In addition to creating a regulatory pathway for biosimilar approvals, the BPCIA also established procedures for resolving patent disputes between a biosimilar applicant (“Applicant”) and a reference product sponsor (“Sponsor”). 42 U.S.C. § 262(l). Under the patent dispute resolution scheme, an Applicant provides the Sponsor with confidential access to its abbreviated biologics license application (aBLA) and manufacturing information no later than 20 days after the FDA accepts the aBLA for review. Id. at § 262(1)(2). This information assists the Sponsor in evaluating potential claims for infringement. After the initial disclosure, the statute then establishes the parameters for a series of exchanges between the parties to identify and narrow the relevant patents and the parties’ respective positions, after which the Sponsor has 30 days to sue the Applicant. Id. at § 262 (l)(3)-(6). The statute also provides that an Applicant “shall” provide notice to the Sponsor of its intent to market the biosimilar 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k). Id. at § 262(l)(8)(A).
In this case, Sandoz sought FDA approval of a biosimilar for Amgen’s biological product Neupogen. On July 7, 2014, the FDA informed Sandoz that it accepted Sandoz’s aBLA for review. The next day, Sandoz notified Amgen that it had filed an aBLA referencing Neupogen, that it believed it would be approved in early to mid-2015 and that it intended to launch its biosimilar product immediately after receiving FDA approval. However, Sandoz refused to provide Amgen with a copy of its aBLA or manufacturing information consistent with the provisions of Section 262(l)(2). On March 6, 2015, the FDA approved Sandoz’s aBLA for all previously approved uses of Amgen’s Neupogen, at which time, Sandoz again provided Amgen with notice of an intent to market its biosimilar.
In October 2014, Amgen sued Sandoz for patent infringement and accused Sandoz of violating the BPCIA for failing to provide the information required under Section 262(l)(2) and for providing a premature, ineffective notice of commercial marketing. Sandoz then filed a counterclaim seeking a declaratory judgment that it correctly interpreted the BPCIA as permitting its preapproval notice of commercial marketing and refusal to provide information to Amgen. Amgen later sought a preliminary injunction.
Following cross-motions for judgment on the pleadings, the district court granted partial judgment in favor of Sandoz. In particular, the district court held that (1) the BPCIA allowed an Applicant to withhold its aBLA and manufacturing information; (2) an Applicant’s decision to withhold that information triggered the relief provided in Section 262(l)(9)(C) (i.e., the right of the Sponsor to file a declaratory suit for infringement); (3) no injunctive relief was available; and (4) an Applicant may give notice of commercial marketing under Section 262 (l)(8)(A) prior to obtaining FDA approval.
On appeal, a divided panel of the Federal Circuit held that Sandoz did not violate the BPCIA when it refused to provide Amgen with its aBLA and manufacturing information, and that the statutory consequence for such failure was Amgen’s right to bring an infringement action under Section 262(l)(9)(C). Regarding the requirement for notice of commercial marketing, the Federal Circuit held that an Applicant may give notice of commercial marketing only after the FDA licenses its product. In other words, Sandoz’s preapproval notice of commercial marketing was ineffective. The ultimate effect of this aspect of the Federal Circuit’s decision is that an Applicant must wait at least 180 days from the date it receives approval for its biosimilar product before it can commercially market that product.
Both Amgen and Sandoz filed petitions seeking Supreme Court review of different aspects of the Federal Circuit’s decision. Sandoz challenged the Federal Circuit’s interpretation of the notice of commercial marketing requirement, while Amgen filed a conditional cross-petition seeking review of the Federal Circuit’s interpretation of the disclosure requirements.
In agreeing to hear the case, the Supreme Court certified questions presented by both parties and allotted the case a full hour of argument time.
The question presented by Sandoz’s Petition is:
Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.
The question presented by Amgen’s Conditional Cross-Petition is:
Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant “shall provide,” and, where an Applicant fails to provide that required information, is the Sponsor’s sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271 (e)(2)(C)(ii)?
Sandoz Inc. v. Amgen Inc., C.A. No. 15-1039, Amgen Inc. v. Sandoz Inc., C.A. No. 15-1195