On June 3rd, 2015, the Federal Circuit heard oral arguments in Amgen Inc. v. Sandoz Inc. case, 2015-1499 involving the BPCIA provisions related to the “patent dance.” The case arises from Amgen’s appeal of the Northern District Court of California’s determination that the “patent dance” provision of the BPCIA are optional, and that biosimilar applicants, such as Sandoz, are justified in providing notice of their intent to market a biosimilar at the time of filing their application with the FDA.
In general, the Federal Circuit panel seemed concerned that Sandoz was gaming the system, too easily avoiding the BPCIA litigation provisions through their reading of the statute. Sandoz did not provide Amgen access to its Biologics License Application (BLA) (completely voiding the first wave of patent litigation) and gave 180 day notice of commercial marketing as soon as their 351(k) application was accepted by FDA for review (thereby short-circuiting the second wave of litigation). The panel had problems with both acts.
For example, the panel asked Sandoz how a referenced product sponsor (RPS) could bring suit under §271(e)(3)(C)(i) (artificial act of infringement by the filing of a 351(k) BLA) if the 351(k) applicant is not required to give notice of its BLA filing like Sandoz did here. All Sandoz could say was that they gave notice of their intent to commercially market. But the Court said that does not answer the question because a suit brought on that notice would be filed under §271(e)(3)(C)(ii), not (C)(i). The Court also questioned whether it made sense to give 180 day notice of commercial marketing at a time when Sandoz had no idea whether or not its BLA would even be approved by the FDA.
Based on the questions and commentary from the panel during the oral arguments, here is an educated guess on how the panel may rule:
Where the statute says the 351(k) applicant “shall” give the RPS access to its application, it means that the applicant must provide the RPS with the terms and conditions under which access to the BLA will be provided, which is similar to the ANDA offer under § 505(j)(4)(C)(i)(III) in the Hatch-Waxman provisions. But, the 351(k) applicant cannot be forced to provide access to its BLA (just like the ANDA applicant can’t be forced under the Hatch Waxman provisions), which the BPCIA statute clearly recognizes. Thus, if the RPS refuses the offered terms and conditions it will still have notice and an opportunity to sue under §271(e)(3)(C)(i);
Where the statute says the 351(k) applicant shall give 180 days prior notice prior to commercial marketing, it must wait until the FDA has indicated that its application is, in fact, ready for approval (similar to when the FDA determines that a notice of a Paragraph IV certification is provided to the Reference Listed Drug holder under Hatch-Waxman and issues a Tentative Approval).
In addition, we could see the Federal Circuit remanding the case with instructions to enjoin commercial marketing by Sandoz until it complies with the foregoing BPCIA notice requirements. Sandoz can easily comply with the first notice requirement by offering access to its BLA under terms and conditions that Amgen will likely refuse; and Sandoz should be able to easily obtain evidence from the FDA as to when its 351(k) application was tentatively approved – and the 180 days-notice for commercial marketing would be calculated from that date.
The Federal Circuit’s decision is expected later this summer.
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Terry G. Mahn is a senior principal in the Washington, D.C., office of Fish & Richardson P.C., and the leader of the firm’s regulatory and government affairs practice group. He joined the firm in 1991 and his practice is primarily before the U.S. Federal Communications Commission (FCC) and Food and Drug Administration (FDA) with...