CAFC denies Amgen discovery in biosimilar patent dispute

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery in the district court. The Court also found that Amgen failed to meet the requirements for mandamus relief. Amgen Inc. v. Hospira, Inc., (Fed. Cir. Aug. 10, 2017) (Before Dyk, Bryson, and Chen, J.) (Opinion for the court, Dyk, J.)

Amgen developed EPOGEN, a biological product, which was approved by the FDA in 1989. In 2014, Hospira filed a “subsection (k)” application seeking approval of a biosimilar version of EPOGEN. The BPCIA governs patent infringement claims resulting from FDA approval of “biological products.”

To obtain FDA approval for a new biological product, the product must be proven “safe, pure, and potent.” A “biosimilar” product is based on an existing “reference” biological product that is already approved. For biosimilars, a party may submit an abbreviated application under subsection (k) of the BPCIA, allowing the application to piggyback on the showing made by the sponsor of a previously approved biologic reference product. The applicant must, among other things, provide the sponsor with a copy of the subsection (k) application “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” After this disclosure, an information exchange occurs between the applicant and the sponsor. In a first phase of litigation, the parties negotiate which of the patents they identify, on a so-called paragraph (l)(3) list, will be subject to immediate action. A second phase of litigation is triggered by the applicant’s notice of commercial marketing, and involves patents that were identified by the parties but not immediately litigated in the first phase.

Hospira provided a copy of its application to Amgen but did not provide separate information concerning the manufacturing process of the biological product as required by statute, arguing that such information was disclosed by the application. Amgen notified Hospira that it had failed to “fully disclose the specific composition of the cell-culture medium used in the manufacture” of Hospira’s biosimilar, but Hospira again referred to the disclosure in its application. The parties proceeded to the next phase of information exchange by identifying patents subject to the suit. Specifically, “Amgen was obligated to provide to Hospira a list of patents for which Amgen believed a claim of patent infringement could reasonably be asserted” against the unlicensed manufacture, use, offer of sale, sale, or importation of the biosimilar. The patents listed by Amgen relate to the biological product and method of producing the biological product but are not related to the specific cell-culture medium used during the manufacturing process. Amgen stated that its cell-culture patents were not included because it could not assess the reasonableness of asserting claims for infringement without additional information from Hospira regarding the cell-culture medium used by Hospira during manufacturing. Ultimately, Amgen filed suit against Hospira on two patents, neither of which is a cell-culture patent.


During litigation, Amgen sought discovery on the composition of Hospira’s cell-culture medium. Hospira refused these requests, and the court denied Amgen’s subsequent motion to compel discovery, finding that the cell-culture information sought by Amgen had “essentially, no relevance to the patents that [were] asserted.” Amgen appealed the district court’s interlocutory order to the Court, and Hospira moved to dismiss the appeal for lack of jurisdiction. The Court denied Hospira’s motion but asked the parties to brief “whether [the Court] has jurisdiction pursuant to the collateral order doctrine or under the All Writs Act.”

The collateral order doctrine excepts a “small class” of decisions from the final-judgment rule and, to apply, requires that the order (1) conclusively determine the disputed question, (2) resolve an important issue completely separate from the merits of the action, and (3) be effectively unreviewable on appeal from a final judgment. The Court found that the discovery order may satisfy the first two conditions, but not whether the order is “effectively unreviewable” after final judgment. According to the court, discovery rulings “are not reviewable at the interlocutory stage because they are reviewable from a final judgment.” Amgen argued that forcing it to wait for a final judgment would defeat the purpose of the BPCIA disclosures, “to enable the sponsor (here Amgen) to commence infringement litigation immediately, prior to FDA approval and commercial marketing of the biological product by the applicant.” The Court disagreed. “[T]here is no clear-cut statutory purpose that would be undermined by denying the immediate appeal.” Additionally, “Congress’s decision not to provide for interlocutory review simply means that immediate appeal is not available.” Thus, the Court held that it lacks jurisdiction over Amgen’s appeal.

The Court then turned to Amgen’s petition for writ of mandamus. To be entitled to mandamus, a party “must have no other adequate means to attain the desired relief and must demonstrate that its right to the writ’s issuance is clear an indisputable.” Even then, “the issuing court, in the exercise of its discretion, must be satisfied that the writ is appropriate under the circumstances.”

Concerning Amgen’s “clear and indisputable right” to the relief sought, the Court found that “[i]nstead of bringing suit on its cell-culture patents, Amgen brought suit on [other] patents.” Amgen argued that it was unable to bring suit on its cell-culture patents under the BPCIA because it was denied information on the cell-culture medium used by Hospira. The Court noted, however, that should a sponsor fail to list a patent that “should have been included on the listed described in [paragraph (l)(3)],” the sponsor “may not bring an action under [the BPCIA] for infringement of the patent with respect to the biological product.”

To alleviate potential Rule 11 concerns, i.e. groundlessly asserting a patent, the BPCIA merely requires the sponsor to list patents that it believes could reasonably be asserted. The statute provides no sanction for asserting a mistaken belief in good faith. If Amgen had included its cell-culture patents in its paragraph (l)(3) list, Hospira would have been required to respond with “detailed statement[s]” as to the cell-culture mediums it uses. Thus, “the reasonableness requirement of [the paragraph (l)(3) list] does not preclude a sponsor from listing a patent for which an applicant has not provided information.” Accordingly, the court denied Amgen’s petition for writ of mandamus.

When filing a BPCIA paragraph (l)(3) list of patents that could potentially be infringed by a biosimilar, all patents that could reasonably be infringed, based on available knowledge without discovery, should be included on that list. In an interlocutory appeal, the Federal Circuit lacks “collateral order” jurisdiction to compel a district court to order discovery concerning non-listed patents, nor is mandamus warranted, because relief is available on appeal from a final judgment.



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