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Amgen Inc. v. Hospira, Inc.

United States Court of Appeals, Federal Circuit

August 10, 2017

AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs-Appellants
v.
HOSPIRA, INC. Defendant-Appellee

         Appeal from the United States District Court for the District of Delaware in No. l:15-cv-00839-RGA, Judge Richard G. Andrews.

          Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, argued for plaintiffs-appellants. Also represented by STEPHEN Accursio Maniscalco, Eric Alan Stone, Jennifer H. Wu; Kevin M. Flowers, John Labbe, Matthew Nielsen, Marshall, Gerstein & Borun LLP, Chicago, IL; THOMAS Francis Lavery, Wendy A. Whiteford, Amgen Inc., Thousand Oaks, CA.

          Thomas J. Meloro, Willkie Farr & Gallagher LLP, New York, NY, argued for defendant-appellee. Also represented by Michael Johnson.

          Before Dyk, Bryson, and Chen, Circuit Judges.

          DYK, CIRCUIT JUDGE.

         Amgen Inc. ("Amgen") appeals an order of the United States District Court for the District of Delaware denying Amgen's motion to compel discovery from Hospira, Inc. ("Hospira") in a patent infringement case governed by the Biologies Price Competition and Innovation Act of 2009 ("BPCIA"), Pub. L. No. 111-148, 124 Stat. 119, 804 (2010) (amending 42 U.S.C. § 262). Amgen alternatively seeks a writ of mandamus ordering the court to compel discovery.

         Because we lack jurisdiction over the district court's order under the collateral order doctrine and find that Amgen fails to satisfy the prerequisites for mandamus, we dismiss the appeal and deny the writ.

         Background

         I

         The parties' dispute arises from the disclosure requirements of the BPCIA, provisions that were recently addressed by the Supreme Court in Sandoz, Inc. v. Amgen, Inc., 137 S.Ct. 1664 (2017). "The BPCIA sets forth a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of [patent] infringement" resulting from the approval of "biological products" by the federal Food and Drug Administration ("FDA"). Sandoz, 137 S.Ct. at 1671. To obtain FDA approval, the sponsor of a new biological product must demonstrate, inter alia, that the new product is "safe, pure, and potent." 42 U.S.C. § 262(a)(2)(C)(i)(I). However, for a "biosimilar" product based on an existing "reference" biological product already approved under section 262(a), [1] a party may instead submit an "abbreviated" application under subsection (k) of the statute. Sandoz, 137 S.Ct. at 1670. Thus, instead of having to demonstrate that its biosimilar is "safe, pure, and potent" to obtain FDA approval, a subsection (k) applicant may "piggyback on the showing made by the [sponsor] of a previously [approved] biologic (reference product)." Id.

         In exchange for this abbreviated pathway to approval, the subsection (k) applicant is subject to a number of obligations relevant to the sponsor's patent rights. One of these obligations is to provide the sponsor with "a copy of the application submitted" under subsection (k), "and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application." 42 U.S.C. § 262(Z)(2)(A). This disclosure leads to a series of information exchanges-described in 42 U.S.C § 262(0(3), (0(4) and (0(5)- between the applicant and the sponsor that "channels the parties into two phases of patent litigation"-described in 42 U.S.C. § 262(0(6) and (0(8). Sandoz, 137 S.Ct. at 1671. "In the first phase, the parties collaborate to identify patents that they would like to litigate immediately" by exchanging patent lists pursuant to paragraph (0(3) and negotiating which of the listed patents will be subject to immediate action under paragraph (0(6). Id. "The second phase of litigation, " under paragraph (0(8), "is triggered by the applicant's notice of commercial marketing and involves any patents that were included on the parties' [paragraph (/)(3)] lists but not litigated in the first phase." Id.; see also Amgen Inc. v. Apotex Inc., 827 F.3d 1052, 1055-57 (Fed. Cir. 2016).

         II

         Hospira filed a subsection (k) application with the FDA in December 2014 seeking approval of a biosimilar of EPOGEN®, a biological product developed by Amgen and approved by the FDA under section 262(a) in 1989. In accordance with paragraph (/)(2)(A), Hospira provided a copy of its application to Amgen. Hospira did not separately provide information concerning "the process . . . used to manufacture the biological product"-again, as required by the statute-but contends that such information was disclosed in its application.

         In a letter to Hospira dated March 31, 2015, Amgen asserted that Hospira had failed to comply with paragraph (/)(2)(A) because Hospira had failed to "fully disclose the specific composition of the cell-culture medium used in the manufacture" of Hospira's biosimilar. J.A. 699.[2] Hospira responded that the components Amgen had identified were "commercially-available raw materials, " and that Hospira had, through its application, "provided sufficient information concerning both its product and the processes used to manufacture its product." J.A. 708.

         Despite their disagreement over Hospira's compliance with paragraph (Z)(2)(A)-a disagreement that we do not resolve-the parties proceeded to the next phase of the BPCIA's information exchange by identifying patents subject to suit. Under paragraph (Z)(3)(A), Am gen was obligated to "provide to [Hospira] ... a list of patents for which [Amgen] believe[d] a claim of patent infringement could reasonably be asserted ... if a person not licensed by [Amgen] engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that [was] the subject of [Hospira's] subsection (k) application." 42 U.S.C. § 262(Z)(3)(A). Amgen listed U.S. Patent Nos. 5, 756, 349, 5, 856, 298, and 6, 632, 637 (the '349, '298, and '637 patents, respectively), under paragraph (/)(3)(A). These patents relate to the biological product and methods of producing the biological product, rather than the specific cell-culture medium used during its manufacturing process.[3] Amgen stated that without information regarding the cell-culture medium used by Hospira, "Amgen [could not] assess the reasonableness of asserting claims for infringement" with respect to other patents owned by Amgen "that claim processes for cultur-ing cells used ...


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