Amgen Inc. v. Apotex Inc.

• Citation: 119 U.S.P.Q.2d 1318,827 F.3d 1052
• Decision Date: 05 July 2016
• Docket Number: 2016-1308
• Parties: Amgen Inc., Amgen Manufacturing Limited, Plaintiffs–Appellees v. Apotex Inc., Apotex Corp., Defendants–Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

827 F.3d 1052

119 U.S.P.Q.2d 1318

Amgen Inc., Amgen Manufacturing Limited, Plaintiffs–Appellees

v.Apotex Inc., Apotex Corp., Defendants–Appellants.

2016-1308

United States Court of Appeals, Federal Circuit.

Decided: July 5, 2016

Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, argued for plaintiffs-appellees. Also represented by Eric Alan Stone, Catherine Nyarady, Jennifer Gordon, Peter Sandel, Jennifer H. Wu, Stephen Accursio Maniscalco; Wendy A. Whiteford, Lois M. Kwasigroch, Kimberlin L. Morley, Amgen Inc., Thousand Oaks, CA; John F. O'Sullivan, Allen P. Pegg, Jason Sternberg, Hogan Lovells US LLP, Miami, FL.

Kerry Brendan McTigue, Cozen O'Connor, Washington, DC, argued for defendants-appellants. Also represented by Aaron S. Lukas, William Blake Coblentz, Barry P. Golob, Donald R. McPhail; John Christopher Rozendaal, David Charles Frederick, Miles Sweet, Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC, Washington, DC.

Carlos T. Angulo, Zuckerman Spaeder LLP, Washington, DC, for amicus curiae Biosimilars Council.

William A. Rakoczy, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for amicus curiae Mylan Inc. Also represented by Lara E. Fitzsimmons.

Charles B. Klein, Winston & Strawn LLP, Washington, DC, for amici curiae Hospira, Inc., Celltrion Healthcare Co., Ltd., Celltrion, Inc. Also represented by Steffen Nathanael Johnson, Andrew Curtis Nichols; Samuel S. Park, Dan Hoang, Chicago, IL.

Gregory Diskant, Patterson Belknap Webb & Tyler LLP, New York, NY, for amicus curiae Janssen Biotech, Inc. Also represented by Irena Royzman, Aron Russell Fischer.

Lisa Barons Pensabene, O'Melveny & Myers LLP, New York, NY, for amicus curiae Biotechnology Innovation Organization. Also represented by Filko Prugo, Daniel Benjamin O'Boyle; Deanna Marie Rice, Washington, DC.

Before Wallach, Bryson, and Taranto, Circuit Judges.

Taranto

, Circuit Judge.

This appeal involves an action brought by Amgen Inc. and Amgen Manufacturing Limited (collectively Amgen) against Apotex Inc. and Apotex Corp. (collectively Apotex) under the Biologics Price Competition and Innovation Act of 2009 (Biologics Act or BPCIA). Apotex has an application pending with the Food and Drug Administration, filed under the Biologics Act, that seeks permission to begin marketing a product allegedly “biosimilar” to Amgen's FDA-approved Neulasta®. For such an applicant, the Biologics Act lays out a step-by-step process for exchanging information and channeling litigation about patents relevant to the application. Apotex and Amgen proceeded several steps into that process, leading to the present suit in which Amgen alleges that Apotex's proposed marketing would infringe an Amgen patent.

This appeal, however, does not involve the merits of the infringement allegations. Rather, it involves Amgen's motion for a preliminary injunction concerning what will happen if and when the FDA licenses Apotex's proposed biosimilar product. Amgen sought a preliminary injunction to enforce a provision of the Biologics Act that requires a biosimilar-product applicant to give notice 180 days before commercially marketing its FDA-licensed product, 42 U.S.C. § 262(l )(8)(A)

. We held in Amgen Inc. v. Sandoz Inc. , 794 F.3d 1347, 1357–58 (Fed. Cir. 2015), among other things, that the 180-day period runs from post- licensure notice. Here, the district court, agreeing with Amgen, preliminarily enjoined Apotex from entering the market unless it has given Amgen notice after receiving the requested FDA license and then waited 180 days.

We affirm. In Amgen v. Sandoz

, we held that the commercial-marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice, and that an injunction was proper to enforce the provision against Sandoz, a biosimilar-product applicant that had entirely skipped the statutory process of information exchange and patent-litigation channeling. Apotex argues that a different result is required here—that the commercial-marketing provision is not mandatory and may not be enforced by an injunction—because it, unlike Sandoz, did launch the statutory process for exchanging patent information and channeling patent litigation. We reject the asserted distinction. We hold that the commercial-marketing provision is mandatory and enforceable by injunction even for an applicant in Apotex's position.

Background

Amgen markets FDA-approved Neulasta

®, whose active ingredient is pegfilgrastim, a human-engineered protein that, in patients undergoing chemotherapy, can stimulate the production of neutrophils (a type of white blood cell) and thereby decrease the incidence of infection. Amgen received a biologics license from the FDA for Neulasta ® in 2002 pursuant to 42 U.S.C. § 262(a). In 2014, Apotex filed an application for an FDA license to market a biosimilar version of Neulasta®, invoking the “abbreviated pathway for regulatory approval of follow-on biological products that are ‘highly similar’ to a previously approved product (‘reference product’),” as described in Amgen v. Sandoz , 794 F.3d at 1351. Congress created that route to FDA licensure in the Biologics Act in 2010. Pub. L. No. 111-148, §§ 7001–7003, 124 Stat. 119, 804–21 (2010), codified as amended at 42 U.S.C. § 262, 35 U.S.C. § 271(e), 28 U.S.C. § 2201(b), 21 U.S.C. § 355 et seq. Apotex's application is pending.

A

When Amgen obtained its license, it had to show that its biological product, Neulasta®, was “safe, pure, and potent.” 42 U.S.C. § 262(a)(2)(C)(i)(I)

. The Biologics Act authorizes enterprises like Apotex to gain approval, after a time, for a product sufficiently similar to the “reference product,” without repeating all of the work of the pioneer, the “reference product sponsor” (defined at id. § 262(l )(1)(A) ). Under § 262(k), an applicant may obtain a license by demonstrating, among other things, that its product is “biosimilar” to a reference product. In so doing, it may use publicly available information about the reference product's safety, purity, and potency to support its application. Id. § 262(k)(2)(A)(i), (iii). For the purpose of “balancing innovation and consumer interests,” Pub. L. No. 111-148, § 7001(b), 124 Stat. at 804, Congress prescribed that a biosimilar-product application under § 262(k) “may not be submitted” until four years after the reference product was first licensed under § 262(a) and that a biosimilar-product license “may not be made effective” until twelve years after the reference product was first licensed. 42 U.S.C. § 262(k)(7)(A), (B).

Of particular relevance here, the Biologics Act contains a detailed, multi-part subsection, § 262(l )

, that is focused in various ways on potential patent disputes between the reference product sponsor and biosimilar-product applicant. That subsection by its terms provides for two stages of litigation—one under paragraph (6), the other under paragraph (8). In this opinion, we will often refer to paragraphs and subparagraphs within that subsection without repeating the “§ 262(l ) ”; unless otherwise made clear, any such shorthand references are to that subsection. We also will usually call the § 262(k) applicant simply the “applicant.”

The § 262(l )

provisions of principal present significance are as follows. Under (2)(A), within 20 days after the FDA notifies the applicant that its application has been accepted for review, the applicant is to give notice to the reference product sponsor by providing the application as well as information describing the manufacturing process. § 262(l )(2)(A). Under (3)(A), within 60 days of receiving that notice, the reference product sponsor is to provide a list of patents that could reasonably be asserted against the applicant and specify which it would be prepared to license to the applicant. § 262(l )(3)(A)

. Under (3)(B), within 60 days after receiving that list, the applicant is to respond with a detailed statement identifying why each patent on the reference product sponsor's list is invalid, unenforceable, or not infringed, or declaring that it does not intend to commercially market the biosimilar product before a particular patent expires, and also addressing the reference product sponsor's statement of readiness to license. § 262(l ) (3)(B)(ii), (iii). The applicant, in its response, may also provide its own list of patents that it believes could reasonably be asserted against it. § 262(l )(3)(B)(i). Under (3)(C), then, within 60 days of receiving the applicant's (3)(B) response, the reference product sponsor is to provide a detailed reply regarding those patents on its (3)(A) list as to which the applicant has asserted non-infringement, invalidity, or unenforceability. § 262(l )(3)(C).

While the reference product sponsor may later supplement its (3)(A) list under paragraph (7), it is the original lists under (3) that form the basis of the next steps in the process leading to immediate litigation under paragraph (6). Those steps begin with paragraph (4), which requires that the reference product sponsor and the applicant enter into good-faith negotiations over which of the patents listed under (3) will be the subject of an immediate patent-infringement action. § 262(l )(4)(A)

. If the parties reach agreement, (6)(A) provides that the reference product sponsor must bring an action for infringement on all such patents within 30 days. § 262(l )(6)(A) ; see 35 U.S.C. § 271(e)(2)(C)(i). The applicant must then notify the FDA. § 262(l ) (6)(C).

If the parties do not reach agreement within 15 days of starting their negotiation, (4)(B) directs the parties to paragraph (5) for the process that determines the scope of immediate litigation. § 262(l )(4)(B)

. That process gives the applicant a scope-limiting ability, based on an exchange of lists of patents to be litigated. The applicant tells the reference product sponsor how many patents will be on the applicant's list; that number caps how many patents the reference product sponsor may list, except that if the...