Case 1:22-cv-00061-TSK-JPM Document 631 Filed 09/01/23 Page 1 of 50 PageID #: 49720
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`Case No. 1:22-cv-00061-TSK
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`JURY TRIAL DEMANDED
`OUTSIDE COUNSELS’ EYES ONLY
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`REGENERON PHARMACEUTICALS, INC.,
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`MYLAN PHARMACEUTICALS INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`PLAINTIFF REGENERON PHARMACEUTICALS, INC.’S RESPONSE
`TO MYLAN’S STATEMENT OF UNCONTROVERTED FACTS
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`Local Rule of Civil Procedure 7.02 provides that “[m]otions for summary judgment shall
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`include or be accompanied by a short and plain statement of uncontroverted facts.” Mylan’s
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`twenty-five-page submission (“Mylan’s Statement”) (ECF 430-2), is neither “short and plain,”
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`nor are the alleged “facts” set forth therein “uncontroverted.” Further, many of the allegations in
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`Mylan’s Statement are neither cited nor even seemingly relied upon in its Motion for Summary
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`Judgment (ECF 429) or Memorandum in Support (ECF 430-1).
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`Nevertheless, Regeneron has endeavored to respond here to Mylan’s Statement as
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`concisely as possible and to the extent it can understand Mylan’s allegations. In those
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`circumstances where Regeneron disputes a Mylan allegation regarding a lack of evidence or
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`absence of opinion, Regeneron has not attempted to identify here every relevant piece of
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`evidence or expert statement among the many thousands of pages of documents, experts’ reports,
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`transcripts, and discovery responses generated or served in this litigation. Rather, Regeneron has
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`attempted to respond to the particular assertions made by Mylan and make clear the nature of the
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`dispute. The paragraph numbering set forth below corresponds to the paragraph numbering of
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`Mylan’s statement.
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`I.
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`U.S. Patent No. 11,104,715
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`1.
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`Regeneron does not dispute that, prior to the filing of its stipulation regarding
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`summary judgment and case narrowing (ECF 433), Regeneron was asserting claims 2-3, 6, 12-
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`14, and 16 of U.S. Patent No. 11,104,715 (“the ’715 patent”).
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`2.
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`Regeneron does not dispute that claims 2-3, 6, and 12-14 of the ’715 patent
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`depend, directly or indirectly, from claim 1 of the ’715 patent.
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`3.
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`Regeneron does not dispute that claim 1 of the ’715 patent recites the following:
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`Regeneron does not dispute that claim 16 of the ’715 patent recites the following:
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`4.
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`2
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`5.
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`Regeneron does not dispute that Mylan has excerpted portions of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpts are incomplete
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`and/or contain modifications to the report, which speaks for itself.
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`6.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpt is incomplete and/or
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`contain modifications to the report, which speaks for itself.
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`7.
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`Regeneron does not dispute that Mylan has excerpted portions of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpts are incomplete
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`and/or contain modifications to the report, which speaks for itself.
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`8.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpt is incomplete and/or
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`contain modifications to the report, which speaks for itself.
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`9.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpt is incomplete and/or
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`contain modifications to the report, which speaks for itself.
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`10.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpt is incomplete and/or
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`contain modifications to the report, which speaks for itself.
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`11.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr.
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`Swartzwelder’s Opening Report, although Regeneron notes that the excerpt is incomplete and/or
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`contain modifications to the report, which speaks for itself.
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`12.
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`Regeneron does not dispute that it is not presently contending that Mylan
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`infringes claims 2-3, 6, 12-14, or 16 of the ’715 patent pursuant to the claim constructions
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`adopted by the Court.
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`13.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr.
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`Swartzwelder’s deposition transcript, although Regeneron notes that the excerpt is incomplete
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`and/or contain modifications to the transcript, which speaks for itself.
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`14.
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`Regeneron does not dispute that it is not presently contending that Mylan
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`infringes claims 2-3, 6, 12-14, or 16 of the ’715 patent pursuant to the claim constructions
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`adopted by the Court.
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`II.
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`U.S. Patent No. 11,084,865
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`15.
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`Regeneron does not dispute that the ’865 patent’s “invention includes liquid
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`pharmaceutical formulations having increased stability.” Mylan Ex. 13 (’865 patent) at 1:49-50.
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`16.
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`Regeneron does not dispute that it is presently asserting claims 4, 7, 9, 11, and 14-
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`18 of the ’865 patent.
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`17.
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`Regeneron does not dispute that claim 18 of the ’865 patent recites: “18. The vial
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`of claim 5, wherein said formulation does not contain phosphate.”
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`18.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr. Trout’s
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`Opening Expert Report, although Regeneron notes that Dr. Trout offered additional opinions
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`with respect to claim 18, Mylan Ex. 15 (Trout Reply) at ¶¶ 37-44.
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`19.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr. Trout’s
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`Opening Expert Report.
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`20.
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`Regeneron does not dispute that Mylan has excerpted a portion of Dr. Trout’s
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`Opening Expert Report and Mylan’s BLA document MYL-AFL-BLA0002664.
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`21.
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`22.
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`23.
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`Regeneron does not dispute that it did not test YESAFILITM to measure phosphate
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`levels.
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`III. U.S. Patent Nos. 11,253,572 and 10,888,601
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`24.
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`It is undisputed that the ’572 and ’601 patents each issued from a series of
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`provisional and nonprovisional patent applications. It is further undisputed that the first
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`provisional application to which the ’572 and ’601 patents claim priority was filed on January
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`13, 2011. Mylan Ex. 17 (’601 patent) at 1:7-20; Mylan Ex. 18 (’572 patent) at 1:7-28; Mylan
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`Ex. 4 (Csaky Resp.) at ¶ 21.
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`25.
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`Regeneron does not dispute that Karen Chu testified during her deposition that
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`“the study in example 1 was referred to as the CLEAR-IT 1 study” in reference to the ’601
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`patent. Mylan Ex. 10 (Chu Tr.) at 169:5-17. Regeneron disputes that Karen Chu was testifying
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`in her 30(b)(6) capacity at the time of that statement. Id. at 123:20-22.
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`26.
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`Regeneron does not dispute that Karen Chu testified during her deposition that
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`“[t]he study in example 2 was the CLEAR-IT 2 study” in reference to the ’601 patent. Mylan
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`Ex. 10 (Chu Tr.) at 169:15-17. Regeneron disputes that Karen Chu was testifying in her 30(b)(6)
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`capacity at the time of that statement. Id. at 123:20-22.
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`27.
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`Regeneron does not dispute that Karen Chu testified during her deposition that
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`“this section under example 4 refers to two parallel Phase III clinical trials carried out to
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`investigate the use of VEGF-T to treat patients with the neovascular form of age-related macular
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`degeneration, so this section appears to be referring to both the VIEW 1 and the VIEW 2 studies”
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`in reference to the ’601 patent. Mylan Ex. 10 (Chu Tr.) at 169:15-17. Regeneron disputes that
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`Karen Chu was testifying in her 30(b)(6) capacity at the time of that statement. Id. at 123:20-22.
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`28.
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`Regeneron disputes that in paragraph 388 of his Responsive Report (Mylan
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`Exhibit 4) Dr. Csaky “agrees that Example 4 in the ‘601 and ‘572 patents lists thirty-seven (37)
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`exclusion criteria, including ocular inflammation and active ocular or periocular
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`infection.” Paragraph 388 (pp. 210-11) of Dr. Csaky’s Responsive Report is set forth below,
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`with citations omitted:
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`Dr. Stewart asserts that the “exclusion criteria” recited in claim
`14—the requirement that a physician assess patients for “active
`intraocular inflammation” or “active ocular or periocular infection”
`and administer aflibercept only if the patients have neither—lacks
`written description support in the specification because the ’572
`patent specification provides certain examples of exclusion criteria
`in the context of a Phase III clinical trial. In the context of clinical
`practice, physicians would understand the concept of exclusion
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`criteria to entail assessing patients for a given condition, excluding
`patients from treatment if the assessment reveals they have the
`condition, and treating patients only if the assessment reveals they
`do not. The POSA would understand the specification’s
`disclosures to teach that aflibercept injections should not be
`administered to patients with active intraocular inflammation or an
`active ocular or periocular infection. Thus, the POSA would
`readily understand active intraocular inflammation and active
`ocular or periocular infection to be exclusion criteria that were
`equally applicable to both clinical trials and regular practice.
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`29.
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`Regeneron does not dispute that at the time Mylan filed its motion, Regeneron
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`was asserting claims 1-14, 16-23 and 25-28 of the ’572 patent, as stated in paragraph 3 of Dr.
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`Csaky’s Reply Report. See Mylan Ex. 19 (Csaky Reply) at ¶ 3. Regeneron disputes that it is
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`currently asserting claims 1-14, 16-23 and 25-28 of the ’572 patent. As reflected in Regeneron’s
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`Stipulation Regarding Summary Judgment and Claim Narrowing, Regeneron is currently
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`asserting claims 6, 7, 12, 13, 18, 19, 22, 23, and 25 of the ’572 patent. ECF 433 at 2.
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`30.
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`Regeneron does not dispute that claims 1-14, 16-23 and 25-28 of the ’572 patent,
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`and the claims from which they depend, recite the following:
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`3. The method of claim 2 wherein the patient gains at least
`7 letters Best Corrected Visual Acuity (BCVA) according to
`Farly Treatment Diabetic Retinopathy Study (ETDRS) letter
`score,
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`4. The method of claim 3 wherein the patient achieves the
`gain in Visual acuity within 24 weeks following the initial
`dose,
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`5. The method of claim 3 wherein only two secondary
`doses are administered to the patient.
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`6. The method of claim 3 wherein the aflibercept
`formulated as an isotonic solution.
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`7. The method of claim 3 wherein the aflibercept
`formulated with a nonionic surfactant.
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`8. The method of claim 2 wherein the patient gains at least
`8 letters Best Corrected Visual Acuity (BCVA) according to
`Early Treatment Diabetic Retinopathy Study (ETDRS) letter
`score.
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`is
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`9. ‘The method of claim 8 wherein the patient achieves the
`gain in Visual acuity within 24 weeks following the initial
`dose.
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`10. The method of claim 2 wherein the patient gains at
`least 9 letters Best Corrected Visual Acuity (BCVA) accord-
`ing to Early Treatment Diabetic Retinopathy Study (ET-
`DRS) letter score.
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`11. The method of claim 10 wherein only two secondary
`doses are administered to the patient.
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`12. The method of claim 10 wherein the aflibercept is
`formulated as an isotonic solution.
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`13. The method of claim 10 wherein the aflibercept is
`formulated with a nonionic surfactant.
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`14. The method of claim 1 wherein exclusion criteria for
`the patient include both of:
`(1) active ocular inflammation; and
`(2) active ocular or periocular infection.
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`15. A method of treating diabetic macular edema in a
`patient in need thereof comprising sequentially administer-
`ing to the patient a single initial dose of 2 mg of aflibercept,
`followed by one or more secondary doses of 2 mg of
`aflibercept, followed by one or moretertiary doses of 2 mg
`ofaflibercept;
`wherein each secondary dose is administered to the
`patient by intravitreal injection approximately 4 weeks
`following the immediately preceding dose; and
`wherein each tertiary dose is administered to the patient
`byintravitreal injection approximately 8 weeks follow-
`ing the immediately preceding dose.
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`16. The method of claim 15 wherein the patient achieves
`a gain in visual acuity within 52 weeks following theinitial
`dose.
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`17. The method of claim 16 wherein the patient gainsat
`least 9 letters Best Corrected Visual Acuity (BCVA) accord-
`ing to Early Treatment Diabetic Retinopathy Study (ET-
`DRS) letter score.
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`18. The method of claim 17 wherein the aflibercept is
`formulated as an isotonic solution.
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`19. The method of claim 17 wherein the aflibercept is
`formulated with a non-ionic surfactant.
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`20. The method of claim 17 wherein the patient achieves
`a gain in visual acuity within 24 weeks following theinitial
`dose.
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`21. The method of claim 16 wherein the patient gainsat
`least 8 letters Best Corrected Visual Acuity (BCVA) accord-
`ing to Early Treatment Diabetic Retinopathy Study (ET-
`DRS) letter score.
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`Mylan Ex. 18 (’572 patent). Regeneron does not dispute that at the time Mylan filed its motion,
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`Regeneron was asserting claims 1-14, 16-23 and 25-28 of the ’572 patent, as stated in paragraph
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`3 of Dr. Csaky’s Reply Report. See Mylan Ex. 19 (Csaky Reply) at ¶ 3. Regeneron disputes that
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`it is currently asserting claims 1-14, 16-23 and 25-28 of the ’572 patent. As reflected in
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`Regeneron’s Stipulation Regarding Summary Judgment and Claim Narrowing, Regeneron is
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`currently asserting claims 6, 7, 12, 13, 18, 19, 22, 23, and 25 of the ’572 patent. ECF 433 at 2.
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`31.
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`Regeneron does not dispute that at the time Mylan filed its motion, Regeneron
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`was asserting claims 5-6, 9, 11-12, 15-17, 19, 21, 23-25, 27-28 and 31-33 of the ’601 patent., as
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`stated in paragraph 3 of Dr. Csaky’s Reply Report. See Mylan Ex. 19 (Csaky Reply) at ¶ 3.
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`Regeneron disputes that it is currently asserting claims 5-6, 9, 11-12, 15-17, 19, 21, 23-25, 27-28
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`and 31-33 of the ’601 patent. As reflected in Regeneron’s Stipulation Regarding Summary
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`Judgment and Claim Narrowing, Regeneron is currently asserting claims 11, 19, and 27 of the
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`’601 patent. ECF 433 at 2.
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`32.
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`Regeneron does not dispute that claims 5-6, 9, 11-12, 15-17, 19, 21, 23-25, 27-28
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`and 31-33 of the ’601 patent, and the claims from which they depend, recite the following:
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`Mylan Ex. 17 (’601 patent). Regeneron does not dispute that at the time Mylan filed its motion,
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`Regeneron was asserting claims 5-6, 9, 11-12, 15-17, 19, 21, 23-25, 27-28 and 31-33 of the ’601
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`patent, as stated in paragraph 3 of Dr. Csaky’s Reply Report. See Mylan Ex. 19 (Csaky Reply) at
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`¶ 3. Regeneron disputes that it is currently asserting claims 5-6, 9, 11-12, 15-17, 19, 21, 23-25,
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`27-28 and 31-33 of the ’601 patent. As reflected in Regeneron’s Stipulation Regarding
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`Summary Judgment and Claim Narrowing, Regeneron is currently asserting claims 11, 19, and
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`27 of the ’601 patent. ECF 433 at 2.
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`33.
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`Regeneron disputes that any currently asserted claim contains the phrase
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`“exclusion criteria for the patient” or “active [intra]ocular inflammation” and/or “active ocular or
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`periocular infection.” Regeneron does not dispute that at the time Mylan filed its motion,
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`Regeneron was asserting claims 9, 17, 25, and 33 of the ’601 patent, which recite the phrase
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`“wherein exclusion criteria for the patient include (1) active intraocular inflammation; or (2)
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`active ocular or periocular infection.” Regeneron does not dispute that at the time Mylan filed its
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`motion, Regeneron was asserting claim 14 of the ’572 patent, which recites the phrase “wherein
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`exclusion criteria for the patient include both of: (1) active ocular inflammation; and (2) active
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`ocular or periocular infection.” Mylan Ex. 18 (’572 patent) at claim 14; Mylan Ex. 17 (’601
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`patent) at claims 9, 17, 25, and 33.
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`34.
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`Regeneron disputes that any currently asserted claim contains the phrase “visual
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`acuity” or contains language related to visual acuity, except by virtue of dependency. Regeneron
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`does not dispute that currently-asserted claims 6, 7, 12, 13, 18, 19, 22, and 23 depend from
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`claims containing, among other language, the phrase “Best corrected Visual Acuity” or “visual
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`acuity.” In addition to the language of the claims from which they depend, claims 6, 12, 18, and
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`22 of the ’572 patent recite the limitation “wherein the aflibercept is formulated as an isotonic
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`14
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`solution. Mylan Ex. 18 (’572 patent) at claims 6, 12, 18, and 22. In addition to the language of
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`the claims from which they depend, claims 7, 13, and 23 recite the limitation “wherein the
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`aflibercept is formulated with a nonionic surfactant” and claim 19 recites the limitation “wherein
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`the aflibercept is formulated with a non-ionic surfactant.” Id. at claims 7, 13, 19, and 23.
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`Regeneron does not dispute that unasserted claims 1 and 16 of the ’572 patent recite, among
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`other language, the phrase “wherein the patient achieves a gain in visual acuity within 52 weeks
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`following the initial dose.” Ex. 18, ’572 patent at claims 1, 16. Regeneron does not dispute that
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`unasserted claim 26 of the ’572 patent recites, among other language, the phrase: “wherein the
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`method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of
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`ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at
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`52 weeks following the initial dose.” Mylan Ex. 18, ’572 patent at claim 26. Regeneron does
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`not dispute that:
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` Claim 2 of the ’572 patent recites, among other language, “wherein the patient achieves a
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`gain in Best Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic
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`Retinopathy Study (ETDRS) letter score.”
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` Claim 3 of the ’572 patent recites, among other language, “wherein the patient gains at
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`least 7 letters Best Corrected Visual Acuity (BCVA) according to Early Treatment
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`Diabetic Retinopathy Study (ETDRS) letter score.”
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` Claim 4 of the ’572 patent recites, among other language, “wherein the patient achieves
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`the gain in visual acuity within 24 weeks following the initial dose.”
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` Claim 8 of the ’572 patent recites, among other language, “wherein the patient gains at
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`least 8 letters Best Corrected Visual Acuity (BCVA) according to Early Treatment
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`Diabetic Retinopathy Study (ETDRS) letter score.”
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` Claim 9 of the ’572 patent recites, among other language, “wherein the patient achieves
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`the gain in visual acuity within 24 weeks following the initial dose.”
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` Claim 10 of the ’572 patent recites, among other language, “wherein the patient gains at
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`least 9 letters Best Corrected Visual Acuity (BCVA) according to Early Treatment
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`Diabetic Retinopathy Study (ETDRS) letter score.”
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` Claim 16 of the ’572 patent recites, among other language, “wherein the patient achieves
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`a gain in visual acuity within 52 weeks following the initial dose.”
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` Claim 20 of the ’572 patent recites, among other language, “wherein the patient achieves
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`a gain in visual acuity within 24 weeks following the initial dose.”
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` Claim 21 of the ’572 patent recites, among other language, “wherein the patient gains at
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`least 8 letters Best Corrected Visual Acuity (BCVA) according to Early Treatment
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`Diabetic Retinopathy Study (ETDRS) letter score.”
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` Claim 28 of the ’572 patent recites, among other language, “wherein the gain in visual
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`acuity is measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter
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`score.”
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` Claim 5 of the ’601 patent recites, among other language, “wherein the patient gains at
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`least 15 letters of Best Corrected Visual Acuity (BCVA) score.”
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` Claim 6 of the ’601 patent recites, among other language, “wherein Best Corrected
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`Visual Acuity (BCVA) is according to Early Treatment Diabetic Retinopathy Study
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`(ETDRS) letter score.”
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` Claim 15 of the ’601 patent recites, among other language, “wherein the patient gains at
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`least 15 letters of Best Corrected Visual Acuity (BCVA) score.”
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` Claim 16 of the ’601 patent recites, among other language, “wherein Best Corrected
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`Visual Acuity (BCVA) is according to Early Treatment Diabetic Retinopathy Study
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`(ETDRS) letter score.”
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` Claim 23 of the ’601 patent recites, among other language, “wherein the patient gains at
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`least 15 letters of Best Corrected Visual Acuity (BCVA) score.”
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` Claim 24 of the ’601 patent recites, among other language, “wherein Best Corrected
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`Visual Acuity (BCVA) is according to Early Treatment Diabetic Retinopathy Study
`
`(ETDRS) letter score.”
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` Claim 31 of the ’601 patent recites, among other language, “wherein the patient gains at
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`least 15 letters of Best Corrected Visual Acuity (BCVA) score.”
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` Claim 32 of the ’601 patent recites, among other language, “wherein Best Corrected
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`Visual Acuity (BCVA) is according to Early Treatment Diabetic Retinopathy Study
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`(ETDRS) letter score.”
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`Regeneron disputes that any of the above claims require use of ETDRS charts or ETDRS
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`protocols, or the use of any other specific protocol to conduct visual acuity measurements.
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`Mylan Ex. 3 (Csaky Opn.) at ¶¶ 219-222 (pp. 102-105), 241 (pp. 113-114), 251 (pp. 117-118),
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`285 (pp. 126-127), 295 (pp. 131-132), 304 (pp. 135-136), 245 (pp. 159-60), 264 (pp. 164), 272
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`(pp. 167-68), 317 (pp. 179-80), 369 (pp. 195), 456 (pp. 216), 526 (pp. 232), 595 (pp. 250).
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`35.
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`Regeneron does not dispute that Mylan does not prescribe or treat patients with
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`medication for purposes of this case. Regeneron alleges that upon approval of YESAFILITM,
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`Mylan will induce physicians to administer YESAFILITM according to the methods of the
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`asserted claims. Mylan Ex. 3 (Csaky Opn.) at ¶¶ 7-8 (pp. 2), 66-365 (pp. 28-153), 227-611 (pp.
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`17
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`153-254); Mylan Ex. 19 (Csaky Reply) at ¶¶ 4-5 (pp. 1-2), 23 (pp. 9), 26 (pp. 10), 28-65 (pp. 11-
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`35).
`
`36.
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`Regeneron does not dispute that Dr. Csaky did not offer the opinion that Mylan
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`would directly infringe the methods of the Asserted Claims. Regeneron’s expert Dr. Csaky
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`instead stated:
`
`I am informed that Regeneron does not at this time allege that
`Mylan will, directly, perform the steps of the Asserted Claims, but
`rather that Mylan—by virtue of marketing YESAFILITM in
`accordance with its proposed labeling—will induce physicians to
`perform acts of direct infringement. As I explained in my Opening
`Report, Mylan’s marketing of YESAFILITM will induce physicians
`to directly and literally infringe the Asserted Claims, or in the
`alternative will induce physicians to directly infringe the Asserted
`Claims under the doctrine of equivalents.
`
`
`Mylan Ex. 19 (Csaky Reply) at ¶ 26.
`
`37.
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`Regeneron disputes the relevance of this “fact,” which is nowhere referenced in
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`Mylan’s Memorandum. Regeneron reserves the right to further respond in the event Mylan
`
`chooses to rely on this disputed fact in reply. Furthermore, Regeneron disputes that Dr. Csaky
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`has not in his expert report performed an element-by-element comparison of the Eylea® labeling
`
`to each and every element in the asserted claims of the ’572 and ’601 patents. Dr. Csaky
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`compared the Eylea® labeling and his experience regarding the administration of Eylea® to
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`every limitation of claims 11, 19, and 27 of the ’601 patent and claims 6, 7, 12, 13, 18, 19, 22,
`
`23, and 25 of the ’572 Patent. See Mylan Ex. 3 (Csaky Opn.) at ¶¶ 78-212 (pp. 38-99) and Appx.
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`C at 5-6 (Claim 1); id. at ¶¶ 213-29 (pp. 99-108) and Appx. C at 6-7 (Claim 2); id. at ¶¶ 230-42
`
`(pp. 108-14) and Appx. C at 7-9 (Claim 3); id. at ¶¶ 266-71 (pp. 121-22) (Claim 6); id. at ¶¶ 272-
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`77 (pp. 122-23) (Claim 7); id. at ¶¶ 297-305 (pp. 132-36) and Appx. C at 14-15 (Claim 10); id. at
`
`¶¶ 319-24 (pp. 139-40) (Claim 12); id. at ¶¶ 325-30 (pp. 140-41) (Claim 13); id. at ¶¶ 342-65,
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`
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`227-32 (pp. 145-55) (Claim 15); id. at ¶¶ 233-239 (pp. 155-157) and Appx. C at 20-22 (Claim
`
`16); id. at ¶¶ 240-46 (pp. 157-60) and Appx. C at 22-23 (Claim 17); id. at ¶¶ 247-52 (pp. 160-61)
`
`(Claim 18); id. at ¶¶ 253-56 (pp. 161-62) (Claim 19); id. at ¶¶ 266-73 (pp. 165-69) and Appx. C
`
`at 25-27 (Claim 21); id. at ¶¶ 274-79 (pp. 169-70) (Claim 22); id. at ¶¶ 280-85 (pp. 170-71)
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`(Claim 23); id. at ¶¶ 286-98 (pp. 171-74) (Claim 25); id. at ¶¶ 405-27 (pp. 203-09) (Claim 10);
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`id. at ¶¶ 428-35 (pp. 209-11) (Claim 11); id. at ¶¶ 474-99 (pp. 221-27) (Claim 18); id. at ¶¶ 500-
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`08 (pp. 227-29) (Claim 19); id. at ¶¶ 543-68 (pp. 237-44) and Appx. D at 20-23 (Claim 26); id. at
`
`¶¶ 569-77 (pp. 244-46) (Claim 27).
`
`38.
`
`Regeneron disputes the relevance of this “uncontroverted” fact, which is nowhere
`
`referenced in Mylan’s Memorandum. Regeneron reserves the right to further respond in the
`
`event Mylan chooses to rely on this disputed fact in reply. Regeneron does not dispute that its
`
`expert, Dr. Manning, did not describe in his reports an element-by-element comparison of the
`
`Eylea® labeling to each and every element of claims 11, 19, and 27 of the ’601 patent and claims
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`6, 7, 12, 13, 18, 19, 22, 23, and 25 of the ’572 Patent.
`
`39.
`
`Regeneron does not dispute that Dr. Csaky opined in paragraph 8 of his opening
`
`expert report that:
`
`[I]f Mylan markets YESAFILITM in accordance with its proposed
`labeling, Mylan will induce infringement of each of claims 5–9,
`11–12, 15–17, 19, 21, 23–25, 27–28, and 31–33 of the ’601 patent.
`If Mylan markets YESAFILITM in accordance with its proposed
`labeling, physicians will in fact perform the methods claimed in
`each of claims 5–9, 11–12, 15–17, 19, 21, 23–25, 27–28, and 31–
`33 of the ’601 patent, and thereby commit acts of direct
`infringement. By virtue of YESAFILITM’s proposed labeling and
`other conduct, Mylan will recommend, encourage, and promote
`this result.
`
`Mylan Ex. 3 (Csaky Opn.) at ¶ 8 (pp. 2). Regeneron does not dispute that paragraphs 54 and 55
`
`of Dr. Csaky’s Opening Report also relate to Dr. Csaky’s opinion that by marketing
`19
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`YESAFILITM, Mylan will induce infringement of claims 11, 19, and 27 of the ’601 patent and
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`claims 6, 7, 12, 13, 18, 19, 22, 23, and 25 of the ’572 Patent.
`
`40.
`
`Regeneron does not dispute that in paragraph 69 of Dr. Csaky’s Opening Report,
`
`Dr. Csaky opines that:
`
`Mylan’s proposed labeling for YESAFILITM, if approved, will also
`instruct physicians that YESAFILITM is a biosimilar
`“interchangeable” with Eylea®. My understanding is that
`“interchangeable” is a particular designation for its proposed
`biosimilar product that Mylan has decided to seek. According to
`FDA: “All FDA-approved biosimilars, including interchangeable
`biosimilars, must be highly similar to and have no clinically
`meaningful differences from the reference product in terms of
`safety and effectiveness. An interchangeable biosimilar is a
`biosimilar that meets additional requirements. A pharmacist may
`substitute an interchangeable biosimilar for its reference product
`without consulting the prescriber, depending on state pharmacy
`laws.” According to FDA, “[f]or approval as an interchangeable
`biosimilar, manufacturers must provide additional data that reflect
`how the interchangeable biosimilar may be used in the marketplace
`with patients.” In particular, “[i]n addition to establishing
`biosimilarity, a manufacturer of an interchangeable biosimilar
`needs to submit information to show that the proposed product can
`be expected to produce the same clinical result as the reference
`product in any given patient.”
`
`Mylan Ex. 3 (Csaky Opn.) at ¶ 69 (pp. 30-31) (citations omitted). Regeneron does not dispute
`
`that in paragraph 70 of Dr. Csaky’s Opening Report, Dr. Csaky states that:
`
`Mylan’s proposed label for YESAFILITM states that “YESAFILITM
`(aflibercept-jbvf) is interchangeable* with EYLEA (aflibercept)”
`and continues, at the asterisked footnote, to explain that: An
`interchangeable product (IP) is a biological product that is
`approved based on data demonstrating that it is highly similar to an
`FDA-approved reference product (RP) and that there are no
`clinically meaningful differences between the products; it can be
`expected to produce the same clinical result as the RP in any given
`patient; and if administered more than once to a patient, the risk in
`terms of safety or diminished efficacy from alternating or
`switching between the use of the RP and IP is not greater than that
`from the PR without such alternation or switch . Interchangeability
`of YESAFILI has been demonstrated for the condition(s) of use,
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`strength(s), dosage form(s), and route(s) of administration
`described in its Full Prescribing Information. The FDA guidance
`Mylan consulted in preparing its label makes clear that such
`language was recommended to be included in interchangeable
`biosimilar labels, but not required. Mylan has made an affirmative
`decision to seek FDA approval of a label containing this language.
`
`Id. at ¶ 70 (pp. 31-32) (citations omitted). Furthermore, Mylan’s expert, Dr. Russell, testified
`
`that as a result of the interchangeability language included in Mylan’s label, Mylan’s “label is
`
`instructing doctors that they can use Eylea the same way they use Yesafili and expect the same
`
`result.” Ex. I at 171:13-22.
`
`41.
`
`Regeneron does not dispute that in paragraph 77 of Dr. Csaky’s Opening Report,
`
`Dr. Csaky opines that “Mylan’s message that YESAFILITM should be used in the same way as
`
`Eylea® matters because ophthalmologists have administered Eylea®—consistent with
`
`Regeneron’s instructions—in a manner that practices the Asserted Claims.” Mylan Ex. 3 (Csaky
`
`Opn.) at ¶ 77 (pp. 38).
`
`42.
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`Regeneron does not understand what Mylan means when it refers to the “‘Dosing
`
`and Indications’ section of YESAFILITM.” Regeneron assumes Mylan intended to reference the
`
`“Dosage and Administration,” “Dosage Forms and Strengths,” and “Contraindications” sections
`
`of the YESAFILITM label. Mylan Ex. 23 (Label) at §§ 2, 3, and 4. Regeneron disputes that Dr.
`
`Csaky has not identified any statements in the proposed “Dosage and Administration,” “Dosage
`
`Forms and Strengths,” and “Contraindications” sections of the YESAFILITM label that will
`
`induce infringement of claim language relating to visual acuity or claim language relating to
`
`exclusion criteria. Dr. Csaky referenced nu