Introduction

Sandoz Inc. v. Amgen Inc. is a landmark case decided by the United States Supreme Court on June 12, 2017. The case centers around the interpretation and enforcement of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), particularly regarding the disclosure requirements and notice timing for biosimilar drug applications. The primary parties involved are Sandoz Inc., a manufacturer seeking to market a biosimilar drug called Zarxio, and Amgen Inc., the manufacturer of Neupogen, the reference biological product.

The key issues in this case involve whether the BPCIA’s requirement for biosimilar applicants to disclose their application and manufacturing information is enforceable by injunction under federal law, and whether an applicant must provide notice of commercial marketing only after obtaining FDA licensure or can do so before licensure.

Summary of the Judgment

The Supreme Court held that the BPCIA's section 262(l)(2)(A), which mandates biosimilar applicants to provide their application and manufacturing information to the reference product sponsor, is not enforceable by injunction under federal law. However, the Court remanded the case to the lower courts to determine if such an injunction is available under state law. Additionally, the Court ruled that applicants may provide notice of commercial marketing either before or after obtaining FDA licensure, contrary to the Federal Circuit’s interpretation that notice must be given post-licensure.

Specifically, the Court reversed part of the Federal Circuit’s decision that had enjoined Sandoz from marketing Zarxio until 180 days after providing notice post-licensure. The Supreme Court concluded that providing notice before licensure does not violate the BPCIA and is permissible under the statute.

Analysis

Precedents Cited

The Court referenced several precedents to support its interpretation of the BPCIA:

• Great-West Life & Annuity Insurance Co. v. Knudson: This case emphasizes that when a statute expressly provides a remedy, courts should be reluctant to imply additional remedies not specified by Congress.
• Touche Ross & Co. v. Redington: Reinforces the principle that when Congress intends to provide a private damage remedy, it must do so expressly.
• RUSSELLO v. UNITED STATES: Supports the interpretation of statutory timing requirements based on the language used in different sections of the BPCIA.

These precedents informed the Court's approach to interpreting the exclusivity of remedies under the BPCIA and the importance of adhering to the statutory language provided by Congress.

Legal Reasoning

The Court’s reasoning focused on a strict interpretation of the BPCIA's language. It determined that §262(l)(2)(A) does not constitute an act of artificial infringement and therefore cannot be remedied under §271(e)(4), which exclusively provides remedies for artificial infringement acts. Instead, the appropriate remedy for non-compliance with §262(l)(2)(A) is found in §262(l)(9)(C), which allows sponsors to bring declaratory judgments but does not authorize injunctions.

Furthermore, the Court analyzed the statutory language of §262(l)(8)(A) concerning the timing of commercial marketing notices. By interpreting the modifier “licensed under subsection (k)” as referring to “commercial marketing,” the Court concluded that applicants are allowed to provide notice before obtaining FDA licensure, thereby overturning the Federal Circuit’s requirement for post-licensure notice.

Impact

This decision has significant implications for the biosimilar pharmaceutical industry:

• Enforcement of Disclosure Requirements: Biosimilar applicants are no longer subject to federal injunctions if they fail to disclose application and manufacturing information, shifting potential enforcement to state law.
• Flexibility in Notice Timing: Applicants have greater flexibility in timing their notices of commercial marketing, allowing them to provide such notices before FDA licensure, which can accelerate the pathway to market.
• Litigation Strategy: Reference product sponsors like Amgen may need to rely more on declaratory judgments under the BPCIA rather than seeking injunctive relief to enforce disclosure and notice requirements.

Overall, the ruling clarifies the scope of federal remedies available under the BPCIA and delineates the boundaries between federal and state law remedies concerning biosimilar market entry.

Complex Concepts Simplified

Conclusion

The Supreme Court’s decision in Sandoz Inc. v. Amgen Inc. clarifies critical aspects of the BPCIA, specifically regarding the enforcement of disclosure requirements and the timing of commercial marketing notices for biosimilars. By ruling that §262(l)(2)(A) is not enforceable by injunction under federal law and allowing notice before FDA licensure, the Court has delineated the boundaries of federal remedies and preserved the role of state law in addressing non-compliance with BPCIA procedural requirements.

This judgment underscores the importance of precise statutory interpretation and reinforces the principle that when Congress specifies exclusive remedies, courts should adhere strictly to those provisions. The decision facilitates a more predictable and structured litigation framework for biosimilar manufacturers and reference product sponsors, thereby impacting future biosimilar market strategies and patent litigation tactics.

In the broader legal context, this case exemplifies the judiciary’s role in interpreting complex legislative frameworks and balancing federal and state remedies to uphold the legislative intent effectively.