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`Case: 1:21-cv-01530 Document #: 1 Filed: 03/19/21 Page 1 of 45 PageID #:1
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`IN THE 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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`v.
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`ALVOTECH HF.,
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`C.A. No. 1:21-cv-1530
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`JURY TRIAL DEMANDED
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`Plaintiffs,
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`Defendant.
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`COMPLAINT
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`Plaintiffs AbbVie Inc. and AbbVie Biotechnology Ltd (collectively, “AbbVie” or
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`“Plaintiffs”) allege as follows against Defendant Alvotech hf. (“Alvotech” or “Defendant”).
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`INTRODUCTION
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`1.
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`AbbVie Inc. is an American company headquartered in this District in North
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`Chicago, Illinois. AbbVie has expended vast resources over decades developing HUMIRA®
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`(adalimumab), a complex biologic drug that is approved to treat eleven diseases and has helped
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`more than one million patients. In 2020, AbbVie invested more than $5 billion in R&D. AbbVie’s
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`hard work, ingenuity, research, and persistent development of HUMIRA®, including work under
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`the supervision of AbbVie’s leadership in North Chicago, Illinois, by AbbVie scientists in a first
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`manufacturing facility in Worcester, Massachusetts and a second facility in Puerto Rico, ultimately
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`created a market worth billions of dollars.
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`2.
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`Biologic drug manufacturing is a complex and sensitive process that requires
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`significant investments in time and expertise to develop and fine-tune on a commercial scale.
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`AbbVie, having spent the resources to develop such high volume, continual processes, carefully
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`guards this information, sharing it with its employees only on a need-to-know basis, including in
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`order to train them on how to perform the commercial, large scale, high quality-manufacturing
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`processes. As discussed further below, this detailed confidential and proprietary information is
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`distinct and of a different nature from AbbVie’s inventions related to adalimumab formulations,
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`improved manufacturing processes, and methods of treatment of debilitating diseases that have
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`been published in AbbVie’s patents related to adalimumab.
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`3.
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`Alvotech, like other biosimilar drug companies, seeks to enter the U.S. market with
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`a copycat version of AbbVie’s HUMIRA®. But Alvotech took a shortcut. Instead of investing the
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`necessary time and resources to independently develop the manufacturing process for its
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`biosimilar, Alvotech embarked on an unlawful plot to surreptitiously take AbbVie’s confidential
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`and proprietary trade secrets related to the confidential large scale manufacturing process for
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`HUMIRA® in order to develop and manufacture its copycat product.
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`4.
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`Alvotech’s plan to steal AbbVie’s technologies started with a plot to target AbbVie
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`from the inside, through its personnel. While he was still employed by AbbVie, Alvotech recruited
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`and hired Rongzan Ho, a team leader of upstream manufacturing for HUMIRA® who had
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`substantial access to AbbVie’s proprietary technologies. Alvotech tasked the former HUMIRA®
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`team leader with developing and overseeing manufacturing for its copycat version of HUMIRA®.
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`5.
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`Just before leaving AbbVie, and for the benefit of and at the direction of Alvotech,
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`Mr. Ho transmitted confidential and proprietary AbbVie trade secret information to his personal
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`email account for use by Alvotech in violation of his obligations to AbbVie. Mr. Ho attempted to
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`email this confidential and proprietary trade secret information to himself three times and, after
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`AbbVie’s security systems blocked his email titled “Useful Information” the first two times, Mr.
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`2
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`Ho deceptively renamed it “Keep in touch (AbbVie)” and overrode the security warning notice to
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`finally succeed in emailing AbbVie’s trade secrets to his personal email account on the third try.
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`Alvotech’s recruit, and by extension Alvotech, unlawfully took AbbVie’s confidential trade secret
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`materials to Alvotech for use in his work there, including by using information taken from AbbVie
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`to develop and implement the manufacturing of a knockoff version of the exact same drug that he
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`was responsible for at AbbVie.
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`6.
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`AbbVie did not know nor could it have reasonably discovered Alvotech’s plan to
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`steal AbbVie’s confidential and proprietary trade secrets related to the commercial manufacturing
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`process for HUMIRA® at that time. Alvotech, including through its employee, concealed its
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`unlawful acquisition and use of AbbVie’s confidential and proprietary trade secrets. First, in
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`connection with and within the scope of his imminent employment at Alvotech, Mr. Ho transmitted
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`confidential and proprietary AbbVie trade secret information to his personal email account.
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`Second, to cover his tracks and dissuade AbbVie from looking closely at his departure, Mr. Ho
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`affirmatively misrepresented that he had “expunged all AbbVie information from any computer,
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`word processor, external storage device, in email or cloud storage or other device belonging to me
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`or under my control.” He also declared that he had “returned all information . . . in [his] possession
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`. . . relating or belonging to AbbVie and/or its affiliates . . . including but not limited to
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`confidential, sensitive and/or proprietary information such as . . . development know-how, trade
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`secrets, techniques, processes, [and] procedures . . . information and documentation . . . .” March
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`2, 2018 Rongzan Ho Decl.. Third, Mr. Ho concealed that he was going to work at Alvotech to
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`help it develop and oversee the manufacture of a copycat of the drug he was responsible for at
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`AbbVie and made misleading statements that he was leaving AbbVie for career development
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`3
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`Case: 1:21-cv-01530 Document #: 1 Filed: 03/19/21 Page 4 of 45 PageID #:4
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`reasons, “mainly to learn single-use bio reactors and other new technologies.” February 14, 2018
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`Rongzan Ho Exit Interview Form.
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`7.
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`On February 24, 2021, AbbVie wrote to Alvotech’s CEO, Mark Levick, regarding
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`its belief that Alvotech had embarked on an unlawful plot to surreptitiously take AbbVie’s
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`confidential and proprietary trade secrets related to the manufacturing process for HUMIRA® to
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`develop and manufacture its competing biosimilar product. AbbVie asked Alvotech to address
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`this belief, particularly given the timing of Alvotech’s hiring of Mr. Ho, the timing of his tenure
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`with Alvotech, and the timing of Alvotech’s announcements regarding its biosimilar to AbbVie’s
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`HUMIRA®. In its March 3, 2021 response, Alvotech did not deny that Mr. Ho worked on a
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`biosimilar to HUMIRA® while employed at Alvotech. Alvotech also did not deny that it deployed
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`Mr. Ho in the exact same role he performed at AbbVie and tasked him with developing and
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`overseeing manufacturing for a biosimilar of the exact same drug that he was responsible for at
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`AbbVie, AVT02, a high-concentration HUMIRA® biosimilar, again in violation of his obligations
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`to AbbVie.1 And while Alvotech stated it would investigate AbbVie’s claims, it never presented
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`the results of any investigation, let alone any exculpatory evidence or even a denial that a theft had
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`occurred. Nor has Alvotech taken any steps to remediate its willful and malicious conduct.
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`8.
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`Further, Alvotech not only recruited AbbVie’s employee, Mr. Ho, but has
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`continued to recruit AbbVie employees with intimate knowledge of the HUMIRA® manufacturing
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`process. At least two additional AbbVie employees have been recruited by Alvotech and hired in
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`May 2020. Alvotech also attempted to recruit, without success, one or more additional AbbVie
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`employees through at least one recruiter, specifically inquiring about a position to work on
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`Alvotech’s biosimilar to AbbVie’s HUMIRA® as part of the job description.
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`1 March 3, 2021 Correspondence from Alvotech counsel to AbbVie counsel (copy on file).
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`4
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`9.
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`Alvotech’s willful and malicious misappropriation of AbbVie’s trade secrets leaves
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`AbbVie no choice but to file this lawsuit seeking injunctive relief and recovery of damages for the
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`harm that has been caused by Alvotech’s illegal conduct. Alvotech’s conduct threatens
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`uncontrolled and irreparable dissemination of AbbVie’s trade secrets around the world, as
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`Alvotech already built a biologics manufacturing facility in Iceland and recently announced a joint
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`venture to build a new biologics manufacturing facility in China. Unless enjoined, Alvotech’s
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`illegal actions will serve as a roadmap to use AbbVie’s trade secrets for both Alvotech and other
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`companies that have not adequately invested in their own independent research and development.
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`THE PARTIES
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`10.
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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. is engaged in the development, sale, and distribution of a broad range of
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`pharmaceutical and biologic drugs, including HUMIRA®.
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`11.
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`Plaintiff AbbVie Biotechnology Ltd (“ABL”) is a corporation organized and
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`existing under the laws of Bermuda, with a place of business at Clarendon House, 2 Church Street,
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`Hamilton HM1l, Bermuda and a manufacturing facility in Barceloneta, Puerto Rico. Through
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`intermediate organizations, Plaintiff AbbVie Inc. owns Plaintiff ABL.
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`12.
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`Defendant Alvotech hf. is a company organized and existing under the laws of
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`Iceland, with its principal place of business at Saemundargata 15-19, 101 Reykjavik, Iceland.
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`JURISDICTION AND VENUE
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`13.
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`This action arises under the Defend Trade Secrets Act of 2019 (“DTSA”), 18 U.S.C.
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`§§ 1836(b)-(c). This action also arises under the Illinois Trade Secrets Act (“ITSA”), 765 ILCS
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`1065/1 et seq.
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`5
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`14.
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`This Court has subject matter jurisdiction over the federal claims asserted in this
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`Complaint under 28 U.S.C. § 1331 because this action arises under the DTSA. Further, this Court
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`has supplemental jurisdiction under 28 U.S.C. § 1367 over the Illinois trade secrets claim because
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`it is so closely related to AbbVie’s claim for misappropriation of trade secrets under the DTSA
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`that it forms part of the same case or controversy.
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`15.
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`In addition, this Court has subject matter jurisdiction under 28 U.S.C. § 1332(a)
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`because the amount in controversy exceeds $75,000, excluding interest and costs, and the parties
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`are citizens of different states and/or foreign states.
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`16.
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`This Court has personal jurisdiction over Alvotech. Alvotech has purposefully
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`directed activities at residents of Illinois and this District, and this action arises out of and relates
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`to those activities. For example, Alvotech, at least through Mr. Ho, knowingly misappropriated
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`trade secrets owned by AbbVie. AbbVie Inc. is headquartered in Illinois and this District, and
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`these trade secrets originated in the United States, including being developed under the leadership
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`of AbbVie’s management in Illinois in the first AbbVie manufacturing facility in Worcester,
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`Massachusetts and a second AbbVie facility in Puerto Rico. During Mr. Ho’s employment,
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`AbbVie’s email server for its Singapore facility and the back-up server for the Singapore file-share
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`server that housed the Excel spreadsheets containing AbbVie’s confidential and proprietary
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`information and trade secrets that Mr. Ho misappropriated were both hosted in Alpharetta,
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`Georgia, further confirming the trade secrets were misappropriated from the United States.
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`Moreover, Alvotech has taken the costly, significant step of submitting an abbreviated Biologics
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`Licensing Application (“aBLA”) to the United States Food and Drug Administration (“FDA”)
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`seeking approval to engage in the commercial use, sale, and/or distribution of its competing
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`biosimilar product throughout the United States, including in Illinois. Furthermore, Alvotech sent
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`6
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`its aBLA to AbbVie Inc. at its corporate headquarters in North Chicago, Illinois. Alvotech’s
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`competing biosimilar product is derived from, utilizes, contains, embodies, or was developed, in
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`whole or in part, with the benefit or use of AbbVie’s trade secret information. Alvotech’s aBLA
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`submission constitutes a formal act that reliably indicates plans to engage, directly or indirectly,
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`in marketing of its competing biosimilar product throughout the United States, including in Illinois.
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`If Alvotech’s aBLA is approved, its competing biosimilar product will be sold in, directed to, and
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`prescribed by physicians practicing in Illinois and/or administered to patients in Illinois. Further,
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`Alvotech’s trade secret misappropriation has led to foreseeable harm and injury to AbbVie
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`throughout the United States, especially in Illinois where AbbVie Inc. resides. As such, Alvotech
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`has established sufficient minimum contacts with this District, such that it should reasonably and
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`fairly anticipate being called into court in this District.
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`17.
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`Venue is proper in this federal District pursuant to 28 U.S.C. § 1391. Alvotech is
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`incorporated in Iceland and may be sued in any judicial district in the United States in which
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`Alvotech is subject to personal jurisdiction. Additionally, venue is proper because AbbVie Inc.
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`resides in this District, has made significant investments of both equipment and engineering talent,
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`manages the trade secret technologies from its headquarters in this District, sells products
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`including HUMIRA® in this District, and has suffered harm in this District.
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`ADDITIONAL FACTUAL ALLEGATIONS
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`A.
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`18.
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`AbbVie Embarked on Decades of Research, Investment, and Innovation
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`HUMIRA® belongs to a category of drugs known as biologics. Biologics are
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`complex proteins manufactured in living cells rather than by chemical synthesis. These are
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`critically important drugs that are difficult to develop, manufacture, formulate, and administer.
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`Within the category of biologics, HUMIRA® is unique because it was the first fully-human
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`antibody approved by the FDA. In bringing HUMIRA® from the laboratory to patients in the
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`7
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`United States and various countries throughout the world, AbbVie operated in uncharted territory.
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`In 1996, AbbVie invented the adalimumab antibody, the active ingredient in HUMIRA®. But that
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`was only the first step. Since then, AbbVie has embarked on over two decades of research,
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`investment, and innovation, including in particular in the United States and in this District.
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`19.
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`As part of its commitment to improve patients’ lives, AbbVie has dedicated
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`substantial resources to an extensive clinical trial program. AbbVie’s clinical research on
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`HUMIRA® includes over 100 clinical trials, many of which were conducted at sites in the United
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`States including sites in this District, and resulted in FDA approval for the treatment of eleven
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`indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis,
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`ankylosing spondylitis, Crohn’s disease (adult and pediatric), ulcerative colitis (adult and
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`pediatric), plaque psoriasis, hidradenitis suppurativa, and uveitis. To date, over 1.1 million patients
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`have benefited from AbbVie’s pioneering work on HUMIRA®.
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`20.
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`AbbVie has also spent many years developing its complex manufacturing processes
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`for adalimumab and HUMIRA®, including in the United States. As discussed above, unlike
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`traditional drugs, HUMIRA® is a complex biologic manufactured in living organisms. The
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`manufacturing process for such a complex biologic is a sophisticated, expensive, and highly
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`specialized process. As discussed below, the manufacturing process for HUMIRA® may be
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`divided into three parts: (1) upstream manufacturing, (2) downstream manufacturing, and (3)
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`formulation.
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`21.
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`The upstream manufacturing process for HUMIRA® begins by establishing a bank
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`of mammalian cells engineered to produce a specific protein, adalimumab. Once the cell bank has
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`been established, cells from the bank are removed, thawed, and cultured in an environment that is
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`precisely controlled to encourage the growth of cells (the expansion stage) and ultimately the
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`8
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`production of adalimumab (the production stage). The production is then harvested to remove
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`cells and cell debris, resulting in an adalimumab-containing solution that may enter the
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`downstream manufacturing process.
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`22.
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`During the downstream manufacturing process, the adalimumab-containing
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`solution is processed to reduce impurities. The purified adalimumab-containing solution may then
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`be formulated into HUMIRA®. Before AbbVie’s launch of HUMIRA®, patients prescribed anti-
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`TNFα biologics had to go to the hospital or infusion clinic to receive their medicine intravenously
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`(e.g., REMICADE®) or mix batches of medicine at home (which was difficult for patients with
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`inflamed joints) and inject themselves twice a week (e.g., ENBREL®). But AbbVie invested in
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`and created a liquid formulation of the HUMIRA® antibody suitable for subcutaneous
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`administration. As a result of AbbVie’s innovation, patients were able, for the first time, to inject
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`their medicine at home, using pre-filled syringes, and take fewer injections. The added
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`convenience and precision has improved patients’ lives and increased compliance without
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`sacrificing HUMIRA®’s outstanding efficacy.
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`23.
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`AbbVie also invested significant resources in developing a high concentration,
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`citrate-free formulation of HUMIRA® including in the United States. This formulation works like
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`original HUMIRA® but requires less liquid to inject and causes less pain following injection, both
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`of which are advantages over the original HUMIRA® formulation. AbbVie’s considerable
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`investment in developing and offering different formulations and concentrations of adalimumab
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`provides substantial benefits to patients.
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`24.
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`AbbVie has been granted patents on aspects of its manufacturing process, but like
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`every manufacturer in the industry, AbbVie maintains considerable details of its large-scale,
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`continual manufacturing process as secrets. These details include, for example, AbbVie’s day-to-
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`9
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`day procedures for monitoring, adjusting, and controlling numerous process parameters, including
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`plant equipment set-up and operation. They also include AbbVie’s day-to-day procedures for
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`monitoring cell count, viable cell density, and indicators of contamination, as well as AbbVie’s
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`day-to-day procedures for measuring, preparing, monitoring, and controlling process components
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`and parameters. The detailed aspects of AbbVie’s manufacturing process, including these
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`parameters and others, ensure a high quality, consistent, and efficient manufacturing process.
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`These processes also reflect years of trial-and-error, and set out what to do in manufacturing
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`adalimumab.
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`Development of AbbVie’s Manufacturing Process for HUMIRA®
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`25.
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`AbbVie’s first manufacturing facility for HUMIRA® was what is now AbbVie
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`Bioresearch Center, Inc.’s (“ABC”) facility in Worcester, Massachusetts. Under the leadership of
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`AbbVie management in North Chicago, Illinois, AbbVie’s scientists at ABC developed AbbVie’s
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`first commercial-scale manufacturing process. When AbbVie outgrew its Worcester facility, it
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`built a new ABL manufacturing facility in Barceloneta, Puerto Rico. Based on AbbVie’s
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`experience and continued investment in research and development, ABC and ABL continued to
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`improve upon the manufacturing process, focusing on quality, consistency, and efficiency. The
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`sum of this know-how was embodied in ABL’s Puerto Rico facility, which was the first AbbVie
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`facility to manufacture AbbVie’s high concentration, citrate-free formulation of HUMIRA®.
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`AbbVie Trade Secrets
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`26.
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`AbbVie’s manufacturing process for HUMIRA® is the product of meticulous, time-
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`consuming, and expensive research. While aspects of the process have been described in patents
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`and patent applications, AbbVie’s more than two decades of experience and investment in its
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`processes have generated substantial know-how for AbbVie in the form of confidential and
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`10
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`proprietary trade secrets. The manufacturing process for HUMIRA® becomes increasingly
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`complex when it is run continually at large scale, and AbbVie’s confidential and proprietary trade
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`secrets include the technical know-how required to run a high quality, efficient, and consistent
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`commercial-scale manufacturing process for adalimumab, as well as protocols to avoid many
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`pitfalls that would otherwise be encountered.
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`27.
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`The highly confidential documents and materials misappropriated by Alvotech,
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`which include very detailed technical requirements and specifications regarding AbbVie’s
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`manufacturing processes for HUMIRA®, are included in “AbbVie’s Trade Secrets.” These
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`confidential materials include shift notes, stock lists, training statuses, weekly checklists, and
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`detailed process steps for the upstream HUMIRA® manufacturing process.
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`28.
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`AbbVie’s Trade Secrets also include the following information, both alone and in
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`combination:
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`a.
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`b.
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`c.
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`d.
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`the materials, equipment (including care and maintenance), step-by-step
`instructions, control parameters, expected yields, and testing and sampling
`techniques for the HUMIRA® manufacturing process;
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`training programs to ensure competency of required personnel, coordinate
`management of resources and equipment, and for commissioning and
`qualification of new equipment and new areas;
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`detailed descriptions of know-how and experience regarding the trial,
`errors to avoid, development, and engineering process runs required to
`bring a new facility online; and
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`detailed descriptions of knowledge and understanding of ABL’s
`manufacturing facilities in Barceloneta, Puerto Rico, and Singapore,
`including their design and operation.
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`29.
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`Such information is critically important because the output of one step in the
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`manufacturing process is the input to the next step. Over its decades of experience manufacturing
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`HUMIRA®, AbbVie has developed sophisticated protocols, procedures, timelines, and checklists
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`to ensure achievement of an efficient and consistent upstream manufacturing process. Such
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`11
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`information is documented, for example, in voluminous multi-sheet Excel spreadsheets amassing
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`hundreds of rows and columns and hundreds of pages of information. AbbVie even has documents
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`providing day-by-day manufacturing instructions for adalimumab spanning multiple months.
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`30. While
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`this
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`information
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`is
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`important for efficiently maintaining existing
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`commercial-scale operations, it is also crucial for launching commercial-scale operations in a new
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`facility. Even with AbbVie’s well-established protocols for producing adalimumab, and its
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`substantial know-how in commercial-scale adalimumab manufacturing, it takes years to bring a
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`new facility online. Indeed, even with an FDA-approved manufacturing process, AbbVie must
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`manufacture various engineering and process batches in order to register a new facility with the
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`FDA as an adalimumab manufacturing site. AbbVie also must ensure that the general operations
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`of the facility, including room classifications, HVAC, gowning procedures, and material and
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`personnel flows, are acceptable to the FDA.
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`B.
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`31.
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`AbbVie Protects Its Confidential and Proprietary Trade Secrets
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`As a leader in the biologics industry, AbbVie has expended considerable resources
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`in R&D, which has resulted in significant confidential and proprietary trade secrets, including the
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`AbbVie Trade Secrets. In 2020, for example, AbbVie invested more than $5 billion in R&D. As
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`a result of its substantial investment in and decades-long dedication to innovation, AbbVie has
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`been awarded patents covering, inter alia, adalimumab and HUMIRA®. But AbbVie also keeps
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`significant aspects of its processes—especially its manufacturing processes—as trade secrets to
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`protect their value and the significant investments AbbVie has made in their development. This
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`confidential information derives considerable independent economic value from being not
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`generally known outside of AbbVie.
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`32.
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`AbbVie protects its confidential and proprietary trade secrets, including the AbbVie
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`Trade Secrets, in numerous ways, including by restricting access to confidential information only
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`12
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`to select individuals, and even then, only subject to strict confidentiality and non-disclosure
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`agreements. For example, as a condition of their employment and as part of their employment
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`agreement, AbbVie’s employees sign non-disclosure agreements pursuant to which they agree,
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`among other things, to not use or disclose AbbVie’s confidential information, including trade
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`secrets, outside of their work for AbbVie.
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`33.
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`AbbVie implements various policies across its drug product development
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`operations to limit access to trade secrets and other sensitive data to those employees who need to
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`know the information. These policies include: marking confidential documents and materials as
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`such where appropriate; restricting access to physical files; maintaining documents out of plain
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`view; requiring secure passwords for, and limiting access to, computers and networks that contain
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`trade secrets; prohibitions against discussing confidential information in common areas such as
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`the cafeteria, lobbies, or intra-company events; and distributing information on a need-to-know
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`basis. AbbVie additionally provides its trade secret policy statement in employee handbooks and
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`legal education programs and conducts periodic reviews of confidentiality policies.
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`34.
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`AbbVie’s trade secret policies for maintaining and managing trade secrets within
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`its drug product development organization apply to all drug product development employees in
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`the United States and Singapore and are kept and managed from an AbbVie site in Lake County,
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`Illinois.
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`35.
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`As to significant non-public and non-patented aspects of all manufacturing
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`processes, including the manufacturing process for HUMIRA®, AbbVie has always maintained
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`these details as quintessential trade secrets. For example, manufacturing processes and details are
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`routinely identified as trade secrets at training seminars for AbbVie scientists and engineers.
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`Managers in manufacturing are responsible for maintaining and managing information regarding
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`
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`13
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`
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`Case: 1:21-cv-01530 Document #: 1 Filed: 03/19/21 Page 14 of 45 PageID #:14
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`AbbVie’s manufacturing processes under a formal data loss prevention program. Much of the
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`information regarding manufacturing processes—while known to specialized professionals
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`responsible for manufacturing—is stored on non-networked servers, is subject to encryption
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`policies, may only be accessed by those who need to know, and requires the use of two-factor
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`authentication. Additionally, all such information is restricted from communication outside of
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`AbbVie personnel and devices and must be returned prior to an employee leaving AbbVie.
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`36.
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`AbbVie also implements policies to limit employees who may need to know trade
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`secret information from disseminating it further. Employee obligations to protect trade secrets
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`include, but are not limited to: prohibitions against disclosing the trade secret information
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`externally; implementing procedures for visitors, such as signing in and out, wearing a visitor’s
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`badge, and requiring an escort; prohibitions against disclosing confidential information during new
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`employee interviews; limiting tours of the facility; having applicants sign a confidentiality and
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`non-disclosure agreement; prohibiting photography on AbbVie premises; prohibiting the use of
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`non-AbbVie devices, and non-AbbVie servers and drives; designating and classifying data,
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`documents and emails according to classification policies; and reminding departing employees of
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`their obligation to keep AbbVie trade secrets confidential, especially with respect to a new
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`employer. All of these measures apply to all non-public information regarding AbbVie’s
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`manufacturing process for HUMIRA®.
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`37.
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`In pursuing business opportunities, AbbVie restricts disclosure of trade secret
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`information by requiring disclosure only if absolutely necessary. If disclosure must occur, AbbVie
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`requires a license or non-disclosure agreement, itself a confidential document, that describes the
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`information being disclosed, states the purpose(s) for the disclosure and the permitted exclusive
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`
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`14
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`Case: 1:21-cv-01530 Document #: 1 Filed: 03/19/21 Page 15 of 45 PageID #:15
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`use(s) of the information, and reiterates the other party’s obligation to maintain the secrecy of the
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`information.
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`C.
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`38.
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`AbbVie Expanded Its Manufacturing to Singapore and Hired Mr. Ho
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`In 2014, AbbVie announced that it would build a new manufacturing facility in
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`Singapore. AbbVie Singapore was being built to manufacture, among other things, a high-
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`concentration (100 mg/mL) HUMIRA® dosage form according to the manufacturing process
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`developed and implemented in the United States under the supervision of AbbVie’s leadership in
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`North Chicago, Illinois, first at ABC in Worcester and then improved by ABL in Puerto Rico, with
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`contributions from others, including in this District.
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`39. Mr. Ho began working at AbbVie Singapore on March 1, 2016, shortly after the
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`building was equipped with electricity. He was hired to work in AbbVie Singapore’s Biologics
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`Operations, which was responsible for the manufacture of the high-concentration citrate-free
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`HUMIRA® dosage form. Mr. Ho learned, among other steps, how AbbVie performs the critical
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`steps of cultivating the genetically engineered cells needed to make adalimumab and causing them
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`to produce large quantities of consistent product in the context of a complex manufacturing
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`environment. Mr. Ho was one of several Team Leaders in Biologics Operations, namely, for
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`AbbVie’s upstream manufacturing of HUMIRA®.
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`40.
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`Having a prominent role as Team Leader for upstream manufacturing, Mr. Ho
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`gained intimate knowledge of AbbVie’s manufacturing process for HUMIRA® that was developed
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`under the supervision of AbbVie’s leadership in North Chicago, Illinois by ABC in Worcester and
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`ABL in Puerto Rico, and which was developed and guarded under AbbVie’s strict disclosure
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`controls.
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`41. Mr. Ho learned how AbbVie prepares adalimumab. He also learned how AbbVie
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`sets up components and process equipment; operates, monitors, and adjusts the operation of
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`
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`15
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`Case: 1:21-cv-01530 Document #: 1 Filed: 03/19/21 Page 16 of 45 PageID #:16
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`equipment including bioreactors, scales, and analytical tools; and performs process sampling for
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`adalimumab.
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`42. Mr. Ho was involved in setting up the plant in Singapore from the ground up so
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`also learned what approaches did not work when manufacturing adalimumab. AbbVie optimized
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`its processes over time, constantly improving to increase efficiencies through trial-and-error and
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`based on AbbVie’s prior experiences. Mr. Ho was aware of and involved in many of these changes
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`to AbbVie’s processes from the beginning, and the processes Mr. Ho worked on and that were
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`disclosed in the trade secret documents he stole from AbbVie reveal how to manufacture
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`adalimumab and what errors and inefficiencies to avoid.
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`43.
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`Through his training at AbbVie, Mr. Ho was qualified to execute, and was certified
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`to train other biotechnologists to execute, many AbbVie upstream manufacturing tasks.
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`44.
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`Further, AbbVie selected Mr. Ho as one of a handful of employees to spend several
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`months at ABL’s manufacturing facility in Puerto R