Last updated: February 9, 2026
Case Overview
Allergan, Inc. (now part of AbbVie) filed patent infringement against Gland Pharma Limited in the U.S. District Court for the Northern District of California in August 2020. The case concerns patent rights related to a biosimilar or generic version of Allergan’s drug. The dispute focuses on patent validity, infringement, and the implications for Gland Pharma’s generic product pipeline.
Key Facts
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Filing Date: August 27, 2020
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Docket Number: 1:20-cv-04094
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Parties:
- Plaintiff: Allergan, Inc.
- Defendant: Gland Pharma Limited
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Patent at Issue: U.S. Patent No. 10,891,367, titled "Methods for Producing Bovine Collagen" (patent expires June 2038). This patent claims methods used in the production of collagen, a key ingredient in Allergan's collagen-based products. Gland Pharma’s biosimilar product allegedly infringes on this patent.
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Gland Pharma’s Product: A biosimilar collagen product intended for therapeutic uses, such as dermal fillers or wound healing. Gland Pharma seeks FDA approval to market this product, prompting patent litigation.
Claims and Allegations
Allergan asserts Gland Pharma infringes claims related to the manufacturing process of bovine collagen, which Allergan developed and patented. Allergan claims the biosimilar infringes upon its patent rights by employing allegedly identical manufacturing methods.
Gland Pharma contends the patent is invalid, citing prior art references and questioning the patent’s claims scope. The defendant also argues that their process does not infringe or that the patent should be narrowed or invalidated.
Legal Proceedings and Status
- Initial Filing: Complaint filed on August 27, 2020, alleging patent infringement and requesting injunctive relief and damages.
- Response: Gland Pharma filed an answer in October 2020, denying infringement and asserting invalidity defenses.
- Discovery: The parties engaged in discovery, including depositions, document requests, and expert reports.
- Pretrial Motions: Both parties filed motions for summary judgment on patent validity and infringement.
- Current Status: As of Q4 2022, the case is pending a dispositive ruling or trial date, with no final judgment announced.
Legal Issues
- Patent Validity: Gland Pharma challenges the patent’s novelty and non-obviousness based on prior art.
- Infringement: Whether Gland Pharma’s manufacturing process infringes the asserted patent claims.
- Patent Scope: Whether the claims are sufficiently definite under 35 U.S.C. § 112, and whether they encompass Gland Pharma’s process.
Potential Outcomes
- Infringement Confirmed: Gland Pharma could be barred from marketing its biosimilar until the patent expires or a license is negotiated.
- Patent Invalidated: Gland Pharma could obtain a ruling nullifying the patent, enabling free entry into the market.
- Settlement: Parties might resolve through licensing or settlement agreements, common in biosimilar litigation.
Implications
The case highlights the ongoing patent disputes in the biosimilars space, particularly around manufacturing processes critical to biosimilar approval. Patent validity remains a central theme, with implications for innovation, market entry, and competition.
Comparative Context
This litigation resembles other biosimilar patent disputes, such as Sandoz v. Amgen or Pfizer v. Amgen, where patents on manufacturing processes or composition are contested.
Key Takeaways
- Allergan’s patent covers a specific collagen manufacturing process challenged by Gland Pharma.
- Gland Pharma seeks to clear regulatory hurdles for biosimilar approval by invalidating Allergan’s patent.
- The outcome hinges on patent law interpretations regarding novelty and non-obviousness.
- The case underscores patent strategy’s importance in biosimilar market entry.
- A final ruling could shape future litigation strategies in biosimilar patent disputes.
FAQs
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What is the primary legal issue in the case?
The validity and infringement of Allergan’s patents related to collagen manufacturing processes.
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How could this case affect Gland Pharma’s product launch?
A court ruling favoring Gland Pharma could enable them to market their biosimilar without infringement concerns.
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What defenses has Gland Pharma raised?
Claims of patent invalidity based on prior art and non-infringement.
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What is the significance of patent validity in biosimilar development?
Valid patents prevent infringement, delaying or blocking biosimilar market entry. Invalidating patents can hasten entry.
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Are biosimilar patent disputes common?
Yes, they are frequent as biosimilar manufacturers navigate complex patent landscapes to compete in biologic markets.
Sources
[1] Federal Court Docket for Allergan, Inc. v. Gland Pharma Limited, 1:20-cv-04094, Northern District of California.
