Supreme Court ruling offers some clarity on biosimilar ‘patent dance’

WASHINGTON — In a decision that will have a big impact on the burgeoning biosimilars market, the Supreme Court on Monday overturned an appeals court decision which said Sandoz had to wait 180 days under federal law after receiving Food and Drug Administration approval to launch its biosimilar of Amgen’s Neupogen (filgrastim), Zarxio (filgrastim-sndz). The court did not rule out the possibility of state law allowing such an injunction, sending that question to a lower court.

Following Zarxio’s approval in 2015 — making it the first approved U.S. biosimilar — the U.S. Court of Appeals for the Federal Circuit granted an injunction of 180 days on its launch, based on its holding that a biosimilar manufacturer can only provide notice to the reference product maker — required to be at least 180 days by the Biologics Price Competition and Innovation Act of 2009 — after gaining FDA approval. According to the Supreme Court’s ruling, Sandoz’s notice, given in 2014 while the application was pending with the FDA, satisfied the BPCIA’s requirement. 

“In sum, because Sandoz fully complied with [the BPCIA] when it first gave notice (before licensure) in July 2014, the Federal Circuit erred in issuing a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure,” Justice Clarence Thomas wrote in the court’s unanimous decision. “Furthermore, because Amgen’s request for state-law relief is predicated on its argument that the BPCIA forbids prelicensure notice, its claim under California’s unfair competition law also fails. We accordingly reverse the Federal Circuit’s judgment as to the notice provision.”

Thomas said that the ruling was based on the wording of the BPCIA, which he said does not impose the two timing requirements that the Federal Circuit did in granting its injunction.

“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,” Thomas wrote.

Sandoz on Monday hailed the decision as a key ruling that will help biosimilars manufacturers navigate the market.

“Biosimilars offer significant value to patients, providers and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the healthcare system,” Sandoz global head of biopharmaceuticals Carol Lynch said. “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,”

And though the decision said that federal law couldn’t be used to slow down the launch of biosimilar drugs, the Supreme Court remanded the case to lower courts to decide whether such a strategy is possible under state law.

Amgen’s Kelly Davenport told Reuters that the company would continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”

Additionally, in a concurring opinion, Justice Stephen Breyer noted that, “In my view, Congress implicitly delegated to the Food and Drug Administration authority to interpret those same terms [at issue in the case]. That being so, if that agency, after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may well have authority to depart from, or to modify, today’s interpretation.”