Introduction
The litigation between Amgen Inc. and Sandoz Inc. is a landmark case in the realm of biosimilar drugs and patent law, particularly under the Biologics Price Competition and Innovation Act (BPCIA). This article delves into the key aspects of the case, including the legal disputes, court decisions, and their implications for the pharmaceutical industry.
Background of the BPCIA
The BPCIA, enacted in 2010, provides a regulatory pathway for the approval of biosimilar biological products. It includes specific requirements for the exchange of information between the biosimilar applicant and the reference product sponsor to facilitate patent dispute resolution[4].
The Dispute Over Zarxio
The dispute began when Sandoz submitted a biosimilar application to the FDA for Zarxio, a biosimilar version of Amgen's Neupogen (filgrastim). On July 7, 2014, the FDA accepted Sandoz's application, and the next day, Sandoz notified Amgen of its intention to commercially market Zarxio immediately upon FDA approval. However, Sandoz refused to provide Amgen with its biosimilar application and manufacturing information as required under §262(l)(2)(A) of the BPCIA[5].
Amgen's Legal Action
In response, Amgen filed a lawsuit against Sandoz in the U.S. District Court for the Northern District of California on October 24, 2014. Amgen alleged violations of the BPCIA, unfair competition under California law, and patent infringement. Specifically, Amgen claimed that Sandoz's failure to disclose the application and manufacturing information and its premature notice of commercial marketing under §262(l)(8)(A) before FDA approval were violations of the BPCIA[5].
Court Decisions
District Court
The District Court dismissed Amgen's unfair competition and conversion claims with prejudice, finding that Sandoz did not violate the BPCIA. The court also denied Amgen's motion for a preliminary injunction based on its state law claims, noting that Amgen had not yet proceeded on its remaining patent infringement claims[5].
Federal Circuit
The Federal Circuit affirmed the dismissal of Amgen's state law claims and held that declaratory judgment remedies, rather than injunctions, were the only available remedies for a failure to provide the application and manufacturing information. The court also remanded the issue of whether California unfair competition law provides a separate remedy and whether the BPCIA preempts state law remedies[4].
Supreme Court
The Supreme Court further clarified the BPCIA requirements in its decision on June 12, 2017. The Court held that Sandoz did not violate the BPCIA by failing to disclose its application and manufacturing information. It also ruled that the BPCIA provides the exclusive remedies for failure to comply with this requirement. Additionally, the Court determined that the 180-day notice of commercial marketing under §262(l)(8)(A) must be provided after obtaining FDA licensure, making this requirement mandatory[1].
Implications and Analysis
BPCIA Compliance
The Supreme Court's decision emphasized that the BPCIA sets out specific and exclusive remedies for non-compliance with its provisions. This means that biosimilar applicants like Sandoz cannot be sued under state law for failing to provide application and manufacturing information, as the BPCIA itself provides the necessary legal framework for such disputes[1].
Patent Infringement
The case also highlighted the importance of patent infringement claims in biosimilar litigation. Amgen's claims of patent infringement against Sandoz were not resolved by the Supreme Court's decision and remained pending in the district court. In a separate case, Amgen successfully defended its patent rights for denosumab, another of its biologic products, against Sandoz's biosimilar version, demonstrating the ongoing significance of patent litigation in this field[2].
State Law Remedies
The Supreme Court's remand on the issue of whether California unfair competition law provides a separate remedy indicates ongoing uncertainty and potential for future litigation regarding the interplay between federal and state laws in biosimilar disputes. This complexity underscores the need for clear legal guidance to navigate these intricate legal landscapes[4].
Settlement and Resolution
In a more recent development, Amgen and Sandoz reached a confidential settlement resolving the remaining patent disputes related to Sandoz's denosumab biosimilar products. This settlement allows Sandoz to launch its biosimilar products on May 31, 2025, or earlier under certain conditions, affirming Amgen's confidence in the strength of its patent rights[2].
Key Takeaways
- BPCIA Compliance: The BPCIA provides exclusive remedies for non-compliance with its provisions, precluding state law claims for such violations.
- Patent Infringement: Patent litigation remains a critical aspect of biosimilar disputes, with significant implications for both the innovator and the biosimilar applicant.
- State Law Interplay: The interplay between federal and state laws in biosimilar disputes is complex and subject to ongoing legal clarification.
- Settlements: Confidential settlements can resolve patent disputes, allowing for the launch of biosimilar products while respecting the innovator's patent rights.
FAQs
Q: What was the main issue in the Amgen v. Sandoz case?
A: The main issue was whether Sandoz violated the BPCIA by not disclosing its biosimilar application and manufacturing information to Amgen and by providing premature notice of commercial marketing.
Q: How did the Supreme Court rule on the BPCIA requirements?
A: The Supreme Court ruled that Sandoz did not violate the BPCIA by failing to disclose its application and manufacturing information and that the 180-day notice of commercial marketing must be provided after FDA licensure.
Q: What was the outcome of the patent infringement claims in this case?
A: The patent infringement claims were not resolved by the Supreme Court's decision and remained pending in the district court. However, in a separate case, Amgen successfully defended its patent rights for denosumab.
Q: Can state law claims be used to enforce BPCIA compliance?
A: No, the BPCIA provides exclusive remedies for non-compliance with its provisions, precluding state law claims for such violations.
Q: What was the result of the settlement between Amgen and Sandoz regarding denosumab biosimilars?
A: The settlement allowed Sandoz to launch its biosimilar products on May 31, 2025, or earlier under certain conditions, while affirming Amgen's confidence in the strength of its patent rights.
Sources
- Supreme Court of the United States. Sandoz Inc. v. Amgen Inc. (06/12/2017).
- Amgen. Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products.
- Unified Patents Portal. 3:18-cv-11026 - Amgen Inc et al. v. Sandoz AG.
- Food and Drug Law Institute (FDLI). Case Note: Sandoz v. Amgen.
- FindLaw Caselaw. AMGEN INC v. SANDOZ INC (2015).
