Sandoz Inc. v. Amgen Inc.
The Court ruled that a federal law governing biosimilar drugs does not let courts order a company to hand over its application and manufacturing information to the maker of the original drug — the only consequence for refusing is that the original drug's maker can sue immediately. The Court sent back to the lower court the question of whether state law might still allow an injunction.
The Court also ruled that a biosimilar maker can notify the original drug's manufacturer of its plans to start selling before, not just after, getting FDA approval, rejecting a stricter reading that would have delayed competition.
“a statute expressly provides a remedy, courts must be especially reluctant to provide additional remedies.”
Explaining why Congress's chosen remedy for nondisclosure excludes federal injunctions.
How it got here: A federal trial court ruled for Sandoz on the disclosure claim and dismissed the state-law claims; the Federal Circuit affirmed in part and required post-licensure notice; both sides sought Supreme Court review.
The Case in Depth
What happened
Amgen has long sold Neupogen, a biologic drug, and holds patents on how it's made and used. Sandoz sought FDA approval to sell a cheaper biosimilar version, Zarxio. Sandoz told Amgen it would not share its application and manufacturing details as a federal law normally requires, and said Amgen could sue immediately instead. Amgen sued for patent infringement and under a California unfair-competition law, seeking court orders forcing Sandoz to comply with the disclosure and notice rules.
The question before the Court
When a company applying to sell a biosimilar drug refuses to hand over its application and manufacturing details, can a court order it to do so, and can it give notice of marketing before getting FDA approval?
Why it matters
Companies developing cheaper biosimilar versions of expensive biologic drugs gain more flexibility in how and when they engage brand-name manufacturers, potentially speeding these products to market. Brand-name drug makers lose one avenue (a federal injunction) for forcing early disclosure of competitors' plans, though they may still have options under state law and can sue immediately if information is withheld.
What changes now
The case returns to the Federal Circuit, which must decide whether California's unfair-competition law provides a remedy for Sandoz's failure to disclose its application information, and if so, whether the federal biosimilar law preempts that state-law remedy. The Court's ruling on the notice-timing question is final: Sandoz's prelicensure notice was valid, so the injunction that had delayed Zarxio's marketing based on that issue is reversed.
What this does not decide
The Court did not decide whether Sandoz's nondisclosure was actually 'unlawful' under California law, or whether federal law preempts a state-law remedy for it — those questions go back to the Federal Circuit. The Court also left open whether a judge could weigh a disclosure violation when deciding a preliminary injunction motion in a later infringement suit.
Concurrences and dissents
Concurrence — Justice Breyer
Justice Breyer agreed with the Court's interpretation but added that he believes Congress implicitly gave the FDA authority to interpret these same statutory terms. He suggested that if the FDA later develops more experience administering the law and concludes a different interpretation would work better, it may have the authority to depart from or modify the Court's reading, though he did not decide that question.
How the Court got there
The legal reasoning, step by step
- The Court examined whether a specific provision requiring biosimilar applicants to disclose application and manufacturing information is enforceable by injunction under federal law. It found that failing to disclose this information is not itself an 'artificial' act of patent infringement — a status Congress created so that patent disputes could be resolved before a drug reaches the market — so the federal remedy provisions for artificial infringement don't apply to this failure.
- Because a separate provision already gives the drug's original manufacturer a specific remedy for nondisclosure (the right to sue immediately for a declaration about the patents), the Court reasoned that Congress's inclusion of this one remedy, without mentioning injunctions, showed it did not intend for courts to order compliance as a matter of federal law.
- The Court supported this conclusion by pointing to a different part of the same law that expressly authorizes injunctions to enforce confidentiality rules — showing Congress knew how to authorize injunctions when it wanted to, and chose not to do so here.
- Turning to the state-law question, the Court held that whether the biosimilar maker's nondisclosure was 'unlawful' under California's unfair-competition statute is a question of state law that the lower appeals court wrongly tried to answer solely by reference to the federal statute, so that question and any related preemption question must be decided on remand.
- On the separate question of when notice of commercial marketing must be given, the Court read the statute's text closely and concluded it imposes only one timing requirement — 180 days before marketing — not a second requirement that the drug already be licensed, because the 'licensed' language described the product at the time of marketing, not a precondition for giving notice.
- The Court noted that a neighboring provision of the same statute explicitly imposed a two-part timing requirement when Congress intended one, reinforcing that no such second requirement was meant to apply here.
Doctrinal impact
Cases affected by this decision
Reaffirms Great-West Life & Annuity Ins. Co. v. Knudson (534 U. S. 204)
Relied on to support the principle that a detailed remedial scheme signals Congress didn't intend extra remedies.
Reaffirms Russello v. United States (464 U. S. 16)
Used to support reading a lack of parallel language as intentional, not accidental, drafting.