Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

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As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that the FDA mandate compliance with the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) information exchange provisions, often referred to as the “Patent Dance.” In particular, Amgen requested that the FDA require a biosimilar applicant to certify that it will timely comply with Section 351(l)(2)(A) of the BPCIA by providing the brand holder with a copy of the biosimilar application and information describing the process(es) used to manufacture the biosimilar product covered by the application.

On March 25, 2015, the FDA denied Amgen’s Citizen Petition. In doing so, the FDA noted that “[n]either section 351(k) nor section 351(l) requires FDA to impose a certification requirement as part of the biosimilar review process.” March 25, 2015 FDA Letter re: Docket No. 2014-P-1771 (“FDA Letter”) at p. 3. The FDA interpreted the BPCIA procedures as being separate from the FDA’s review of the biosimilar application, and noted that the BPCIA “generally does not describe any FDA involvement in monitoring or enforcing the information exchange by creating a certification process or otherwise.” Id. Further, the FDA compared the BPCIA’s lack of an express certification requirement with the Federal Food, Drug, and Cosmetic Act, which explicitly requires certification of each patent submitted by 505(b)(2) and ANDA sponsors for the listed drug referenced in the Orange Book. Id. at p. 4. Based on this comparison, the FDA concluded that the imposition of a certification requirement for biosimilar applications is not compelled under the BPCIA and, instead, is simply a matter of regulatory discretion. Id. The FDA also observed that there is litigation over whether the Patent Dance provisions are mandatory, the conclusion of which could clarify the interpretation of section 351(l). Id. In view of the ongoing litigation and the discretionary nature of Amgen’s requested action, the FDA declined to exercise its discretion to require that biosimilar applicants certify compliance with section 351(l). Id.

The FDA’s denial comes on the heels of the District Court of the Northern District of California’s denial of Amgen’s bid for a preliminary injunction to prevent market entry of Sandoz Inc.’s FDA approved biosimilar, Zarxio®. See Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional. The District Court also interpreted section 351(l) as being optional, which supports the FDA’s decision not to require certification. Id. However, the FDA correctly noted that the litigation is ongoing. Amgen filed its Notice of Appeal the same day the FDA denied its Citizen Petition, appealing all of the District Court’s rulings to the Federal Circuit. Amgen Inc. et al. v. Sandoz Inc. et al., Case No. 3:14-cv-04741-RS, Doc. No. 112.

K&L Gates will continue to monitor any developments that arise relating to the interpretation of the BPCIA.

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