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Sandoz Inc. v. Amgen Inc.

United States Court of Appeals, Federal Circuit

December 5, 2014

SANDOZ INC., Plaintiff-Appellant,

Appeal from the United States District Court for the Northern District of California. in No. 3:13-cv-02904. MMC, Judge Maxine M. Chesney.

JAMES F. HURST, Winston & Strawn LLP, of Chicago, Illinois, argued for plaintiff-appellant. With him on the brief were MAUREEN L. RURKA and JAMES M. HILMERT.

DAVID T. PRITIKIN, Sidley Austin LLP, of Chicago, Illinois, argued for defendants-appellees. With him on the brief were VERNON M. WINTERS, of San Francisco, California, and JEFFREY P. KUSHAN, of Washington, DC. Of counsel on the brief were WENDY A. WHITEFORD, J. DREW DIAMOND, and GAIL A. KATZ, Amgen, Inc., of Thousand Oaks, California, for Amgen Inc. Of counsel were JAMES A. HIGH, JR., of Washington, DC, M. PATRICIA THAYER, of San Francisco, California, and SAMUEL N. TIU, of Los Angeles, California.

Before DYK, TARANTO, and CHEN, Circuit Judges. TARANTO, Circuit Judge.


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Taranto, Circuit Judge.

Sandoz Inc. sued Amgen Inc. and Hoffman-La Roche Inc. to obtain a declaratory judgment that two patents, owned by Hoffman-La Roche and exclusively licensed to Amgen, are invalid and unenforceable and will not be infringed if Sandoz uses, offers to sell or sells, or imports a drug product " biosimilar" to Amgen's Enbrel® . At the time it brought suit, Sandoz had not (as it still has not) filed an application for approval of its contemplated product by the Food and Drug Administration (FDA) and had only just begun certain testing required for its contemplated FDA filing. The district court dismissed the case, determining that no Article III controversy (yet) existed between the parties and also that the suit was barred by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), Pub. L. No. 111-148, § § 7001-7003, 124 Stat. 119, 804-21 (2010) (codified principally at 42 U.S.C. § 262). Sandoz Inc. v. Amgen Inc., No. CV-13-2904 MMC, 2013 WL 6000069, at *2-3 (N.D. Cal. Nov. 12, 2013). We affirm, concluding that Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction. We do not address the district court's interpretation of the BPCIA.


Amgen markets Enbrel®, a " biological product" under 42 U.S.C. § 262(i), as a therapy for rheumatoid arthritis. The active ingredient in Enbrel® is the protein etanercept.[1] Amgen's predecessor, Immunex, received an FDA Biologics License for Enbrel®, under 42 U.S.C. § 262(a) and 21 C.F.R. pt. 601, in 1998. Sandoz began developing its own etanercept product in 2004.

In late 2011 and early 2012, the Patent and Trademark Office issued Patent Nos. 8,063,182 and 8,163,522 to Hoffman-LaRoche. The '182 patent claims specified

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proteins and related pharmaceutical compositions. The '522 patent claims certain methods of using host cells that include specified polynucleotides that encode certain proteins, specified polynucleotides themselves, and vectors and cells containing specified polynucleotides. Amgen has identified those two patents as among four patents " for etanercept." J.A. 3146; see J.A. 3129 (press release stating that the '182 patent is " related to Enbrel® " ). Sandoz alleges in its complaint that, " [a]ccording to Amgen, the patents cover . . . 'etanercept,'" J.A. 2002; see Sandoz, 2013 WL 6000069, at *1, although Sandoz alleges that Amgen is wrong, J.A. 2010.

Sandoz needs FDA approval to enter the market with its own etanercept drug, and in 2010 Sandoz began a series of meetings with the FDA to plan for an application based on biosimilarity to Enbrel® . That year, Congress enacted the BPCIA, borrowing from (though not copying) the Hatch-Waxman Act's process for use of an Abbreviated New Drug Application (ANDA), rather than a full New Drug Application, to obtain approval of generic versions of previously approved drugs. E.g., 21 U.S.C. § 355(j). The BPCIA establishes an FDA regulatory-approval process--more abbreviated than the full Biologics License Application process--for biological products that are shown to be " biosimilar" to a " reference product" already approved by the FDA. See 42 U.S.C. § 262(k).[2] On June 24, 2013, after close consultation with the FDA, Sandoz announced a large-scale human (Phase III) trial for its contemplated etanercept product. See 21 C.F.R. § 312.21 (Phase III trials " usually include from several hundred to several thousand subjects" ). This trial, expected to run into 2015, was to be completed before Sandoz filed any application for FDA approval.

The same day that Sandoz began its Phase III trial, Sandoz filed a complaint against Amgen and Hoffman-LaRoche (hereafter collectively " Amgen" ). Sandoz sought a declaratory judgment that " the manufacture, use, sale, offering for sale, or importation of its etanercept product will not infringe, directly or indirectly, any valid claim of" either the '182 or the '522 patent, that both patents are unenforceable due to prosecution laches, and that both patents are invalid. J.A. 2015-18. Sandoz had not--and still has not--filed an application for FDA approval to market an etanercept product.

Amgen moved to dismiss the complaint, arguing, among other things, that the court lacked jurisdiction because no immediate, real controversy between the parties yet existed. The district court granted the motion. It agreed with Amgen that Sandoz had not " established a 'real and immediate injury or threat of future injury'" caused by Amgen and so had not established a case or controversy. Sandoz, 2013 WL ...

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