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Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch
What You Need To Know

Case Background

In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who participate in the Biologics Price Competition and Innovation Act’s (“BPCIA”) exchange provisions (known as the “patent dance”) are required to provide a notice of commercial marketing 180 days before launch of their product.  Apotex, which has an application pending with the FDA seeking permission to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim), argued that 180 days’ notice before its commercial launch was not required because it participated in the patent dance.  Although the Federal Circuit previously held in Amgen v. Sandoz that 180 days’ notice of launch was required when the applicant failed to participate in the patent dance, the Court did not address what occurs when the applicant does participate in the patent dance.  Amgen v. Sandoz, 794 F.3d 1347, 1357-58 (Fed. Cir. 2015).  In Apotex, the Federal Circuit rejected Apotex’s arguments and determined that the notice provision is mandatory even when an applicant participates in the patent dance and enforceable by injunction if an applicant refuses to provide such notice.

Decision

A key aspect of the Federal Circuit’s decision concerned when such notice may occur.  Under the BPCIA, the applicant must provide notice of commercial marketing “not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”  42 U.S.C. § 262(l)(8)(A).  In Amgen, the Federal Circuit held that an applicant may only provide notice after the FDA has licensed the product.  The BPCIA states that such license “may not be made effective” by the FDA until the Reference Product Sponsor’s 12-year data exclusivity term has ended.  42 U.S.C. § 262(k)(7)(A).  Many believed that the effect of the Sandoz decision was that biosimilar applicants could not receive a license for 12 years, could not provide notice of commercial marketing until the 12-year term ended, and accordingly would be kept off the market for an extra 180 days after the expiration of the 12-year data exclusivity period.  Although recognizing an extension of data exclusivity would occur for products that have already been on the market for 12 years, in Apotex, the Federal Circuit clarified that the FDA may provide the license before the end of the 12-year data exclusivity term, but may only make it “effective” after 12 years runs:

Moreover, it is implicit in the Biologics Act that any such delay beyond 12 years should occur less and less as time goes by. Doubtless, there will be some exclusivity periods beyond 12 years in the early years of the Biologics Act, as biosimilars are introduced for reference products licensed well before the Act was adopted in 2010. But as time passes, more and more of the reference products will be newer, and a biosimilar-product applicant, entitled to file an application a mere four years after licensure of the reference product, § 262(k)(7)(B), can seek approval long before the 12-year exclusivity period is up. See Amgen v. Sandoz, 794 F.3d at 1358 (the “extra 180 days will not likely be the usual case, as [biosimilar-product applications] will often be filed during the 12-year exclusivity period”). In such circumstances, we have been pointed to no reason that the FDA may not issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date—a possibility suggested by § 262(k)(7)(A)’s language about when the FDA approval may “be made effective.” And we read (8)(A) as allowing the 180-day notice of commercial marketing to be sent as soon as the license issues, even if it is not yet effective, because it is at the time of the license that “the product, its therapeutic uses, and its manufacturing processes are fixed.” Id. at 1358.

Amgen v. Apotex, Slip Op. at 17.  Accordingly, a biosimilar applicant may provide a notice of commercial marketing whenever the FDA determines the product is approvable.

Observations

Currently, there is no indication that the FDA will provide “tentative licensing” similar to how it provides “tentative approval” for generic applicants under the Hatch-Waxman Act.  The Federal Circuit’s decision, however, implicitly recognizes the problems associated with requiring the 180 days’ notice of commercial marketing to occur only after the 12-year data exclusivity period has expired.  Indeed, Sandoz focused on this problem in its pending petition for certiorari to the Supreme Court in Amgen v. Sandoz.  The Federal Circuit’s clarification of the timing of notice may prevent the need for the Supreme Court to review the Federal Circuit’s prior holding in Sandoz

The Federal Circuit’s decision in Apotex is a victory for Reference Product Sponsors who have already enjoyed over 12 years of data exclusivity, as it will allow them to enjoy the additional exclusivity provided during the 180-day window between licensing of the biosimilar product and commercial launch.  Future biosimilar applicants, however, will greatly benefit if they are provided licenses by the FDA before the 11.5 year mark, which would allow them to launch upon the completion of the 12-year data exclusivity window.

For more information on patent strategies under the Biosimilars Act, please contact our biosimilars team.

Access the full opinion on the CAFC website >>