`
`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.:
`
`JURY TRIAL DEMANDED
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) invented, developed, and sells
`
`Eylea®, the market-leading treatment for certain serious eye diseases. Defendant Mylan
`
`Pharmaceuticals Inc. (“Mylan”) is seeking FDA approval under the Biologics Price Competition
`
`and Innovation Act (“BPCIA”), 42 U.S.C. §§ 262(k)-(l), to commercialize “M710,” a proposed
`
`biosimilar of Eylea®. To vindicate its patent rights, Regeneron brings this Complaint seeking a
`
`judgment of patent infringement against Mylan under 35 U.S.C. § 271(e) and pursuant to the
`
`BPCIA.
`
`NATURE OF THE CASE
`
`1.
`
`Regeneron is a leading science-based American biotechnology company
`
`dedicated to improving human health and tackling the most urgent medical issues facing the
`
`Nation. Founded and led for over 30 years by physician-scientists, Regeneron has developed
`
`life-transforming medicines for people with serious diseases, including cancer, atopic dermatitis,
`
`asthma, eye diseases, cardiovascular and metabolic diseases, Ebola, and COVID-19, the latter of
`
`which has been used across the country, including by the former President. Regeneron’s cutting-
`
`edge scientific advances were supported, in large part, by its ophthalmic product, Eylea®, which
`
`1
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 2 of 39 PageID #: 2
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`
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`FDA approved in 2011.
`
`2.
`
`Eylea® has been administered millions of times to treat certain ophthalmic
`
`disorders that, if left untreated, can lead to permanent blindness. Its active ingredient is a
`
`genetically engineered fusion protein called aflibercept. It works by blocking the overproduction
`
`of a naturally occurring protein in the eye that can cause the formation of new blood vessels,
`
`leading to vision loss. Based on extensive clinical testing by Regeneron, FDA approved Eylea®
`
`in 2011 to treat an ophthalmic disorder called neovascular age-related macular degeneration. As
`
`a result of Regeneron’s additional clinical testing, Eylea® is now also approved for use in treating
`
`other serious disorders of the eye: diabetic macular edema, macular edema following retinal
`
`vein occlusion, and diabetic retinopathy. And other clinical trials are ongoing, including to treat
`
`a retinal disease in premature babies called retinopathy of prematurity. In addition to benefitting
`
`the many patients it has been used to treat, Eylea® is also a critical source of research and
`
`development funding for Regeneron.
`
`3.
`
`Last October, Mylan filed for FDA approval under the BPCIA to commercialize a
`
`“biosimilar” copy of Eylea®. Enacted in 2010 as part of the Affordable Care Act, the BPCIA
`
`provides for a substantially abbreviated regulatory approval pathway for biosimilars by letting
`
`applicants rely on the extensive 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., 137 S. Ct. 1664 (2017).
`
`4.
`
`On December 28, 2021, FDA notified Mylan that its application—i.e., its
`
`abbreviated Biologic License Application, or “aBLA” No. 761274—for M710 had been accepted
`
`for review. Mylan’s submission of its aBLA constitutes an act of patent infringement under 35
`
`U.S.C. § 271(e).
`
`2
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 3 of 39 PageID #: 3
`
`
`
`5.
`
`By statute, Regeneron could not immediately file a lawsuit for Mylan’s § 271(e)
`
`infringement. The BPCIA prohibits filing such a suit until certain requirements of 42 U.S.C.
`
`§ 262(l), commonly called the “patent dance,” are satisfied. In the patent dance, the BPCIA
`
`directs exchanges of certain information between the innovator company (or “reference product
`
`sponsor”) and the biosimilar (or “subsection (k)”) applicant. At the end of the patent dance, the
`
`reference product sponsor is authorized to initiate litigation against the biosimilar applicant
`
`within thirty days in a venue of its choosing. Mylan, the subsection (k) applicant, and
`
`Regeneron, the reference product sponsor, completed the final step of the patent dance—the
`
`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
`
`§ 271(e).
`
`THE PARTIES, JURISDICTION, AND VENUE
`
`6.
`
`Regeneron Pharmaceuticals, Inc. is a corporation organized under the laws of the
`
`State of New York, with its principal place of business at 777 Old Saw Mill River Road,
`
`Tarrytown, NY 10591. The company is dedicated to discovering, developing, and
`
`commercializing medicines to treat patients with debilitating and life-threatening diseases.
`
`Regeneron owns each of the patents asserted in this Complaint: U.S. Patent Nos. 7,070,959;
`
`9,222,106; 9,254,338; 9,669,069; 9,816,110; 10,130,681; 10,406,226; 10,415,055; 10,464,992;
`
`10,669,594; 10,857,205; 10,888,601; 10,927,342; 10,973,879; 11,053,280; 11,066,458;
`
`11,084,865; 11,104,715; 11,174,283; 11,186,625; 11,253,572; 11,299,532; 11,306,135; and
`
`11,332,771 (collectively, the “asserted patents” or the “patents in suit”).
`
`7.
`
`On information and belief, Mylan Pharmaceuticals Inc. is a corporation organized
`
`under the laws of the State of West Virginia, having a principal place of business at 781 Chestnut
`
`Ridge Road, Morgantown, West Virginia 26505. On information and belief, Mylan
`
`3
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 3
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 4 of 39 PageID #: 4
`
`
`
`Pharmaceuticals Inc. is a wholly owned subsidiary of Viatris Inc. (“Viatris”).
`
`8.
`
`On information and belief, Mylan develops, manufactures, distributes, sells,
`
`and/or imports drug products for the entire United States market and does business in every state,
`
`including West Virginia, either directly or indirectly.
`
`9.
`
`Regeneron’s claims for patent infringement arise under the patent laws of the
`
`United States, Titles 35 and 42 of the United States Code. This Court has subject matter
`
`jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`10. Mylan and its development partners have publicly announced their intention to
`
`ignore Regeneron’s patent rights and launch an aflibercept biosimilar product before the
`
`expiration of the patents asserted in this action.
`
`11.
`
`On information and belief, Momenta Pharmaceuticals Inc. is or was Mylan’s
`
`development partner for its proposed aflibercept biosimilar product. In August 2020, Momenta
`
`publicly announced that it “believe[d]” its collaboration with Mylan to market an aflibercept
`
`biosimilar product “has the potential to launch in the 2023 time frame,”1 before the expiry of the
`
`asserted patents.
`
`12.
`
`Viatris later announced its intention to become the “first to market” an aflibercept
`
`biosimilar product. Rajiv Malik, the president of Viatris, explained that becoming “the first to
`
`market [an aflibercept biosimilar product] is becoming [sic] decisive advantage. And that’s
`
`where we’re going to focus on that how can we be the first to market.”2
`
`
`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.
`
`4
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 4
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 5 of 39 PageID #: 5
`
`
`
`13.
`
`This Court has personal jurisdiction over Mylan because it is incorporated in the
`
`State of West Virginia; because Mylan is seeking approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of M710 in the United States, including
`
`in the State of West Virginia; and because, if its product receives FDA approval, Mylan intends
`
`to market, distribute, offer for sale, and/or sell it in the United States, including in the State of
`
`West Virginia, deriving substantial revenue therefrom.
`
`14.
`
`In addition, Mylan has consented to jurisdiction in the State of West Virginia in
`
`one or more prior cases arising out of its manufacture, use, offer for sale, sale, and/or importation
`
`of Mylan pharmaceutical products in the United States, including in the State of West Virginia.
`
`15.
`
`Venue is proper in this District pursuant to 28 U.S.C. § 1391 and § 1400(b).
`
`Venue is proper because Mylan Pharmaceuticals Inc. is incorporated in the State of West
`
`Virginia and resides in this judicial district.
`
`FACTUAL BASIS FOR RELIEF
`
`16.
`
`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 notwithstanding minor differences in clinically inactive components,” with “no clinically
`
`meaningful differences between the biological product and the reference product in terms of the
`
`safety, purity, and potency of the product.” Id. § 262(i)(2)(A)-(B).
`
`17.
`
`The BPCIA reduces substantially the time and expense otherwise required to gain
`
`FDA approval, by allowing a biosimilar applicant like Mylan to rely on most of the prior clinical
`
`testing that Regeneron conducted to establish the safety and efficacy of the reference product
`
`(Eylea®). Regeneron, the reference product sponsor, invested many years of effort into its design
`
`and development of Eylea® and received numerous patents rewarding this research. In exchange
`
`5
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 5
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 6 of 39 PageID #: 6
`
`
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`for this accelerated and far less expensive application process, the BPCIA obligates a biosimilar
`
`applicant to address a reference product sponsor’s relevant patents in a manner that permits
`
`adjudication of patent rights before commercialization of the biosimilar product. The BPCIA
`
`does so, inter alia, through its patent dance.
`
`18.
`
`The patent dance between Regeneron and Mylan proceeded substantially as
`
`follows within the timeframes specified in the BPCIA. Mylan informed Regeneron that its
`
`aBLA for M710 was accepted for FDA review on December 28, 2021. Mylan provided
`
`Regeneron access to Mylan’s aBLA through an online review platform. Under § 262(l)(3)(A),
`
`Regeneron next provided Mylan with a list of patents for which “a claim of patent infringement
`
`could reasonably be asserted” if Mylan commercialized its product. Under § 262(l)(7),
`
`Regeneron also provided to Mylan a “supplement to the list” for several additional patents that
`
`issued following Regeneron’s service of its original patent list provided under § 262(l)(3)(A).
`
`19.
`
`Upon receiving Regeneron’s patent lists, Mylan served “detailed statements” for
`
`the patents on the original or supplemental list. By statute, a biosimilar applicant’s detailed
`
`statements must either represent that it will not begin commercial marketing of its biosimilar
`
`product before the patent expires (under § 262(l)(3)(B)(ii)(II)) or allege that the patent is invalid,
`
`unenforceable, or not infringed (under § 262(l)(3)(B)(ii)(I)). Remarkably, Mylan’s “detailed
`
`statements” respected not one of Regeneron’s patents; rather, according to Mylan, every one of
`
`Regeneron’s listed patents is not infringed, invalid, and unenforceable.
`
`20.
`
`Under § 262(l)(3)(C), Regeneron provided its detailed responses to Mylan’s
`
`contentions, setting forth particular grounds for infringement based on the confidential
`
`information in Mylan’s aBLA and rebutting Mylan’s noninfringement, invalidity and
`
`unenforceability allegations. Regeneron did not contend infringement on one of the patents on
`
`6
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 6
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 7 of 39 PageID #: 7
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`its list and informed Mylan it did not plan to assert that patent.
`
`21.
`
`Next, under § 262(l)(4)(A), Regeneron initiated negotiations over which patents
`
`on Regeneron’s list should be litigated in a § 271(e) infringement action. Regeneron proposed
`
`litigating a targeted subset of the listed patents, in order to facilitate the Court’s adjudication of
`
`the parties’ primary disputes on a full record before approval of Mylan’s product. Mylan refused
`
`to do so. Instead, it proposed to litigate twenty-five of the listed patents. Next, under
`
`§ 262(l)(5)(B), the parties exchanged the lists of patents that each believed should be part of the
`
`infringement action under § 271(e). Mylan listed twenty-five patents, whereas Regeneron listed
`
`twelve (each of which was also on Mylan’s list).
`
`22.
`
`If the parties disagree on the patents that should be part of the litigation,
`
`§ 262(l)(6)(B) requires the innovator company to bring suit on every patent selected by either
`
`party. Thus, despite Regeneron’s efforts to focus this case on a targeted subset of asserted
`
`patents, Mylan’s expansive listing of patents requires Regeneron by statute to include each one
`
`of those patents in this Complaint. Regeneron therefore brings this action for infringement of
`
`twenty-four patents,3 while remaining amenable to approaches for streamlining this proceeding
`
`in conformity with the BPCIA’s goal of adjudicating patent disputes before approval or
`
`commercialization of the proposed biosimilar product.4
`
`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.
`
`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.
`
`7
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 7
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 8 of 39 PageID #: 8
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`
`
`FIRST CAUSE OF ACTION
`(INFRINGEMENT OF THE ’959 PATENT)
`
`23.
`
`24.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 7,070,959 (the “’959 patent”) (Exhibit 1 hereto), was
`
`duly and legally issued on July 4, 2006.
`
`25.
`
`26.
`
`27.
`
`Regeneron is the owner of all right, title, and interest in the ’959 patent.
`
`The ’959 patent has not yet expired.
`
`The ’959 patent claims a method of producing aflibercept 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).
`
`28.
`
`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 ’959 patent is an act of infringement of one or more claims of
`
`the ’959 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`29.
`
`For example, manufacture, use, offer for sale, and/or sale, or import into the
`
`United States, of M710 will infringe, inter alia, claim 11 of the ’959 patent.
`
`30.
`
`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`one or more claims of the ’959 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.
`
`31. 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 ’959
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`8
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 8
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 9 of 39 PageID #: 9
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`
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`32.
`
`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 ’959 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
`
`SECOND CAUSE OF ACTION
`(INFRINGEMENT OF THE ’106 PATENT)
`
`33.
`
`34.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 9,222,106 (the “’106 patent”) (Exhibit 2 hereto), was
`
`duly and legally issued on December 29, 2015.
`
`35.
`
`36.
`
`37.
`
`Regeneron is the owner of all right, title, and interest in the ’106 patent.
`
`The ’106 patent has not yet expired.
`
`The ’106 patent claims methods of making 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).
`
`38.
`
`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 ’106 patent is an act of infringement of one or more claims of
`
`the ’106 patent under 35 U.S.C. § 271(e)(2)(C)(i).
`
`39.
`
`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 20 of the ’106
`
`patent.
`
`40.
`
`Regeneron will be irreparably harmed if Mylan is not enjoined from infringing
`
`9
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 9
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 10 of 39 PageID #: 10
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`
`
`one or more claims of the ’106 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.
`
`41. 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 ’106
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`42.
`
`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 ’106 patent entitles Regeneron to fees under 35 U.S.C.
`
`§ 271(e)(4) and § 285.
`
`THIRD CAUSE OF ACTION
`(INFRINGEMENT OF THE ’338 PATENT)
`
`43.
`
`44.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 9,254,338 (the “’338 patent”) (Exhibit 3 hereto), was
`
`duly and legally issued on February 9, 2016.
`
`45.
`
`46.
`
`47.
`
`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 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).
`
`48.
`
`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
`
`10
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 10
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 11 of 39 PageID #: 11
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`
`
`M710 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).
`
`49.
`
`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 ’338 patent.
`
`50.
`
`Regeneron will be irreparably harmed if Mylan 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 Mylan from any further infringement.
`
`Regeneron has no adequate remedy at law.
`
`51. 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 ’338
`
`patent will cause Regeneron injury, entitling Regeneron to damages or other monetary relief
`
`under 35 U.S.C. § 271(e)(4)(C).
`
`52.
`
`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.
`
`FOURTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’069 PATENT)
`
`53.
`
`54.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`United States Patent No. 9,669,069 (the “’069 patent”) (Exhibit 4 hereto), was
`
`duly and legally issued on June 6, 2017.
`
`55.
`
`56.
`
`57.
`
`Regeneron is the owner of all right, title, and interest in the ’069 patent.
`
`The ’069 patent has not yet expired.
`
`The ’069 patent claims uses of a biological product and was included on the list of
`
`11
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 11
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 12 of 39 PageID #: 12
`
`
`
`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
`
`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.
`
`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.
`
`FIFTH CAUSE OF ACTION
`(INFRINGEMENT OF THE ’110 PATENT)
`
`63.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`12
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 12
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 13 of 39 PageID #: 13
`
`
`
`64.
`
`United States Patent No. 9,816,110 (the “’110 patent”) (Exhibit 5 hereto), was
`
`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
`
`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).
`
`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
`
`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
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 13
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 14 of 39 PageID #: 14
`
`
`
`72.
`
`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
`
`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
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 14
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 15 of 39 PageID #: 15
`
`
`
`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
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2028 Page 15
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`
`
`Case 1:22-cv-00061-TSK Document 1 Filed 08/02/22 Page 16 of 39 PageID #: 16
`
`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