Amgen Inc. v. Sandoz Inc.
| Decision Date | 21 July 2015 |
| Docket Number | No. 2015–1499.,2015–1499. |
| Citation | 794 F.3d 1347 |
| Parties | AMGEN INC., Amgen Manufacturing Limited, Plaintiffs–Appellants v. SANDOZ INC., Defendant–Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, N.Y., argued for plaintiffs-appellants. Also represented by Eric Alan Stone, Jennifer H. Wu, Jennifer Gordon, Peter Sandel, Michael T. Wu, Arielle K. Linsey ; Wendy A. Whiteford, Lois M. Kwasigroch, Kimberlin L. Morley, Amgen Inc., Thousand Oaks, CA; Vernon M. Winters, Alexander David Baxter, Sidley Austin LLP, San Francisco, CA.
Deanne Maynard, Morrison & Foerster LLP, Washington, DC, argued for defendant-appellee. Also represented by Joseph R. Palmore, Marc A. Hearron ; Rachel Krevans, San Francisco, CA; Julie Park, San Diego, CA.
Michael A. Morin, Latham & Watkins LLP, Washington, DC, for amicus curiae AbbVie Inc. Also represented by David Penn Frazier, Gregory G. Garre, Melissa Arbus Sherry, Casey L. Dwyer, Robert J. Gajarsa.
Gregory Diskant, Patterson Belknap Webb & Tyler LLP, New York, N.Y., for amicus curiae Janssen Biotech, Inc. Also represented by Irena Royzman ; Dianne B. Elderkin, Barbara Mullin, Akin Gump, Strauss, Hauer & Feld, LLP, Philadelphia, PA.
Lisa Barons Pensabene, O'Melveny & Myers LLP, New York, N.Y., for amicus curiae Biotechnology Industry Organization. Also represented by Filko Prugo.
Carlos T. Angulo, Zuckerman Spaeder LLP, Washington, DC, for amicus curiae Generic Pharmaceutical Association.
Charles B. Klein, Winston & Strawn LLP, Washington, DC, for amici curiae Hospira, Inc., Celltrion Healthcare Co., Ltd., Celltrion, Inc. Also represented by Andrew C. Nichols ; Samuel S. Park, Chicago, IL; Peter E. Perkowski, Los Angeles, CA.
Before NEWMAN, LOURIE, and CHEN, Circuit Judges.
This appeal presents issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), Pub.L. No. 111–148, §§ 7001–7003, 124 Stat. 119, 804–21 (2010). Amgen Inc. and Amgen Manufacturing Ltd. (collectively, “Amgen”) appeal from the decision of the United States District Court for the Northern District of California (1) dismissing Amgen's state law claims of unfair competition and conversion with prejudice because Sandoz Inc. (“Sandoz”) did not violate the information-disclosure and notice-of-commercial-marketing provisions of the BPCIA, respectively codified at 42 U.S.C. § 262(l )(2)(A) and (l )(8)(A) ; (2) granting judgment on the pleadings to Sandoz on its counterclaims seeking a declaratory judgment that it correctly interpreted the BPCIA; and (3) denying Amgen's motion for a preliminary injunction based on its state law claims. Amgen Inc. v. Sandoz Inc., No. 14–cv–04741, 2015 WL 1264756 (N.D.Cal. Mar. 19, 2015) (“Opinion ”).
For the reasons stated below, we affirm the dismissal of Amgen's state law claims of unfair competition and conversion, vacate the judgment on Sandoz's counterclaims and direct the district court to enter judgment consistent with our interpretation of the BPCIA, and remand for further proceedings consistent with this opinion.
In 2010, as part of the Patient Protection and Affordable Care Act, Congress enacted the BPCIA,1 which established an abbreviated pathway for regulatory approval of follow-on biological products that are “highly similar” to a previously approved product (“reference product”). 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. ). Congress established such “a biosimilar pathway balancing innovation and consumer interests.” BPCIA, Pub.L. No. 111–148, § 7001(b), 124 Stat. at 804.
The BPCIA has certain similarities in its goals and procedures to the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch–Waxman Act), Pub.L. No. 98–417, 98 Stat. 1585 (1984), but it has several obvious differences. We note this as a matter of historical interest, but otherwise do not comment on those similarities and differences.
Traditionally, the Food and Drug Administration (“FDA”) approves a biological product for commercial marketing by granting a biologics license under 42 U.S.C. § 262(a). An applicant filing a biologics license application (“BLA”) typically provides clinical data to demonstrate the safety and efficacy of its product. In contrast, under the abbreviated pathway created by the BPCIA, codified at 42 U.S.C. § 262(k), an applicant filing an abbreviated biologics license application (“aBLA” or “subsection (k) application”) instead submits information to demonstrate that its product is “biosimilar” to or “interchangeable” with a previously approved reference product, together with “publicly-available information regarding the [FDA]'s previous determination that the reference product is safe, pure, and potent.” 42 U.S.C. § 262(k)(2)-(5) ; see also id. § 262(i). The BPCIA thus permits a biosimilar applicant to rely in part on the approved license of a reference product.
To balance innovation and price competition, Congress enacted the BPCIA to provide a four-year and a twelve-year exclusivity period to a reference product, both beginning on the date of first licensure of the reference product. Specifically, a subsection (k) application “may not be submitted to the Secretary until the date that is 4 years after the date on which the reference product was first licensed under subsection (a),” id. § 262(k)(7)(B), and approval of a subsection (k) application “may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a),” id. § 262(k)(7)(A). Thus, a sponsor of an approved reference product (the “reference product sponsor” or “RPS”) receives up to twelve years of exclusivity against follow-on products, regardless of patent protection.
Moreover, the BPCIA established a patent-dispute-resolution regime by amending Titles 28, 35, and 42 of the United States Code. The BPCIA amended the Patent Act to create an artificial “act of infringement” and to allow infringement suits based on a biosimilar application prior to FDA approval and prior to marketing of the biological product. See 35 U.S.C. § 271(e)(2)(C), (e)(4), (e)(6). The BPCIA also established a unique and elaborate process for information exchange between the biosimilar applicant and the RPS to resolve patent disputes. See 42 U.S.C. § 262(l ).
Under that process, codified at 42 U.S.C. § 262(l ), the biosimilar applicant grants the RPS confidential access to its aBLA and the manufacturing information regarding the biosimilar product no later than 20 days after the FDA accepts its application for review. Id. § 262(l )(1)-(2). The parties then exchange lists of patents for which they believe a claim of patent infringement could reasonably be asserted by the RPS, as well as their respective positions on infringement, validity, and enforceability of those patents. Id. § 262(l )(3). Following that exchange, which could take up to six months, the parties negotiate to formulate a list of patents (“listed patents”) that would be the subject of an immediate infringement action, id. § 262(l )(4)-(5), and the RPS then sues the biosimilar applicant within 30 days, id. § 262(l )(6). That information exchange and negotiation thus contemplates an immediate infringement action brought by the RPS based only on listed patents.
Subsection 262(l ) also provides that the applicant give notice of commercial marketing to the RPS at least 180 days prior to commercial marketing of its product licensed under subsection (k), which then allows the RPS a period of time to seek a preliminary injunction based on patents that the parties initially identified during information exchange but were not selected for the immediate infringement action, as well as any newly issued or licensed patents (collectively, “non-listed patents”). Id. § 262(l )(7)-(8).
Subsection 262(l ) additionally provides, in paragraph (l )(9)(A), that if the applicant discloses the information “required under paragraph (2)(A),” then neither the RPS nor the applicant may bring a declaratory judgment action based on the non-listed patents prior to the date on which the RPS receives the notice of commercial marketing under paragraph (l )(8)(A). Id. § 262(l ) (9)(A). Paragraphs (l )(9)(B) and (l )(9)(C), however, permit the RPS, but not the applicant, to seek declaratory relief in the event that the applicant fails to comply with certain provisions of subsection (l ). Id. § 262(l )(9)(B)-(C).
Amgen has marketed filgrastim
under the brand name Neupogen ® (“Neupogen ”) since 1991. In May 2014, Sandoz filed an aBLA, seeking FDA approval of a biosimilar filgrastim product, for which Neupogen is the reference product. On July 7, 2014, Sandoz received notification from the FDA that it had accepted Sandoz's application for review.
On July 8, 2014, Sandoz notified Amgen that it had filed a biosimilar application referencing Neupogen
; that it believed that the application would be approved in “Q1/2 of 2015”; and that it intended to launch its biosimilar product immediately upon FDA approval. J.A. 1472. Later in July, in response to Amgen's inquiry, Sandoz confirmed that the FDA had accepted its application for review, but Sandoz informed Amgen that it had “opted not to provide Amgen with Sandoz's biosimilar application within 20 days of the FDA's notification of acceptance” and that Amgen was entitled to sue Sandoz under § 262(l )(9)(C). J.A. 1495–96. Sandoz thus did not disclose its aBLA or its product's manufacturing information to Amgen according to § 262(l )(2)(A).
Subsequently, on March 6, 2015, the FDA approved Sandoz's aBLA for all approved uses...
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