The Supreme Court issued its first ruling on the patent provisions of the Biologics Price Competition and Innovation Act (BPCIA).
The Court unanimously held that the law’s “patent dance” information exchange is optional. Additionally, the Court concluded that biosimilar applicants do not have to wait for Food and Drug Administration (FDA) approval to provide the 180-day notice of commercial marketing that is required before a product can be sold to the public.
The Court’s decision in Amgen v. Sandoz is a victory for biosimilar applicants, says John Kilyk, Jr., a member in Leydig’s Chicago office. “Biosimilar developers should be pleased by this decision on both counts,” Kilyk says. “Biosimilar applicants can make the strategic choice to opt out of the ‘patent dance’ and now have the ability, if they take timely action, to launch their products at a significantly earlier time.”
Patent dance optional
Affirming one aspect of the U.S. Court of Appeals for the Federal Circuit’s decision, the Supreme Court concluded that failure to participate in the “patent dance’s” information exchange is not itself actionable insofar as it does not allow a reference product sponsor to compel the biosimilar applicant under the BPCIA to participate in the “patent dance.” Kilyk cautions that there remains the chance that such relief may be available under state law.
“The Supreme Court, in remanding this case to the Federal Circuit, left open the possibility that there still may be relief available under state-based unfair competition laws against a biosimilar applicant that doesn’t participate in the ‘patent dance,’” Kilyk says. “However, most attorneys believe this is an unlikely possibility.”
Notice of commercial marketing before FDA approval
The BPCIA requires biosimilar applicants to provide the reference product sponsor with a notice of commercial marketing 180 days before they can begin marketing a product. The Federal Circuit held that Sandoz’s notice, provided before the FDA issued its license, was ineffective because a biosimilar applicant “may only give effective notice of commercial marketing after the FDA has licensed its product.” Since no FDA license can become effective until the end of the 12-year exclusivity period, the Federal Circuit’s decision effectively added six more months of waiting before an applicant could launch a product.
In an opinion written by Justice Thomas, the Supreme Court reversed this portion of the Federal Circuit’s decision, relying on the plain language of § 262(l)(8)(A) of the BPCIA, which contains no mention of FDA licensing. Since the only timing requirement is the 180-day notice period, the Supreme Court concluded that FDA approval is not a prerequisite for a valid notice.
“A biosimilar applicant should consider issuing the notice at the same time it files its FDA application so it can, if desired, commence marketing immediately upon approval, since the FDA typically takes more than 180 days to approve applications,” advises Michael J. Schubert, an associate in Leydig’s Chicago office. “However, there are other strategic considerations beyond the scope of this discussion that may inform when notice should be provided,” Schubert notes.
“The Supreme Court’s ruling provides biosimilar applicants with additional options regarding the lead-up to, and framing of, patent litigation and the timing of biosimilar product market launch,” Schubert adds.
“More choices are now available to a biosimilar applicant regarding the launch of a biosimilar product,” Kilyk says. “I don’t know of a biosimilar applicant who is complaining about the Supreme Court’s decision.”