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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 1 of 128 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`REGENERON PHARMACEUTICALS, INC.
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`
`Plaintiff,
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`
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`v.
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`SAMSUNG BIOEPIS, CO., LTD.,
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`
`Defendant.
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`
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`CASE NO.:
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`JURY TRIAL DEMANDED
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`
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`COMPLAINT
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron” or “Plaintiff”), invented,
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`developed, and sells EYLEA®, the market-leading treatment for several serious eye diseases.
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`Defendant Samsung Bioepis Co., Ltd. (“Bioepis” or “Defendant”) is seeking
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`brings this Complaint1 pursuant to 28 U.S.C. §§ 2201-2202 and under 42 U.S.C. § 262(l)(9)(A)
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` To vindicate its patent rights, Regeneron
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`1 As explained in its forthcoming memorandum in support of its motion to seal, Regeneron is bound by the provisions
`of 42 U.S.C. § 262(l)(1), which dictate that Bioepis determine, “in its sole discretion,” what information constitutes
`Bioepis confidential information, that no such “confidential information shall be included in any publicly-available
`complaint or other pleading,” and any violation of paragraph 1 could result in “irreparable harm for which there is no
`adequate legal remedy” and for which “the court shall consider immediate injunctive relief to be an appropriate and
`necessary remedy.” Therefore, Regeneron initiates this case by filing a public version of this Complaint with
`redactions to any information that Bioepis has represented is Bioepis confidential information.
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`1
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`1:23-cv-94 Kleeh
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`11/21/2023
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`

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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 2 of 128 PageID #: 2
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`seeking declaratory judgment of patent infringement against the Defendant under 35 U.S.C.
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`§§ 271(a)-(c) and (g), and a judgment of patent infringement against the Defendant under 35
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`U.S.C. § 271(e).
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`NATURE OF THE CASE
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`1.
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`Regeneron is a leading science-based American biotechnology company dedicated
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`to improving human health and tackling the most urgent medical issues facing the Nation. Founded
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`and led for over 30 years by physician-scientists, Regeneron has developed life-transforming
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`medicines for people with serious diseases, including cancer, atopic dermatitis, asthma, eye
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`diseases, cardiovascular and metabolic diseases, Ebola, and COVID-19, which have been used
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`across the country. Regeneron’s cutting-edge scientific advances are supported, in large part, by
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`its ophthalmic product, EYLEA®, which FDA approved in 2011.
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`2.
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`EYLEA® has been administered millions of times to treat certain ophthalmic
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`disorders that, if left untreated, can lead to permanent blindness. Its active ingredient is a
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`genetically engineered fusion protein called aflibercept. It works by blocking the overproduction
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`of a naturally occurring protein in the eye that can cause the formation of new blood vessels,
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`leading to vision loss. Based on extensive clinical testing by Regeneron, FDA approved EYLEA®
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`in 2011 to treat an ophthalmic disorder called neovascular (wet) age-related macular degeneration
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`(“wAMD”) and in 2014 to treat diabetic macular edema (“DME”). As a result of Regeneron’s
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`additional clinical testing, EYLEA® is now also approved for use in treating other serious disorders
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`of the eye: macular edema following retinal vein occlusion and diabetic retinopathy. Most recently,
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`FDA granted approval for EYLEA® to treat retinopathy of prematurity in preterm infants, which
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`is the leading cause of childhood blindness worldwide. In addition to benefitting the many patients
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`it has been used to treat, EYLEA® is also a critical source of research and development funding
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`2
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`

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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 3 of 128 PageID #: 3
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`for Regeneron to develop other life-transforming medicines.
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`3.
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` Enacted in 2010 as part of the Affordable Care
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`
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`Act, the BPCIA provides for an abbreviated regulatory approval pathway for biosimilars by letting
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`applicants rely on the extensive clinical testing previously conducted, at great expense, by the
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`innovator company that developed the medicine the applicant wants to copy. See Sandoz Inc. v.
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`Amgen Inc., 582 U.S. 1 (2017).
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`4.
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`5.
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` Regeneron files this action to obtain relief before
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`Bioepis launches SB15 in the United States.
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`THE PARTIES, JURISDICTION, AND VENUE
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`6.
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`Plaintiff Regeneron is a corporation organized and existing under the laws of the
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`State of New York with its principal place of business located at 777 Old Saw Mill River Road,
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`Tarrytown, New York 10591. Regeneron is dedicated to discovering, developing, and
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`commercializing medicines to treat patients with debilitating and life-threatening diseases.
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`Regeneron owns each of the patents asserted in this Complaint (collectively, the “asserted patents”
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`3
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 4 of 128 PageID #: 4
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`or the “patents in suit”):
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`Patent
`9,222,106
`9,254,338
`9,315,281
`9,562,238
`9,816,110
`10,130,681
`10,415,055
`10,464,992
`10,669,594
`10,828,345
`10,888,601
`10,905,786
`10,918,754
`10,927,342
`11,053,280
`11,066,458
`11,084,865
`11,104,715
`11,174,283
`11,253,572
`11,299,532
`11,306,135
`11,312,936
`11,332,771
`11,472,861
`11,485,770
`11,535,663
`11,542,317
`11,548,932
`11,555,176
`11,559,564
`11,707,506
`11,732,024
`11,753,459
`11,769,597
`11,788,102
`7,070,959
`
`First Named Inventor
`Gang Chen
`George D. Yancopoulos
`Tikiri Jean Dissanayake
`Gang Chen
`Ying Shen
`George D. Yancopoulos
`Gang Chen
`Eric Furfine
`Serge Monpoeho
`George D. Yancopoulos
`George D. Yancopoulos
`Philip Stephen Shodder
`Philip Stephen Shodder
`Amy S. Johnson
`Andrew Tustian
`Eric Furfine
`Eric Furfine
`Shawn Lawrence
`Andrew Tustian
`George D. Yancopoulos
`Andrew Tustian
`Shunhai Wang
`Amy S. Johnson
`Shadia Abike Oshodi
`Shawn Lawrence
`Shunhai Wang
`Shawn Lawrence
`Shunhai Wang
`Shunhai Wang
`Wei Xue
`George D. Yancopoulos
`George D. Yancopoulos
`Eric Furfine
`Shunhai Wang
`Lorah Perlee
`Ying Shen
`Nicholas J. Papadopoulos
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`7.
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`On information and belief, Bioepis is a company organized and existing under the
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`laws of the Republic of Korea with its principal place of business located at 76, Songdogyoyuk-
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`4
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`

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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 5 of 128 PageID #: 5
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`ro, Yeonsu-gu, Incheon, Republic of Korea. Bioepis is a biopharmaceutical company that
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`specializes in research and development of biosimilars and biopharmaceuticals.
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`8.
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`On information and belief, Bioepis, directly or indirectly, manufactures its drug
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`products abroad. On information and belief, Bioepis directly, or via its subsidiaries, affiliates, or
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`other agents, develops, distributes, or sells within the United States or imports into the United
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`States Bioepis’s drug products, including SB15, under the general direction and control of Bioepis.
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`Non-limiting examples are provided below.
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`9.
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`Bioepis is the holder of aBLA No. 761054 for RENFLEXIS, an approved
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`biosimilar of Remicade. On information and belief, Bioepis manufactures and imports
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`RENFLEXIS, directly or indirectly, into the United States. For example, between April 2, 2020
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`and October 22, 2023, Bioepis imported 72 shipments of RENFLEXIS into the United States. As
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`another example, between August 17, 2019 and October 25, 2023, Samsung Biologics Co. Ltd.
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`(“Samsung Biologics”)—the corporate parent of Bioepis—imported 57 shipments of
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`RENFLEXIS into the United States.
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`10.
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` On
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`information and belief, between August 29, 2021 and March 28, 2023, Bioepis imported or
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`directed one or more of its subsidiaries, affiliates, or agents to import 17 shipments of SB15 into
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`the United States. Each of these shipments contained product described as “AFLIBERCEPT
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`(INHIBITOR (GROWTH FACTOR)).” On information and belief, between July 2, 2019 and June
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`8, 2023, Samsung Biologics imported or directed one or more of its subsidiaries, affiliates, or
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`agents to import 19 shipments of SB15 into the United States. Each of these shipments contained
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`product described as “AFLIBERCEPT (INHIBITOR (GROWTH FACTOR)).”
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`5
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 6 of 128 PageID #: 6
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`11.
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`On information and belief, Bioepis and its respective subsidiaries, affiliates, and
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`agents will function as an integrated organization and a single business enterprise in the
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`manufacture of SB15, in the importation of SB15 into the United States, and in the sale or offer
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`for sale of SB15 in the United States.
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`12.
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`On information and belief, Bioepis and its respective subsidiaries, affiliates, and
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`agents develop, manufacture, distribute, sell, and/or import drug products for the entire United
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`States market and do business in every state, including West Virginia, either directly or indirectly.
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`13.
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`This action arises under the BPCIA, 42 U.S.C. § 262(l), the Patent Laws of the
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`United States, Title 35 of the United States Code, and the Declaratory Judgment Act, 28 U.S.C.
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`§§ 2201-2202. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1332,
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`1338, 2201(a), and 2202.
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`14.
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`This Court has personal jurisdiction over Bioepis because
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`has “substantial connection” with West Virginia, and therefore satisfies the minimum contacts
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` This conduct is “suit-related,”
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`requirement.
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`15.
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`Alternatively, this Court has personal jurisdiction over Bioepis because Bioepis
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`develops, manufactures, distributes, sells, and/or imports drug products for the West Virginia
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`market, including other biosimilar products such as RENFLEXIS, and because it does business in
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`West Virginia, either directly or indirectly. These activities are so continuous and systematic as to
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`6
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 7 of 128 PageID #: 7
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`render Bioepis essentially at home in West Virginia. Daimler AG v. Bauman, 571 U.S. 117, 127
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`(2014).
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`16.
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` Alternatively, this Court has personal jurisdiction over Bioepis pursuant to Federal
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`Rule of Civil Procedure 4(k)(2).
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`17.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(c)(3), 1400(b). Bioepis is
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`a foreign corporation and is therefore subject to suit in any judicial district. Id.
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`FACTUAL BASIS FOR RELIEF
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`18.
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`The BPCIA provides a mechanism to obtain FDA approval for a biological product
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`that is “biosimilar” to a previously licensed “reference product” such as EYLEA®. 42 U.S.C. §
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`262(k). In order to be approved, biosimilars must be “highly similar to the reference product
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`notwithstanding minor differences in clinically inactive components,” with “no clinically
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`meaningful differences between the biological product and the reference product in terms of the
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`safety, purity, and potency of the product.” Id. § 262(i)(2)(A)-(B).
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`19.
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`The BPCIA reduces substantially the time and expense otherwise required to gain
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`FDA approval, by allowing a biosimilar applicant
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` to rely on most of the prior clinical
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`testing that Regeneron conducted to establish the safety and efficacy of the reference product
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`(EYLEA®). Regeneron, the reference product sponsor, invested many years of effort into its design
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`and development of EYLEA® and received patents rewarding this research. In exchange for this
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`accelerated and far less expensive application process, the BPCIA obligates a biosimilar applicant
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`to address a reference product sponsor’s relevant patents in a manner that permits adjudication of
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`patent rights before commercialization of the biosimilar product. The BPCIA does so, inter alia,
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`through a set of pre-litigation exchanges or steps outlined in 42 U.S.C. § 262(l) (herein referred to
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`as the “patent dance”).
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`7
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 8 of 128 PageID #: 8
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`xtww6éQNNNN
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 9 of 128 PageID #: 9
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 10 of 128 PageID #: 10
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`31.
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`42 U.S.C. § 262(l)(9)(A) provides that, “[i]f a subsection (k) applicant provides the
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`application and information required under paragraph (2)(A), neither the reference product sponsor
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`nor the subsection (k) applicant may, prior to the date notice is received under paragraph (8)(A),
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`10
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 11 of 128 PageID #: 11
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`bring any action under section 2201 of title 28 for a declaration of infringement, validity, or
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`enforceability of any patent that is described in clauses (i) and (ii) of paragraph (8)(B).”
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`32.
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`33.
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`Bioepis’s
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`, presents a controversy of sufficient immediacy to support declaratory judgment of
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`patent infringement under 35 U.S.C. § (a)-(c) and (g).
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`34.
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`Regeneron therefore brings this action for a judgment of infringement and
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`declaratory judgment of infringement of patents described in paragraph 8(B)(i) and (ii). 42 U.S.C.
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`§ 262(l)(9)(A).
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`CLAIMS FOR RELIEF
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`COUNT 1: INFRINGEMENT OF U.S. PATENT NO. 9,222,106 UNDER 35 U.S.C. § 271(e)
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`35.
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`Regeneron incorporates by reference all of the allegations set forth above as if fully
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`set forth below.
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`36.
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`United States Patent No. 9,222,106 (“the ’106 patent”) (Exhibit 1 hereto), was duly
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`and legally issued on December 29, 2015.
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`Regeneron is the owner of all right, title, and interest in the ’106 patent.
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`The ’106 patent has not yet expired.
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`The ’106 patent claims methods of making biological products and
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`37.
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` the
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`11
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 12 of 128 PageID #: 12
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`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of SB15
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`before the expiration of the ’106 patent is an act of infringement of one or more claims of the ’106
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`patent under 35 U.S.C. § 271(e)(2)(C)(i).
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`41.
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`For example, on information and belief, manufacture, use, offer for sale, and/or
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`sale, or import into the United States, of SB15 will infringe, inter alia, claim 20 of the ’106 patent.
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`42.
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`Regeneron will be irreparably harmed if Bioepis is not enjoined from infringing
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`one or more claims of the ’106 patent. Regeneron is entitled to injunctive relief at least under 35
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`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Bioepis from any further infringement.
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`Regeneron has no adequate remedy at law.
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`43.
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`Bioepis’s commercial manufacture, use, offer for sale, and/or sale within the United
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`States, or importation into the United States, of SB15 before the expiration of the ’106 patent will
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`cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief under 35
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`U.S.C. § 271(e)(4)(C).
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`44.
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` the
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`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
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`into the United States, of SB15 before the expiration of the ’106 patent entitles Regeneron to fees
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`under 35 U.S.C. § 271(e)(4) and § 285.
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`COUNT 2: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’106
`PATENT UNDER 35 U.S.C. § 271 (b), (g)
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`45.
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`Regeneron incorporates by reference all of the allegations set forth above as if fully
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`set forth below.
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`46.
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`On information and belief,
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` the commercial
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`manufacture, use, and/or sale of SB15 before the expiration of the ’106 patent.
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`12
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`47.
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`48.
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`On information and belief,
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` Bioepis intends to
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`and will immediately infringe one or more claims of the ’106 patent under 35 U.S.C. § 271(g) by
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`importing into the United States or offering to sell, selling, or using within the United States,
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`directly or indirectly, SB15 manufactured by the process patented in one or more claims of the
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`’106 patent. On information and belief,
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` Bioepis will induce
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`infringement of one or more claims of the ’106 patent under 35 U.S.C. § 271(b) by actively
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`inducing one or more of its subsidiaries, affiliates, or agents to import into the United States or to
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`sell, offer to sell, or use within the United States SB15 manufactured by the process patented in
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`one or more claims of the ’106 patent. Bioepis has knowledge of and is aware of the ’106 patent
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`at least due to
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` and the filing of this Complaint. On information and belief, Bioepis has also had knowledge
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`of the ’106 patent based on its active monitoring of Regeneron’s patents. For example, Bioepis
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`has filed five petitions for inter partes review against various Regeneron patents since 2023. On
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`information and belief, Bioepis will manufacture, directly or indirectly, SB15 by using a process
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`patented in one or more claims of the ’106 patent. On information and belief, Bioepis will provide
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`this SB15 to one or more of its subsidiaries, affiliates, or agents knowing or willfully blind to the
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`fact that one or more of its subsidiaries, affiliates, or agents will directly infringe one or more
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`claims of the ’106 patent.
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`49.
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`, an actual controversy has arisen and now exists between the parties
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`concerning whether Bioepis’s use, offer to sell, and/or sale within the United States, or importation
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`13
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 14 of 128 PageID #: 14
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`into the United States, of SB15 has infringed and/or will infringe one or more claims of the ’106
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`patent. An actual controversy has also arisen and now exists between the parties concerning
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`whether Bioepis has infringed and/or will infringe one or more claims of the ’106 patent by actively
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`inducing the importation, use, offer to sell, and/or sale of SB15.
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`50.
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`Regeneron is entitled to a declaratory judgment that Bioepis has infringed and/or
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`would infringe claims of the ’106 patent by using, offering to sell, and/or selling within the United
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`States, or importing into the United States, SB15, or by actively inducing the infringement of
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`Bioepis’s SB15, before the expiration of the ’106 patent.
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`51.
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`Regeneron would be irreparably harmed if Bioepis is not enjoined from infringing
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`claims of the ’106 patent. Regeneron does not have an adequate remedy at law and is entitled to
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`injunctive relief prohibiting Bioepis from making, using, offering to sell, and/or selling within the
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`United States, or importing into the United States, SB15, or actively inducing the infringement of
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`one or more claims of the ’106 patent, before the expiration of the ’106 patent.
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`COUNT 3: INFRINGEMENT OF U.S. PATENT NO. 9,254,338 UNDER 35 U.S.C. § 271(e)
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`52.
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`Regeneron incorporates by reference all of the allegations set forth above as if fully
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`set forth below.
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`53.
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`United States Patent No. 9,254,338 (“the ’338 patent”) (Exhibit 2 hereto), was duly
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`and legally issued on February 9, 2016.
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`54.
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`55.
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`56.
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`57.
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`Regeneron is the owner of all right, title, and interest in the ’338 patent.
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`The ’338 patent has not yet expired.
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`The ’338 patent claims methods of treatment using biological products and
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` the
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`14
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 15 of 128 PageID #: 15
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`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of SB15
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`before the expiration of the ’338 patent is an act of infringement of one or more claims of the ’338
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`patent under 35 U.S.C. § 271(e)(2)(C)(i).
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`58.
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`For example, the sale of SB15
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`will contribute to and induce infringement of, inter alia, claim 1 of the ’338 patent.
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`59.
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`Regeneron will be irreparably harmed if Bioepis is not enjoined from infringing
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`one or more claims of the ’338 patent. Regeneron is entitled to injunctive relief at least under 35
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`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Bioepis from any further infringement.
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`Regeneron has no adequate remedy at law.
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`60.
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`Bioepis’s commercial manufacture, use, offer for sale, and/or sale within the United
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`States, or importation into the United States, of SB15 before the expiration of the ’338 patent will
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`cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief under 35
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`U.S.C. § 271(e)(4)(C).
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`61.
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` the
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`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
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`into the United States, of SB15 before the expiration of the ’338 patent entitles Regeneron to fees
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`under 35 U.S.C. § 271(e)(4) and § 285.
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`COUNT 4: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’338
`PATENT UNDER 35 U.S.C. § 271 (b), (c)
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`62.
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`Regeneron incorporates by reference all of the allegations set forth above as if fully
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`set forth below.
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`63.
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`On information and belief,
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` the commercial
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`manufacture, use, and/or sale of SB15 before the expiration of the ’338 patent.
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`15
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`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 16 of 128 PageID #: 16
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`64.
`
`
`
`
`
`65.
`
`On information and belief,
`
`, Bioepis intends to and will
`
`immediately infringe the ’338 patent under 35 U.S.C. § 271(b) and/or (c) as a result of its activities
`
`relating to the manufacture, importation, offer for sale, sale, use, or promotion of use of SB15.
`
`66.
`
`Bioepis has knowledge of and is aware of the ’338 patent at least due to
`
`, and the
`
`filing of this Complaint. On information and belief, Bioepis has also had knowledge of the ’338
`
`patent based on its active monitoring of Regeneron’s patents. For example, Bioepis has filed five
`
`petitions for inter partes review against various Regeneron patents since 2023. Bioepis knows
`
`and/or is willfully blind to the fact that the use of SB15 will practice the methods prescribed in one
`
`or more claims of the ’338 patent at least as of
`
`.
`
`67.
`
`Bioepis has an affirmative intent to actively induce infringement by others of one
`
`or more claims of the ’338 patent at least because it
`
`
`
` in a
`
`manner that infringes one or more claims of the ’338 patent.
`
`68.
`
`Upon information and belief, Bioepis knows and/or is willfully blind to the fact that
`
`,
`
`which will directly infringe one or more claims of the ’338 patent.
`
`69.
`
`Upon information and belief, Bioepis knows or is willfully blind to the fact that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ’338 patent,
`
`either literally or under the doctrine of equivalents, at least by
`
`
`
`
`
`16
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`

`

`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 17 of 128 PageID #: 17
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`70.
`
`In view of
`
`
`
`, an actual controversy has arisen and now exists between the parties
`
`concerning whether Bioepis has infringed and/or will infringe by actively inducing and/or
`
`contributing to the infringement of one or more claims of the ’338 patent.
`
`71.
`
`Regeneron is entitled to a declaratory judgment that Bioepis has infringed and/or
`
`would infringe claims of the ’338 patent by actively inducing or contributing to the infringement
`
`of one or more claims of the ’338 patent, before the expiration of the ’338 patent.
`
`72.
`
`Regeneron would be irreparably harmed if Bioepis is not enjoined from infringing
`
`one or more claims of the ’338 patent. Regeneron does not have an adequate remedy at law and is
`
`entitled to injunctive relief prohibiting Bioepis from making, using, offering to sell, and/or selling
`
`within the United States, or importing into the United States, SB15, or actively inducing or
`
`contributing to the infringement of one or more claims of the ’338 patent, before the expiration of
`
`the ’338 patent.
`
`COUNT 5: INFRINGEMENT OF U.S. PATENT NO. 9,315,281 UNDER 35 U.S.C. § 271(e)
`
`73.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`74.
`
`United States Patent No. 9,315,281 (“the ’281 patent”) (Exhibit 3 hereto), was duly
`
`and legally issued on April 19, 2016.
`
`75.
`
`76.
`
`77.
`
`
`
`78.
`
`Regeneron is the owner of all right, title, and interest in the ’281 patent.
`
`The ’281 patent has not yet expired.
`
`The ’281 patent claims, inter alia, methods of making biological products and
`
`
`
`
`
` the
`
`17
`
`

`

`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 18 of 128 PageID #: 18
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`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of SB15
`
`before the expiration of the ’281 patent is an act of infringement of one or more claims of the ’281
`
`patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`79.
`
`For example, on information and belief, manufacture, use, offer for sale, and/or
`
`sale, or import into the United States, of SB15 will infringe, inter alia, claim 1 of the ’281 patent.
`
`80.
`
`Regeneron will be irreparably harmed if Bioepis is not enjoined from infringing
`
`one or more claims of the ’281 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Bioepis from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`81.
`
`Bioepis’s commercial manufacture, use, offer for sale, and/or sale within the United
`
`States, or importation into the United States, of SB15 before the expiration of the ’281 patent will
`
`cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief under 35
`
`U.S.C. § 271(e)(4)(C).
`
`82.
`
` the
`
`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
`
`into the United States, of SB15 before the expiration of the ’281 patent entitles Regeneron to fees
`
`under 35 U.S.C. § 271(e)(4) and § 285.
`
`COUNT 6: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’281
`PATENT UNDER 35 U.S.C. § 271 (b), (g)
`
`83.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`84.
`
`On information and belief,
`
`
`
`
`
` the commercial
`
`manufacture, use, and/or sale of SB15 before the expiration of the ’281 patent.
`
`18
`
`

`

`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 19 of 128 PageID #: 19
`
`85.
`
`
`
`
`
`86.
`
`On information and belief,
`
`, Bioepis intends to
`
`and will immediately infringe one or more claims of the ’281 patent under 35 U.S.C. § 271(g) by
`
`importing into the United States or offering to sell, selling, or using within the United States,
`
`directly or indirectly, SB15 manufactured by the process patented in one or more claims of the
`
`’281 patent. On information and belief,
`
`, Bioepis will induce
`
`infringement of one or more claims of the ’281 patent under 35 U.S.C. § 271(b) by actively
`
`inducing one or more of its subsidiaries, affiliates, or agents to import into the United States or to
`
`sell, offer to sell, or use within the United States SB15 manufactured by the process patented in
`
`one or more claims of the ’281 patent. Bioepis has knowledge of and is aware of the ’281 patent
`
`at least due to
`
`
`
`, and the filing of this Complaint. On information and belief, Bioepis has also had knowledge
`
`of the ’281 patent based on its active monitoring of Regeneron’s patents. For example, Bioepis
`
`has filed five petitions for inter partes review against various Regeneron patents since 2023. On
`
`information and belief, Bioepis will manufacture, directly or indirectly, SB15 by using a process
`
`patented in one or more claims of the ’281 patent. On information and belief, Bioepis will provide
`
`this SB15 to one or more of its subsidiaries, affiliates, or agents knowing or willfully blind to the
`
`fact that one or more of its subsidiaries, affiliates, or agents will directly infringe one or more
`
`claims of the ’281 patent.
`
`87.
`
`In view of
`
`
`
` an actual controversy has arisen and now exists between the parties
`
`concerning whether Bioepis’s use, offer to sell, and/or sale within the United States, or importation
`
`19
`
`

`

`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 20 of 128 PageID #: 20
`
`into the United States, of SB15 has infringed and/or will infringe one or more claims of the ’281
`
`patent. An actual controversy has also arisen and now exists between the parties concerning
`
`whether Bioepis has infringed and/or will infringe one or more claims of the ’281 patent by actively
`
`inducing the importation, use, offer to sell, and/or sale of SB15.
`
`88.
`
`Regeneron is entitled to a declaratory judgment that Bioepis has infringed and/or
`
`would infringe claims of the ’281 patent by using, offering to sell, and/or selling within the United
`
`States, or importing into the United States, SB15, or by actively inducing the infringement of
`
`Bioepis’s SB15, before the expiration of the ’281 patent.
`
`89.
`
`Regeneron would be irreparably harmed if Bioepis is not enjoined from infringing
`
`claims of the ’281 patent. Regeneron does not have an adequate remedy at law and is entitled to
`
`injunctive relief prohibiting Bioepis from making, using, offering to sell, and/or selling within the
`
`United States, or importing into the United States, SB15, or actively inducing the infringement of
`
`one or more claims of the ’281 patent, before the expiration of the ’281 patent.
`
`COUNT 7: INFRINGEMENT OF U.S. PATENT NO. 9,562,238 UNDER 35 U.S.C. § 271(e)
`
`90.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`91.
`
`United States Patent No. 9,562,238 (“the ’238 patent”) (Exhibit 35 hereto), was
`
`duly and legally issued on February 7, 2017.
`
`Regeneron is the owner of all right, title, and interest in the ’238 patent.
`
`The ’238 patent has not yet expired.
`
`The ’238 patent claims methods of making biological products and
`
`92.
`
`93.
`
`94.
`
`95.
`
`
`
`
`
` the
`
`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of SB15
`
`20
`
`

`

`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 21 of 128 PageID #: 21
`
`before the expiration of the ’238 patent is an act of infringement of one or more claims of the ’238
`
`patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`96.
`
`For example, on information and belief, manufacture, use, offer for sale, and/or
`
`sale, or import into the United States, of SB15 will infringe, inter alia, claim 1 of the ’238 patent.
`
`97.
`
`Regeneron will be irreparably harmed if Bioepis is not enjoined from infringing
`
`one or more claims of the ’238 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Bioepis from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`98.
`
`Bioepis’s commercial manufacture, use, offer for sale, and/or sale within the United
`
`States, or importation into the United States, of SB15 before the expiration of the ’238 patent will
`
`cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief under 35
`
`U.S.C. § 271(e)(4)(C).
`
`99.
`
` the
`
`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
`
`into the United States, of SB15 before the expiration of the ’238 patent entitles Regeneron to fees
`
`under 35 U.S.C. § 271(e)(4) and § 285.
`
`COUNT 8: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’238
`PATENT UNDER 35 U.S.C. § 271 (b), (g)
`
`100. Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`101. On information and belief,
`
`
`
`
`
` the commercial
`
`manufacture, use, and/or sale of SB15 before the expiration of the ’238 patent.
`
`21
`
`

`

`Case 1:23-cv-00094-TSK Document 1 Filed 11/21/23 Page 22 of 128 PageID #: 22
`
`102.
`
`
`
`
`
`103. On information and belief,
`
`, Bioepis intends to
`
`and will immediately infringe one or more claims of the ’238 patent under 35 U.S.C. § 271(g) by
`
`importing into the United States or offering to sell, selling, or using within the United States,
`
`directly or indirectly, SB15 manufactured by the process patented in one or more claims of the
`
`’238 patent. On information and belief,
`
`, Bioepis will induce
`
`infringement of one or more claims of the ’238 patent under 35 U.S.C. § 271(b) by actively
`
`inducing one or more of its subsidiaries, affiliates, or agents to import into the United States or to
`
`sell, offer to sell, or use within the United States SB15 manufactured by the process patented in
`
`one or more claims of the ’238 patent. Bioepis has knowledge of and is aware of the ’238 patent
`
`at least due to
`
`
`
` and the filing of this