Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions and legal position both provide the District Court with another opportunity to parse Congressional intent and the practical implications of the Biologic Price Competition and Innovation Act (BPCIA).
The biosimilar at issue is NEULASTA®, generically pegfilgrastim, "a recombinantly expressed, 175-amino acid form of a protein known as human granulocyte-colony stimulating factor ("G-CSF") conjugated to a 20 kD monomethoxypolyethylene glycol (m-PEG) at the N-terminus of the G-CSF," as set forth in Paragraph 54 of the complaint. The basis for Amgen's cause of action is Sandoz's refusal to comply with certain of the "patent dispute resolution" provisions of the BPCIA, specifically 42 U.S.C. § 262(l)(4) and § 262(l)(5). In addition, Sandoz coupled its refusal with a demand that Amgen file suit under 42 U.S.C. § 262(l)(6) before those provisions were completed, and threated to seek penalties under the statute. These penalties would leave Amgen with recourse only to a reasonable royalty unless Amgen filed suit within 30 days of Sandoz's notice of non-compliance. That date was March 4, 2016 (the date of the filing of this complaint) (¶8). These actions constitute disruption of "an intricate and carefully orchestrated set of procedures" that comprise the "patent dispute resolution" provisions provided under the statute (¶11).
The complaint sets forth the procedures and advantage of using the abbreviated biosimilar pathway under 42 U.S.C. § 262(k) (¶¶41-49), and asserts that Congress intended there to be a "balance" between these advantageous provisions and the patent litigation provisions of 42 U.S.C. § 262(l) (¶¶50-53). The complaint then sets out the activities and behaviors between the parties that raised Amgen's basis for filing suit for declaratory judgment. As set forth in the complaint, Sandoz received notice that FDA accepted its aBLA on October 26, 2015 (¶63). Unlike in litigation involving Amgen's NEUPOGEN® (see "Sandoz' NEUPOGEN® Biosimilar Now on the Market"), in this case Sandoz timely complied with the provisions of § 262(l)(2) (¶64) and disclosed its biosimilar application (or "aBLA") and relevant manufacturing methods. Sandoz also complied with § 262(l)(3)(B) reciting its basis for alleging Amgen's patents would not be infringed, or were invalid or unenforceable (¶66) in response to Amgen providing Sandoz with its patent list, consisting of U.S. Patent Nos. 8,940,878 ("the '878 patent") and 5,824,784 ("the '784 patent") as required under § 262(l)(3)(A) (¶65). However, before Amgen could respond to Sandoz's non-infringement, invalidity, and unenforceability contentions pursuant to § 262(l)(3)(C), Sandoz gave Amgen notice that it would not comply with the provisions of 42 U.S.C. § 262(l)(4) and § 262(l)(5) and "waived" its right to Amgen's statement under § 262(l)(3)(C). Sandoz then invoked the provisions of 42 U.S.C. § 262(l)(6), demanding Amgen sue within the statutorily required 30 days or suffer the consequences of forfeiture of the right to seek an injunction and/or lost profits damages (¶67).
Amgen asserts one count, for a declaratory judgment with regard to whether Sandoz can "unilaterally compel" Amgen to file suit within 30 days of its "repudiation" of the "patent dispute resolution" provisions of the BPCIA (¶¶71-75). Amgen's Prayer for Relief seeks the following:
"A. a declaration that Defendants have failed to comply with the requirements of the BPCIA mandatory information-exchange provisions, including 42 U.S.C. § 262(l)(4) and § 262(l)(5) if necessary;
B. a declaration that Defendants' failure to comply with the requirements of the BPCIA mandatory information-exchange provisions, including 42 U.S.C. § 262(l)(4) and § 262(l)(5) if necessary, means that there can be no "immediate patent infringement action" under 42 U.S.C. § 262(l)(6);
C. a declaration that Plaintiffs' not filing a patent infringement action by March 4, 2016 -- before the parties have complied with 42 U.S.C. § 262(l)(4), and § 262(l)(5) if necessary -- does not deprive Plaintiffs of the remedies for infringement available under 35 U.S.C. § 271(e)(4), including lost profits damages and injunctive relief;
D. an order compelling Defendants to comply with the BPCIA mandatory information-exchange provisions set forth in 42 U.S.C. § 262(l)(4) and § 262(l)(5) if necessary;
E. an order compelling Defendants to compensate Plaintiffs for and awarding damages incurred as a result of Defendants' actions or inactions; as well as attorneys' fees, costs and expenses and "such other relief as [the] Court may deem just and proper."
So far, Sandoz has read the judicial tea leaves accurately and prevailed in convincing both the district court and Federal Circuit that its interpretation of the litigation provisions of the BPCIA has been correct. As in earlier litigation, Sandoz has used the apparent complexity of these provisions to its tactical advantage, here requiring Amgen to initiate litigation or risk having its remedies greatly restricted. It remains to be see whether Sandoz's current interpretation will once again have sufficient traction to be accepted by the courts, or whether the "stop-start" nature of its actions will provoke a less approving response as this case progresses.
