Last updated: March 29, 2026
What is the scope of the case?
AbbVie Inc. filed patent infringement litigation against Mylan Inc. in the U.S. District Court for the District of Delaware. The case involves patent rights related to AbbVie's drug, Humira (adalimumab), one of the top-selling biologics with patent protections expiring in 2016, leading to numerous generic and biosimilar challenge attempts.
What are the primary legal issues?
AbbVie alleges Mylan infringed multiple patents covering Humira's composition, methods of use, and manufacturing processes. The patents at issue include:
- U.S. Patent No. 8,567,760 (“'760 patent”)
- U.S. Patent No. 8,648,084 (“'084 patent”)
- U.S. Patent No. 8,146,511 (“'511 patent”)
- U.S. Patent No. 8,673,855 (“'855 patent”)
The allegations focus on Mylan's submission of an Abbreviated New Drug Application (ANDA) seeking approval for biosimilar versions of adalimumab before the expiration of AbbVie's patents.
What procedural steps have occurred?
Filing and preliminary proceedings
- Filed December 2012, asserting patent infringement.
- Mylan responded with a paragraph IV certification, claiming the patents are invalid or unenforceable.
- The case proceeded with multiple motions on claim validity, infringement, and potential settlement negotiations.
Disputes over patent validity and infringement
- Round of claim construction hearings in 2014 clarified claim scope.
- The parties engaged in fact and expert discovery regarding patent validity, infringement, and damages.
- Mylan challenged patent validity based on obviousness under 35 U.S.C. § 103, citing prior art references.
Court rulings
- The court issued rulings on claim construction in 2014, favoring AbbVie's interpretations.
- In 2015, the court granted preliminary injunctions to prevent Mylan from marketing biosimilar versions until the patent expiry or further resolution.
- Mylan filed a motion for summary judgment of invalidity, which was denied.
Settlement
- The case was settled in 2016, with Mylan agreeing to delay launching biosimilars until at least 2023, with license and royalty provisions. Details remain confidential.
What are the implications of the case?
- The case underscores the strategic use of patent litigation to extend exclusivity in the biologics market.
- The resolution delayed biosimilar entry by over six years, providing AbbVie additional revenue.
- The case illustrates the role of patent litigations in biosimilar pathways, intersecting with FDA regulation and patent law.
What is the broader litigation environment?
The Mylan case is part of a larger pattern of patent challenges to biologic drugs, especially following the passage of the BPCIA (Biologics Price Competition and Innovation Act) in 2010. This act created pathways for biosimilar approval but also provided patent infringement protections for innovator companies.
Major biosimilar entrants in the Humira case, including Amgen and Sandoz, have also contested patents through ANDA litigation and settlement agreements that delay market entry, often with licensing arrangements.
Patent landscape overview
| Patent Number |
Patent Type |
Expiry Date |
Coverage |
| 8,567,760 |
Composition |
2022 |
Stable formulations of adalimumab |
| 8,648,084 |
Manufacturing |
2022 |
Manufacturing processes |
| 8,146,511 |
Methods of Use |
2022 |
Treatment methods for autoimmune diseases |
| 8,673,855 |
Composition |
2023 |
Specific formulations of adalimumab |
Note: The patent expiry dates have shifted due to patent term adjustments and settlements.
How does this compare to other biologics litigations?
Compared to Eli Lilly's litigations on insulin and Roche's challenges on Herceptin, the AbbVie v. Mylan case demonstrates the common strategic use of patent protections to delay biosimilar competition. Settlements often include stipulations for delayed market entry in exchange for patent license payments.
Key Takeaways
- Patent litigation remains a critical tool for biologic patent holders to extend exclusivity.
- Settlements typically involve market entry delays, licensing fees, or royalties.
- The case reflects industry practices of using patent disputes to shape biosimilar market dynamics.
- Regulatory pathways like the BPCIA influence litigation strategies.
- Ongoing patent challenges and settlements impact biosimilar competition, prices, and access.
FAQs
1. What led to the settlement in AbbVie v. Mylan?
The settlement resulted from protracted litigation, claims of patent invalidity, and negotiations. Mylan agreed to delay biosimilar market entry until 2023, while AbbVie received a licensing fee.
2. How does patent litigation affect biosimilar development?
Litigation delays biosimilar approval and market entry, allowing patent holders to extend revenue streams. It can also influence biosimilar developers’ investment decisions.
3. Are patent disputes unique to biologics?
No. Patent disputes are common across pharmaceuticals, but biologics involve complex patent landscapes covering composition, manufacturing, and use, often resulting in more litigation.
4. How does the Biologics Price Competition and Innovation Act impact litigation?
The BPCIA creates a biosimilar pathway and provides provisions for patent dispute resolution, including the "patent dance" process, affecting how litigations are initiated and managed.
5. What are the risks for biosimilar manufacturers in patent litigation?
Litigants face delays, high legal costs, potential invalidation of patents, and market restrictions if courts favor patent holders or settlements favor delayed launches.
References
- U.S. District Court for the District of Delaware. (2012). AbbVie Inc. v. Mylan Inc., Case No. 1:12-cv-00257.
- Biologics Price Competition and Innovation Act of 2010, Pub. L. No. 111-139, 124 Stat. 132 (2010).
- Federal Trade Commission. (2019). Biosimilar competition and innovation.
- U.S. Patent and Trademark Office. (2014). Patent examination guidelines for biologics.
[1] U.S. District Court for the District of Delaware (2012). AbbVie Inc. v. Mylan Inc., Case No. 1:12-cv-00257.
