US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval
The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars.
The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the patent situation of a biologic and proposed biosimilar before the biosimilar comes to market.
One of the major questions the court discussed in April and sought to answer was whether biosimilar companies would have to wait six months after FDA approval before launch, as Amgen had tried to persuade the court, but which Sandoz said effectively created six months of additional exclusivity.
Delivering the opinion, Justice Clarence Thomas wrote: "An applicant may provide notice of commercial marketing before obtaining a license … Amgen’s contrary arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language."
The opinion further explains: "The statute’s use of the word ‘licensed’ merely reflects the fact that, on the ‘date of the first commercial marketing,’ the product must be ‘licensed.’ ... Accordingly, the applicant may provide notice either before or after receiving FDA approval."
Carol Lynch, global head of biopharmaceuticals at Sandoz, told Focus in a statement: "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."
Mandatory Patent Dance?
On the question of whether it’s "enforceable by an injunction under either federal or state law" that a biosimilar applicant must provide the biologic reference product sponsor with its application and manufacturing information, the Supreme Court said that should be decided by states.
The opinion says, "There is no dispute about how the federal scheme actually works, and thus nothing for us to decide as a matter of federal law. The mandatory or conditional nature of the BPCIA’s [Biologics Price Competition and Innovation Act, which established the pathway by which biosimilars are approved] requirements matters only for purposes of California’s unfair competition law, which penalizes ‘unlawful’ conduct. Whether Sandoz’s conduct was ‘unlawful’ under the unfair competition law is a state-law question, and the court below erred in attempting to answer that question by referring to the BPCIA alone.
"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 opinion says.
Erika Lietzan, a professor at University of Missouri School of Law, told Focus that she read this part of the ruling "as very narrow -- that a reference product sponsor does not have access to a federal injunction to enforce the requirement that a biosimilar applicant provide a copy of its application and marketing information. This seems quite narrow, and when describing the federal scheme the court unambiguously states repeatedly that a biosimilar applicant is 'required' to provide its application. This leaves open the possibility that the requirement may be enforceable by the reference product sponsor under state law (including, but not limited to, California's unfair competition law). The dispute over whether providing the application should be characterized as 'mandatory' or a 'condition precedent' turns out to be irrelevant; it matters only for purposes of California's unfair competition law, and it cannot be answered by reference to the BPCIA alone."
More FDA Involvement?
The opinion also might set the stage for FDA to be more involved in the patent dance and interpreting the BPCIA further.
In a concurring opinion, Justice Stephen Breyer wrote: "In my view, Congress implicitly delegated to the Food and Drug Administration authority to interpret those same terms. 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."