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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`No. 21 C 2258
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`Judge John Z. Lee
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`ABBVIE INC. and ABBVIE
`BIOTECHNOLOGY LTD,
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`Plaintiffs,
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`v.
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`ALVOTECH HF.,
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`Defendant.
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`MEMORANDUM OPINION AND ORDER
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`Plaintiffs AbbVie Inc. and AbbVie Biotechnology Ltd
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`(collectively
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`“Plaintiffs” or “Abbvie”) filed suit against Defendant Alvotech hf. pursuant to 35
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`U.S.C. § 271(e)(2)(C)(i), seeking injunctive relief to prevent Alvotech hf. from
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`infringing certain patents related to the biologic drug, HUMIRA®. In turn,
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`Alvotech hf., which is an Icelandic corporation, moved to dismiss, arguing that the
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`Biosimilar Price Competition and Innovation Act (“BPCIA”) requires Abbvie to sue
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`Alvotech hf.’s United States subsidiary, Alvotech USA, instead of or in addition to
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`Alvotech hf. And, because Alvotech USA is at home only in the Eastern District
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`of Virginia, Alvotech hf. further argues that this lawsuit must be dismissed for
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`lack of venue. For the following reasons, Alvotech hf.’s motion is denied.
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 2 of 30 PageID #:1197
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`A. HUMIRA®
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`I.
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`Background1
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`HUMIRA® is the first fully human antibody ever approved by the U.S. Food
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`and Drug Administration (“FDA”). Compl. ¶ 1, ECF No. 1. It is used to treat
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`several autoimmune conditions, such as rheumatoid arthritis, psoriatic arthritis,
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`psoriasis, Crohn’s disease (adult and pediatric), and juvenile idiopathic arthritis.
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`Id. ¶ 8.
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` HUMIRA® belongs to a category of drugs known as biologics. Id. ¶ 7.
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`Biologics are comprised of complex proteins manufactured in living cells as
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`opposed to using chemical synthesis, which is how small molecule drugs are
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`derived. Id. Abbvie holds the drug’s Biologic License Application (“BLA”). Id.
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`¶ 20. The development of HUMIRA® has produced a vast portfolio of patents and
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`trade secret manufacturing processes. Id. ¶ 1.
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`B. The Biosimilar Price Competition and Innovation Act of 2009
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`In 2009, Congress passed the BPCIA, which establishes an abbreviated
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`process by which nearly identical biologic drugs—called “biosimilars”—can seek
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`FDA approval and enter the market as generics of an already-approved biologic.
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`Id. ¶ 3. To do so, an applicant submits an abbreviated Biologics License
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`Application (“aBLA”) to the FDA, which provides information about why the
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`generic should be considered a biosimilar of the original drug (the “reference
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`For the reasons discussed below, the Court accepts all well-pleaded facts as true and
`1
`draws all reasonable inferences in Abbvie’s favor.
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`2
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 3 of 30 PageID #:1198
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`product”). See 42 U.S.C. § 262(k). This process is abbreviated because the
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`biosimilar product can piggyback off research establishing that the reference
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`product is “safe, pure, and potent.” Id. § 262(a)(2)(C).
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`The aBLA applicant—known as the “subsection (k) applicant” because the
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`requirements are laid out in 42 U.S.C. § 262(k)—must provide notice of its aBLA
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`to the “reference product sponsor.” Id. § 262(l)(2). Following that notice, the
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`statute requires the subsection (k) applicant and reference product sponsor to
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`engage in an exchange of information about patents covering the reference product
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`and its manufacture, which is known colloquially as the “patent dance.” Id.
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`§ 262(l); see also Alvotech hf.’s Mem. Supp. Mot. Dismiss (“Mot. Dismiss”) at 1,
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`ECF No. 27.
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`As part of the exchange, the subsection (k) applicant must provide “a
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`detailed statement that describes, on a claim by claim basis, the factual and legal
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`basis of the opinion of the subsection (k) applicant that [the relevant] patent is
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`invalid, unenforceable, or will not be infringed by the commercial marketing of the
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`biological product that is the subject of the subsection (k) application.” 42 U.S.C.
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`§ 262(l)(3)(B)(2). Through this process, the parties are encouraged to identify any
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`patent disputes that should be litigated in a declaratory judgment action before
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`the biosimilar drug makes it to the market. See generally id. § 262(l). At the end
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`of the patent dance, if the parties cannot agree on an out-of-court resolution for
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`their patent disputes, the statute instructs the reference product sponsor to bring
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`3
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 4 of 30 PageID #:1199
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`a patent infringement lawsuit with respect to the patents the biosimilar drug
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`would allegedly infringe. Id. § 262(l)(6).
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`When Congress passed the BPCIA in 2009, it was not writing on a blank
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`slate. The BPCIA’s aBLA procedure closely resembles one that was already
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`available under the Hatch-Waxman Act for small molecule drugs. Under the
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`Hatch-Waxman Act, a party seeking approval of a generic small molecule drug
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`may submit an abbreviated New Drug Application (“ANDA”), which piggybacks off
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`research pertaining to an existing small molecule drug, if the ANDA applicant can
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`demonstrate that the two drugs are “bioequivalent.” See 21 U.S.C. § 355(j). Like
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`a subsection (k) aBLA applicant, an ANDA applicant must notify the existing
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`drug’s relevant patent owners about its application, and the notice must “include
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`a detailed statement of the factual and legal basis of the opinion of the applicant
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`that [any relevant] patent[s] [are] invalid or will not be infringed.” 21 U.S.C.
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`§ 355(j)(2)(B).
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`To enable the adjudication of such patent disputes before the ANDA
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`applicant or subsection (k) applicant begins to manufacture, market, or sell its
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`new product, Congress created an “artificial act of infringement,” see Sandoz Inc.
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`v. Amgen Inc., 137 S. Ct. 1664, 1672 (2017), as part of the patent statutes. See 35
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`U.S.C. § 271(e)(2). That section states:
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`It shall be an act of infringement to submit–
`(A) an application under section 505(j) of the Federal
`Food, Drug, and Cosmetic Act or described in section
`505(b)(2) of such Act [i.e., an ANDA] for a drug
`claimed in a patent or the use of which is claimed in
`a patent,
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`4
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 5 of 30 PageID #:1200
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`. . . or
`(C)(i) with respect to a patent that is identified in the
`list of patents described in section 351(l)(3) of the
`Public Health Service Act [i.e., a patent identified in
`the patent dance,] . . . an application seeking approval
`of a biological product [i.e., an aBLA], or
`(ii) if the applicant for the application fails to provide
`the application and information required under
`section 351(l)(2)(A) of such Act
`[i.e.,
`fails to
`participate in the patent dance], an application
`seeking approval of a biological product [i.e., an
`aBLA] for a patent that could be identified pursuant
`to section 351(l)(3)(A)(i) of such Act [i.e., a patent that
`could have been identified in the patent dance],
`if the purpose of such submission
`is to obtain
`approval . . . to engage in the commercial manufacture,
`use, or sale of a . . . biological product claimed in a patent
`or the use of which is claimed in a patent before the
`expiration of such patent.
`35 U.S.C. § 271(e)(2).2
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`Section 271(e)(2) existed prior to the passage of the BPCIA. And the 2009
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`Act amended the statute to add subsection (C) to address biologics.
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`C. The Instant Lawsuit
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`Alvotech hf. is a company organized and existing under the laws of Iceland,
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`with its principal place of business in Reykjavik. Compl. ¶ 27. Alvotech hf. is in
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`the business of developing, manufacturing, marketing, and selling biologic drugs.
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`Id. ¶ 28.
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`Subsection (B) governs applications relating to “a drug or veterinary biological product
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`which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma
`technology, or other processes involving site specific genetic manipulation techniques,” and
`it is not relevant here. See 35 U.S.C. § 271(e)(2)(B).
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`5
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 6 of 30 PageID #:1201
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`Beginning in at least May 2018, Alvotech hf. began clinical trials for a
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`biosimilar to Humira, called AVT02. Id. ¶ 35. In January 2019, Alvotech USA
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`was incorporated under the laws of Virginia to become the “wholly-owned,
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`regulatory affairs, governmental policy and legal subsidiary” of Alvotech hf. Id.
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`¶¶ 33–34
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`(quoting Office
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`Locations,
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`Alvotech,
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`“Our
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`Locations,”
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`https://www.alvotech.com/company/office-locations (last visited April 6, 2021)). In
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`August 2020, Alvotech hf. and Teva Pharmaceuticals announced a strategic
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`partnership for the commercialization of AVT02 in the United States. Id. ¶ 37.
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`In the early fall of 2020, Alvotech USA3 submitted an aBLA seeking FDA
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`approval for AVT02. Compl. ¶ 41; AVT02 aBLA at 1. As required, Alvotech USA
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`notified Abbvie of its application, and the parties engaged in the patent dance.
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`Compl. ¶¶ 44–51. In the end, the two entities identified four patents to be litigated
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`in the first stage of these proceedings, with another sixty-two to be litigated in a
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`second stage of litigation envisioned by the statute (but not relevant to this
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`decision). Id. ¶¶ 49–50; see also 42 U.S.C. § 262(l)(6), (8).
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`Abbvie then filed this patent infringement suit, naming Alvotech hf.—but
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`not Alvotech USA—as the defendant. According to Abbvie, it did so because
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`As noted previously, the Court “accept[s] as true all well-pleaded facts alleged” in
`3
`reviewing a motion to dismiss, see Tamayo, 526 F.3d at 1081. But the Court may also
`“consider documents attached to a motion to dismiss if they are referred to in the plaintiff's
`complaint and are central to his claim,” Brownmark Films, LLC v. Comedy Partners, 682
`F.3d 687, 690 (7th Cir. 2012) (cleaned up). As such, while Abbvie’s complaint does not
`distinguish between Alvotech hf and Alvotech USA when discussing the aBLA and related
`patent dance, the Court has considered the aBLA itself, which is attached to Alvotech hf.’s
`motion to dismiss as Exhibit D. See Mot. Dismiss, Ex. D, Application to Market a New or
`Abbreviated New Drug or Biologic for Human Use (“AVT02 aBLA”), ECF No. 28-4.
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`6
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 7 of 30 PageID #:1202
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`Alvotech hf., not Alvotech USA, is the entity that will engage in the manufacture,
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`commercialization, marketing, and sale of AVT02, if it is approved. By contrast,
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`Alvotech USA is not involved with drug development, manufacturing, or sales. Id.
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`¶ 38. Abbvie also asserts that Alvotech hf. created and prepared the information
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`in the aBLA, even though Alvotech USA appears as the nominal applicant on the
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`form. Id. ¶ 34.
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`Alvotech hf. has moved to dismiss the complaint pursuant to Rules 12(b)(1)
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`(lack of subject matter jurisdiction), 12(b)(2) (lack of personal jurisdiction), 12(b)(6)
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`(failure to state a claim), and 12(b)(7) (failure to join an indispensable party). All
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`four arguments are premised on Alvotech hf.’s contention that Alvotech USA,
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`which is domiciled in Virginia, is the real party in interest and must be joined as
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`a defendant in this case.
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`II. Analysis
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`A.
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`Alvotech’s Invocation of Rule 12(b)(1)
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`Alvotech hf. first argues that the Court lacks subject matter jurisdiction
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`over this case, because Abbvie named the wrong defendant. In Alvotech hf.’s view,
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`the proper defendant is Alvotech USA, not its Icelandic parent corporation. But
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`such an argument is not jurisdictional in nature and is more properly analyzed
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`under Rule 12(b)(6), rather than Rule 12(b)(1).
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`Federal courts have “original jurisdiction of any civil action arising under
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`any Act of Congress relating to patents.” 28 U.S.C. § 1338(a). The Federal Circuit
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`has emphasized that “while Congress can restrict the federal question jurisdiction
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`7
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 8 of 30 PageID #:1203
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`granted in [28 U.S.C.] § 1331 or § 1338, for example by mandating that a certain
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`threshold fact be established in order for the federal court to have jurisdiction over
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`a particular cause of action,” “it is critical to distinguish between a statutory
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`limitation that is truly jurisdictional and one that is simply an element of the claim
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`that must be established on the merits.” Litecubes, LLC v. N. Light Prod., Inc.,
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`523 F.3d 1353, 1361–62 (Fed. Cir. 2008) (citing Arbaugh v. Y&H Corp., 546 U.S.
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`500, 515–16 (2006)).
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`The Supreme Court clarified the difference in Arbaugh v. Y&H Corp., 546
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`U.S. 500. In that case, the plaintiff brought suit under Title VII of the Civil Rights
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`Act of 1964, which “makes it unlawful ‘for an employer . . . to discriminate,’ inter
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`alia, on the basis of sex.” Id. at 503 (quoting 42 U.S.C. § 2000e–2(a)(1)). Title VII
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`defines an “‘employer’ to include only those having ‘fifteen or more employees.’”
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`Id. (quoting 42 U.S.C. § 2000e(b)). The question presented was “whether the
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`numerical qualification contained in Title VII's definition of “employer” affects
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`federal-court subject-matter jurisdiction or, instead, delineates a substantive
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`ingredient of a Title VII claim for relief.” Id.
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`The Supreme Court held that the numerical qualification was not
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`jurisdictional, declaring that “[i]f the Legislature clearly states that a threshold
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`limitation on a statute’s scope shall count as jurisdictional, then courts and
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`litigants will be duly instructed and will not be left to wrestle with the issue. But
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`when Congress does not rank a statutory limitation on coverage as jurisdictional,
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`8
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 9 of 30 PageID #:1204
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`courts should treat the restriction as nonjurisdictional in character.” Id. at 515–
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`16 (citation omitted).
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`In the patent context, the Federal Circuit has held that “[s]ection 271(e)(2)
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`is not a jurisdictional statute in the strict sense of the word.” Allergan, Inc. v.
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`Alcon Lab’ys, Inc., 324 F.3d 1322, 1330 (Fed. Cir. 2003). While “section 271(e)(2)
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`‘provide[s] patentees with a defined act of infringement sufficient to [a] create case
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`or controversy,’” “[o]nce Congress creates an act of infringement, jurisdiction in
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`the district court is proper under 28 U.S.C. § 1338(a).” Allergan, 324 F.3d at 1330
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`(quoting Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997)).
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`“Therefore, section 1338(a) provides for jurisdiction in the district court for [a] suit
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`[under § 271(e)].” Id. Thus, § 271(e) creates a right of action for an artificial act
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`of infringement, while § 1338(a) confers subject matter jurisdiction over the
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`dispute. Id.
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`Astrazeneca Pharmaceuticals LP v. Aurobindo Pharma Ltd., No. CIV.A. 07-
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`810-JJF-LP, 2009 WL 483131 (D. Del. Feb. 25, 2009), is illustrative. There, one of
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`the defendants, Aurobindo USA, argued that it was not a “submit[ter]” within the
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`meaning of § 271(e). It then asserted that this argument “attack[ed] the factual
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`basis for Plaintiffs’ assertion of jurisdiction” under Fed. R. Civ. P. 12(b)(1), and so
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`the court had no duty to accept the complaint’s allegations as true. Id. at *1.
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`The court quickly rejected this argument, holding that “the issue of whether
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`[the defendant] submitted the [abbreviated drug approval] application for
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`purposes of Section 271(e)(2) is a question that goes to the merits of one of the
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`9
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 10 of 30 PageID #:1205
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`elements of Plaintiffs’ infringement claim under Section 271(e)(2),” and so the
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`argument was properly evaluated under Fed. R. Civ. P. 12(b)(6). Id. at *3
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`(considering an ANDA).4
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`As in Astrazeneca, the Court concludes that Alvotech hf.’s argument is not
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`appropriately raised under Rule 12(b)(1), but Rule 12(b)(6). See Thornton v. M7
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`Aerospace LP, 796 F.3d 757, 765 (7th Cir. 2015) (citing Bell v. Hood¸ 327 U.S. 678,
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`682 (1946) (holding that “[j]urisdiction is not defeated by the possibility that the
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`allegations might fail to state a cause of action on which a party could actually
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`recover. . . . [t]he failure to state a proper cause of action calls for judgment on the
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`merits and not a dismissal for want of jurisdiction”)).5 Alvotech hf.’s reliance on
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`Semiconductor Energy Laboratory Co. v. Nagata, 706 F.3d 1365, 1370 (Fed. Cir.
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`2013), is misplaced. In that case, the Federal Circuit held that the plaintiff’s claim
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`for “assignor estoppel” was, in reality, only a defense and did not exist as a
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`standalone right of action. Id. Here, Abbvie relies on § 271(e) to assert its cause
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`Contrary to Alvotech hf.’s assertion, the court’s decision did not hinge on the fact that
`4
`another ANDA applicant was already joined as a defendant; instead, the court relied on the
`decisions in Allergan, 324 F.3d at 1330, Litecubes, 523 F.3d 1353, and Arbaugh, 546 U.S.
`500, as well as § 271(e)’s legislative history, to conclude that there is “no evidence that
`Congress intended the elements of that section to be jurisdictional prerequisites.” Aurobindo,
`2009 WL 483131, at *2.
`5
`Additionally, it is worth noting that Alvotech hf. has not provided any evidence that
`contradicts the relevant factual allegations pertinent to the Court’s exercise of subject matter
`jurisdiction. The letters between Abbvie and Alvotech USA that Alvotech hf. attached to its
`motion are not inconsistent with Abbie’s assertion that Alvotech hf. created and prepared the
`information in the AVT02 aBLA. See Alvotech hf.’s Mot. Dismiss, Exs. A–I, ECF Nos. 21-1
`to 28-9.
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`10
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 11 of 30 PageID #:1206
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`of action. Thus, Alovotech’s hf.’s request to dismiss the case under Rule 12(b)(1)
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`is denied.
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`B. Alvotech hf.’s Motion Under Rule 12(b)(6)
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`Turning to the first of Alvotech hf.’s remaining arguments, it contends that
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`the complaint must be dismissed pursuant to Fed. R. Civ. P. 12(b)(6), because
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`Alvotech hf. did not “submit” the aBLA for AVT02 within the meaning of 35 U.S.C.
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`§ 271(e)(2).
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`1.
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`Legal Standard
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`A motion to dismiss under Rule 12(b)(6) challenges whether a plaintiff’s
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`complaint “contain[s] sufficient factual matter . . . to ‘state a claim to relief that is
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`plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl.
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`Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “A claim has facial plausibility when
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`the plaintiff pleads factual content that allows the court to draw the reasonable
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`inference that the defendant is liable for the misconduct alleged.” Id.
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`When “reviewing the sufficiency of a complaint under the plausibility
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`standard,” courts “accept the well-pleaded facts in the complaint as true.” Alam
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`v. Miller Brewing Co., 709 F.3d 662, 665–66 (7th Cir. 2013). At the same time,
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`“allegations in the form of legal conclusions are insufficient to survive a Rule
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`12(b)(6) motion.” McReynolds v. Merrill Lynch & Co., Inc., 694 F.3d 873, 885 (7th
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`Cir. 2012) (citing Iqbal, 556 U.S. at 678).
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`11
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 12 of 30 PageID #:1207
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`
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`2. Discussion
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`A claim for patent infringement “has long been understood to require no
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`more than the unauthorized use of a patented invention.” Glob.-Tech Appliances,
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`Inc. v. SEB S.A., 563 U.S. 754, 761 n.2 (2011) (distinguishing between direct and
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`induced infringement). As discussed above, 35 U.S.C. § 271(e)(2)(C) provides that
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`it is an act of infringement “to submit . . . an [aBLA] seeking approval of a
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`biological product . . . if the purpose of such submission is to obtain approval . . .
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`to engage in the commercial manufacture, use, or sale of a . . . biological product
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`claimed in a patent or the use of which is claimed in a patent before the expiration
`of such patent.”
`Keying off this language, Alvotech hf. asserts that Alvotech USA—not
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`Alvotech hf.— is the entity that “submit[ted]” the aBLA within the meaning of 35
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`U.S.C. § 271(e)(2)(C), because Alvotech USA is listed as the subsection (k)
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`applicant on the aBLA form. See AVT02 aBLA at 1. As Alvotech hf. sees it,
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`because it is not listed as the subsection (k) applicant on the aBLA form, it cannot
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`be the “submit[ter]” of the aBLA under 35 U.S.C. § 271(e)(2)(C).
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`In response, Abbvie points to a number of courts that have adopted a broader
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`interpretation of the word “submit” as it appears in § 271(e)(2), albeit in the
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`context of the Hatch-Waxman Act (that is, in cases involving § 271(e)(2)(A), rather
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`than § 271(e)(2)(C)). For example, in Allergan, Inc. v. Teva Pharmaceuticals USA,
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`Inc., No. 2:15-cv-1455-WCB, 2016 WL 1572193 (E.D.Tex. Apr. 19, 2016), Mylan
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`Pharmaceuticals Inc., a wholly-owned subsidiary of Mylan Inc., argued the parent
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`12
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 13 of 30 PageID #:1208
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`company should be dismissed from the patent infringement suit because the
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`subsidiary—not the parent company—had signed and filed the ANDA. Reciting
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`Allergan’s allegation that the Mylan subsidiary and the parent worked in concert
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`to develop, market, and distribute Mylan’s pharmaceutical products, the district
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`court denied the motion, holding that “[a]n entity submits an ANDA if it
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`participates in the preparation of the ANDA and intends to benefit directly from
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`the ANDA by selling the ANDA product upon approval.” Id. at *5.
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`Similarly, in Endo Pharmaceuticals Inc. v. Actavis Inc., No. 14-1381-RGA,
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`2017 WL 522825 (D. Del. Feb. 8, 2017), a defendant, Teva Pharmaceuticals, argued
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`that it was improperly sued under § 271(e)(2), because its subsidiary had applied
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`for the ANDA and, therefore, Teva could not be considered the entity that
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`“submitted” the application. The district court made short shrift of this argument,
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`noting that “[t]here is no explicit requirement in § 271(e) that a party must have
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`prepared or filed the ANDA itself in order to be a proper defendant.” Id. at *1.
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`And, given the “allegations that Defendant Teva is the owner and real party in
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`interest of the ANDA and will benefit from the ANDA if it is approved,” the court
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`denied Teva’s motion. Id.; see also Otsuka Pharms. Co., Ltd., v. Hetero USA, Inc.,
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`No. 19-1954-LPS, 2020 WL 6822971, at *2 (D. Del. Nov. 20, 2020) (holding that
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`“whether the entity is a submitter depends on whether it is also going to engage
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`in the commercial manufacture, use, or sale of the proposed generic product” and
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`whether the entity will “financially benefit, in a significant manner, from the
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`FDA’s approval of the application” (cleaned up)).
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`13
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 14 of 30 PageID #:1209
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`These district court decisions all are grounded in In re Rosuvastatin
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`Calcium Patent Litigation, 703 F.3d 511 (Fed. Cir. 2012). In that case, the
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`plaintiff, a brand-name drug manufacturer, brought a patent infringement suit
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`against Apotex U.S., a subsidiary of Apotex Canada, under § 271(e)(2)(A). See id.
`
`at 527. Apotex U.S. moved to dismiss the case, arguing that it merely signed the
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`ANDA in its capacity as the agent of its parent corporation, Apotex Canada, the
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`actual entity that would be developing and manufacturing the generic drug. Based
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`on this, Apotex U.S. argued, it was not a “submit[ter]” within the meaning of
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`§ 271(e)(2)(A).
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`The Federal Circuit disagreed, adopting the district court’s holding that:
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`a wholly-owned subsidiary of a foreign ANDA applicant,
`which signs an ANDA as the agent of its parent-
`applicant, and which intends to benefit directly if the
`ANDA is approved by participating in the manufacture,
`importation, distribution and/or sale of the generic drug
`[i]s subject to suit under § 271(e) as the one who has
`“submitted” the ANDA.
`Id. at 528 (citation omitted). In doing so, the Federal Circuit rejected Apotex U.S.’s
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`argument that the court should look to the statute creating the ANDA process, 21
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`U.S.C. § 355(j), and its implementing regulation, 21 C.F.R. § 314.3(b), to construe
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`the meaning of “submit” for the purposes of § 271(e)(2). Id.6
`
`
`This is not altogether surprising given that both 35 U.S.C. § 355 and 21 C.F.R. §
`6
`314.3(b) tend to define “applicant” as someone who “submits” an application, leading to a
`circular argument. See, e.g., 21 U.S.C. §355(b)(1)(A) (noting that an applicant shall “submit”
`to the Secretary as part of the application certain materials); 21 C.F.R. § 314.3(b) (“Applicant
`is any person who submits an [application] or ANDA or an amendment or supplement to an
`NDA or ANDA under this part to obtain FDA approval of a new drug and any person who
`owns an approved [application] or ANDA.”).
`
`
`
`14
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`
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 15 of 30 PageID #:1210
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`Here, Alvotech hf. attempts to distinguish Rosuvastatin, arguing that
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`Rosuvastatin and the above-referenced district cases involved an ANDA
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`application submitted pursuant to the Hatch-Waxman Act, not an aBLA submitted
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`pursuant to the BPCIA, as we have here. But the word “submit” appears in the
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`general section of § 271(e)(2) and applies equally to § 271(e)(2)(A) (the Hatch-
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`Waxman Act) and § 271(e)(2)(C) (the BPCIA). Under Alvotech hf.’s approach, the
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`same word would have two different meanings, violating the basic rule of statutory
`
`construction that “identical words used in different parts of the same statute are
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`presumed to have the same meaning.” See Robers v. United States, 572 U.S. 639,
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`643 (2014) (cleaned up).7
`
`Alvotech hf. also argues that because, under the BPCIA, a party must
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`participate in the patent dance before it is permitted to file a patent infringement
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`action, the only parties that can be sued are the ones who previously engaged in
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`the dance. But the language of the BPCIA itself does not bear this out. For
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`example, § 262(l)(6) states:
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`If the subsection (k) applicant and the reference product
`sponsor [engage in the patent dance and identify which
`patents to litigate], the reference product sponsor shall
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`Additionally, Alvotech hf. points out that this case is unique, because Abbvie has
`7
`chosen not to sue the actual entity that signed the subsection (k) applicant, while, in the
`Hatch-Waxman cases discussed above, the actual applicant was joined as a defendant. But,
`as discussed below, nothing in § 271(e)(2) or § 262(l) requires that the actual signatory to the
`application be so joined. In fact, in Adverio Pharma GmbH v. Alembic Pharms. Ltd., No. CV
`18-73-LPS, 2019 WL 581618, at *5 (D. Del. Feb. 13, 2019), the district court concluded that
`an entity that “merely assists in collecting materials for submission to the FDA, signs the
`ANDA, presents the ANDA to the FDA for approval, and acts in an ongoing manner as the
`liaison between the FDA and the applicant during the regulatory process, but will have no
`involvement with the ANDA product following FDA approval” was not a submitter for the
`purposes of § 271(e)(2).
`
`
`
`15
`
`
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 16 of 30 PageID #:1211
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`bring an action for patent infringement with respect to
`each such patent.
`42 U.S.C. § 262(l)(6).8 Neither it nor any other provision in BPCIA mandates that
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`the reference product sponsor sue the entity that actually signed and filed the
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`subsection (k) application.
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`Now, it is true that § 262(l)(8)(B) states that “the reference product sponsor
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`may seek a preliminary injunction prohibiting the subsection (k) applicant from
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`engaging in the commercial manufacture or sale” of the biosimilar drug in
`
`question. 42 U.S.C. § 262(l)(8)(B) (emphasis added). But this does not help
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`Alvotech hf. either. First, the language is permissive, not mandatory. Second, the
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`statute defines a “subsection (k) applicant” as “a person that submits an
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`application under subsection (k),” 42 U.S.C. § 262(l)(1)(A) (emphasis added),
`
`leading back to the question of what “submit” means in the context of the BPCIA.
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`Third, under Alvotech hf.’s construction, in a case where the corporate entity that
`
`files the subsection (k) application is not involved in the manufacture of the
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`biosimilar drug or its sale (take, for example, a wholly owned subsidiary that is
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`only tasked with obtaining the necessary legal and regulatory approvals),
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`§ 262(l)(8)(B) would preclude the reference product sponsor from obtaining any
`
`
`The Court has elided subsections (i) and (ii) of 42 U.S.C. § 262(l)(6), which provide for
`8
`the situation where the subsection (k) applicant and the reference product sponsor agree on
`which patents to litigate first, and the situation in which they do not agree. The language
`quoted above is the same in both subsections.
`
`
`
`16
`
`
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 17 of 30 PageID #:1212
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`preliminary injunctive relief at all. Congress could not have intended such a
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`nonsensical result.9
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`Furthermore, Alvotech hf.’s argument that direct participation in the patent
`
`dance is a prerequisite to being sued ignores the fact that the BPCIA specifically
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`authorizes the reference product sponsor to file suit even when the patent dance
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`does not occur. See 42 U.S.C. § 262(l)(9) (permitting “the reference product
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`sponsor, but not the subsection (k) applicant, [to] bring an action . . . for a
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`declaration of infringement, validity, or enforceability of any patent that claims
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`the biological product or a use of the biological product” where the applicant fails
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`to provide the information required under the Act).
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`Finally, the Supreme Court’s decision in Sandoz Inc. v. Amgen Inc., 137 S.
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`Ct. 1664 (2017), is helpful to this analysis. The question presented was whether,
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`in the event that the subsection (k) applicant failed to notify the reference product
`
`
`Alvotech hf. also points out that 42 U.S.C. § 262(l)(6)(C)(i) states: “Not later than 30
`9
`days after a complaint is served to a subsection (k) applicant in an action for patent
`infringement described under this paragraph, the subsection (k) applicant shall provide the
`Secretary with notice and a copy of such complaint.” According to Alvotech hf., this implies
`that the subsection (k) applicant must be a party to this lawsuit. But this is unpersuasive
`for several reasons. First, this case was filed over thirty days ago, and no party has asserted
`that notice was not provided in accordance with that section, regardless of the fact that
`Alvotech USA is not a defendant. Furthermore, as noted above, because 42 U.S.C.
`§ 262(l)(1)(A) defines the subsection (k) applicant as one who “submits an application,” this
`provision does not compel the conclusion that Alvotech USA is the only entity responsible for
`providing the described notice. Finally, the Court notes that, in a similar situation under the
`Hatch-Waxman Act, where an entity that was dismissed as a defendant was responsible for
`notifying the FDA when a judgment was entered, the court solved the problem by noting that
`“[s]hould this case result in entry of judgment against Alembic, and should INC continue not
`to be a party, [the plaintiff] may ask the Court to exercise whatever authority it has over
`Alembic to ensure that the FDA receives the required notice of judgment.” See Adverio, 2019
`WL 581618, at *6.
`
`
`
`
`
`17
`
`
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`Case: 1:21-cv-02258 Document #: 51 Filed: 08/23/21 Page 18 of 30 PageID #:1213
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`sponsor about the aBLA as mandated by 42 U.S.C. § 262(l)(2)(A), the jilted
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`reference product sponsor could sue for injunctive relief to require production of
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`the aBLA and manufacturing information. Id. at 1669. In the end, the Supreme
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`Court determined that the Federal Circuit incorrectly concluded that a subsection
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`(k) applicant’s failure to disclose its aBLA was an element of the act of artificial
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`infringement under § 271(e)(2). Id. at 1674. In reaching its conclusion, the
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`Federal Circuit had focused on the language in § 271(e)(2)(C)(ii):
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`“[i]t shall be an act of infringement to submit[,] if the
`applicant for the application fails to provide the
`application
`and
`information
`required
`under
`[§ 262(l)(2)(A)], an application seeking approval of a
`biological product for a patent that could be identified
`pursuant to [§ 262(l)(3)(A)(i)]”
`Id. (emphasis in ori