Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 1 of 39 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
` ELECTRONICALLY
` FILED
`Aug 02 2022
` U.S. DISTRICT COURT
` Northern District of WV
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Plaintiff,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`1:22-CV-61 (Kleeh)
`Case No.:
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`JURY TRIAL DEMANDED
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) invented, developed, and sells
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`Eylea®, the market-leading treatment for certain serious eye diseases. Defendant Mylan
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`Pharmaceuticals Inc. (“Mylan”) is seeking FDA approval under the Biologics Price Competition
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`and Innovation Act (“BPCIA”), 42 U.S.C. §§ 262(k)-(l), to commercialize “M710,” a proposed
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`biosimilar of Eylea®. To vindicate its patent rights, Regeneron brings this Complaint seeking a
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`judgment of patent infringement against Mylan under 35 U.S.C. § 271(e) and pursuant to the
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`BPCIA.
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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
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`dedicated to improving human health and tackling the most urgent medical issues facing the
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`Nation. Founded and led for over 30 years by physician-scientists, Regeneron has developed
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`life-transforming medicines for people with serious diseases, including cancer, atopic dermatitis,
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`asthma, eye diseases, cardiovascular and metabolic diseases, Ebola, and COVID-19, the latter of
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`which has been used across the country, including by the former President. Regeneron’s cutting-
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`edge scientific advances were supported, in large part, by its ophthalmic product, Eylea®, which
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`1
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`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 age-related macular degeneration. As
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`a result of Regeneron’s additional clinical testing, Eylea® is now also approved for use in treating
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`other serious disorders of the eye: diabetic macular edema, macular edema following retinal
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`vein occlusion, and diabetic retinopathy. And other clinical trials are ongoing, including to treat
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`a retinal disease in premature babies called retinopathy of prematurity. In addition to benefitting
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`the many patients it has been used to treat, Eylea® is also a critical source of research and
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`development funding for Regeneron.
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`3.
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`Last October, Mylan filed for FDA approval under the BPCIA to commercialize a
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`“biosimilar” copy of Eylea®. Enacted in 2010 as part of the Affordable Care Act, the BPCIA
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`provides for a substantially 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., 137 S. Ct. 1664 (2017).
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`4.
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`On December 28, 2021, FDA notified Mylan that its application—i.e., its
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`abbreviated Biologic License Application, or “aBLA” No. 761274—for M710 had been accepted
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`for review. Mylan’s submission of its aBLA constitutes an act of patent infringement under 35
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`U.S.C. § 271(e).
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`2
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`5.
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`By statute, Regeneron could not immediately file a lawsuit for Mylan’s § 271(e)
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`infringement. The BPCIA prohibits filing such a suit until certain requirements of 42 U.S.C.
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`§ 262(l), commonly called the “patent dance,” are satisfied. In the patent dance, the BPCIA
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`directs exchanges of certain information between the innovator company (or “reference product
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`sponsor”) and the biosimilar (or “subsection (k)”) applicant. At the end of the patent dance, the
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`reference product sponsor is authorized to initiate litigation against the biosimilar applicant
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`within thirty days in a venue of its choosing. Mylan, the subsection (k) applicant, and
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`Regeneron, the reference product sponsor, completed the final step of the patent dance—the
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`exchange of lists of patents pursuant to § 262(l)(5)—on July 5. Regeneron then promptly
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`brought this action as required by § 262(l)(6) to address Mylan’s patent infringement under
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`§ 271(e).
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`THE PARTIES, JURISDICTION, AND VENUE
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`6.
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`Regeneron Pharmaceuticals, Inc. is a corporation organized under the laws of the
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`State of New York, with its principal place of business at 777 Old Saw Mill River Road,
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`Tarrytown, NY 10591. The company 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: U.S. Patent Nos. 7,070,959;
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`9,222,106; 9,254,338; 9,669,069; 9,816,110; 10,130,681; 10,406,226; 10,415,055; 10,464,992;
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`10,669,594; 10,857,205; 10,888,601; 10,927,342; 10,973,879; 11,053,280; 11,066,458;
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`11,084,865; 11,104,715; 11,174,283; 11,186,625; 11,253,572; 11,299,532; 11,306,135; and
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`11,332,771 (collectively, the “asserted patents” or the “patents in suit”).
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`7.
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`On information and belief, Mylan Pharmaceuticals Inc. is a corporation organized
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`under the laws of the State of West Virginia, having a principal place of business at 781 Chestnut
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`Ridge Road, Morgantown, West Virginia 26505. On information and belief, Mylan
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`3
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`Pharmaceuticals Inc. is a wholly owned subsidiary of Viatris Inc. (“Viatris”).
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`8.
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`On information and belief, Mylan develops, manufactures, distributes, sells,
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`and/or imports drug products for the entire United States market and does business in every state,
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`including West Virginia, either directly or indirectly.
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`9.
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`Regeneron’s claims for patent infringement arise under the patent laws of the
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`United States, Titles 35 and 42 of the United States Code. This Court has subject matter
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`jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a).
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`10. Mylan and its development partners have publicly announced their intention to
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`ignore Regeneron’s patent rights and launch an aflibercept biosimilar product before the
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`expiration of the patents asserted in this action.
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`11.
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`On information and belief, Momenta Pharmaceuticals Inc. is or was Mylan’s
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`development partner for its proposed aflibercept biosimilar product. In August 2020, Momenta
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`publicly announced that it “believe[d]” its collaboration with Mylan to market an aflibercept
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`biosimilar product “has the potential to launch in the 2023 time frame,”1 before the expiry of the
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`asserted patents.
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`12.
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`Viatris later announced its intention to become the “first to market” an aflibercept
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`biosimilar product. Rajiv Malik, the president of Viatris, explained that becoming “the first to
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`market [an aflibercept biosimilar product] is becoming [sic] decisive advantage. And that’s
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`where we’re going to focus on that how can we be the first to market.”2
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`
`1 Momenta Pharmaceuticals Inc., Form 10-Q, at 26 (Aug. 10, 2020),
`https://seekingalpha.com/filings/pdf/14323380.
`
`2 Goldman Sachs 42nd Annual Global Healthcare Conference, Viatris Inc. Presentation (June 10,
`2021), https://seekingalpha.com/article/4434224-viatris-inc-vtrs-management-presents-goldman-
`sachs-42nd-annual-global-healthcare-conference.
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`4
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`

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`13.
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`This Court has personal jurisdiction over Mylan because it is incorporated in the
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`State of West Virginia; because Mylan is seeking approval to engage in the commercial
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`manufacture, use, offer for sale, sale, and/or importation of M710 in the United States, including
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`in the State of West Virginia; and because, if its product receives FDA approval, Mylan intends
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`to market, distribute, offer for sale, and/or sell it in the United States, including in the State of
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`West Virginia, deriving substantial revenue therefrom.
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`14.
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`In addition, Mylan has consented to jurisdiction in the State of West Virginia in
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`one or more prior cases arising out of its manufacture, use, offer for sale, sale, and/or importation
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`of Mylan pharmaceutical products in the United States, including in the State of West Virginia.
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`15.
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`Venue is proper in this District pursuant to 28 U.S.C. § 1391 and § 1400(b).
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`Venue is proper because Mylan Pharmaceuticals Inc. is incorporated in the State of West
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`Virginia and resides in this judicial district.
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`FACTUAL BASIS FOR RELIEF
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`16.
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`The BPCIA provides a mechanism to obtain FDA approval for a biological
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`product that is “biosimilar” to a previously licensed “reference product” such as Eylea®. 42
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`U.S.C. § 262(k). In order to be approved, biosimilars must be “highly similar to the reference
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`product 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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`17.
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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 Mylan 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 numerous patents rewarding this research. In exchange
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`5
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`for this accelerated and far less expensive application process, the BPCIA obligates a biosimilar
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`applicant to address a reference product sponsor’s relevant patents in a manner that permits
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`adjudication of patent rights before commercialization of the biosimilar product. The BPCIA
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`does so, inter alia, through its patent dance.
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`18.
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`The patent dance between Regeneron and Mylan proceeded substantially as
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`follows within the timeframes specified in the BPCIA. Mylan informed Regeneron that its
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`aBLA for M710 was accepted for FDA review on December 28, 2021. Mylan provided
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`Regeneron access to Mylan’s aBLA through an online review platform. Under § 262(l)(3)(A),
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`Regeneron next provided Mylan with a list of patents for which “a claim of patent infringement
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`could reasonably be asserted” if Mylan commercialized its product. Under § 262(l)(7),
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`Regeneron also provided to Mylan a “supplement to the list” for several additional patents that
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`issued following Regeneron’s service of its original patent list provided under § 262(l)(3)(A).
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`19.
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`Upon receiving Regeneron’s patent lists, Mylan served “detailed statements” for
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`the patents on the original or supplemental list. By statute, a biosimilar applicant’s detailed
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`statements must either represent that it will not begin commercial marketing of its biosimilar
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`product before the patent expires (under § 262(l)(3)(B)(ii)(II)) or allege that the patent is invalid,
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`unenforceable, or not infringed (under § 262(l)(3)(B)(ii)(I)). Remarkably, Mylan’s “detailed
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`statements” respected not one of Regeneron’s patents; rather, according to Mylan, every one of
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`Regeneron’s listed patents is not infringed, invalid, and unenforceable.
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`20.
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`Under § 262(l)(3)(C), Regeneron provided its detailed responses to Mylan’s
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`contentions, setting forth particular grounds for infringement based on the confidential
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`information in Mylan’s aBLA and rebutting Mylan’s noninfringement, invalidity and
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`unenforceability allegations. Regeneron did not contend infringement on one of the patents on
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`6
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`
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`its list and informed Mylan it did not plan to assert that patent.
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`21.
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`Next, under § 262(l)(4)(A), Regeneron initiated negotiations over which patents
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`on Regeneron’s list should be litigated in a § 271(e) infringement action. Regeneron proposed
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`litigating a targeted subset of the listed patents, in order to facilitate the Court’s adjudication of
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`the parties’ primary disputes on a full record before approval of Mylan’s product. Mylan refused
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`to do so. Instead, it proposed to litigate twenty-five of the listed patents. Next, under
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`§ 262(l)(5)(B), the parties exchanged the lists of patents that each believed should be part of the
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`infringement action under § 271(e). Mylan listed twenty-five patents, whereas Regeneron listed
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`twelve (each of which was also on Mylan’s list).
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`22.
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`If the parties disagree on the patents that should be part of the litigation,
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`§ 262(l)(6)(B) requires the innovator company to bring suit on every patent selected by either
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`party. Thus, despite Regeneron’s efforts to focus this case on a targeted subset of asserted
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`patents, Mylan’s expansive listing of patents requires Regeneron by statute to include each one
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`of those patents in this Complaint. Regeneron therefore brings this action for infringement of
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`twenty-four patents,3 while remaining amenable to approaches for streamlining this proceeding
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`in conformity with the BPCIA’s goal of adjudicating patent disputes before approval or
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`commercialization of the proposed biosimilar product.4
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`3 The twenty-four patents include each of Mylan’s listed patents minus the one patent for which
`Regeneron did not serve contentions and no longer asserts against Mylan.
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`4 The infringement allegations in this Complaint do not reference any specific content of Mylan’s
`aBLA, which Mylan has designated as confidential under an agreement pursuant to 42 U.S.C.
`§ 262(l)(1)(A). To be clear, Regeneron has already served upon Mylan hundreds of pages of
`detailed contentions setting forth and putting Mylan on notice of the factual and legal basis for
`the allegations made in this lawsuit.
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`7
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`FIRST CAUSE OF ACTION
`(INFRINGEMENT OF THE ’959 PATENT)
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`23.
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`24.
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`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
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`United States Patent No. 7,070,959 (the “’959 patent”) (Exhibit 1 hereto), was
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`duly and legally issued on July 4, 2006.
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`25.
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`26.
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`27.
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`Regeneron is the owner of all right, title, and interest in the ’959 patent.
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`The ’959 patent has not yet expired.
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`The ’959 patent claims a method of producing aflibercept and was included on the
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`list of patents provided by Regeneron to Mylan pursuant to 42 U.S.C. § 262(l)(3)(A). The patent
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`also was included on the lists of patents exchanged by Regeneron and Mylan pursuant to 42
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`U.S.C. § 262(l)(5).
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`28.
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`The submission of Mylan’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
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`M710 before the expiration of the ’959 patent is an act of infringement of one or more claims of
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`the ’959 patent under 35 U.S.C. § 271(e)(2)(C)(i).
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`29.
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`For example, manufacture, use, offer for sale, and/or sale, or import into the
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`United States, of M710 will infringe, inter alia, claim 11 of the ’959 patent.
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`30.
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`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
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`one or more claims of the ’959 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 Mylan from any further infringement.
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`Regeneron has no adequate remedy at law.
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`31. Mylan’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 M710 before the expiration of the ’959
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`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
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`8
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`

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`under 35 U.S.C. § 271(e)(4)(C).
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`32.
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`The submission of Mylan’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
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`M710 before the expiration of the ’959 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
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`SECOND CAUSE OF ACTION
`(INFRINGEMENT OF THE ’106 PATENT)
`
`33.
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`34.
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`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
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`United States Patent No. 9,222,106 (the “’106 patent”) (Exhibit 2 hereto), was
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`duly and legally issued on December 29, 2015.
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`35.
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`36.
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`37.
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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 Mylan pursuant to 42 U.S.C. § 262(l)(3)(A). The
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`patent also was included on the lists of patents exchanged by Regeneron and Mylan pursuant to
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`42 U.S.C. § 262(l)(5).
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`38.
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`The submission of Mylan’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
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`M710 before the expiration of the ’106 patent is an act of infringement of one or more claims of
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`the ’106 patent under 35 U.S.C. § 271(e)(2)(C)(i).
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`39.
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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 M710 will infringe, inter alia, claim 20 of the ’106
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`patent.
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`40.
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`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
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`9
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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 Mylan from any further infringement.
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`Regeneron has no adequate remedy at law.
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`41. Mylan’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 M710 before the expiration of the ’106
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`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
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`under 35 U.S.C. § 271(e)(4)(C).
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`42.
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`The submission of Mylan’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
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`M710 before the expiration of the ’106 patent entitles Regeneron to fees under 35 U.S.C.
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`§ 271(e)(4) and § 285.
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`THIRD CAUSE OF ACTION
`(INFRINGEMENT OF THE ’338 PATENT)
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`43.
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`44.
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`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
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`United States Patent No. 9,254,338 (the “’338 patent”) (Exhibit 3 hereto), was
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`duly and legally issued on February 9, 2016.
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`45.
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`46.
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`47.
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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 uses of a biological product and was included on the list of
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`patents provided by Regeneron to Mylan pursuant to 42 U.S.C. § 262(l)(3)(A). The patent also
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`was included on the lists of patents exchanged by Regeneron and Mylan pursuant to 42 U.S.C. §
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`262(l)(5).
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`48.
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`The submission of Mylan’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
`
`10
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`M710 before the expiration of the ’338 patent is an act of infringement of one or more claims of
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`the ’338 patent under 35 U.S.C. § 271(e)(2)(C)(i).
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`49.
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`For example, the sale of M710 pursuant to the label proposed in Mylan’s aBLA
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`will contribute to and induce infringement of, inter alia, claim 1 of the ’338 patent.
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`50.
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`Regeneron will be irreparably harmed if Mylan 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 Mylan from any further infringement.
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`Regeneron has no adequate remedy at law.
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`51. Mylan’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 M710 before the expiration of the ’338
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`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
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`under 35 U.S.C. § 271(e)(4)(C).
`
`52.
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`The submission of Mylan’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
`
`M710 before the expiration of the ’338 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
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`FOURTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’069 PATENT)
`
`53.
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`54.
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`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
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`United States Patent No. 9,669,069 (the “’069 patent”) (Exhibit 4 hereto), was
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`duly and legally issued on June 6, 2017.
`
`55.
`
`56.
`
`57.
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`Regeneron is the owner of all right, title, and interest in the ’069 patent.
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`The ’069 patent has not yet expired.
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`The ’069 patent claims uses of a biological product and was included on the list of
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`11
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`
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`patents provided by Regeneron to Mylan pursuant to 42 U.S.C. § 262(l)(3)(A). The patent also
`
`was included on the lists of patents exchanged by Regeneron and Mylan pursuant to 42 U.S.C.
`
`§ 262(l)(5).
`
`58.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’069 patent is an act of infringement of one or more claims of
`
`the ’069 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`59.
`
`For example, the sale of M710 pursuant to the label proposed in Mylan’s aBLA
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`will contribute to and induce infringement of, inter alia, claim 1 of the ’069 patent.
`
`60.
`
`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`one or more claims of the ’069 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Mylan from any further infringement.
`
`Regeneron has no adequate remedy at law.
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`61. Mylan’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of M710 before the expiration of the ’069
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`62.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’069 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
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`FIFTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’110 PATENT)
`
`63.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`12
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`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 13 of 39 PageID #: 13
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`64.
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`United States Patent No. 9,816,110 (the “’110 patent”) (Exhibit 5 hereto), was
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`duly and legally issued on November 14, 2017.
`
`65.
`
`66.
`
`67.
`
`Regeneron is the owner of all right, title, and interest in the ’110 patent.
`
`The ’110 patent has not yet expired.
`
`The ’110 patent claims methods related to manufacturing a biological product and
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`was included on the list of patents provided by Regeneron to Mylan pursuant to 42 U.S.C. §
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`262(l)(3)(A). The patent also was included on the lists of patents exchanged by Regeneron and
`
`Mylan pursuant to 42 U.S.C. § 262(l)(5).
`
`68.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’110 patent is an act of infringement of one or more claims of
`
`the ’110 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`69.
`
`For example, on information and belief, manufacture, use, offer for sale, and/or
`
`sale, or import into the United States, of M710 will infringe, inter alia, claim 18 of the ’110
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`patent.
`
`70.
`
`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`one or more claims of the ’110 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Mylan from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`71. Mylan’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of M710 before the expiration of the ’110
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`13
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`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 14 of 39 PageID #: 14
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`
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`72.
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`The submission of Mylan’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
`
`M710 before the expiration of the ’110 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
`
`SIXTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’681 PATENT)
`
`73.
`
`74.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 10,130,681 (the “’681 patent”) (Exhibit 6 hereto), was
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`duly and legally issued on November 20, 2018.
`
`75.
`
`76.
`
`77.
`
`Regeneron is the owner of all right, title, and interest in the ’681 patent.
`
`The ’681 patent has not yet expired.
`
`The ’681 patent claims uses of a biological product and was included on the list of
`
`patents provided by Regeneron to Mylan pursuant to 42 U.S.C. § 262(l)(3)(A). The patent also
`
`was included on the lists of patents exchanged by Regeneron and Mylan pursuant to 42 U.S.C.
`
`§ 262(l)(5).
`
`78.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’681 patent is an act of infringement of one or more claims of
`
`the ’681 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`79.
`
`For example, the sale of M710 pursuant to the label proposed in Mylan’s aBLA
`
`will contribute to and induce infringement of, inter alia, claim 1 of the ’681 patent.
`
`80.
`
`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`one or more claims of the ’681 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Mylan from any further infringement.
`
`14
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`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 15 of 39 PageID #: 15
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`
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`Regeneron has no adequate remedy at law.
`
`81. Mylan’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of M710 before the expiration of the ’681
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`82.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’681 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
`
`SEVENTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’226 PATENT)
`
`83.
`
`84.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 10,406,226 (the “’226 patent”) (Exhibit 7 hereto), was
`
`duly and legally issued on September 10, 2019.
`
`85.
`
`86.
`
`87.
`
`Regeneron is the owner of all right, title, and interest in the ’226 patent.
`
`The ’226 patent has not yet expired.
`
`The ’226 patent claims methods of manufacturing biological products and was
`
`included on the list of patents provided by Regeneron to Mylan pursuant to 42 U.S.C.
`
`§ 262(l)(3)(A). The patent also was included on the lists of patents exchanged by Regeneron and
`
`Mylan pursuant to 42 U.S.C. § 262(l)(5).
`
`88.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’226 patent is an act of infringement of one or more claims of
`
`the ’226 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`15
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`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 16 of 39 PageID #: 16
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`
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`89.
`
`For example, on information and belief, manufacture, use, offer for sale, and/or
`
`sale, or import into the United States, of M710 will infringe, inter alia, claim 3 of the ’226
`
`patent.
`
`90.
`
`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`one or more claims of the ’226 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Mylan from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`91. Mylan’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of M710 before the expiration of the ’226
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`92.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’226 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
`
`EIGHTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’055 PATENT)
`
`93.
`
`94.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 10,415,055 (the “’055 patent”) (Exhibit 8 hereto), was
`
`duly and legally issued on September 17, 2019.
`
`95.
`
`96.
`
`97.
`
`Regeneron is the owner of all right, title, and interest in the ’055 patent.
`
`The ’055 patent has not yet expired.
`
`The ’055 patent claims methods of making proteins and was included on the list
`
`of patents provided by Regeneron to Mylan pursuant to 42 U.S.C. § 262(l)(3)(A). The patent
`
`16
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`

`

`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 17 of 39 PageID #: 17
`
`
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`also was included on the lists of patents exchanged by Regeneron and Mylan pursuant to 42
`
`U.S.C. § 262(l)(5).
`
`98.
`
`The submission of Mylan’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
`
`M710 before the expiration of the ’055 patent is an act of infringement of one or more claims of
`
`the ’055 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`99.
`
`For example, on information and belief, manufacture, use, offer for sale, and/or
`
`sale, or import into the United States, of M710 will infringe, inter alia, claim 23 of the ’055
`
`patent.
`
`100. Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`one or more claims of the ’055 patent. Regeneron is entitled to injunctive relief at least under 35
`
`U.S.C. § 271(e)(4)(B) and § 271(e)(4)(D) preventing Mylan from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`101. Mylan’s commercial manufacture, use, offer for sale, and/or sale within the
`
`United States, or importation into the United States, of M710 before the expiration of the ’055
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`102. The submission of Mylan’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
`
`M710 before the expiration of the ’055 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
`
`NINTH CAUSE OF ACTION
`(INFRINGEMENT OF TH