As we reported in earlier posts (link, link), the 180-day commercial notice provisions of the BPCIA at issue in Amgen v. Sandoz are being litigated in Janssen v. Celltrion, an action pending in the District of Massachusetts. Earlier today, Celltrion filed a Supplemental Brief in Support of its Partial Summary Judgment in light of the Federal Circuit’s decision in Amgen v. Sandoz, available here.
Celltrion takes the position that it should not be enjoined from launching its biosimilar product for 180 days because it timely provided its aBLA to Janssen. In its supplemental brief, Celltrion distinguishes its factual situation from Amgen v. Sandoz.
By way of background, Celltrion provided its aBLA, detailing the process used to manufacture its proposed biosimilar product, to Janssen within the 20-day statutory deadline set out in the Biologics Price Competition and Innovation Act (“BPCIA”). See 42 U.S.C. § 262(l)(2)(A) (the “applicant” “shall provide” the aBLA and other information “[n]ot later than 20 days after” FDA accepts the application). In response, Janssen served its patent list pursuant to the process set out in BPCIA, identifying six patents. Celltrion and Hospira agreed that each of the patents identified by Janssen would be the subject of a patent infringement suit, and also served their notice of commercial marketing.
Janssen then sued Celltrion and Hospira, asserting infringement of all six patents, and alleged that Celltrion and Hospira violated paragraph (l)(8)(A) by serving an ineffective notice of commercial marketing, seeking to enjoin their biosimilar launch “until at least 180 days after Defendants provide Janssen with proper notice.” See 42 U.S.C. § 262 (l)(8)(A) (providing that an “applicant” shall provide notice of commercial marketing to the reference product sponsor “not later than 180 days before the date of the first commercial marketing” of the biosimilar product).
Celltrion advances that:
Under a straightforward reading of Amgen, the BPCIA’s notice of commercial marketing provision “is mandatory” only if a biosimilar applicant “completely fails to provide its aBLA and the required manufacturing information to the RPS” within 20 days of FDA accepting the aBLA. 794 F.3d at 1360 (emphasis added). Because Sandoz failed to provide its aBLA to Amgen, the court there was not called upon to address the precise factual situation before the Court here – where Celltrion did provide such information. As shown below, however, the court’s analysis as a whole permits only one conclusion: the BPCIA does not require Celltrion, which did timely produce its aBLA, to provide any notice of commercial marketing. Amgen thus forecloses Janssen’s claim … that Defendants violated the notice provision and Janssen’s related request for an automatic, bondless injunction divorced from patent rights.
We will be sure to post any updates as soon as its public. Stay tuned…