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Amgen Inc. v. Sandoz Inc.

United States Court of Appeals, Federal Circuit

May 8, 2019

AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs-Appellants
v.
SANDOZ INC., SANDOZ INTERNATIONAL GMBH, SANDOZ GMBH, Defendants-Appellees AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs-Appellants
v.
SANDOZ INC., SANDOZ INTERNATIONAL GMBH, SANDOZ GMBH, LEK PHARMACEUTICALS, D.D., Defendants-Appellees

          Appeal from the United States District Court for the Northern District of California in Nos. 3:14-cv-04741-RS, 3:16-cv-02581-RS, Judge Richard Seeborg.

          Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, argued for plaintiffs-appellants. Also represented by Jennifer Gordon, Golda Lai, Stephen Accursio Maniscalco, Peter Sandel, Eric Alan Stone, Jacob Whitt, Jennifer H. Wu; Lois M. Kwasigroch, Kimberlin L. Morley, Wendy A. Whiteford, Amgen Inc., Thousand Oaks, CA.

          Deanne Maynard, Morrison & Foerster LLP, Washington, DC, argued for defendants-appellees. Also represented by Bryan Leitch, Brian Robert Matsui; Erik Jeffrey Olson, Eric C. Pai, Palo Alto, CA.

          Before Lourie, O'Malley, and Reyna, Circuit Judges.

          Lourie, Circuit Judge.

         Amgen Inc. and Amgen Manufacturing Ltd. (collectively, "Amgen") appeal from two decisions of the United States District Court for the Northern District of California in two patent infringement actions brought by Amgen under the Biologics Price Competition and Innovation Act ("BPCIA"), 42 U.S.C. § 262 (2012). The court construed claims of U.S. Patents 6, 162, 427 (the "'427 patent") and 8, 940, 878 (the "'878 patent"), Amgen Inc. v. Sandoz Inc., No. 14-CV-04741-RS, 2016 WL 4137563 (N.D. Cal. Aug. 4, 2016) ("Claim Construction Order"), and granted summary judgment of noninfringement of claim 7 of the '878 patent by Sandoz's filgrastim biosimilar and its proposed pegfilgrastim biosimilar, Amgen Inc. v. Sandoz Inc., 295 F.Supp.3d 1062, 1064 (N.D. Cal. 2017) ("Decision"). We conclude that the district court correctly construed the claims and granted summary judgment of noninfringement of claim 7. The judgment of the district court is therefore affirmed.

         Background

         Amgen created and commercialized two related biologic products, filgrastim (marketed as Neupogen®) and pegfilgrastim (marketed as Neulasta®), indicated for treating neutropenia, a deficiency of white blood cells. Neutropenia often results from exposure to certain chemotherapeutic regimens or radiation therapy during cancer treatment. Filgrastim is a recombinant analog of granulocyte-colony stimulating factor ("G-CSF"), a naturally-occurring human glycoprotein that stimulates the production of neutrophils and stem cells and their release into the bloodstream. Pegfilgrastim is materially identical but much larger because it is conjugated to a polyethylene glycol molecule, which enables long-acting administration. Both of Amgen's products are generally indicated to stimulate neutrophil production, and Neupogen® is further indicated to mobilize stem cells from the bone marrow into the bloodstream for collection for autologous stem cell transplantation.

         In 2014, Sandoz submitted to the Food and Drug Administration ("FDA") an abbreviated Biologics License Application ("aBLA") to market a biosimilar filgrastim product. While Sandoz's aBLA referenced Neupogen®, Sandoz elected not to provide Amgen with its aBLA or manufacturing information. In October 2014, Amgen filed a complaint for, inter alia, a declaratory judgment that Sandoz's proposed biosimilar would infringe the '427 patent. See 35 U.S.C. § 271(e)(2)(C) (defining submission of an aBLA as an act of patent infringement); 42 U.S.C. § 262(1)(9)(C) (allowing a reference product sponsor to bring a declaratory judgment action regarding "any patent that claims the biological product or a use of the biological product" when the biosimilar applicant does not provide its aBLA and manufacturing information).[1] In 2015, Sandoz received FDA approval for its filgrastim biosimilar, Zarxio®. After Sandoz launched Zarxio®, Amgen amended its complaint to plead infringement of the '878 patent under 35 U.S.C. §§ 271(e)(2)(C)(ii), (g).

         In 2015, Sandoz submitted an aBLA to market a bio-similar pegfilgrastim product referencing Neulasta®. In May 2016, Amgen filed a complaint for infringement of the '878 patent under 35 U.S.C. § 271(e)(2)(C)(i) and 42 U.S.C. § 262(1)(6)(A). Sandoz has not yet received approval for its proposed pegfilgrastim biosimilar.

         The '878 patent discloses methods of protein purification by adsorbent chromatography, a well-known method that involves separating the components of a solution ("the mobile phase") based upon their chemical attraction to the molecules or ions that comprise a stationary separation matrix ("the stationary phase"). The '878 patent refers to several methods of chromatography, including protein affinity and non-protein affinity methods like ion exchange. '878 patent col. 15 ll. 17-24. The '878 patent further discloses use of a salt or pH gradient to control the elution of the protein of interest, as well as the preceding elution (or "washing") from the matrix of unwanted components of a refold solution containing the protein of interest. Id. col. 16 ll. 2-22. Claim 7, recited below, is directed to the use of a non-affinity separation matrix.

7. A method of purifying a protein expressed in a non-native limited solubility form in a non-mammalian expression system comprising:
(a) expressing a protein in a non-native limited solubility form in a non-mammalian cell;
(b) lysing a non-mammalian cell;
(c) solubilizing the expressed protein in a solubilization solution comprising one or more of the following:
(i) a denaturant;
(ii) a reductant; and
(iii) a surfactant;
(d) forming a refold solution comprising the solubilization solution and a refold buffer, the refold buffer comprising one or more of the following:
(i) a denaturant;
(ii) an aggregation ...

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