and Carolina M. Wirth
Following the Federal Circuit’s denial to rehear the Amgen Inc. v. Sandoz case en banc
Amgen and Sandoz had until January 14, 2016 to file petitions for certiorari with the Supreme Court. At the Federal Circuit level, each party won one of the issues in dispute relating to interpretation of the Biologics Price Competition and Innovation Act (BPCIA). Thus, each party had an opportunity to request Supreme Court review of the issue decided adverse to their position. On December 23, 2015, Sandoz submitted a request for an extension of time until February 16, 2016 to submit its petition. The Chief Justice granted Sandoz’s request on December 29, 2015.2
Amgen, on the other hand, did not file for an extension and did not submit a petition by the January 14th deadline.
Amgen’s decision not to seek Supreme Court review is surprising following the company’s petition for rehearing at the Federal Circuit. With Amgen not filing a petition for cert
, it is unlikely that the issue of whether the patent dance provisions of the BPCIA are mandatory will be reviewed.3
Thus, under the Federal Circuit panel decision, the patent information exchange (“patent dance”) provisions are in fact optional. If biosimilar applicants can gain the benefit of expedited licensure under the BPCIA without having to disclose potential trade secret information under 42 U.S.C. § 262(l
)(2), it is generally thought that few applicants will choose to engage in the patent dance. With biosimilar applicants opting out of the patent dance, reference product sponsors will be free to bring a declaratory judgement suit under 42 U.S.C. § 262(l
)(9) for any patent that claims the biologic product or use thereof. However, having little to no information about the biosimilar product or its method of manufacture will make it difficult for the reference product sponsor to meet the pleading requirements to file an infringement suit. Summary of key issues litigated to date:
1. Are the patent information exchange (“patent dance”) provisions of the BPCIA mandatory? No. The Federal Circuit decided this issue in favor of Sandoz. The patent dance provisions are set forth in section 351(l
) of the Public Health Service Act (42 U.S.C. § 262(l
)). Under section (l
)(2), a biosimilar applicant is to notify the reference product sponsor within 20 days of receiving notice from the Federal Drug Administration (FDA) that its biosimilar application has been accepted. The biosimilar applicant is also to provide a copy of its biosimilar application and manufacturing information to the reference product sponsor. In this case, Sandoz (the biosimilar applicant) provided notice of its application acceptance to Amgen (the reference product sponsor) but did not provide the application or manufacturing information. 2. When can the 180 day pre-commercialization notice period be given by the biosimilar applicant to the reference product sponsor? Notice can be given once a biosimilar application is approved. The Federal Circuit decided this issue in favor of Amgen. Under section (l
)(8)(A), a biosimilar applicant is to provide 180 days’ notice to the reference product sponsor prior to commercialization of the biosimilar product. Sandoz argued that notice could be provided once the biosimilar application was accepted, while Amgen argued that notice could only be given once the application was approved. The denial by the Federal Circuit to rehear the case en banc
was somewhat surprising given that the issues were of first impression for interpretation of the BPCIA. The panel was also split, with three very different opinions on how the BPCIA provisions should be interpreted presented by Judges Lourie, Chen, and Newman. If Sandoz files a petition for cert
, Supreme Court review could be granted on the pre-commercialization notice issue. However, it is questionable whether either proposed interpretation of section (l
)(8)(A) will have substantial effect in the future when it is more likely that biosimilar applications will be primarily filed during the exclusivity period of the reference product. It would be best to resolve the issue, however, as the courts are continuing to interpret the commercial marketing notice provisions.4 Download PDF 1 Amgen Inc. v. Sandoz Inc.
, 794 F.3d 1347, 1351 (Fed. Cir. 2015) (reh’g denied Oct. 16, 2015). 2 See
It is possible
that, if Sandoz files a petition for cert, the issue could be raised by Amgen in a conditional cross-petition asking the Supreme Court to review both parties’ issues if review is granted. See
Supreme Court Rule 12.5. 4
See Amgen Inc. v. Apotex Inc.
, Case No. 15-61631, Order (S.D. Fla. Dec. 9, 2015) (finding 180 day pre-commercialization notice under 42 U.S.C. §262(l)(8)(A) is mandatory regardless of whether biosimilar applicant complies with 42 U.S.C. §262(l
)(2)). See blog post about decision here