Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 1 of 122 PageID #: 1965
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
`Plaintiff,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`Case No.: 1:22-cv-00061-TSK
`
`MYLAN PHARMACEUTICALS INC.’S ANSWER, DEFENSES, AND
`COUNTERCLAIMS TO PLAINTIFF’S COMPLAINT
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`Mylan Pharmaceuticals Inc. (“Mylan” or “Defendant”) by and through its undersigned
`
`attorneys, hereby submits its Answer, Defenses, and Counterclaims to the Complaint of Plaintiff,
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`Regeneron Pharmaceuticals, Inc. (“Regeneron” or “Plaintiff”), as follows:
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`GENERAL DENIAL
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`Pursuant to Federal Rule of Civil Procedure 8(b)(3), Mylan denies each and every
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`allegation in the Complaint, whether express or implied, except those specifically and expressly
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`admitted below. Any factual allegation admitted below is admitted only as to the specific admitted
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`facts, not as to any purported conclusions, characterizations, implications, or speculation that may
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`arguably follow from the admitted facts. To the extent any allegation in the Complaint is vague
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`and/or ambiguous, Mylan denies such allegations. Mylan denies that Plaintiff is entitled to the
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`relief requested or any other relief.
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`The headings and subheadings in Mylan’s Answer are used solely for purposes of
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`convenience and organization to mirror those appearing in the Complaint; to the extent that any
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`headings or other non-numbered statements in the Complaint contain or imply any allegations,
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`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 1
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 2 of 122 PageID #: 1966
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`Mylan denies each and every allegation therein. Each of the numbered paragraphs in the Answer
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`below corresponds to the same-numbered paragraphs in the Complaint.
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`RESPONSES TO ALLEGATIONS PERTAINING TO
`NATURE OF THE ACTION
`
`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
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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, the latter of which has
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`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 FDA
`
`approved in 2011.
`
`ANSWER: Mylan admits that, according to the online records of the Food and Drug
`
`Administration (“FDA”), the “Original Approval” date for Biologic License Application (“BLA”)
`
`No. 125387 for Eylea® (aflibercept), is identified as on or about November 18, 2011. Mylan lacks
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`sufficient knowledge and information to form a belief as to the truth of the remaining allegations
`
`contained in paragraph 1 of the Complaint and, on that basis, denies all remaining allegations of
`
`this paragraph.
`
`2.
`
`Eylea® has been administered millions of times to treat certain ophthalmic disorders
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`that, if left untreated, can lead to permanent blindness. Its active ingredient is a genetically
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`engineered fusion protein called aflibercept. It works by blocking the overproduction of a naturally
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`occurring protein in the eye that can cause the formation of new blood vessels, leading to vision
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`loss. Based on extensive clinical testing by Regeneron, FDA approved Eylea® in 2011 to treat an
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`ophthalmic disorder called neovascular age-related macular degeneration. As a result of
`
`- 2 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 2
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

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`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 3 of 122 PageID #: 1967
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`Regeneron’s additional clinical testing, Eylea® is now also approved for use in treating other
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`serious disorders of the eye: diabetic macular edema, macular edema following retinal vein
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`occlusion, and diabetic retinopathy. And other clinical trials are ongoing, including to treat a retinal
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`disease in premature babies called retinopathy of prematurity. In addition to benefitting the many
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`patients it has been used to treat, Eylea® is also a critical source of research and development
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`funding for Regeneron.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required. To
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`the extent an answer is required, Mylan admits that aflibercept is the active ingredient in Eylea®;
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`that aflibercept can inhibit certain proteins that promote angiogenesis (or formation of blood
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`vessels) in the eye; that, according to FDA’s online records, the “Approval Date” for BLA No.
`
`125387 for Eylea® (aflibercept), is identified as on or about November 18, 2011; and that,
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`according to the currently approved label for Eylea® (aflibercept), available from the online
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`records of FDA, FDA has approved Eylea® (aflibercept) for the following indications:
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`Mylan lacks sufficient knowledge and information to form a belief as to the truth of the
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`remaining allegations contained in paragraph 2 of the Complaint and, on that basis, denies all
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`remaining allegations of this paragraph.
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`3.
`
`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
`
`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
`
`- 3 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 3
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 4 of 122 PageID #: 1968
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`innovator company that developed the medicine the applicant wants to copy. See Sandoz Inc. v.
`
`Amgen Inc., 137 S. Ct. 1664 (2017).
`
`ANSWER: Paragraph 3 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that the Biologics Price Competition and Innovation
`
`Act (“BPCIA”) created an abbreviated approval process for biologic products, known as biosimilar
`
`products, that are “highly similar to the reference product” and exhibit “no clinically meaningful
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`differences between the biological product and the reference product in terms of the safety, purity,
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`and potency of the product.” 42 U.S.C. § 262(i); see also 42 U.S.C. § 262(k). Answering further,
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`Mylan admits that, on or about October 29, 2021, Mylan Pharmaceuticals Inc. submitted Biologic
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`License Application (or BLA) No. 761274 to FDA, seeking approval of M710 (or YESAFILI), a
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`proposed biosimilar to EYLEA®. To the extent that there are other allegations contained in
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`paragraph 3 not expressly admitted above, such allegations are denied.
`
`4.
`
`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
`
`for review. Mylan’s submission of its aBLA constitutes an act of patent infringement under 35
`
`U.S.C. § 271(e).
`
`ANSWER: Paragraph 4 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, Mylan admits that, pursuant to 42 U.S.C. § 262(k), Mylan
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`Pharmaceuticals Inc. submitted its BLA No. 761274 to FDA seeking approval of M710, a proposed
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`biosimilar to EYLEA® (“Mylan’s Proposed BLA Product”). Mylan further admits that FDA
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`notified Mylan that its BLA had been accepted for review on or about December 28, 2021. To the
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`extent that there are other allegations contained in paragraph 4 not expressly admitted above, such
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`allegations are denied.
`
`- 4 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 4
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 5 of 122 PageID #: 1969
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`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
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`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 brought this action as required by
`
`§ 262(l)(6) to address Mylan’s patent infringement under § 271(e).
`
`ANSWER: Paragraph 5 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that “[t]he BPCIA sets forth a carefully calibrated
`
`scheme for preparing to adjudicate, and then adjudicating, claims of infringement.” Sandoz Inc.
`
`v. Amgen Inc., 137 S. Ct. 1664, 1670 (2017) (citing 42 U.S.C. § 262(l)). Mylan further admits that
`
`the BPCIA scheme includes multiple steps, including disclosure of information, potential
`
`resolution of patent disputes, and if necessary and appropriate, the commencement of a patent
`
`infringement action. Answering further, Mylan admits that, on July 5, 2022, pursuant to 42 U.S.C.
`
`§ 262(l)(5)(B)(i), the parties exchanged the lists of patents that each party believed should be the
`
`subject of an action for patent infringement. Mylan denies any remaining allegations contained in
`
`paragraph 5 of the Complaint, including that Regeneron “promptly” filed the current patent
`
`infringement action against Mylan.
`
`- 5 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 5
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 6 of 122 PageID #: 1970
`
`RESPONSES TO ALLEGATIONS PERTAINING TO
`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;
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`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;
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`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”).
`
`ANSWER: Paragraph 6 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that the electronic records of the United States
`
`Patent and Trademark Office (“PTO”) identify Regeneron as the purported “assignee” of U.S.
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`Patent Nos. 7,070,959 (“the ’959 patent”), 9,222,106 (“the ’106 patent”), 9,254,338 (“the ’338
`
`patent”), 9,669,069 (“the ’069 patent”), 9,816,110 (“the ’110 patent”), 10,130,681 (“the ’681
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`patent”), 10,406,226 (“the ’226 patent”), 10,415,055 (“the ’055 patent”), 10,464,992 (“the ’992
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`patent”), 10,669,594 (“the ’594 patent”), 10,857,205 (“the ’205 patent”), 10,888,601 (“the ’601
`
`patent”), 10,927,342 (“the ’342 patent”), 10,973,879 (“the ’879 patent”), 11,053,280 (“the ’280
`
`patent”), 11,066,458 (“the ’458 patent”), 11,084,865 (“the ’865 patent”), 11,104,715 (“the ’715
`
`patent”), 11,174,283 (“the ’283 patent”), 11,186,625 (“the ’625 patent”), 11,253,572 (“the ’572
`
`patent”), 11,299,532 (“the ’532 patent”), 11,306,135 (“the ’135 patent”), and 11,332,771 (“the
`
`’771 patent”) (collectively, “the Patents-in-Suit”). Mylan lacks sufficient knowledge and
`
`information to form a belief as to the truth of the allegations contained in paragraph 6 of the
`
`- 6 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 6
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 7 of 122 PageID #: 1971
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`Complaint and, on that basis, denies them.
`
`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
`
`Pharmaceuticals Inc. is a wholly owned subsidiary of Viatris Inc. (“Viatris”).
`
`ANSWER: Paragraph 7 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, Mylan admits that it is a West Virginia corporation with a place
`
`of business at 3711 Collins Ferry Road, Morgantown, West Virginia 26505. Answering further,
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`Mylan admits that it is an indirect wholly-owned subsidiary of Viatris Inc. To the extent there are
`
`allegations contained in paragraph 7 not expressly admitted above, such allegations are denied.
`
`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.
`
`ANSWER: Paragraph 8 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, denied. Answering further, Mylan admits that it develops,
`
`manufactures and sells pharmaceutical and biologic drug products. To the extent there are
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`allegations contained in paragraph 8 not expressly admitted above, such allegations are denied.
`
`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).
`
`ANSWER: Paragraph 9 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that Regeneron purports to bring suit under 35
`
`U.S.C. § 271(e). To the extent there are allegations contained in paragraph 9 not expressly
`
`- 7 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 7
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 8 of 122 PageID #: 1972
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`admitted above, such allegations are denied.
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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 expiration
`
`of the patents asserted in this action.
`
`ANSWER: Denied.
`
`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
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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
`
`asserted patents.
`
`ANSWER: Paragraph 11 contains legal conclusions to which no answer is required. To
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`the extent and answer is required, Mylan admits that Momenta Pharmaceuticals Inc., Form 10-Q,
`
`at 26 (Aug. 10, 2020), https://seekingalpha.com/filings/pdf/14323380, states:
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`To the extent there are allegations contained in paragraph 11 not expressly admitted above, such
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`allegations are denied.
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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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`1 Momenta
`Form
`Inc.,
`Pharmaceuticals
`https://seekingalpha.com/filings/pdf/14323380.
`- 8 -
`
`10-Q,
`
`at
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`26
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`(Aug.
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`10,
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`2020),
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 8
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 9 of 122 PageID #: 1973
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`market [an aflibercept biosimilar product] is becoming [sic] decisive advantage. And that’s where
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`we’re going to focus on that how can we be the first to market.”2
`
`ANSWER: Mylan admits that 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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`states:
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`To the extent there are allegations contained in paragraph 12 not expressly admitted above, such
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`allegations are denied.
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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 to
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`market, distribute, offer for sale, and/or sell it in the United States, including in the State of West
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`Virginia, deriving substantial revenue therefrom.
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`ANSWER: Paragraph 13 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, solely for the purposes of this litigation only, Mylan does not
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`contest personal jurisdiction in this judicial District. To the extent there are allegations contained
`
`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.
`- 9 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 9
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 10 of 122 PageID #: 1974
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`in paragraph 13 not expressly admitted above, such allegations are denied.
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`14.
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`In addition, Mylan has consented to jurisdiction in the State of West Virginia in one
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`or more prior cases arising out of its manufacture, use, offer for sale, sale, and/or importation of
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`Mylan pharmaceutical products in the United States, including in the State of West Virginia.
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`ANSWER: Paragraph 14 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, solely for the purposes of this litigation only, Mylan does not
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`contest personal jurisdiction in this judicial District. To the extent there are allegations contained
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`in paragraph 14 not expressly admitted above, such allegations are denied.
`
`15.
`
`Venue is proper in this District pursuant to 28 U.S.C. § 1391 and § 1400(b). Venue
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`is proper because Mylan Pharmaceuticals Inc. is incorporated in the State of West Virginia and
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`resides in this judicial district.
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`ANSWER: Paragraph 15 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, solely for the purposes of this litigation only, Mylan does not
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`contest venue under 28 U.S.C. § 1400(b) in this judicial District. To the extent there are allegations
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`contained in paragraph 15 not expressly admitted above, such allegations are denied.
`
`RESPONSES TO ALLEGATIONS PERTAINING TO
`FACTUAL BASIS FOR RELIEF
`
`16.
`
`The BPCIA provides a mechanism to obtain FDA approval for a biological product
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`that is “biosimilar” to a previously licensed “reference product” such as Eylea®. 42 U.S.C.
`
`§ 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).
`
`ANSWER: Paragraph 16 contains legal conclusions to which no answer is required. To
`
`- 10 -
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 10
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 11 of 122 PageID #: 1975
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`the extent an answer is required, Mylan admits that the BPCIA created an abbreviated approval
`
`process for biosimilar products that are “highly similar to the reference product” and exhibit “no
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`clinically meaningful differences between the biological product and the reference product in
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`terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i); see also 42 U.S.C.
`
`§ 262(k). To the extent that there are other allegations contained in paragraph 16 not expressly
`
`admitted above, such allegations are denied.
`
`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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`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 does
`
`so, inter alia, through its patent dance.
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`ANSWER: Paragraph 17 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, Mylan admits that the BPCIA describes a process whereby the
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`reference product sponsor and the biosimilar applicant exchange information in advance of a
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`specific and statutorily prescribed action for patent infringement, often referred to as the “patent
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`dance.” To the extent that there are other allegations contained in paragraph 17 not expressly
`
`admitted above, such allegations are denied.
`
`18.
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`The patent dance between Regeneron and Mylan proceeded substantially as follows
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`within the timeframes specified in the BPCIA. Mylan informed Regeneron that its aBLA for M710
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`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 11
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`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 12 of 122 PageID #: 1976
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`was accepted for FDA review on December 28, 2021. Mylan provided Regeneron access to
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`Mylan’s aBLA through an online review platform. Under § 262(l)(3)(A), Regeneron next provided
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`Mylan with a list of patents for which “a claim of patent infringement could reasonably be
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`asserted” if Mylan commercialized its product. Under § 262(l)(7), Regeneron also provided to
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`Mylan a “supplement to the list” for several additional patents that issued following Regeneron’s
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`service of its original patent list provided under § 262(l)(3)(A).
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`ANSWER: Paragraph 18 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, Mylan admits that it alerted Regeneron that its BLA was accepted
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`for review on or about December 28, 2021; that Mylan provided Regeneron with access to Mylan’s
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`BLA and other information that describes the process or processes used to manufacture Mylan’s
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`Proposed BLA Product pursuant to 42 U.S.C. § 262(l)(2)(A) on or about January 17, 2022; that
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`Regeneron purported to provide a list pursuant to § 262(l)(3)(A) on or about February 22, 2022;
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`and that Regeneron purported to provide supplements to its § 262(l)(3)(A) list through the
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`mechanism provided by § 262(l)(7). To the extent that there are other allegations contained in
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`paragraph 18 not expressly admitted above, such allegations are denied.
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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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`ANSWER: Paragraph 19 contains legal conclusions to which no answer is required. To
`
`- 12 -
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`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 12
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`

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`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 13 of 122 PageID #: 1977
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`the extent an answer is required, Mylan admits that 42 U.S.C. § 262(l)(3)(B)(ii)(I) states:
`
`a detailed statement that describes, on a claim by claim basis, the
`factual and legal basis of the opinion of the subsection (k) applicant
`that such patent is invalid, unenforceable, or will not be infringed by
`the commercial marketing of the biological product that is the
`subject of the subsection (k) application.
`
`42 U.S.C. § 262(l)(3)(B)(ii)(I). Mylan further admits that on or about April 14, 2022, Mylan
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`provided Regeneron with detailed statements pursuant to § 262(l)(3)(B)(ii)(I) and on or about May
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`5 and June 16, 2022, Mylan provided detailed statements in response to Regeneron’s § 262(l)(7)
`
`supplements, setting forth Mylan’s description of the factual and legal bases as to why the listed
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`patents are invalid, unenforceable, or not infringed. Mylan further admits that its detailed
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`statements satisfied all statutory requirements. To the extent that there are other allegations
`
`contained in paragraph 19 not expressly admitted above, such allegations are denied.
`
`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 information
`
`in Mylan’s aBLA and rebutting Mylan’s noninfringement, invalidity and unenforceability
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`allegations. Regeneron did not contend infringement on one of the patents on its list and informed
`
`Mylan it did not plan to assert that patent.
`
`ANSWER: Paragraph 20 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that Regeneron informed Mylan that it did not
`
`intend to assert U.S. Patent No. 10,828,345. To the extent that there are other allegations contained
`
`in paragraph 20 not expressly admitted above, such allegations are denied.
`
`21.
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`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
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`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
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`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 13
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`

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`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 14 of 122 PageID #: 1978
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`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).
`
`ANSWER: Paragraph 21 contains legal conclusions to which no answer is required. To
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`the extent an answer is required, Mylan admits that it listed twenty-five patents and Regeneron
`
`listed twelve patents on the parties’ respective § 262(l)(5)(B) lists. To the extent that there are
`
`other allegations contained in paragraph 21 not expressly admitted above, such allegations are
`
`denied.
`
`22.
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`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
`
`ANSWER: Paragraph 22 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that Plaintiff’s Complaint alleges infringement of
`
`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.
`
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`Regeneron Pharmaceuticals, Inc. Exhibit 2026 Page 14
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
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`

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`Case 1:22-cv-00061-TSK Document 47 Filed 08/25/22 Page 15 of 122 PageID #: 1979
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`twenty-four (24) patents. To the extent there are allegations contained in paragraph 22 not
`
`expressly admitted above, such allegations are denied.
`
`RESPONSES TO ALLEGATIONS PERTAINING TO
`FIRST CAUSE OF ACTION
`(THE ’959 PATENT)
`
`23.
`
`Regeneron incorporates paragraphs 1-22 as if fully set forth herein.
`
`ANSWER: Mylan incorporates by reference its responses to paragraphs 1-22 as if fully
`
`set forth herein.
`
`24.
`
`United States Patent No. 7,070,959 (the “’959 patent”) (Exhibit 1 hereto), was duly
`
`and legally issued on July 4, 2006.
`
`ANSWER: Paragraph 24 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that, on its face, the ’959 patent indicates that it
`
`issued on or about July 4, 2006, and that Regeneron purports to attach a copy of the ’959 patent as
`
`Exhibit 1 to the Complaint. Mylan denies any suggestion that the ’959 patent was duly and legally
`
`issued, as well as any suggestion or implication that the ’959 patent is valid or enforceable or that
`
`Mylan infringes any claim of the ’959 patent. To the extent there are allegations contained in
`
`paragraph 24 not expressly admitted above, such allegations are denied.
`
`25.
`
`Regeneron is the owner of all right, title, and interest in the ’959 patent.
`
`ANSWER: Paragraph 25 contains legal conclusions to which no answer is required. To
`
`the extent an answer is required, Mylan admits that, on its face, the ’959 patent lists the assignee
`
`as Regeneron Pharmaceuticals, Inc. To the extent there are allegations contained