Supreme Court Rules in Amgen v. Sandoz

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The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

On June 12, 2017, the Supreme Court released its opinion in Amgen v. Sandoz. The landmark decision states that biosimilar applicants can notify manufacturers before FDA approves their product. This means biosimilar makers won’t have to wait six-months after their product is approved to bring it to market. 

In a statement, Carol Lynch, global head of Biopharmaceuticals at Sandoz said the Supreme Court decision will allow the company to “expedite patient access” to biosimilars. “The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” Lynch said.

Kevin Noonan, partner at McDonnell Boehnen Hulbert & Berghoff and chair of the firm’s Biotechnology & Pharmaceuticals Practice Group told BioPharm International the decision will allow biosimilar applicants to notify reference product sponsors under "circumstances that create uncertainty about when the FDA will approve." 

"While permitting the reference product sponsor to immediately bring suit, also means that what is the basis for the suit will be unclear. It seems to be the opposite of the ordered litigation regime the statute appeared to provide," Noonan said. 

In its opinion, the court also said that the Biologics Price Competition and Innovation Act (BPCIA) requirement that a biosimilar applicant provides the sponsor with its application and manufacturing information “is not enforceable by injunction under federal law, but the Federal Circuit on remand should determine whether a state-law injunction is available.”

“We decline to resolve this particular dispute definitively because it does not present a question of federal law. The BPCIA, standing alone, does not require a court to decide whether §262(l)(2)(A) is mandatory or conditional; the court need only determine whether the applicant supplied the sponsor with the information required under §262(l)(2)(A),” the court wrote.

The decision further clarifies sections of the so-called patent-dance between biosimilar applicants and reference product sponsors. Although there may be need for further clarification by Congress, the court writes.  


“The plausibility of the contentions on both sides illustrates why such disputes are appropriately addressed to Congress, not the courts,” the opinion reads. “Even if we were persuaded that Amgen had the better of the policy arguments, those arguments could not overcome the statute’s plain language, which is our ‘primary guide’ to Congress’ preferred policy.”

Noonan told this publication that "the court is telling the parties to look to Congress for any remedy or change in the law." Congress could make changes to the BPCIA if it decides to amend the Affordable Care Act, he continued. 

"Congress could include changes that would address the issues presented to the court in this case," Noonan said. "These could be as simple as 'notice will not be effective under the statute if even prior to FDA approval.'"

Source: United States Supreme Court

*This article was updated on June 13, 2017 to include comments from Kevin Noonan.