Although there have only been a handful of disputes involving the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), Amgen and Sandoz have been the protagonists in four of them.  In the first two cases, one involving the autoimmune-disease drug Enbrel and the other involving the cancer drug Neupogen, Sandoz tried to bypass the patent litigation provisions of the BPCIA entirely.  In the case of Enbrel, Sandoz brought an (unsuccessful) declaratory judgment action before filing its regulatory application, and in the case of Neupogen, it argued (successfully) that initiating the BPCIA’s pre-suit information exchanges (also known as the “patent dance”) was optional.  Other biosimilar makers, such as Apotex, have taken a different course.  Apotex participated in and completed the patent dance for its proposed biosimilar of Amgen’s Neupogen as well as its proposed biosimilar of Amgen’s Neulasta, a long-lasting version of Neupogen.  Apotex also proceeded to negotiate with Amgen and determine which of the patents identified during the patent dance should be the subject of the first phase of BPCIA litigation (the so-called “immediate litigation phase’).

In its latest skirmish with Amgen, involving its own proposed Neulasta biosimilar, Sandoz has again allegedly attempted to avoid the BPCIA’s patent dance, but this time only partially.  (Sandoz apparently has taken the same approach in a recent case involving Enbrel).  As described in Amgen’s March 4 complaint, after Sandoz’s application for its proposed Neulasta biosimilar was accepted for review, Sandoz initiated the patent dance, but then cut it short and demanded that Amgen file an immediate patent infringement suit.  Sandoz contended that Amgen would otherwise lose its rights to lost profits and injunctive relief.  Amgen responded with a suit for a declaration that it had no obligation to go forward with the immediate litigation phase after Sandoz cut off the pre-suit procedures.

Amgen filed its latest suit against Sandoz in the District of New Jersey and the case has been assigned to Judge Chesler.  In its complaint, Amgen explains that Sandoz provided Amgen with its abbreviated Biologics License Application (aBLA) for its proposed biosimilar on November 2015, 20 days after FDA accepted the application for review.  42 U.S.C. § 262 (l)(2)(A).  Sandoz also provided information relating to the manufacturing information for its proposed biosimilar product.  42 U.S.C. § 262 (l)(2)(A).  In January 2016, Amgen then responded with its list of patents that could be asserted against Sandoz.  42 U.S.C. § 262 (l)(3)(A).  On February 2, 2016, Sandoz provided Amgen with its noninfringement or invalidity contentions as set forth in the BPCIA.  42 U.S.C. § 262 (l)(3)(B).  According to the complaint, on the same date Sandoz also stated that it no longer wished to follow the procedures of the BPCIA and that it was “waiving” its right to receive Amgen’s infringement contentions and responsive validity arguments under 42 U.S.C. § 262 (l)(3)(C).  Sandoz also cut off the BPCIA procedures for selecting the patents to be litigated in the immediate litigation phase, i.e., 42 U.S.C. § 262 (l)(4) and (5), and “insisted” that Amgen file an immediate litigation suit within 30 days of its February 2 letter, by March 4, 2016, or be limited to a reasonable royalty as its damages for any infringement by Sandoz.

The BPCIA requires the innovator company, here Amgen, to sue the biosimilar maker for patent infringement within 30 days of the completion of 42 U.S.C. § 262 (l)(4) or (5), the selection of the patents to be litigated immediately, in order to be able to recover lost profits or obtain an injunction.  42 U.S.C. § 262 (l)(6).  In its lawsuit against Apotex involving Apotex’s proposed biosimilar of Neulasta, Amgen did just that.  It sued Apotex for patent infringement within 30 days of the selection of patents to be litigated immediately in accordance with the procedures in 42 U.S.C. § 262 (l)(4).  But here, according to the complaint, Sandoz refused to participate in the selection procedures, on the ground that it consented to being sued on any patent identified by Amgen.  Sandoz nevertheless contended that the 30-day deadline for filing suit applied and that Amgen would still lose its rights to lost profits or injunctive relief if it did not file suit within that time period.

In response, Amgen filed suit on March 4, but it did not bring a claim for patent infringement.  Instead, it sued for a declaration that Sandoz did not comply with the provisions of the BPCIA that are a prerequisite to a patent lawsuit in the immediate litigation phase.  Amgen’s complaint contends that Amgen is therefore under no obligation to file an immediate patent infringement suit and that it may still seek lost profits or an injunction whenever it ultimately chooses to sue.  Amgen also alleges that by failing to comply with the provisions of the BPCIA, including 42 U.S.C. § 262 (l)(4) or (5), Sandoz lost the ability to bring a declaratory judgment action involving any of the patents included by Amgen in its list of patents that can be asserted against Sandoz.  42 U.S.C. § 262 (l)(9)(B).

Neulasta is an extremely successful product and the stakes are undoubtedly high for both parties.  FDA’s target date for action on Sandoz’s biosimilar application is 10 months from the filing of the application, i.e., the second half of this year.  Sandoz’s apparent decision to cut off the BPCIA procedures will likely prolong its legal wrangling with Amgen and delay resolution of patent disputes.