Sandoz Inc. v. Amgen Inc.
137 S.Ct. 1664, 198 L. Ed. 2d 114, 2017 U.S. LEXIS 3723 (2017)
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Rule of Law:
Under the Biologics Price Competition and Innovation Act (BPCIA), a biosimilar applicant's failure to disclose its application and manufacturing information is not enforceable by a federal injunction, as the statute provides an exclusive federal remedy. Furthermore, the applicant may provide the required 180-day notice of commercial marketing before receiving FDA licensure.
Facts:
- Amgen Inc. markets a biologic drug called Neupogen (filgrastim), used to stimulate white blood cell production, and holds related patents.
- Sandoz Inc. developed Zarxio, a biosimilar version of Neupogen.
- In May 2014, Sandoz filed an application with the Food and Drug Administration (FDA) seeking approval to market Zarxio.
- On July 7, 2014, the FDA accepted Sandoz's application for review.
- One day later, Sandoz notified Amgen of its application and its intent to market Zarxio immediately upon FDA approval.
- Sandoz explicitly informed Amgen that it would not provide its application and manufacturing information as specified by the BPCIA's information-exchange provisions.
Procedural Posture:
- Amgen sued Sandoz in the U.S. District Court for the Northern District of California, alleging patent infringement and violations of California's unfair competition law based on Sandoz's failure to comply with BPCIA provisions.
- The District Court granted partial judgment on the pleadings to Sandoz regarding the BPCIA claims.
- Amgen, as appellant, appealed to the U.S. Court of Appeals for the Federal Circuit, with Sandoz as the appellee.
- The Federal Circuit affirmed in part and vacated in part, holding that federal law does not provide an injunction to compel disclosure but that the 180-day marketing notice is only effective if given after FDA licensure.
- The U.S. Supreme Court granted certiorari to review both holdings.
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Issue:
1. Is a biosimilar applicant's failure to provide its application and manufacturing information to a reference product sponsor, as required by 42 U.S.C. § 262(l)(2)(A), enforceable by an injunction under federal law? 2. Does 42 U.S.C. § 262(l)(8)(A) require a biosimilar applicant to wait until after it receives FDA licensure before giving the sponsor a 180-day notice of commercial marketing?
Opinions:
Majority - Justice Thomas
1. No. The BPCIA does not authorize a federal injunction to compel a biosimilar applicant to disclose its application and manufacturing information under § 262(l)(2)(A). The statute provides an exclusive federal remedy in § 262(l)(9)(C), which permits the sponsor to immediately bring a patent infringement action. The court reasoned that where a statute expressly provides a detailed remedy, courts should not create additional ones. Congress also explicitly authorized injunctive relief for other BPCIA violations, such as breaches of confidentiality, indicating its omission of an injunction here was intentional. The court remanded the question of whether an injunction is available under state law for the lower court to decide. 2. No. A biosimilar applicant may provide the 180-day notice of commercial marketing required by § 262(l)(8)(A) before receiving FDA licensure. The statute requires notice 180 days 'before the date of the first commercial marketing of the biological product licensed under subsection (k).' The phrase 'licensed under subsection (k)' modifies 'biological product,' not the act of giving notice. This means the product must be licensed by the time of marketing, but the notice itself can be given prior to licensure.
Concurring - Justice Breyer
Yes, the Court's interpretation of the statute is reasonable. However, Congress has implicitly delegated authority to the Food and Drug Administration (FDA) to interpret these terms. If the FDA, with more experience administering the BPCIA, determines that a different interpretation better serves the statute's goals, it may have the authority to depart from the Court's holding under the principles established in National Cable & Telecommunications Assn. v. Brand X Internet Services.
Analysis:
This decision resolves two critical ambiguities in the BPCIA's 'patent dance,' a complex information exchange and litigation process. The ruling significantly alters the strategic landscape for both biosimilar applicants and reference product sponsors. By precluding federal injunctions to compel disclosure, the Court allows applicants to opt out of the patent dance and instead face immediate litigation, giving them more control over the process. The holding that pre-licensure notice is valid allows biosimilar companies to start the 180-day marketing countdown earlier, potentially accelerating market entry by six months and reducing the effective market exclusivity for the original biologic drug.
