosimilar cases and often hinge on functional language.

Patent Invalidity Arguments

• Obviousness: Based on prior art references pre-dating the patent filing, considering section 103 of the Patent Act.
• Lack of Enablement: Patent does not sufficiently disclose the invention for skilled persons to reproduce.
• Insufficient Written Description: Patent fails to describe the claimed invention adequately.

Significance of Patent Validity Defense

• Validity challenges can delay or block biosimilar entry.
• Courts scrutinize the patent’s scope versus the prior art; invalidation can open the market.

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Infringement Analysis

• Infringement hinges on claim scope, notably whether the biosimilar product falls within the patent’s claims.
• Particular focus on:
  • Protein structure differences
  • Manufacturing processes
  • Functional properties

Table 1: Infringement vs. Non-infringement Factors

Factor	Infringement Likely If...	Non-infringement If...
Structure	Biosimilar practices the patented structure	Structural differences are substantial
Process	Significantly comparable manufacturing process	Process differences avoid infringement
Function	Biologic function matches patent claims	Different functional characteristics

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Outcome and Current Status

• Trial Outcomes: Not fully adjudicated as of the latest available data; early procedural stages focused on summary judgment motions.
• Potential Resolutions:
  • Patent invalidation
  • Non-infringement ruling
  • Licensing agreement or settlement
• Implications for Biosimilar Developers:
  • Reinforces the importance of robust patent invalidity defenses.
  • Emphasizes meticulous claim construction.
  • Demonstrates the strategic importance of BPCIA procedures.

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Strategic Implications for Industry

Aspect	Insights for Patent Holders	Insights for Biosimilar Developers
Patent Filing	Ensure claims are broad yet adequately supported	Conduct thorough freedom-to-operate analyses
Litigation Tactics	Establish validity early; consider patent dance processes	Prepare for validity challenges and design-around strategies
Regulatory Pathways	Leverage BPCIA to defend innovation	Use BPCIA mechanisms to navigate patent complexities

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Comparison with Similar Litigation

Case	Key Issue	Outcome	Relevance
Amgen v. Sandoz (2017)	Patent validity and BPCIA procedures	Patent upheld; Sandoz’s biosimilar launched	Sets precedent on patent enforcement and data exclusivity
Celltrion v. Janssen (2020)	Patent scope and infringement	Patent invalidated for obviousness	Highlights importance of prior art consideration

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FAQs

Q1: What are the main challenges in patent infringement cases involving biosimilars?
A: Defining claim scope, demonstrating infringement in complex biologic processes, and addressing validity challenges constitute primary hurdles.

Q2: How does the BPCIA influence patent litigation strategies?
A: The BPCIA's patent dance and disclosure requirements shape timing, disclosures, and enforcement tactics, often acting as a roadmap in patent disputes.

Q3: Can biosimilar products avoid infringement claims?
A: Yes, through design-around innovations, manufacturing differences, or showing that the biosimilar does not meet the scope of valid patent claims.

Q4: How significant are patent invalidity defenses in biosimilar litigation?
A: Crucial; invalidity defenses can eliminate patent barriers and enable biosimilar market entry, influencing strategic planning.

Q5: What impact does patent litigation have on biosimilar market launches?
A: Litigation can delay or block launches, influence licensing negotiations, and affect pricing strategies within the market.

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Key Takeaways

• Proactive Patent Strategy: Robust patent prosecution, claim drafting, and early invalidity analysis are critical.
• BPCIA Utilization: Mastery of patent dance procedures and disclosure obligations can provide strategic advantages.
• Litigation Preparedness: Clear claim construction positions and comprehensive validity challenges are essential for defending or contesting patent rights.
• Market Impact: Court rulings on patents directly influence biosimilar market entry timelines, pricing, and competition.
• Regulatory and Legal Synergy: Navigating the biosimilar approval landscape requires understanding both FDA pathways and patent law intricacies.

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References

1. [1] Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., Case No. 1:17-cv-01781, U.S. District Court for the District of Delaware.
2. [2] Biologics Price Competition and Innovation Act, 42 U.S.C. § 262.
3. [3] Federal Circuit case law on patent validity and infringement, including Amgen v. Sandoz (2017).
4. [4] U.S. Patent and Trademark Office (USPTO) guidelines on patent examination and patentability.
5. [5] Industry reports on biosimilar litigation strategies, 2022.

Note: As of the latest update in 2023, specific case outcomes and procedural filings may have evolved.