Under 42 U.S.C. §262 (l)(2)(A) of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), an Applicant seeking FDA approval of a biosimilar must provide its application and manufacturing information to the reference product sponsor within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The BPCIA then channels the parties into two phases of patent litigation. In the first, within 60 days after a copy of the application and manufacturing information is provided, the sponsor provides a list of patents that can reasonably be asserted. The parties collaborate to identify patent(s) on the list for immediate litigation. §262 (l)(4) (if parties agree on patents to be litigated); §262(l)(5)(B) (if parties disagree). The second phase -- triggered when the Applicant, pursuant to §262(l)(8)(A), gives the sponsor notice at least 180 days before commercially marketing the biosimilar -- involves any listed patents not litigated in the first phase. Failure to comply with the procedural requirements in the first phase may lead to the sponsor immediately bringing a declaratory judgment action for infringement of “any patent that claims the biological product or a use of the biological product” pursuant to §262(l)(9)(B) or (C).
In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that an Applicant’s biosimilar must already be “licensed” or approved by the FDA at the time Applicant gives its 180-day notice of intent to begin commercial marketing. Under this interpretation of the statute, the Federal Circuit noted that notice is not provided until “the marketing of the proposed biosimilar product is imminent.” Id. at 1358. If such holding was left intact, 180-day notice of commercial launch would have triggered ITC jurisdiction based on the theory of imminent infringement. The Federal Circuit previously approved ITC jurisdiction based on likely future infringement, but withdrew its opinion on that issue because it was unnecessary to resolve the case at hand. Amgen Inc. v. Int’l Trade Comm’n, 519 F.3d 1343, 1351-52 (Fed. Cir. 2008) (withdrawn and replaced by revised opinion reported at 565 F.3d 846 (Fed. Cir. 2009)).
However, in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 1195 (June 12, 2017) , the Supreme Court reversed the Federal Circuit and held that the Applicant “may provide notice either before or after receiving FDA approval” without any further guidance as to when such notice shall occur. In view of the Supreme Court’s decision, an Applicant likely will not give notice after receiving FDA approval because that will prolong the sponsor’s exclusivity by another 180 days. To the extent an Applicant provides notice before receiving FDA approval, it may be difficult for a patent holder to argue that infringement is imminent, since it is unknown when, if ever, the biosimilar product will be approved. For example, in the instant case, only a day after the FDA informed Sandoz that its application had been accepted for review, Sandoz notified Amgen that it had submitted an application and that it intended to market its biosimilar Zarxio immediately upon receiving FDA approval. Thus, in the absence of other evidence of actual or imminent infringement, a pre-approval notice of intent to begin commercial marketing may be insufficient to confer jurisdiction over the biosimilar product in the ITC.