Case: 1:21-cv-02899 Document #: 1 Filed: 05/28/21 Page 1 of 308 PageID #:1
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`UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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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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`Civil Action No. 1:21-cv-02899
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`COMPLAINT
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`INTRODUCTION
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`1.
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`This is the second action for patent infringement that AbbVie Inc. and AbbVie
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`Biotechnology Ltd (“ABL,” collectively referred to as “AbbVie” or “Plaintiffs”) have brought
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`against Alvotech hf. (“Alvotech”) under the Biosimilar Price Competition and Innovation Act of
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`2009 (“BPCIA”) in connection with Alvotech’s proposed biosimilar version of AbbVie’s ground-
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`breaking drug HUMIRA®. AbbVie brought the first action in this District on April 27, 2021, to
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`adjudicate Alvotech’s infringement of four AbbVie patents that Alvotech selected for the first
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`phase of litigation prescribed by the BPCIA. See AbbVie Inc. and AbbVie Biotechnology Ltd v.
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`Alvotech hf., Civ. No. 1:21-cv-02258 (N.D. Ill. Apr. 27, 2021) (Lee, J.). Rather than answer or
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`otherwise respond to that complaint, however, Alvotech sought an end-run around AbbVie’s
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`choice of forum by filing a declaratory judgment action on those same four patents in the Eastern
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`District of Virginia on May 11, 2021. Alvotech USA Inc. and Alvotech hf. v. AbbVie Inc. and
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`AbbVie Biotechnology Ltd, Civ. No. 2:21-cv-00265 (E.D. Va. May 11, 2021) (Jackson, J.).
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`Alvotech’s filing and additional actions, discussed below, have triggered this second suit under
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`the BPCIA to protect AbbVie’s rights and promote the orderly disposition of all the patent
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`infringement issues raised by Alvotech’s proposed biosimilar product.
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`2.
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`AbbVie’s patents at issue in this suit and in the first-filed BPCIA action already
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`pending in this District result from decades of work by AbbVie’s scientists and clinicians
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`developing HUMIRA®—the first fully human antibody ever approved by the U.S. Food and Drug
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`Administration (“FDA”)—and expanding its use into a variety of diseases and patient populations,
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`as well as launching a new, higher-concentration, citrate-free formulation with reduced injection
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`volume and pain upon injection. Over one million patients have benefited from AbbVie’s
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`pioneering work, which also has produced a robust portfolio of patents and trade secrets, including
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`trade secret manufacturing processes.
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`3.
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`Numerous biosimilar companies—now including Alvotech—have taken note of
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`AbbVie’s success as well, attempting to make biosimilar versions of HUMIRA®. Ultimately, each
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`of the prior biosimilar applicants recognized the strength of the portfolio and sought licenses from
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`AbbVie. AbbVie settled with each, allowing market entry years before expiration of many of its
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`patents. As a result, biosimilar versions of HUMIRA® will enter the U.S. market in 2023.
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`4.
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`AbbVie’s HUMIRA® patent portfolio is also notable for its proven quality.
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`Numerous biosimilar makers have previously filed a total of 20 inter partes review (“IPR”)
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`petitions challenging 14 of AbbVie’s patents at the Patent Trial and Appeal Board (“PTAB”) of
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`the United States Patent and Trademark Office (“USPTO”). Despite the lower burden of proof
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`compared to district court proceedings (a preponderance of the evidence rather than clear and
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`convincing evidence and, at the time, a broad claim construction standard) and the high
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`invalidation rate in IPRs, AbbVie prevailed on nine of its patents in 13 IPRs, with challenges to
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`two more patents withdrawn. Ultimately, each of the prior biosimilar applicants recognized the
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`strength of the portfolio and sought licenses from AbbVie.
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`5.
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`Of particular relevance, the PTAB has already rejected five petitions challenging
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`the validity of AbbVie patents at issue in this proceeding. Specifically, the PTAB rejected a
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`petition challenging the validity of U.S. Patent No. 8,911,737, directed to treatment of Crohn’s
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`disease. The PTAB also rejected a petition challenging the validity of U.S. Patent No. 9,187,559,
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`directed to induction dosing to treat Crohn’s disease. The PTAB similarly rejected a petition
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`challenging the validity of U.S. Patent No. 8,974,790, directed to treatment of ulcerative colitis.
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`The PTAB also rejected two petitions challenging the validity of U.S. Patent No. 9,512,216,
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`directed to treatment of chronic plaque psoriasis.
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`6.
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`AbbVie’s investment in HUMIRA® development includes over 100 clinical trials
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`and has resulted in FDA approval for the treatment of 13 different disease conditions, including
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`rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease (adult
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`and pediatric), ulcerative colitis (adult and pediatric), hidradenitis suppurativa (adult and
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`pediatric), uveitis (adult and pediatric), and juvenile idiopathic arthritis. AbbVie has continued to
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`dedicate substantial resources to an extensive clinical trial program, including research specifically
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`to benefit children. For example, in February of this year, AbbVie received FDA approval to treat
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`pediatric patients living with moderately to severely active ulcerative colitis, making HUMIRA®
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`the first and only subcutaneous biologic treatment option for pediatric patients five years and older
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`with this condition.
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`7.
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`AbbVie also has continued to improve and develop the HUMIRA® product itself.
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`First, AbbVie invested in and created a subcutaneous, high concentration, liquid formulation of
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`the HUMIRA® antibody. Before AbbVie’s launch of HUMIRA®, patients had to go to the hospital
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`to receive their medicine intravenously, or mix batches of their medicine at home (difficult for
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`patients with inflamed joints) and inject themselves twice a week. As a result of AbbVie’s
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`dedication, innovation, and investment, patients were able to inject the medicine at home using
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`pre-filled syringes or automatic injection devices, and take fewer injections. The added
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`convenience and precision improved patients’ lives and increased compliance, all without
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`sacrificing HUMIRA®’s outstanding efficacy.
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`8.
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`But AbbVie did not stop there. Through continuing investment into formulation
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`research, AbbVie developed a new, higher-concentration (100 mg/mL), citrate-free formulation
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`with reduced pain upon injection. AbbVie’s inventive new formulation leverages the surprising
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`inventions patented by AbbVie researchers, namely that the active ingredient, adalimumab, can be
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`formulated at high concentrations without a buffer, while maintaining solubility and stability—
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`including during long-term storage or other processing steps. It is this latest innovative
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`formulation that Alvotech seeks to copy. Alvotech’s founder and Chairman—Robert Wessman—
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`explained earlier this year how Alvotech monitored and sought to replicate AbbVie’s advances,
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`switching gears from a 50 mg/mL concentration copy of adalimumab to a 100 mg/mL high-
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`concentration version as soon as Alvotech “heard that AbbVie was getting ready to launch
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`100mg.” Wallace, David, “Celltrion Wins Global First Approval For High-Concentration Humira
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`Biosimilar,” Generics Bulletin (Feb. 15, 2021), attached as Exhibit 1 (“We were actually active in
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`developing 50mg three or four years back,” Wessman noted, but “when we heard that AbbVie was
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`getting ready to launch 100mg we stopped that and started to focus only on 100mg. We did not
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`even consider 50mg any more.”).
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`9.
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`AbbVie has also spent many years developing and improving the complex
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`manufacturing processes for HUMIRA® and its active ingredient, adalimumab. Unlike traditional
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`drugs, HUMIRA® is a complex biologic created in living organisms. So even minor changes to
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`the manufacturing process can impact the drug’s stability, purity, and efficacy. AbbVie obtained
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`patents and developed trade secrets covering innovations in manufacturing.
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`10.
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`In late 2020, Alvotech filed its abbreviated Biologics License Application
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`(“Alvotech’s aBLA”) seeking FDA approval to launch its own biosimilar of HUMIRA®.
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`11.
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`The BPCIA permits Alvotech to file its aBLA, but it does so only in tandem with a
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`specific framework for innovator companies like AbbVie to litigate their patents before a would-
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`be biosimilar applicant launches its product. In particular, the BPCIA contemplates two waves of
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`litigation. The first wave follows an exchange between the parties under 42 U.S.C. § 262(l)(3) of
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`information about the biosimilar applicant’s proposed product and the reference product sponsor’s
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`patents that the biosimilar product would infringe. After that exchange, the biosimilar applicant
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`can elect how many (and which) of the reference product sponsor’s patents it would like to litigate
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`in the first wave. 42 U.S.C. § 262(l)(4)-(6). The second wave of litigation, which may involve
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`additional patents, is not triggered until the biosimilar applicant provides its notice of commercial
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`marketing, after which the reference product sponsor may sue for relief on its remaining patents.
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`42 U.S.C. § 262(l)(8)-(9).
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`12.
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`Alvotech chose to litigate only four patents in the first wave, despite the fact that
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`AbbVie identified 62 patents that would be infringed by Alvotech’s biosimilar product. See
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`AbbVie Inc. and AbbVie Biotechnology Ltd v. Alvotech hf., Civ. No. 1:21-cv-02258 (N.D. Ill. Apr.
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`27, 2021) (Lee, J.). Yet, Alvotech then abandoned the BPCIA’s procedures by seeking to litigate
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`the same four patents in a declaratory judgment action in a different federal court after AbbVie
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`filed its first BPCIA-prescribed suit. On the same day it filed its Eastern District of Virginia
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`complaint, Alvotech provided AbbVie with Alvotech’s notice of commercial marketing under 42
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`U.S.C. § 262(l)(8)(A).
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`13.
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`Filing a separate suit on the same patents in an effort to change courts is improper,
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`particularly given that Alvotech has yet to even respond to AbbVie’s complaint in this District.
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`While Alvotech argues to the court in the Eastern District of Virginia that jurisdiction in the
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`Northern District of Illinois is improper (which is incorrect), it has not lodged any such arguments
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`here, embarking instead on its forum-shopping gambit.
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`14.
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`Alvotech’s attempt to forum-shop is not the first time it has shown its unwillingness
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`to adhere to the requirements of the BPCIA. As part of the exchanges under 42 U.S.C. § 262(l)(3),
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`Alvotech was required to provide not only its aBLA, but also its manufacturing information to
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`AbbVie. See 42 U.S.C. § 262(l)(2)(A) (applicant shall provide “such other information that
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`describes the process or processes used to manufacture the biological product that is the subject of
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`such application”). Despite multiple requests, Alvotech failed to fulfill its obligations and disclose
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`necessary manufacturing information for its biosimilar product. Instead of properly investigating
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`its own records, Alvotech in many instances provided incomplete information, hedging its
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`disclosures about its own product and processes with statements like “upon information and
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`belief” and “as will be confirmed through further discovery.”
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`15.
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`Nor are Alvotech’s refusals to adhere to the BPCIA framework the only shortcuts
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`Alvotech has taken to make up for its own delays in developing its biosimilar product. On
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`March 19, 2021, AbbVie filed suit against Alvotech for theft of trade secrets related to the
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`commercial manufacturing process for HUMIRA®, crucial to launching a new manufacturing
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`facility. AbbVie Inc. and AbbVie Biotechnology Ltd v. Alvotech hf., Civ. No. 1:21-cv-01530, Dkt.
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`1 at ¶¶ 3, 5, 28, 30 (N.D. Ill. Mar. 19, 2021) (Leinenweber, J.). Manufacturing a biologic drug—
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`particularly on a commercial scale—requires complex and finely tuned manufacturing techniques
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`that are distinct from the manufacturing, formulation, and indication inventions in AbbVie’s patent
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`portfolio. AbbVie invested substantial time and expertise to develop, scale, and fine-tune its
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`proprietary high-volume manufacturing processes, and carefully guards this trade secret
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`information—including sharing it with its employees only on a need-to-know basis.
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`16.
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`Instead of investing the necessary time and resources to develop its own
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`manufacturing process for its biosimilar version of HUMIRA®, Alvotech surreptitiously acquired
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`AbbVie’s confidential and proprietary trade secrets, including by hiring at least one such
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`employee: Rongzan Ho, a Team Leader for upstream manufacturing at AbbVie, who
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`circumvented AbbVie’s security protocols to email himself AbbVie manufacturing trade secrets
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`before leaving to join Alvotech in the very same role. Id. at ¶¶ 3, 40, 58, 63. Just before leaving
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`AbbVie, for Alvotech’s benefit and at its direction, Mr. Ho transmitted AbbVie’s confidential and
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`proprietary trade secret information—including voluminous Excel spreadsheets full of sensitive
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`manufacturing data—to his personal email account. Id. at ¶¶ 54-64. These confidential materials
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`contained detailed and closely guarded information concerning AbbVie’s upstream manufacturing
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`process for HUMIRA® which AbbVie had developed over decades of research. Id. Alvotech then
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`installed Mr. Ho in the precisely the same role, supervising upstream manufacturing of the exact
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`same product (AVT02, Alvotech’s copy of HUMIRA®), for the purpose of using and benefitting
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`from Mr. Ho’s intimate knowledge of AbbVie’s trade secrets. Id. at ¶¶ 54-64, 89.
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`17.
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`Now, Alvotech’s decision to provide its notice of commercial marketing pursuant
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`to 42 U.S.C. § 262(l)(8)(A) indicates that Alvotech may attempt to market its biosimilar version
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`of HUMIRA® at-risk before resolution of AbbVie’s related patent infringement action in this
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`District.1 Under the BPCIA, that notice of commercial marketing also triggers this declaratory
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`judgment action so AbbVie can enforce the 58 patents that Alvotech declined to litigate in both
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`the related action in this District and its improper declaratory judgment action in the Eastern
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`District of Virginia. 42 U.S.C. § 262(l)(8)-(9). The fact that Alvotech seeks to market its
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`biosimilar version of HUMIRA® potentially before the expiration of AbbVie’s patents and before
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`the conclusion of AbbVie’s related patent infringement action reinforces that there is a substantial
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`controversy, between parties having adverse legal interests, of sufficient immediacy and reality to
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`warrant relief, including in the form of a preliminary injunction.
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`NATURE OF THE ACTION
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`18.
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`19.
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`Plaintiffs for their Complaint against Alvotech further allege as follows:
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`This civil action arises under the Patent Laws of the United States, 35 U.S.C. §§ 1,
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`et seq., including 35 U.S.C. § 271(a)-(c), (e)(2)(C), and (g), the BPCIA, including 42 U.S.C.
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`§ 262(l), and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202.
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`20.
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`This lawsuit results from Alvotech’s infringement of AbbVie patents that concern
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`AbbVie’s groundbreaking drug, HUMIRA®.
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`21.
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`AbbVie Inc. is the holder of Biologic License Application (“BLA”) No. 125057 for
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`HUMIRA®, whose active pharmaceutical ingredient is the antibody, adalimumab.
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`22.
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`In 1996, after many years of intense research, AbbVie’s predecessor first created
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`adalimumab. Adalimumab, a biologic, is a fully human, high-affinity, and neutralizing therapeutic
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`antibody against human TNF-α, a protein made by the human body as part of the body’s immune
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`response. The mechanisms by which TNF-α affects the body are complex and not completely
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`1 AbbVie intends to move to consolidate this action with AbbVie Inc. and AbbVie Biotechnology
`Ltd v. Alvotech hf., Civ. No. 1:21-cv-02258 (N.D. Ill. Apr. 27, 2021) (Lee, J.).
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`understood (even today). Inventing the adalimumab antibody itself, however, was only the first
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`step in a long process. Following the isolation and characterization of adalimumab, AbbVie and
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`its predecessors spent more than two decades and hundreds of millions of dollars on scientific
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`studies and clinical trials to determine how to use HUMIRA® to treat patients for different diseases,
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`how to formulate HUMIRA® for easier administration, how to improve and further develop the
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`formulation, how to manufacture HUMIRA®, and how to develop devices for administration.
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`AbbVie’s scientific and clinical investments in HUMIRA® continue to this day—leading, for
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`example, to the February 2021 approval of HUMIRA® to treat pediatric patients living with
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`moderately to severely active ulcerative colitis.
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`23.
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`AbbVie’s innovative work has been recognized by the medical and scientific
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`community. For example, in 2007, HUMIRA® was awarded the Galien Prize, perhaps the most
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`prestigious honor in the pharmaceutical and biotechnology world.
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`24. More importantly, AbbVie’s work has benefited patients immensely. Children
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`have gone from wheelchairs to playgrounds, and adults have gone from bed to work. AbbVie is
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`very proud of the fact that HUMIRA® has improved the lives of more than one million patients to
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`date.
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`25.
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`Although Alvotech had the option of litigating all (or any subset) of the patents
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`identified by AbbVie during the exchanges required under the BPCIA, Alvotech chose instead to
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`limit the initial lawsuit to only four of AbbVie’s 62 identified patents. Alvotech then chose to
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`serve a notice of commercial marketing and file a duplicative lawsuit on those same four patents
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`in the Eastern District of Virginia. Pursuant to the BPCIA, AbbVie now brings this suit seeking
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`additional relief, including an injunction, on the remaining patents based on Alvotech’s notice of
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`commercial marketing.
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`PARTIES
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`26.
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`Plaintiff AbbVie Inc. is a corporation organized and existing under the laws of
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`Delaware with its corporate headquarters at 1 North Waukegan Road, North Chicago, Illinois
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`60064. AbbVie Inc. owns patents relating to HUMIRA® and owns Biologics License Application
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`No. 125057 for HUMIRA®. AbbVie Inc. also employs thousands of people in Illinois—including
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`named inventors of the patents in suit—and is engaged in the development, sale, and distribution
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`of a broad range of pharmaceutical and biologic drugs, including HUMIRA®. Indeed, HUMIRA®
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`was developed and is marketed under the leadership of AbbVie’s management in Illinois.
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`27.
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`Plaintiff ABL is a corporation organized and existing under the laws of Bermuda,
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`with a place of business at 4th Floor, Washington House, 16 Church Street, Hamilton HM11,
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`Bermuda. Through intermediate organizations, Plaintiff AbbVie Inc. owns Plaintiff ABL. ABL
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`has licensed its patents relating to HUMIRA® to AbbVie Inc. and also maintains extensive business
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`relationships with AbbVie Inc., including supplying AbbVie Inc. with HUMIRA® for marketing.
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`28.
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`On information and belief, Defendant Alvotech is a company organized and
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`existing under the laws of the Republic of Iceland, with its principal place of business at
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`Sæmundargata 15-19, 101 Reykjavík, Iceland.
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`29.
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`Alvotech is in the business of developing, manufacturing, marketing, and selling
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`biosimilar drugs, including the proposed biosimilar version of AbbVie’s HUMIRA® (adalimumab)
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`product, AVT02. Alvotech has taken steps to enable AVT02 to be distributed and sold in the State
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`of Illinois, including in this District, and throughout the United States.
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`JURISDICTION AND VENUE
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`30.
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`This is an action for patent infringement under the Patent Laws of the United States,
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`35 U.S.C. §§ 1, et seq., including 35 U.S.C. § 271(a)-(c), (e)(2)(C), and (g), the BPCIA, including
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`42 U.S.C. § 262(l), and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202. This Court has
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`subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201(a), and 2202.
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`31.
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`This Court has personal jurisdiction over Alvotech for at least the reasons set forth
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`below.
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`32.
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`Alvotech has purposefully directed activities at residents of Illinois and this
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`District, and this action arises out of and relates to those activities. For example, Alvotech has
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`taken the costly, significant step of submitting Alvotech’s aBLA to the FDA seeking approval to
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`engage in the commercial manufacture, use, sale, and/or distribution of the Alvotech aBLA
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`Product in Illinois, including in this District, and Alvotech will do so upon approval of its aBLA.
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`The submission of Alvotech’s aBLA is therefore tightly tied, both in purpose and planned effect,
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`to the deliberate making of sales of Alvotech’s aBLA Product in Illinois, including in this District,
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`and reliably indicates that Alvotech’s aBLA Product will be marketed in Illinois, including in this
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`District. Furthermore, Alvotech sent Alvotech’s aBLA to AbbVie Inc. at its corporate
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`headquarters in North Chicago, Illinois. Alvotech also provided notice of commercial marketing
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`indicating its intent to market its product nationwide, including in this District.
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`33.
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`Alvotech prepared and submitted Alvotech’s aBLA and intends to directly benefit
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`from the sale of the Alvotech aBLA product. Prior to the submission of Alvotech’s aBLA (and
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`prior to the formation of its wholly-owned U.S. subsidiary, Alvotech USA), Alvotech met with the
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`FDA regarding Alvotech’s AVT02. Alvotech prepared, created, approved, and/or assembled
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`documentation in support of Alvotech’s aBLA. Alvotech then directed Alvotech USA to act as its
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`agent between the FDA and Alvotech during the regulatory process.
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`34.
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`Alvotech USA is the “wholly-owned, regulatory affairs, governmental policy and
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`legal subsidiary” of Alvotech.
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` See Office Locations, Alvotech, “Our Locations,”
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`https://www.alvotech.com/company/office-locations (last visited April 6, 2021), attached as
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`Exhibit 2. On information and belief, Alvotech USA is a small company that is not involved with
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`drug development, manufacturing, marketing, or sales. On information and belief, Alvotech USA
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`only has one office with a few thousand square feet on part of one floor of an office building, and
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`has fewer than 15 employees—none of whom are manufacturing, sales, or marketing employees,
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`but rather work in legal or regulatory positions.
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`35.
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`Alvotech, not Alvotech USA, created and prepared the information in the aBLA.
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`Indeed, at least one clinical trial for AVT02 began before Alvotech USA even came into existence,
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`and Alvotech communicated and/or met with the FDA before beginning that trial. Compare
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`ClinicalTrials.gov, “Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02
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`(100MG/ML)
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`and Humira
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`(100MG/ML)
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`in Healthy Volunteers
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`(ALVOPAD),”
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`https://clinicaltrials.gov/ct2/show/NCT03579823?term=AVT02&draw=2&rank=1 (last visited
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`Mar. 10, 2021), attached as Exhibit 3 (study start date - May 21, 2018) with Exhibit 4 (Alvotech
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`USA incorporated on January 11, 2019). Alvotech has also stated that its aBLA “filings were
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`based on the results of a comprehensive development program and data package comprising of a
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`totality of evidence demonstrating a high degree of similarity of AVT02 compared to its reference
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`product.” See Press Release, Alvotech, “Alvotech announces that the U.S. FDA and EMA have
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`accepted regulatory submissions for AVT02, a proposed biosimilar to Humira® (adalimumab),”
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`Nov. 19, 2020, https://www.alvotech.com/newsroom/alvotech-announces-that-the-u.s.-fda-and-
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`ema-have-accepted, attached hereto as Exhibit 5.
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`36.
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`To support its aBLA, Alvotech submitted data generated by clinical trials to the
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`FDA. See 42 U.S.C. § 262(k)(2)(A)(i)(I)(cc) (“An application . . . shall include information
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`demonstrating that — the biologic product is a biosimilar to a reference product based upon data
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`12
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`Case: 1:21-cv-02899 Document #: 1 Filed: 05/28/21 Page 13 of 308 PageID #:13
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`derived from . . . a clinical study or studies . . . that are sufficient demonstrate safety, purity, and
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`potency in 1 or more appropriate conditions of use for which the reference product is licensed and
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`intended to be used and for which licensure is sought for the biological product.”); see also 21
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`C.F.R. § 601.2(a) (“To obtain a biologics license . . . the manufacturer . . . shall submit data
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`derived from . . . clinical studies which demonstrate that the manufactured product meets
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`prescribed requirements of safety, purity, and potency . . . .”). For example, Alvotech has and is
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`currently sponsoring, directing, and/or authorizing at least six clinical trials of the Alvotech aBLA
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`Product. Clinical trials for the Alvotech aBLA Product began at least as early as May 21, 2018
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`and Alvotech manufactured the Alvotech aBLA Product lots that were used in the clinical trials
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`and described in the aBLA. See Exhibit 3.
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`37.
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`Additionally, Alvotech publicized its Phase I and Phase III clinical trials comparing
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`the Alvotech aBLA Product to HUMIRA®. See Press Release, Alvotech, “Alvotech announces
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`positive top-line results for two comparative studies for AVT02, a proposed biosimilar to
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`HUMIRA® (adalimumab),” May 12, 2020, https://www.alvotech.com/newsroom/alvotech-
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`announces-positive-top-line-results-for-two-comparative-studies-for-avt02-a-proposed-
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`biosimilar-to-humira-adalimumab, attached hereto as Exhibit 6. Alvotech specifically stated that
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`“Alvotech is developing [the Alvotech aBLA Product] as a proposed biosimilar to HUMIRA®
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`(adalimumab) with high concentration (100 mg/mL) dosage forms.” Id.
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`38.
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`On information and belief, Alvotech will financially benefit in a significant manner
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`from the approval of Alvotech’s aBLA, since Alvotech will engage in the commercial manufacture
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`and supply of the Alvotech aBLA Product in Illinois, including this District. For example,
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`Alvotech and Teva Pharmaceutical Industries Ltd. (“Teva”) entered into an “exclusive strategic
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`partnership for the commercialization in the U.S.” of the Alvotech aBLA Product and Alvotech
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`Case: 1:21-cv-02899 Document #: 1 Filed: 05/28/21 Page 14 of 308 PageID #:14
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`will share in profits from sales in the U.S. See Press Release, Alvotech, “Alvotech and Teva
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`announce strategic partnership to collaborate in the U.S. biosimilar market,” Aug. 5, 2020,
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`https://www.alvotech.com/newsroom/alvotech-and-teva-announce-strategic-partnership-to,
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`attached as Exhibit 7; see also Exhibit 5 (stating that the Alvotech aBLA Product is one of the
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`biosimilar product candidates part of the Alvotech-Teva strategic partnership). Under the
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`“partnership agreement,” Alvotech “will be responsible for the development, registration and
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`supply of the [AVT02], while Teva will be exclusively commercializing [AVT02] in the U.S.”
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`Exhibit 7; see also Exhibit 5.
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`39.
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`On information and belief, if Alvotech’s aBLA is approved, the Alvotech aBLA
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`Product will be administered to patients in Illinois, and within this District. These activities, as
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`well as Alvotech’s manufacturing, marketing, selling, and/or distributing of the Alvotech aBLA
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`Product, will have a substantial effect within Illinois, and within this District, and will constitute
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`infringement of U.S. Patent Nos. 6,805,686, 8,231,876, 8,420,081, 8,663,945, 8,708,968,
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`8,715,664, 8,808,700, 8,883,156, 8,889,136, 8,895,009, 8,906,372, 8,906,373, 8,906,646,
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`8,911,737, 8,911,964, 8,916,153, 8,926,975, 8,961,973, 8,961,974, 8,974,790, 8,986,693,
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`8,992,926, 8,999,337, 9,061,005, 9,062,106, 9,067,992, 9,085,618, 9,085,619, 9,085,620,
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`9,090,688, 9,090,689, 9,090,867, 9,096,666, 9,102,723, 9,150,645, 9,181,337, 9,181,572,
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`9,187,559, 9,234,032, 9,266,949, 9,273,132, 9,284,370, 9,284,371, 9,290,568, 9,315,574,
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`9,328,165, 9,334,319, 9,339,610, 9,346,879, 9,359,434, 9,499,614, 9,499,616, 9,505,834,
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`9,512,216, 9,522,953, 9,546,212, 9,550,826, 9,624,295, 9,669,093, 9,683,033, 9,708,400, and
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`Case: 1:21-cv-02899 Document #: 1 Filed: 05/28/21 Page 15 of 308 PageID #:15
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`9,957,318, in the event that the Alvotech aBLA Product is approved before any of these patents
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`expire.2
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`40.
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`For the reasons described above, among others, the submission of Alvotech’s aBLA
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`was suit-related conduct with a substantial connection to Illinois and this District, the exercise of
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`personal jurisdiction over Alvotech does not offend traditional notions of fair play and substantial
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`justice, and this Court may properly exercise personal jurisdiction over Alvotech.
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`VENUE
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`41.
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`Venue lies in this District pursuant to 28 U.S.C. § 1391, including because, inter
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`alia, Alvotech is a foreign entity, and thus is subject to suit in any jurisdiction in the United States
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`including the Northern District of Illinois. 28 U.S.C. § 1391(c).
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`THE PARTIES’ EXCHANGES UNDER THE BPCIA
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`42.
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`On information and belief, in late August or early September 2020, Alvotech
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`submitted aBLA No. 761205 to the FDA pursuant to the BPCIA, specifically 42 U.S.C. § 262(k),
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`requesting that its biosimilar adalimumab product AVT02 be licensed for commercial sale by
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`relying on AbbVie’s demonstration that HUMIRA® is safe, pure, and potent. The BPCIA provides
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`an abbreviated pathway for approval of a biologic product that is “biosimilar” to a “reference
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`product.” Alvotech has demonstrated its intention to utilize AbbVie’s data and work discovering
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`and developing adalimumab through the use of the abbreviated BPCIA biosimilar pathway.
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`43.
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`To facilitate the protection of biologic innovators’ patent rights, Congress created
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`an act of infringement related to the submission of an application under subsection 262(k), see 35
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`U.S.C. § 271(e)(2)(C), and enumerated a set of pre-litigation exchanges under the BPCIA that are
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`2 U.S. Patent Nos. 8,420,081, 8,926,975, 8,961,973, and 9,085,619 are the subject of AbbVie’s
`earlier infringement suit against Alvotech. See AbbVie Inc. and AbbVie Biotechnology Ltd v.
`Alvotech hf., Civ. No. 1:21-cv-02258 (N.D. Ill. Apr. 27, 2021) (Lee, J.).
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`15
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`Case: 1:21-cv-02899 Document #: 1 Filed: 05/28/21 Page 16 of 308 PageID #:16
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`outlined at 42 U.S.C. § 262(l). The subsection (l) procedures are intended to ensure that the maker
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`of an innovative biologic product that is the subject of a biosimilar application will have sufficient
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`time and opportunity to enforce its patent rights before a biosimilar product enters the market. The
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`BPCIA also requires that a subsection (k) applicant give at least 180 days’ notice before the first
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`commercial marketing of a biosimilar licensed by the FDA. 42 U.S.C. § 262(l)(8)(A). The statute
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`specifically contemplates injunctive relief, including preliminary injunctive relief, to prevent
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`unlawful infringement.
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`44.
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`Alvotech represents that the FDA accepted Alvotech’s aBLA for the Alvotech
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`aBLA Product for review on or before November 5, 2020.
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`45.
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`On November 5, 2020, Alvotech contacted AbbVie and indicated that it had
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`submitted an aBLA to the FDA and that the FDA accepted the aBLA for review. Subsequently,
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`in a November 19, 2020 press release, Alvotech announced that the FDA had accepted the aBLA
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`for review.
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`46.
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`In November 2020, the parties began exchanging information in accordance with
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`the procedures outlined in the BPCIA. On or about November 5, 2020, Alvotech provided outside
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`counsel for AbbVie, and AbbVie’s designated in-house attorneys in North Chicago, with access
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`to Alvotech’s aBLA.
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`47.
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`On January 4, 2021, pursuant to 42 U.S.C. § 262(l)(3)(A), AbbVie provided
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`Alvotech with its list of patents for which it believe