On July 22, 2016, the Hon. Stanley R. Chesler of the United States District Court for the District of New Jersey dismissed Amgen’s complaint against Sandoz seeking declaratory judgment to enforce the “patent dance” provisions of the BPCIA. The parties had engaged in some of the “patent dance” after Sandoz filed with FDA an aBLA for its biosimilar of Amgen’s Neulasta®, which the FDA accepted on October 26, 2015. In particular, the parties proceeded through the 42 U.S.C. § 262(l)(2) and (3)(A) provisions, whereby Amgen identified two patents it believed could “reasonably be asserted against the Sandoz Pegfilgrastim Product.” (D.I. 52 at 4.) Sandoz then provided its (l)(3)(B) contentions that the asserted patents are invalid, unenforceable, or will not be infringed by Sandoz, and then notified Amgen via letter that it agreed with Amgen’s patent list, thereby waiving the remainder of the dance provisions. Sandoz stated that since once of the two asserted patents was at the time the subject of litigation between the parties in the Northern District of California in a patent infringement suit related to Sandoz’s proposed filgrastim biosimilar product, and since Amgen had already provided Sandoz with its (l)(3)(C) infringement and validity contentions in that litigation, Sandoz unilaterally waived its right to receive Amgen’s (l)(3)(C) contentions in the present action related to pegfilgrastim. Thus, to timely file a patent infringement suit under the provisions of the BPCIA, and therefore preserve all potential remedies, Sandoz contended that Amgen would need to file its suit within thirty days of Sandoz’s letter (by March 4, 2016). If Amgen did not file by March 4, Sandoz contended that Amgen would only be able to seek reasonable royalties.
In response, on March 4, 2016, Amgen filed its complaint alleging that Sandoz sought to “circumvent the BPCIA process by refusing to participate in the required procedures and by threatening to seek penalties that limit Plaintiffs’ [Amgen’s] relief for infringement to a reasonable royalty.” (D.I. 1 at 5.) Amgen alleged that this is the third time district courts have been forced to grapple with biosimilar applicants waiving certain steps of the BPCIA patent dance (specifically 42 U.S.C. § 262(l)(4) and (5)) to accelerate the process and proceed directly to (l)(6) patent infringement actions. (D.I. 1 at 6.) Amgen’s complaint sought a number of “declarations” from the court, including that Sandoz had failed to comply with the BPCIA provisions and that Amgen was not deprived of other remedies for failing to file an infringement action by a certain date. Amgen also requested that Sandoz be compelled to comply with the BPCIA provisions, including the negotiation provisions of § 262(l)(4) and, in the event negotiations are unsuccessful, the requirements under § 262(l)(5) involving the identification of the number of patents to be asserted and the simultaneous exchange of patent lists.
After Amgen filed its complaint, Sandoz sent a letter to Amgen proposing that Amgen provide its (l)(3)(c) statements to Sandoz by April 4, 2016 per Amgen’s interpretation of the BPCIA, and then suggesting the parties complete the remainder of the dance provisions. In this letter, Sandoz agreed not the challenge whether the limiting provisions of 35 U.S.C. § 271(e)(6), related to patent infringement remedies under the BPCIA, apply to this case. (D.I. 52 at 6.) The parties continued negotiating and proceeded through the remaining “patent dance” steps. On May 3, 2016, Sandoz filed a motion to dismiss the complaint because Sandoz had proceeded through the “patent dance” under Amgen’s interpretation of the BPCIA process. On May 12, 2016, Amgen filed suit for patent infringement under § 262(l)(6) in the Northern District of California.
Judge Chesler dismissed the New Jersey suit for lack of “case or controversy.” Amgen had not met its burden to establish jurisdiction for declaratory judgment because the parties had completed or agreed to waive all of the information exchange provisions of the BPCIA. The court refused to issue an advisory opinion on the consequences of skipping steps (l)(4) and/or (l)(5) for some yet unfiled future case. The court also found that all issues were mooted because there was no “continuing controversy between the parties.” (D.I. 52 at 11.) The court disagreed with Amgen that the allegedly wrongful behavior could easily recur and therefore should be adjudicated now. The Court opined there could be no recurrence because “the parties have already completed the (l)(4) and (l)(5) information exchanges, and Amgen has brought a timely suit under (l)(6) in the Northern District of California.” (D.I. 52 at 12.) That the situation occurred or could occur again in other cases in other courts, including, for instance, in the context of the ongoing litigation between Sandoz and Amgen’s subsidiary Immunex also in the district of New Jersey, did not save Amgen’s complaint. And because the court did not decide this case on the merits, it offers little guidance to other courts faced with biosimilar applicants that have waived or skipped steps of the “patent dance.”
Before this decision, the parties had filed competing letters to the court advocating that the Federal Circuit’s opinion in Amgen v. Apotex supported their respective positions. Amgen argued that the Federal Circuit held that the BPCIA does not preclude the relief Amgen sought: a declaratory judgment that Sandoz’s reading of the BPCIA was wrong. Amgen pointed out that Apotex confirmed that (9)(B) (a patent infringement action) is not the exclusive remedy for violation of other subsections of the BPCIA. (See D.I. 49.) On the other hand, Sandoz argued that the Apotex case supported its position since it emphasized that “non-compliance with the BPCIA exchange process is not a violation of the BPCIA” and that “a patent-merits infringement suit is the exclusive remedy for failure to provide the information under (2)(A).” (D.I. 50.) Judge Chesler did not address these arguments in his opinion, nor did he cite the Apotex decision.
We will continue to follow developments in this case and update this post as appropriate.
Authors: Jenny Shmuel, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial.
Over the last several...