Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 1 of 133 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
` ELECTRONICALLY
` FILED
`Nov 08 2023
` U.S. DISTRICT COURT
` Northern District of WV
`
`REGENERON PHARMACEUTICALS, INC.
`
`Plaintiff,
`
`v.
`
`CELLTRION, INC.,
`
`Defendant.
`
`CASE NO.:
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`1:23-CV-89 (Kleeh)
`
`JURY TRIAL DEMANDED
`
`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 Celltrion, Inc. (“Celltrion” or “Defendant”) is seeking FDA approval under the
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`Biologics Price Competition and Innovation Act (“BPCIA”), 42 U.S.C. §§ 262(k)-(l), to
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`commercialize “CT-P42,” a proposed biosimilar of EYLEA®. Celltrion has served its notice of
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`commercial marketing pursuant to 42 U.S.C. § 262(l)(8)(A) (“Notice of Commercial Marketing”),
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`indicating its intent to begin marketing and selling CT-P42 immediately upon receiving approval
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`from the U.S. Food and Drug Administration (“FDA”). To vindicate its patent rights, Regeneron
`
`brings this Complaint pursuant to 28 U.S.C. §§ 2201-2202 and under 42 U.S.C. § 262(l)(9)(A)
`
`seeking declaratory judgment of patent infringement against the Defendant under 35 U.S.C.
`
`§§ 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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`1
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`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 2 of 133 PageID #: 2
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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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`for Regeneron to develop other life-transforming medicines.
`
`3.
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`On June 30, 2023, Celltrion publicly announced that it had filed abbreviated
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`Biologics Drug Application (“aBLA”) No. 761377 with FDA for CT-P42, a biosimilar copy of
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`2
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`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 3 of 133 PageID #: 3
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`EYLEA®. Enacted in 2010 as part of the Affordable Care Act, the BPCIA provides for an
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`abbreviated regulatory approval pathway for biosimilars by letting applicants rely on the extensive
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`clinical testing previously conducted, at great expense, by the innovator company that developed
`
`the medicine the applicant wants to copy. See Sandoz Inc. v. Amgen Inc., 582 U.S. 1 (2017).
`
`4.
`
`Celltrion’s submission of its aBLA constitutes an act of patent infringement under
`
`35 U.S.C. § 271(e). Celltrion has also served its Notice of Commercial Marketing. Pursuant to 42
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`U.S.C. § 262(k)(7)(A), Celltrion’s aBLA may be approved as soon as EYLEA®’s regulatory
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`exclusivity expires on May 18, 2024. Regeneron files this action to obtain relief before Celltrion
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`launches CT-P42 in the United States.
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`THE PARTIES, JURISDICTION, AND VENUE
`
`5.
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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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`or the “patents in suit”):
`
`Patent
`9,222,106
`9,254,338
`9,315,281
`9,816,110
`10,130,681
`10,415,055
`10,464,992
`10,669,594
`10,828,345
`10,888,601
`
`
`
`First Named Inventor
`Gang Chen
`George D. Yancopoulos
`Tikiri Jean Dissanayake
`Ying Shen
`George D. Yancopoulos
`Gang Chen
`Eric Furfine
`Serge Monpoeho
`George D. Yancopoulos
`George D. Yancopoulos
`
`3
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`

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`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
`11,459,374
`11,472,861
`11,485,770
`11,505,593
`11,525,833
`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
`11,793,926
`7,070,959
`
`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
`Andrew Tustian
`Shawn Lawrence
`Shunhai Wang
`Shunhai Wang
`Yuetian Yan
`Shawn Lawrence
`Shunhai Wang
`Shunhai Wang
`Wei Xue
`George D. Yancopoulos
`George D. Yancopoulos
`Eric Furfine
`Shunhai Wang
`Lorah Perlee
`Ying Shen
`Andrew Cook
`Nicholas J. Papadopoulos
`
`6.
`
`Celltrion is a company organized and existing under the laws of the Republic of
`
`Korea with its principal place of business located at 23, Academy-ro, Yeonsu-gu, Incheon, Korea
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`22014. Celltrion is, among other things, engaged in the development of biologic drugs, including
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`a proposed biosimilar version of Regeneron’s EYLEA®, CT-P42.
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`4
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`7.
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`Upon information and belief, Celltrion, directly or indirectly, manufactures its drug
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`products abroad. Upon information and belief, Celltrion directly, or via its subsidiaries, affiliates,
`
`or other agents, develops, distributes, or sells within the United States or imports into the United
`
`States Celltrion’s drug products, including CT-P42, under the general direction and control of
`
`Celltrion.
`
`8.
`
`For example, it was announced in August 2023 that Celltrion will merge with
`
`Celltrion Healthcare Co. Ltd. by the end of 2023, and will merge with Celltrion Pharm Inc. six
`
`months later. A report from Celltrion’s Board of Directors to its Shareholders states that, “[l]eading
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`in the development and commercialization of the world’s first antibody biosimilars in major
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`markets like the U.S. and Europe, our companies have cemented themselves as top-tier players in
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`the global biosimilars landscape.” Exhibit 39 (emphasis added). “As we aim to leverage the
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`accelerating market growth, merged Celltrion (MergeCo) will concentrate on optimizing
`
`operations to improve both agility and efficiency. This involves consolidating our existing
`
`subsidiaries, which have until now operated independently with distinct focuses on development,
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`production, and sales. The goal is to evolve into a fully integrated global life sciences company.”
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`Id. (emphasis added).
`
`9.
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`A presentation on Celltrion’s website regarding the Celltrion-Celltrion Healthcare
`
`Co. Ltd. merger states that the merger will simplify transactions and allow Celltrion to directly
`
`recognize revenue “vis-à-vis end-market product sales” with “[m]inimum related party transaction
`
`and working capital impact.” Exhibit 40.
`
`10.
`
`Celltrion’s stated goal of evolving its affiliates and their respective subsidiaries into
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`a fully integrated global life sciences company is supported by its past and current activities
`
`relating to its drug products. Non-limiting examples are described below.
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`
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`5
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`11.
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`Celltrion is the holder of aBLA No. 125544 for Inflectra (infliximab), an approved
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`biosimilar of Remicade. The Inflectra label indicates that Celltrion manufactures Inflectra for sale
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`in the United States. Importation records identify Celltrion Healthcare Co. Ltd. on shipments of
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`infliximab from March and July of 2022.
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`12.
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`Celltrion is the holder of aBLA No. 761219 for Yuflyma, an approved biosimilar
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`of Humira. The Yuflyma label identifies Celltrion USA, Inc., a subsidiary and/or affiliate of
`
`Celltrion, as the distributor of Yuflyma in the United States.
`
`13.
`
`On information and belief, Celltrion itself imported or directed one or more of its
`
`subsidiaries, affiliates, or agents to import CT-P42 into the United States. For example, in April,
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`June, and July 2022, shipments of “AFLIBERCEPT (INHIBITOR (GROWTH FACTOR))” were
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`imported into the United States. In June 2023—the same month Celltrion publicly announced that
`
`it had filed its aBLA with FDA for CT-P42—an additional shipment of “AFLIBERCEPT
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`(INHIBITOR (GROWTH FACTOR))” was imported into the United States. On information and
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`belief, at least some of the importation of CT-P42 was done for commercial purposes and not
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`“solely for uses reasonably related to the development and submission of information under a
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`Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological
`
`products.” 35 U.S.C. § 271(e)(1).
`
`14.
`
`On information and belief, Celltrion, Celltrion Healthcare Co. Ltd., Celltrion Pharm
`
`Inc., and their respective subsidiaries, affiliates, and agents, including Celltrion USA, Inc., will
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`function as an integrated organization and a single business enterprise in the manufacture of CT-
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`P42, in the importation of CT-P42 into the United States, and in the sale or offer for sale of CT-
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`P42 in the United States.
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`6
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`15.
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`On information and belief, Celltrion, Celltrion Healthcare Co. Ltd., Celltrion Pharm
`
`Inc., and their respective subsidiaries, affiliates, and agents, including Celltrion USA, Inc.,
`
`develop, manufacture, distribute, sell, and/or import drug products for the entire United States
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`market and do business in every state, including West Virginia, either directly or indirectly.
`
`16.
`
`This action arises under the BPCIA, 42 U.S.C. § 262(l), the Patent Laws of the
`
`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.
`
`17.
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`This Court has personal jurisdiction over Celltrion because Celltrion has filed its
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`aBLA for CT-P42 with FDA, seeking approval to engage in the commercial manufacture, use,
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`offer for sale, sale, and/or importation of CT-P42 in the United States, including in the State of
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`West Virginia; and because, if its product receives FDA approval, Celltrion intends to—by itself
`
`or through others—market, distribute, offer for sale, and/or sell it in the United States, including
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`in the State of West Virginia, deriving substantial revenue therefrom. This conduct is “suit-
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`related,” has “substantial connection” with West Virginia, and therefore satisfies the minimum
`
`contacts requirement.
`
`18.
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`Alternatively, this Court has personal jurisdiction over Celltrion because Celltrion
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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 Yuflyma, and because it does business in West
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`Virginia, either directly or indirectly. These activities are so continuous and systematic as to render
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`Celltrion essentially at home in West Virginia. Daimler AG v. Bauman, 571 U.S. 117, 127 (2014).
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`19.
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` Alternatively, this Court has personal jurisdiction over Celltrion pursuant to
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`Federal Rule of Civil Procedure 4(k)(2).
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`7
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`20.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(c)(3), 1400(b). Celltrion
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`is a foreign corporation and is therefore subject to suit in any judicial district. Id.
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`FACTUAL BASIS FOR RELIEF
`
`21.
`
`The BPCIA provides a mechanism to obtain FDA approval for a biological product
`
`that is “biosimilar” to a previously licensed “reference product” such as EYLEA®. 42 U.S.C.
`
`§ 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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`22.
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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 like Celltrion 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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`23.
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`The ongoing patent dance between Regeneron and Celltrion has proceeded
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`substantially as follows. On September 1, 2023, Celltrion contacted outside counsel for Regeneron
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`and indicated its intent to participate in the patent dance procedure. On September 13, 2023,
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`Celltrion served a copy of its Biologics License Application for CT-P42 (“Celltrion aBLA”) under
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`8
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`42 U.S.C. § 262(l)(2)(A).
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`24.
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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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`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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`25.
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`Celltrion served to Regeneron its Notice of Commercial Marketing, indicating its
`
`intent to begin marketing and selling CT-P42 immediately upon receiving approval from the FDA.
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`Pursuant to 42 U.S.C. § 262(k)(7)(A), approval of Celltrion’s aBLA may be made effective as
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`soon as EYLEA®’s regulatory exclusivity expires on May 18, 2024.
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`26.
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`Celltrion’s submission of its aBLA, combined with its Notice of Commercial
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`Marketing, 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).
`
`27.
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`On November 7, 2023, Regeneron served on Celltrion “a list of patents for which
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`the reference product sponsor believes a claim of patent infringement could reasonably be asserted
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`by the reference product sponsor” (“3A list”) under § 262(l)(3)(A).
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`28.
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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.
`
`§ 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)
`
`29.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
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`9
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`30.
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`United States Patent No. 9,222,106 (“the ’106 patent”) (Exhibit 1 hereto), was duly
`
`and legally issued on December 29, 2015.
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`31.
`
`32.
`
`33.
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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 was included
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`on the list of patents provided by Regeneron to Celltrion pursuant to 42 U.S.C. § 262(l)(3)(A).
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`34.
`
`The submission of Celltrion’s aBLA to obtain FDA approval to engage in the
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`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of CT-
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`P42 before the expiration of the ’106 patent is an act of infringement of one or more claims of the
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`’106 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`35.
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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 CT-P42 will infringe, inter alia, claim 20 of the ’106
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`patent.
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`36.
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`Regeneron will be irreparably harmed if Celltrion 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 Celltrion from any further infringement.
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`Regeneron has no adequate remedy at law.
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`37.
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`Celltrion’s commercial manufacture, use, offer for sale, and/or sale within the
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`United States, or importation into the United States, of CT-P42 before the expiration of the ’106
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`patent will cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief
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`under 35 U.S.C. § 271(e)(4)(C).
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`38.
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`The submission of Celltrion’s aBLA to obtain FDA approval to engage in the
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`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
`
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`10
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`into the United States, of CT-P42 before the expiration of the ’106 patent entitles Regeneron to
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`fees 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) and (g)
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`39.
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`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
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`40.
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`On information and belief, Celltrion submitted its aBLA referencing Regeneron’s
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`EYLEA® and seeking FDA approval under 42 U.S.C. § 262(k) to engage in the commercial
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`manufacture, use, and/or sale of CT-P42 before the expiration of the ’106 patent.
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`41.
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`Celltrion served to Regeneron its Notice of Commercial Marketing, indicating its
`
`intent to begin marketing and selling CT-P42 immediately upon receiving approval from the FDA.
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`42.
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`On information and belief, following FDA approval of its CT-P42, Celltrion
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`intends to and will immediately infringe one or more claims of the ’106 patent under 35 U.S.C.
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`§ 271(g) by importing into the United States or offering to sell, selling, or using within the United
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`States, directly or indirectly, CT-P42 manufactured by the process patented in one or more claims
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`of the ’106 patent. On information and belief, following FDA approval of its CT-P42, Celltrion
`
`will induce infringement of one or more claims of the ’106 patent under 35 U.S.C. § 271(b) by
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`actively inducing one or more of its subsidiaries, affiliates, or agents to import into the United
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`States or to sell, offer to sell, or use within the United States CT-P42 manufactured by the process
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`patented in one or more claims of the ’106 patent. Celltrion has knowledge of and is aware of the
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`’106 patent at least due to Regeneron’s disclosure of patents pursuant to 42 U.S.C. § 262(l)(3)(A)
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`and the filing of this Complaint. On information and belief, Celltrion has also had knowledge of
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`the ’106 patent based on its active monitoring of Regeneron’s patents. For example, Celltrion has
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`filed seven petitions for inter partes review or post grant review against various Regeneron patents
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`11
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`since 2021. On information and belief, Celltrion will manufacture, directly or indirectly, CT-P42
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`by using a process patented in one or more claims of the ’106 patent. On information and belief,
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`Celltrion will provide this CT-P42 to one or more of its subsidiaries, affiliates, or agents knowing
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`or willfully blind to the fact that one or more of its subsidiaries, affiliates, or agents will directly
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`infringe one or more claims of the ’106 patent.
`
`43.
`
`In view of Celltrion’s submission of its aBLA and service of its Notice of
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`Commercial Marketing, an actual controversy has arisen and now exists between the parties
`
`concerning whether Celltrion’s use, offer to sell, and/or sale within the United States, or
`
`importation into the United States, of CT-P42 has infringed and/or will infringe one or more claims
`
`of the ’106 patent. An actual controversy has also arisen and now exists between the parties
`
`concerning whether Celltrion has infringed and/or will infringe one or more claims of the ’106
`
`patent by actively inducing the importation, use, offer to sell, and/or sale of CT-P42.
`
`44.
`
`Regeneron is entitled to a declaratory judgment that Celltrion has infringed and/or
`
`would infringe claims of the ’106 patent by using, offering to sell, and/or selling within the United
`
`States, or importing into the United States, CT-P42, or by actively inducing the infringement of
`
`Celltrion’s CT-P42, before the expiration of the ’106 patent.
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`45.
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`Regeneron would be irreparably harmed if Celltrion is not enjoined from infringing
`
`claims of the ’106 patent. Regeneron does not have an adequate remedy at law and is entitled to
`
`injunctive relief prohibiting Celltrion from making, using, offering to sell, and/or selling within
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`the United States, or importing into the United States, CT-P42, or actively inducing the
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`infringement of 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)
`
`46.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
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`12
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`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 13 of 133 PageID #: 13
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`47.
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`United States Patent No. 9,254,338 (“the ’338 patent”) (Exhibit 2 hereto), was duly
`
`and legally issued on February 9, 2016.
`
`48.
`
`49.
`
`50.
`
`Regeneron is the owner of all right, title, and interest in the ’338 patent.
`
`The ’338 patent has not yet expired.
`
`The ’338 patent claims methods of treatment using biological products and was
`
`included on the list of patents provided by Regeneron to Celltrion pursuant to 42 U.S.C.
`
`§ 262(l)(3)(A).
`
`51.
`
`The submission of Celltrion’s aBLA to obtain FDA approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of CT-
`
`P42 before the expiration of the ’338 patent is an act of infringement of one or more claims of the
`
`’338 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`52.
`
`For example, the sale of CT-P42 pursuant to the label proposed in Celltrion’s aBLA
`
`will contribute to and induce infringement of, inter alia, claim 1 of the ’338 patent.
`
`53.
`
`Regeneron will be irreparably harmed if Celltrion is not enjoined from infringing
`
`one or more claims of the ’338 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Celltrion from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`54.
`
`Celltrion’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of CT-P42 before the expiration of the ’338
`
`patent will cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`55.
`
`The submission of Celltrion’s aBLA to obtain FDA approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
`
`
`
`13
`
`
`
`

`

`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 14 of 133 PageID #: 14
`
`into the United States, of CT-P42 before the expiration of the ’338 patent entitles Regeneron to
`
`fees under 35 U.S.C. § 271(e)(4) and § 285.
`
`COUNT 4: DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’338
`PATENT UNDER 35 U.S.C. § 271 (b) or (c)
`
`56.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`57.
`
`On information and belief, Celltrion submitted its aBLA referencing Regeneron’s
`
`EYLEA® and seeking FDA approval under 42 U.S.C. § 262(k) to engage in the commercial
`
`manufacture, use, and/or sale of CT-P42 before the expiration of the ’338 patent.
`
`58.
`
`Celltrion served to Regeneron its Notice of Commercial Marketing, indicating its
`
`intent to begin marketing and selling CT-P42 immediately upon receiving approval from the FDA.
`
`59.
`
`Following FDA approval, Celltrion 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 CT-P42.
`
`60.
`
`Celltrion has knowledge of and is aware of the ’338 patent at least due to its filing
`
`of a petition for inter partes review of the ’338 patent (IPR2022-00258) on December 9, 2021,
`
`Regeneron’s disclosure of patents pursuant to 42 U.S.C. § 262(l)(3)(A), and the filing of this
`
`Complaint. On information and belief, Celltrion has also had knowledge of the ’338 patent based
`
`on its active monitoring of Regeneron’s patents. For example, Celltrion has filed seven petitions
`
`for inter partes review or post grant review against various Regeneron patents since
`
`2021. Celltrion knows and/or is willfully blind to the fact that the use of CT-P42 will practice the
`
`methods prescribed in one or more claims of the ’338 patent at least as of December 9, 2021.
`
`61.
`
`Celltrion has an affirmative intent to actively induce infringement by others of one
`
`or more claims of the ’338 patent at least because it filed an aBLA that includes a proposed label
`
`
`
`14
`
`
`
`

`

`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 15 of 133 PageID #: 15
`
`with directions that instruct medical practitioners to administer and/or patients to use CT-P42 in a
`
`manner that infringes one or more claims of the ’338 patent.
`
`62.
`
`Upon information and belief, Celltrion knows and/or is willfully blind to the fact
`
`that medical practitioners will administer and/or patients will use CT-P42 according to its proposed
`
`label, which will directly infringe one or more claims of the ’338 patent.
`
`63.
`
`Upon information and belief, Celltrion 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 recommending such infringing acts
`
`in its proposed label for the Celltrion aBLA product.
`
`64.
`
`In view of Celltrion’s submission of its aBLA and service of its Notice of
`
`Commercial Marketing, an actual controversy has arisen and now exists between the parties
`
`concerning whether Celltrion has infringed and/or will infringe by actively inducing and/or
`
`contributing to the infringement of one or more claims of the ’338 patent.
`
`65.
`
`Regeneron is entitled to a declaratory judgment that Celltrion 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.
`
`66.
`
`Regeneron would be irreparably harmed if Celltrion 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 Celltrion from making, using, offering to sell, and/or selling
`
`within the United States, or importing into the United States, CT-P42, or actively inducing or
`
`contributing to the infringement of one or more claims of the ’338 patent, before the expiration of
`
`the ’338 patent.
`
`
`
`15
`
`
`
`

`

`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 16 of 133 PageID #: 16
`
`COUNT 5: INFRINGEMENT OF U.S. PATENT NO. 9,315,281 UNDER 35 U.S.C. § 271(e)
`
`67.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`68.
`
`United States Patent No. 9,315,281 (“the ’281 patent”) (Exhibit 3 hereto), was duly
`
`and legally issued on April 19, 2016.
`
`69.
`
`70.
`
`71.
`
`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 was
`
`included on the list of patents provided by Regeneron to Celltrion pursuant to 42 U.S.C. §
`
`262(l)(3)(A).
`
`72.
`
`The submission of Celltrion’s aBLA to obtain FDA approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale, or import into the United States, of CT-
`
`P42 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).
`
`73.
`
`For example, on information and belief, manufacture, use, offer for sale, and/or
`
`sale, or import into the United States, of CT-P42 will infringe, inter alia, claim 13 of the ’281
`
`patent.
`
`74.
`
`Regeneron will be irreparably harmed if Celltrion 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 Celltrion from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`75.
`
`Celltrion’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of CT-P42 before the expiration of the ’281
`
`
`
`16
`
`
`
`

`

`Case 1:23-cv-00089-TSK Document 1 Filed 11/08/23 Page 17 of 133 PageID #: 17
`
`patent will cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`76.
`
`The submission of Celltrion’s aBLA to obtain FDA approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale within the United States, or importation
`
`into the United States, of CT-P42 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) and (g)
`
`77.
`
`Regeneron incorporates by reference all of the allegations set forth above as if fully
`
`set forth below.
`
`78.
`
`On information and belief, Celltrion submitted its aBLA referencing Regeneron’s
`
`EYLEA® and seeking FDA approval under 42 U.S.C. § 262(k) to engage in the commercial
`
`manufacture, use, and/or sale of CT-P42 before the expiration of the ’281 patent.
`
`79.
`
`Celltrion served to Regeneron its Notice of Commercial Marketing, indicating its
`
`intent to begin marketing and selling CT-P42 immediately upon receiving approval from the FDA.
`
`80.
`
`On information and belief, following FDA approval of its CT-P42, Celltrion
`
`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, CT-P42 manufactured by the process patented in one or more claims
`
`of the ’281 patent. On information and belief, following FDA approval of its CT-P42,