As we reported in an earlier post, the 180-day commercial notice provisions of the BPCIA at issue in Amgen v. Sandoz are also being litigated in Janssen v. Celltrion, an action pending in the District of Massachusetts. The parties’ cross-motions for partial summary judgment [here and here] on whether Celltrion’s pre-FDA-licensure notice of commercial marketing was legally effective under the BPCIA, and the plaintiffs’ motion for a preliminary and permanent injunction, were pending when the Federal Circuit issued its decision in Amgen v. Sandoz.
On August 24, 2015, plaintiffs Janssen Biotech, Inc. and New York University (collectively, “Janssen”) filed a supplemental memorandum of law in support of their pending motion for partial summary judgment and for a preliminary and permanent injunction.
According to Janssen, both it and Celltrion agree, in the wake of Amgen v. Sandoz, that Celltrion’s 180-day notice of commercial launch was “not effective.” Interestingly, however, Celltrion has taken the position that the Federal Circuit’s holding also means that Janssen’s request for a 180-day injunction must be denied. Janssen Br. Ex. A. (pp. 30-31 of Janssen’s brief). In the e-mail exchange attached to Janssen’s brief, Celltrion asserts that the Federal Circuit in Amgen v. Sandoz “held that the BPCIA does not require applicants like Celltrion that have timely produced its aBLA to provide any notice of commercial marketing,” and that “[h]ere, unlike in Amgen, the notice of commercial marketing is not mandatory because the statute expressly provides a remedy when notice is not provided.” Janssen Br. Ex. A at 1. Celltrion highlights Judge Lourie’s language stating that where “a subsection (k) applicant completely fails to provide its aBLA and the required manufacturing information to the RPS by the statutory deadline, the requirement of (l)(8)(A) is mandatory.” Ex. A at 1 (citing Fed. Cir. Op.).
As we’ve noted elsewhere [here and here] and discussed during our August 12th webinar (a link to which can be found here and in the margin to the right), the Federal Circuit opinion left lingering questions about whether the notice of commercial marketing was mandatory upon all biosimilar applicants. Wrestling with the meaning of the word “shall,” the majority held that the BPCIA’s command that a biosimilar applicant “shall” make the disclosures that initiate the “patent dance” did not mean “must,” because elsewhere the BPCIA and 35 U.S.C. § 271(e)(2)(C) contemplated that an applicant might choose to opt out of the dance, and provided specific consequences if that were to happen. In contrast, “shall” in the section (l)(8)(A) notice provision meant “must” if the applicant opts out of the patent dance, because the notice provision does not specify any consequences for failure to provide such notice.
Judge Lourie, writing for the majority, reasoned that although (l)(9)(B) provides that the RPS may bring a declaratory judgment action for failure to comply with certain patent dance steps including the notice provision, that provision applies only after the applicant has already complied with the disclosure provisions of (l)(2)(A). To many observers, this begs the following question: If an applicant has opted out of the patent disclosure provisions, then is the notice of commercial marketing mandatory?
In his dissent, Judge Chen’s view was that the (l)(8) notice provision “does not serve as a standalone provision; it is part and parcel to, and contingent upon, the preceding steps in the (l )(2)- (l )(8) litigation management regime.” Fed. Cir. Op. at 37. Judge Chen notes that “nothing in the majority opinion suggests that this automatic injunction remedy would be available in cases where the applicant complied with (l )(2)(A) by providing its aBLA to the RPS, but later failed to provide notice under (l )(8)(A). In fact, the majority’s opinion creates an uncomfortable result in which the language of (l )(8)(A) is interpreted in two different ways, based on the (k) applicant’s actions.” Fed. Cir. Op. at 45.
It appears that Janssen and Celltrion are now posed to duke this issue out in district court. Janssen argues that there is no room in the Federal Circuit’s split decision to argue that biosimilar applicants do not have to provide notice of commercial marketing if they comply with the disclosure provisions of the patent dance. The Federal Circuit, Janssen asserts, held that the notice requirement is a “standalone notice provision” with a “clear” purpose: “requiring notice of commercial marketing be given to allow the RPS a period of time to assess and act upon its patent rights.” Fed. Cir. Op. at 21 (quoted in Janssen Br. 5). Thus, Janssen argues, “the reasoning of Amgen compels the conclusion that a notice of commercial marketing is mandatory in all circumstances, and certainly here.” Janssen Br. 7. To allow applicants to opt out of the notice provision “would eviscerate the purpose of the [provision] as described in Amgen.” Janssen Br. 10.
In the alternative, Janssen argues that “[e]ven if Amgen could be read to hold that paragraph (l)(8)(A) is mandatory only where the biosimilar applicant, like Sandoz, does not comply with paragraph (l)(2)(A), it would still mean that the notice is mandatory in this case,” because Celltrion did not provide the manufacturing information as required by paragraph (l)(2)(A), and thus is in the same position as Sandoz. Janssen Br. 16.
Janssen concludes that it is entitled to an injunction “enforcing the statutory 180 day notice period” because Amgen found that “procedural injury” to the RPS for violation of the notice provision is “sufficient” and warrants an “automatic statutory injunction.” Janssen Br. 19.
Celltrion’s opposition brief is due September 14, 2015. We will be sure to post Celltrion’s rebuttal when it becomes public. Stay tuned . . .