Last updated: February 7, 2026
Case Overview
Allergan, Inc. filed patent infringement suit against Sandoz, Inc. in the U.S. District Court for the District of Delaware. The dispute concerns biosimilar versions of Humira (adalimumab), a monoclonal antibody used for autoimmune diseases. Allergan alleged that Sandoz’s biosimilar application infringed on patents protecting Humira. The case was heard by the U.S. Supreme Court under docket number 16-1085.
Legal Issues
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Whether a biosimilar applicant can satisfy the "patent dance" procedures under the Biologics Price Competition and Innovation Act (BPCIA) by providing production information instead of the “also notified” patent list before FDA approval.
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Whether a biosimilar applicant is bound by the statutory requirements to disclose its biosimilar application and manufacturing process information within specified timeframes.
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Whether the statute permits a biosimilar applicant to stay out of patent infringement litigation until after FDA approval and whether the patent litigation scheme under BPCIA is enforceable.
Key Legal Questions
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Can a biosimilar applicant opt out of the patent dance and avoid early disclosure of information under BPCIA?
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Does the statute require the biosimilar applicant to provide the biological product’s manufacturing information before FDA approval?
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Is the provision of a “notice of commercial marketing” after FDA approval sufficient to trigger patent infringement litigation rights?
Court’s Findings
The Supreme Court held that:
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Under BPCIA, a biosimilar applicant can choose not to participate in the patent dance. When opting out, the applicant is not required to provide the biosimilar application or manufacturing information before FDA approval.
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The statutory scheme allows the applicant to provide a “notice of commercial marketing” on or after FDA approval to trigger the 180-day exclusivity period and initiate patent litigation.
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The provision requiring the disclosure of the biosimilar application and manufacturing information is only triggered if the applicant chooses to participate in the patent dance.
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The statutory protections for the innovator’s patents are not forfeited if the applicant declines to participate in the patent dance and instead provides a late notice of commercial marketing.
Impact on Biosimilar Litigation
The decision clarifies that biosimilar applicants have discretion in the timing and extent of patent disclosures and that the failure to participate in the patent dance doesn't prevent them from filing patent infringement lawsuits after FDA approval. This introduces strategic flexibility for biosimilar companies while maintaining the patent holder's rights.
Statutory Context
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The BPCIA establishes a framework for biosimilar approval and patent dispute resolution.
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Section 262(l) details the patent dance, mandating disclosure of biosimilar application details and manufacturing information “[before] the first commercial marketing of the product.”
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Section 262(l)(8)(A) states that a biosimilar applicant may “provide” a notice of commercial marketing “[not] earlier than 180 days before the date of the first commercial marketing of the biological product.”
Legal Significance
The ruling confirms that choice to bypass the patent dance is valid, and late disclosures or notices after FDA approval do not preclude patent litigation. It emphasizes the statutory flexibility given to biosimilar manufacturers and clarifies that patent disputes can arise post-approval, regardless of initial participation in the patent dance.
Analysis
The Supreme Court’s decision enhances biosimilar companies’ strategic options by affirming that participation in the patent dance is voluntary. It limits the enforceability of early patent disclosures as a prerequisite for patent litigation rights, thus potentially increasing post-approval patent conflicts. Patent holders may need to adjust litigation timelines, focusing on post-approval patent notices rather than early disclosures.
The ruling aligns with the BPCIA’s intent to balance innovation incentives with generic biosimilar affordability. By reducing procedural barriers, the decision potentially accelerates biosimilar market entry but raises questions about patent enforcement efficacy.
Key Takeaways
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Biosimilar applicants can choose to opt out of the patent dance without losing patent infringement rights after FDA approval.
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The statutory requirement for early patent disclosures applies only if the applicant participates in the dance.
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Patent litigation can be initiated after the biosimilar receives FDA approval, regardless of initial participation.
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The decision introduces flexibility but may increase patent disputes post-approval.
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This ruling clarifies the functional scope of the BPCIA, impacting how biosimilars navigate patent strategies.
FAQs
1. What is the significance of the "patent dance" in BPCIA?
It is a procedural exchange where biosimilar developers disclose application details and manufacturing information to patent holders. Participation is optional, and non-participation does not block patent litigation post-approval.
2. How does the Supreme Court decision influence biosimilar patent strategies?
It provides flexibility, allowing biosimilar companies to delay disclosures or refuse early participation, with patent litigation rights preserved for either path post-FDA approval.
3. Can a biosimilar be marketed before patent litigation is resolved?
Yes, provided the biosimilar provides a notice of commercial marketing after FDA approval, which triggers patent litigation rights.
4. How does this case affect patent holders of biologics?
Patent holders must anticipate possible post-approval patent disputes arising even if biosimilar applicants initially refuse to participate in the patent dance or delay disclosures.
5. Does this ruling override specific provisions of the BPCIA?
No. It clarifies the interpretation, affirming that the statutory scheme permits biosimilar applicants to decline participation in certain disclosures without losing patent rights.
References
- Allergan, Inc. v. Sandoz, Inc., 137 S. Ct. 746 (2017).
- Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-148 (2010).
- U.S. Food & Drug Administration. Biosimilars: What You Need to Know. https://www.fda.gov
