Download Denied Again: FDA Denies Amgen’s Citizen Petition Patent Dance

March 2015
Practice Groups:
Biosimilars/Follow-on
Biologics
Food, Drugs, Medical
Devices and
Cosmetics (FDA)
Denied Again: FDA Denies Amgen’s Citizen Petition
Requesting Certification of Compliance with BPCIA
Patent Dance
By Jennifer M. Dienes, Margaux L. Nair, Maria E. Doukas, and Christopher J. Betti, Ph.D.
IP Litigation
IP Procurement and
Portfolio
Management
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
Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification
of Compliance with BPCIA Patent Dance
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.
Authors:
Jennifer M. Dienes
[email protected]
+1.312.807.4219
Margaux L. Nair
[email protected]
+1.312.807.4280
Maria E. Doukas
[email protected]
+1.312.807.4223
Christopher J. Betti, Ph.D.
[email protected]
+1.312.807.4313
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