The Federal Circuit issued its opinion in the Amgen v. Hospira appeal (16-2179) on August 10, 2017, dismissing the appeal for lack of jurisdiction and denying Amgen’s petition for a writ of mandamus. The decision affirmed the district court’s denial of Amgen’s motion to compel the discovery of cell culture information because it was unrelated to the patents-in-suit, which did not concern cell-culture medium used during manufacture. The Court also provided useful guidance to future reference product sponsors (“RPSs”) participating in the patent dance under the Biologics Price Innovation and Competition Act (“BPCIA”): you can list all potentially assertable patents on your list pursuant to U.S.C. § 262(l)(3)(A) of the BPCIA, even if you don’t have all the information you need to be sure of infringement.
As discussed in more detail in our previous blogs (e.g., here, and here), this dispute started during the patent dance between Amgen and Hospira over a biosimilar of Amgen’s Epogen®. Hospira produced its abbreviated Biologic License Application (aBLA) at the start of the dance, but Amgen asked for some additional cell culture media components that were not available in the aBLA. Hospira refused to provide the information. Amgen then declined to list cell culture patents on its (3)(A) list. Amgen reasoned that (3)(A) is limited to patents “for which the reference product sponsor believes a claim of patent infringement could reasonably be asserted” – and without the additional cell culture media information, Amgen could not determine whether its cell culture patents “could reasonably be asserted.” Amgen was also concerned it could be subject to Rule 11 sanctions if it ultimately was forced to bring suit on a patent without a good faith belief in infringement. The parties continued dancing on other patents, culminating in a first wave of litigation that did not involve any cell culture manufacturing patents. Amgen then tried to obtain the manufacturing information during discovery, but ultimately was unable to get the information. In denying Amgen’s motion to compel, the district court ruled that Amgen was precluded under Federal Rule of Civil Procedure 26 from seeking discovery unrelated to the patents in suit. Amgen appealed. Hospira moved to dismiss, arguing that the discovery order was not a “collateral order.” The Federal Circuit denied the motion while leaving the question of jurisdiction open, requesting briefing on the merits as well as additional briefing on whether the Court has jurisdiction under the collateral order doctrine or the All Writs Act.
The Federal Circuit has now held that it lacks jurisdiction to hear the dispute. The denial of a discovery motion was not a collateral order because it was not “effectively unreviewable.” Amgen had argued that without an immediate appeal, Amgen would be unable to commence infringement litigation on cell culture patents prior to Hospira’s launch, thereby undermining the statutory purpose of the BPCIA. The Federal Circuit disagreed, holding that “there is no clear-cut statutory purpose that would be undermined by denying immediate appeal.” Therefore, this dispute was akin to a “run-of-the-mill discovery dispute” that could be appealed at the end of the district court litigation.
Amgen was also not entitled to mandamus under the All Writs Act because Amgen did not establish a “clear and undisputable” right to the relief. The Court delved into the merits of the dispute, holding that Amgen did not have a right to the relief because the Federal Rules of Civil Procedure apply to a BPCIA litigation, and the information Amgen seeks is not relevant to the patents in dispute and therefore outside the scope of discovery.
The Federal Circuit walked through “five potential avenues” available to an RPS seeking to secure process information pursuant to (2)(A). (Slip Op. at 9-10.) Two of the avenues—a federal injunction to comply with (2)(A) and a patent infringement suit for failing to comply with (2)(A)—have been foreclosed by the Supreme Court in Amgen v. Sandoz. A third avenue—an injunction to comply with (2)(A) under state law—is not at issue, because Amgen did not bring state law claims. The fourth avenue is bringing suit under 25 U.S.C. § 271(e)(C)(i), but this is tied to the patents that Amgen listed under (3)(A), and Amgen did not list any cell culture patents. The final avenue is bringing suit under § 271(e)(2)(C)(ii) for patents that “could be identified” on a (3)(A) list. However, Amgen has not brought suit on any of these cell culture patents, and the Federal Circuit explicitly noted that it was not addressing which patents could be litigated under (C)(ii). (Slip Op. at 13.)
In its analysis, the Federal Circuit explained that there would be no Rule 11 sanctions for mistakenly listing a patent on a (3)(A) list: “The statute provides no sanction for holding or asserting a mistaken belief in good faith” when listing patents on the (3)(A) list. (Slip Op. at 12.) Thus, the Federal Circuit concluded that “the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A).” And once the patent is listed, the applicant has to come forward with additional disclosures that will likely prevent a baseless litigation. Also, the Federal Circuit notes that Rule 11 only requires good faith “to the best of the person’s” ability under a reasonable inquiry. “Thus, if a sponsor forms a belief based on an inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11.” (Slip Op. at 12.) In support, it cited other cases declining to find a Rule 11 violation where the defendant withheld relevant information. E.g., Hoffman-La Roche Inc. v. Invamed Inc., 213 F.3d 1359, 1363-64 (Fed. Cir. 2000). (Slip Op. at 12.)
Amgen may have been in a better position if it had listed its cell culture patents on its (3)(A) list. Now it may be too late for Amgen to sue before launch, since the BPCIA “penalizes sponsors that decline to participate in the BPCIA’s information exchanges because under 35 U.S.C. § 271(e)(6)(C), a sponsor that fails to list a patent that ‘should have been included in the list described in [paragraph (l)(3)(A)] . . . may not bring an action under this section for infringement of the patent with respect to the biological product,’” at least before the biosimilar launch. (Slip Op. at 11.) Amgen’s ability to sue on these patents before launch may now turn on whether it can prove that Hospira “fail[ed] to provide the … information required under section 351(l)(2)(A),” which would allow Amgen sue under § 271(e)(2)(C)(ii).
We will continue to monitor these cases and provide updates.
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.
Dr. Jenny Shmuel 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...