Prominent among the first generation of U.S. biosimilar litigations under the Biologics Price Competition and Innovation Act (“BPCIA”) are the disputes between Amgen and Sandoz concerning Amgen’s related cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim). Sandoz’s Neupogen biosimilar application led to the Federal Circuit’s only BPCIA decision to date, Amgen v. Sandoz, 794 F. 3d 1347 (Fed. Cir. 2015), which addressed basic disputes about the BPCIA’s procedural requirements. Since the Amgen v. Sandoz decision, Amgen and Sandoz have continued to litigate at the trial court level over Sandoz’s biosimilar versions of Neupogen and Neulasta. Based on recent court filings, Sandoz has used a different litigation strategy with its proposed Neulasta biosimilar than it did with Neupogen.
The BPCIA calls for elaborate pre-suit information exchanges between the biosimilar applicant and the maker of the original biologic, commonly referred to as the “patent dance.” The patent dance begins when the biosimilar applicant provides a copy of its application and other manufacturing information to the innovator, and ends with the reference product sponsor providing its infringement and validity contentions. The parties then engage in a statutory process to determine which patents will be litigated immediately in the so-called “immediate litigation phase” of the BPCIA. For its first biosimilar product, Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen, Sandoz chose not to initiate the patent dance, declining to provide its regulatory application or manufacturing information to Amgen. Amgen sued, and, in Amgen v. Sandoz, the Federal Circuit agreed with Sandoz that it could opt out of the patent dance. The Federal Circuit also held, however, that Sandoz was required to observe a statutory 180-day notice period after approval so that Amgen would have the opportunity to assess and potentially bring a preliminary injunction motion on its patents before launch. After the 180-day period passed, Sandoz launched Zarxio last September. Zarxio was the first biosimilar approved in the United States. On remand from the Federal Circuit, Amgen continues to pursue its patent infringement claims related to Zarxio.
Since Amgen v. Sandoz, Sandoz has elected to provide its application and manufacturing information in subsequent biosimilar applications: proposed versions of the auto-immune drug Enbrel and of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Neupogen. With respect to Neulasta, Sandoz initiated the patent dance by providing information, but it initially did not follow the process to its statutory conclusion. Rather, it cut the BPCIA procedures short before Amgen provided its infringement and validity contentions and before negotiations as to what patents would be litigated immediately had taken place. It demanded that Amgen file an immediate patent infringement suit within thirty days of Sandoz having served its contentions or lose its rights to lost profits and injunctive relief.
In March, Amgen filed a lawsuit against Sandoz for taking this approach, arguing that refusing to complete the patent dance violated the BPCIA. Amgen sued in the District of New Jersey, but did not bring any patent infringement claims. Rather, it sought a declaratory judgment that Sandoz failed to comply with the BPCIA’s statutory process, and therefore, that Amgen is not obliged to assert an immediate infringement action, and may seek lost profits or injunctive relief whenever it decides to sue on those patents. Amgen also argued that, by abandoning the BPCIA’s statutory procedures, Sandoz lost the ability to bring a declaratory judgment action involving the ’878 and ’784 patents. See 42 U.S.C. § 262(l)(9(B).
On May 12, 2016, however, Amgen filed a new complaint indicating that Sandoz ended up completing the patent dance for Neulasta after all. Amgen’s new action, filed in the Northern District of California, asserts U.S. Patent Nos. 8,940,878 (“the ‘878 patent”) and 5,824,784 (“the ‘784 patent”) against Sandoz’s proposed biosimilar version of Neulasta. The complaint alleges that the parties’ exchange of information began in November 2015 and culminated in an April 12, 2016 agreement that the ‘878 patent, which covers a method of purifying proteins and expires in 2031, and the ‘784 patent, which covers a biological product and expired in October 2015, should be the subject of immediate litigation. Amgen sued on the agreed upon patents, seeking damages and an injunction against further infringement of the ‘878 patent.
After agreeing to complete the patent dance and agreeing with Amgen as to which patents should be litigated immediately, Sandoz filed a motion to dismiss Amgen’s March New Jersey BPCIA action for lack of subject matter under Fed. R. Civ. P. 12(b)(1), contending that Amgen’s claims were moot now that Sandoz had completed the statutory process. Amgen filed an opposition on June 13, 2016, arguing that Sandoz did not render the dispute moot when it “capitulated” to Amgen’s demand to resume the patent dance because the issue was likely to recur, and indeed was actively being raised in a number of additional disputes. In a June 20 reply, Sandoz contended again that there was no live controversy and that Amgen was simply asking for an advisory opinion. The court has not yet ruled on Sandoz’s motion.
Meanwhile, on May 27, 2016, the parties stipulated to relate the Neulasta patent infringement action to the ongoing Neupogen patent infringement litigation, which is on remand from the Federal Circuit after the Amgen v. Sandoz decision. Although Sandoz’s Neupogen biosimilar Zarxio is now on the market, its proposed biosimilar of Neulasta is not. FDA’s target date for a decision on Sandoz’s biosimilar application is 10 months from the October 2015 filing of the application, i.e., the second half of this year.