Amgen Inc. v. Hospira, Inc.

• Decision Date: 10 August 2017
• Docket Number: 2016-2179
• Citation: 866 F.3d 1355
• Parties: AMGEN INC., Amgen Manufacturing, Limited, Plaintiffs-Appellants v. HOSPIRA, INC., Defendant-Appellee
• Court: U.S. Court of Appeals — Federal Circuit

866 F.3d 1355

AMGEN INC., Amgen Manufacturing, Limited, Plaintiffs-Appellants

v.HOSPIRA, INC., Defendant-Appellee

2016-2179

United States Court of Appeals, Federal Circuit.

Decided: August 10, 2017

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 Biologics 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. , ––– U.S. ––––, 137 S.Ct. 1664, 198 L.Ed.2d 114 (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(l )(2)(A). This disclosure leads to a series of information exchanges—described in 42 U.S.C § 262(l )(3), (l )(4) and (l )(5) —between the applicant and the sponsor that "channels the parties into two phases of patent litigation"—described in 42 U.S.C. § 262(l )(6) and (l )(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 (l )(3) and negotiating which of the listed patents will be subject to immediate action under paragraph (l )(6). Id. "The second phase of litigation," under paragraph (l )(8), "is triggered by the applicant's notice of commercial marketing and involves any patents that were included on the parties' [paragraph (l )(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 (l )(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 (l )(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 (l )(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 (l )(3)(A), Amgen 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(l )(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 (l ) (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 culturing cells used in manufacturing biological products." J.A. 702. Consistent with this position, Amgen never identified a cell-culture patent as part of its own BPCIA disclosures. Ultimately, Amgen filed suit against Hospira on the '349 and '298 patents. As noted, neither of the asserted patents is a cell-culture patent.

Relying on our statement in Amgen Inc. v. Sandoz Inc. , 794 F.3d 1347 (Fed. Cir. 2015), rev'd in part and vacated in part , Sandoz , 137 S.Ct. at 1664, that a sponsor may seek information withheld by an applicant under paragraph (l )(2)(A) "through discovery," 794 F.3d at 1356, Amgen sought discovery on the composition of Hospira's cell-culture medium in its suit on the '349 and '298 patents. Hospira refused Amgen's discovery requests, and Amgen ultimately filed a motion to compel discovery. The district court denied Amgen's motion, stating that the cell-culture information sought by Amgen had "essentially, no relevance to the patents that are asserted," J.A. 37, a conclusion that Amgen does not now dispute.

Amgen appealed the district court's interlocutory order. Hospira then moved this court to dismiss Amgen's appeal for lack of jurisdiction. We denied Hospira's motion, but asked the parties to brief "whether this court has jurisdiction pursuant to the collateral order doctrine or under the All Writs Act." Order, Amgen, Inc. v. Hospira, Inc. , No. 16-2179 (Fed. Cir. Aug. 12, 2016), ECF No. 16.

DISCUSSION

I

We first address our jurisdiction over this appeal. Ordinarily, an appeal must be from a "final" judgment that "ends the litigation on the merits and leaves nothing for the court to do but execute the judgment." Coopers & Lybrand v. Livesay , 437 U.S. 463, 467, 98 S.Ct. 2454, 57 L.Ed.2d 351 (1978) (quoting Catlin v. United States , 324 U.S. 229, 233, 65 S.Ct. 631, 89 L.Ed. 911 (1945) ). The collateral order doctrine provides a narrow exception to this general rule. See Microsoft Corp. v. Baker , –––U.S. ––––, 137 S.Ct. 1702, 1708 n.3, 198 L.Ed.2d 132 (2017). "To come within the ‘small class' of decisions excepted from the final-judgment rule by [the collateral order doctrine], the order must conclusively determine the disputed question, resolve an important issue completely separate from the merits of the action, and be effectively unreviewable on appeal from a final judgment." Livesay , 437 U.S. at 468, 98 S.Ct. 2454 ; Cohen v. Beneficial Indus. Loan Corp. , 337 U.S. 541, 546, 69 S.Ct. 1221, 93 L.Ed. 1528 (1949).

Here, it appears that the district court's discovery order may satisfy the first two conditions of being an appealable collateral order; the order conclusively denied Amgen's motion to compel discovery, and Amgen's entitlement to discovery is separable from the merits since the discovery sought is concededly not relevant to the asserted infringement claims. The issue is whether the district court's order is "effectively unreviewable" on appeal from a final judgment. Livesay , 437 U.S. at 468, 98 S.Ct. 2454.

As noted in Livesay, "rulings on discovery" generally do not qualify for the collateral order doctrine's exception to the final judgment rule. Id. at 470, 98 S.Ct. 2454. "[T]he rule remains settled that most discovery orders are not final," and "courts routinely dismiss appeals from orders granting ... [or] denying discovery." 15B Charles Alan Wright & Arthur R. Miller § 3914.23 (2d ed. June 2017) ; see also, e.g. , Mohawk Indus., Inc. v. Carpenter , 558 U.S. 100, 112, 130 S.Ct. 599, 175 L.Ed.2d 458 (2009) ( "privilege-related disclosure orders" not subject to collateral appeal); Firestone Tire & Rubber Co. v. Risjord , 449 U.S. 368, 377, 101 S.Ct. 669, 66 L.Ed.2d 571 (1981) (noting that the Court has ...