Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`JURY TRIAL DEMANDED
`
`OUTSIDE COUNSELS’ EYES ONLY
`
`
`
`
`Defendant.
`
`
`REGENERON’S OPPOSITION TO MYLAN’S
`MOTION FOR SUMMARY JUDGMENT
`
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`Case 1:22-cv-00061-TSK-JPM Document 443 *SEALED* Filed 05/08/23 Page 1 of 32 Case 1:22-cv-00061-TSK-JPM Document 632 Filed 09/01/23 Page 1 of 219 PageID #:
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`PageID #: 3184649770
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`
`
`

`

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`PageID #: 3184749771
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`
`
`I.
`
`II.
`
`III.
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`
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................................1
`A.
`Subsequent Procedural Developments .....................................................................1
`
`B.
`
`C.
`
`Much of Mylan’s Motion is Moot ...........................................................................2
`
`Mylan Has Not Moved for Summary Judgment on Various Asserted
`Claims. .....................................................................................................................4
`
`MYLAN IS NOT ENTITLED TO SUMMARY JUDGMENT OF CLAIM 18 OF
`THE ’865 PATENT .............................................................................................................5
`
`THE METHOD OF TREATMENT PATENTS ................................................................10
`Mylan’s Motion Does Not Address All Asserted Claims of the Method of
`A.
`Treatment Patents...................................................................................................11
`
`B.
`
`C.
`
`Mylan’s “Direct Infringement” Ground Targets a Theory that Regeneron
`Is Not Advancing. (Responsive to Section V of Mylan’s Brief) ..........................12
`
`Mylan Is Not Entitled to Summary Judgment of No Inducement with
`Respect to Claims 1-14, 16-23, and 26-28 of the ’572 Patent. (Responsive
`to Section VI of Mylan’s Brief) .............................................................................12
`
`1.
`
`2.
`
`Overview of Claims Implicated by Mylan’s “Visual Acuity”
`Inducement Arguments. (’572 Claims 6, 7, 12, 13, 18, 19, 22, and
`23) ..............................................................................................................13
`
`The Court’s Claim Construction Order Forecloses Mylan’s
`Argument Regarding Inducement. (Responsive to Section VI of
`Mylan’s Brief) ............................................................................................14
`
`3.
`
`Mylan’s Remaining Arguments Are Meritless. .........................................15
`
`a.
`
`b.
`
`Mylan’s Divided Infringement Argument Is Meritless.
`(Responsive to Sections VI.A and VI.B of Mylan’s Brief) ...........15
`
`Mylan’s “Lack of Inducement” Argument Is Meritless.
`(Responsive to Section VI.C of Mylan’s Brief) .............................17
`
`1)
`
`2)
`
`3)
`
`Mylan Applies the Wrong Inducement Standard...............18
`
`Mylan Induces Visual Acuity Measurements ....................18
`
`Mylan Induces Visual Acuity Measurements of 7, 8,
`and 9 Letter Gains as Recited in Claims 6, 7, 12, 13,
`18, 19, 22, and 23 of the ’572 Patent. ................................20
`
`4.
`
`Claims 6, 7, 12, 13, 18, 19, 22, and 23 of the ’572 Patent Are Not
`Invalid. (Responsive to Section VI.D of Mylan’s Brief) ..........................22
`
`D.
`
`Mylan’s Request for Summary Judgment of Invalidity Is Flawed as to
`Claims 6, 7, 12, and 13 of the ’572 Patent and Moot as to the Other
`Challenged Claims. ................................................................................................24
`
`i
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`IV.
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`
`
`CONCLUSION ..................................................................................................................25
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`
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`ii
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`
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`TABLE OF AUTHORITIES
`
`CASES
`
`Akamai Techs., Inc. v. Limelight Networks, Inc.,
`
`797 F.3d 1020 (Fed. Cir. 2015)................................................................................................17
`
`Am. Med. Sys., Inc. v. Biolitec, Inc.,
`
`618 F.3d 1354 (Fed. Cir. 2010)................................................................................................15
`
`Amgen Inc. v. Apotex Inc.,
`
`712 F. App’x 985 (Fed. Cir. 2017) ............................................................................................9
`
`AstraZeneca LP v. Apotex, Inc.,
`
`633 F.3d 1042 (Fed. Cir. 2010)................................................................................................23
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs.,
`
`246 F.3d 1368 (Fed. Cir. 2001)................................................................................................14
`
`Conoco, Inc. v. Energy & Environmental Int’l,
`
`460 F.3d 1349 (Fed. Cir. 2006)..............................................................................................7, 8
`
`DSW, Inc. v. Shoe Pavilion, Inc.,
`
`537 F.3d 1342 (Fed. Cir. 2008)..................................................................................................4
`
`First Quality Tissue, LLC v. Irving Consumer Prod. Ltd.,
`
`2020 WL 3542321 (D. Del. June 30, 2020) .............................................................................14
`
`Glaxo Grp. Ltd. v. Apotex, Inc.,
`
`376 F.3d 1339 (Fed. Cir. 2004)..................................................................................................7
`
`GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.,
`
`7 F.4th 1320 (Fed. Cir. 2021) ............................................................................................11, 21
`
`Laitram Corp. v. Cambridge Wire Cloth Co.,
`
`863 F. 2d 855 (Fed. Cir. 1988).................................................................................................15
`
`Norian Corp. v. Stryker Corp.,
`
`363 F.3d 1321 (Fed. Cir. 2004)..................................................................................................8
`
`Otsuka Pharm. Co. v. Lupin Ltd.,
`
`2022 WL 2952759 (D. Del. July 26, 2022) ...............................................................................7
`
`Sandt Tech., Ltd. v. Resco Metal & Plastics Corp.,
`
`264 F.3d 1344 (Fed. Cir. 2001) .....................................................................................5, 13, 24
`
`Simpson Performance Products, Inc. v. Zamp Inc.,
`
`2019 WL 1052031 (W.D.N.C. 2019) ......................................................................................15
`
`
`
`iii
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`
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`Summit 6, LLC v. Samsung Elecs. Co.,
`
`802 F.3d 1283 (Fed. Cir. 2015)................................................................................................14
`
`Sunovion Pharm. Inc. v. Teva Pharm. USA, Inc.,
`
`2013 WL 211289 (D.N.J. Jan. 17, 2013) ...................................................................................9
`
`Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc.,
`
`731 F.3d 1271 (Fed. Cir. 2013)..................................................................................................9
`
`Symantec Corp. v. Computer Associates Intern., Inc.,
`
`522 F.3d 1279 (Fed. Cir. 2008)................................................................................................15
`
`Trintec Indus., Inc. v. Top-U.S.A. Corp.,
`
`295 F.3d 1292 (Fed. Cir. 2002)................................................................................................23
`
`TypeRight Keyboard Corp. v. Microsoft Corp.,
`
`374 F.3d 1151 (Fed. Cir. 2004)..................................................................................3, 4, 13, 25
`
`Union Carbide v. Shell Oil Co.,
`
`308 F.3d 1167 (Fed. Cir. 2002)....................................................................................11, 24, 25
`
`United States v. Smalls,
`
`720 F.3d 193 (4th Cir. 2013) ...................................................................................................13
`
`WL Gore & Associates, Inc. v. Garlock, Inc.,
`
`842 F. 2d 1275 (Fed. Cir. 2003).........................................................................................10, 14
`
`Zurich Am. Ins. Co. v. Dove Enter., Inc.,
`
`2020 WL 4926171 (N.D.W. Va. June 12, 2020) .....................................................................13
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 271 ..............................................................................................................................12
`
`
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`
`iv
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`Regeneron Pharmaceuticals, Inc. (“Regeneron”) opposes the Motion for Summary
`
`Judgment filed by Mylan Pharmaceuticals Inc. (“Mylan”) (ECF 429). Mylan also provided, with
`
`its Motion, a 25-page document styled as a “short and plain statement of uncontroverted facts”
`
`required by L.R. Civ. P. 7.02(a) (ECF 432-1). Mylan’s document is neither short nor plain, and
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`many of the facts it alleges are not uncontroverted. Regeneron identifies disputed facts in its
`
`Response to Defendant Mylan Pharmaceuticals Inc.’s L.R. Civ. P. 7.02 Statement of
`
`Uncontroverted Facts (“Facts”), filed contemporaneously herewith.
`
`I.
`
`INTRODUCTION
`
`Mylan’s Summary Judgment Motion (ECF 429, “Mot.”) and Memorandum in support
`
`(ECF 432, “Br.”) seek summary judgment with respect to certain claims of U.S. Patent Nos.
`
`10,888,601 (“the ’601 Patent), 11,084,865 (“the ’865 Patent”), 11,253,572 (“the ’572 Patent”), and
`
`11,104,715 (“the ’715 Patent”). In view of subsequent developments, many of the claims and/or
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`bases on which Mylan seeks judgment no longer require resolution. With respect to those issues
`
`that are still pending, Mylan’s Motion is deeply flawed. Mylan misreads the claims, disregards
`
`various claim limitations that legally foreclose the relief Mylan seeks, and ignores documents,
`
`testimony, and expert evidence that prevent judgment in Mylan’s favor.
`
`A.
`
`Subsequent Procedural Developments
`
`Mylan’s Motion was filed on April 20, six days before Regeneron notified Mylan, in
`
`accordance with the Court’s Scheduling Order (ECF 87 at 2), that Regeneron was narrowing the
`
`initial proceedings to the following three patents and 21 asserted claims:
`
`U.S. Patent No. 10,888,601
`U.S. Patent No. 11,084,865
`U.S. Patent No. 11,253,572
`
`
`
`Claims 11, 19, and 27
`Claims 4, 7, 9, 11, and 14-18
`Claims 6, 7, 12, 13, 18, 19, 22, 23, and 25
`
`At the same time it complied with the Court’s order to narrow the proceedings, Regeneron
`
`also addressed the effect of the Court’s Order on Claim Construction (ECF 427) on several
`
`
`
`1
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`3. “There is no direct
`infringement by Mylan
`of any claims of the
`’572 or ’601 patents.”
`Mot. 1.
`
`4. “There is no induced
`infringement for the
`claims of the ’572
`patent.” Mot. 1.
`
`This ground is directed
`to claims 1-14, 16-23,
`and 26-28 of the ’572
`patent. Br. 13, 16.
`
`Regeneron has never
`asserted that Mylan or its
`successor will directly
`infringe claims of the ’572
`and ’601 patents by
`marketing YESAFILITM.
`Infra Section III.B.
`Instead, Regeneron asserts
`that Mylan or its successor
`will indirectly infringe the
`claims of the ’572 and ’601
`patents by inducing
`physicians to perform acts
`of direct infringement. Id.
`Regeneron opposes
`judgment of no inducement
`with respect to all claims
`of the ’572 Patent.
`
`Subject to all appellate
`rights, Regeneron does not
`oppose summary judgment
`of invalidity as to claims 1-
`5, 8-11, 14, and 26-28 of
`the ’572 Patent under the
`Court’s Order on Claim
`Construction, thereby
`mooting Mylan’s Motion
`for a judgment of no
`infringement as to these
`claims.
`
`
`
`5. “There is no induced
`infringement and/or the
`claims are invalid for at
`least claims 1-14 and
`26-28 of the ’572
`patent; and claims 5-6
`
`Subject to all appellate
`rights, Regeneron does not
`oppose summary judgment
`of invalidity as to claims 5-
`
`3
`
`No.
`
`Because Regeneron has never alleged
`direct infringement of the ’601 and
`’572 Patents, infra Section III.B,
`Mylan’s Motion is moot. Regeneron
`does not intend to present evidence of
`direct infringement by Mylan at trial.
`Entry of partial summary judgment on
`this basis would not remove any issue
`or asserted claim from the case.
`
`Partial resolution required.
`
`Regeneron continues to assert claims 6,
`7, 12, 13, 18, 19, 22, 23, and 25 of the
`’572 Patent. Claim 25 is not subject to
`Mylan’s Motion. Br. 13, 16.
`
`The Court must resolve Mylan’s
`Motion for summary judgment of “no
`induced infringement” with respect to
`claims 6, 7, 12, 13, 18, 19, 22, and 23
`of the ’572 patent.
`
`Because Regeneron does not oppose
`summary judgment of invalidity as to
`claims 1-5, 8-11, 14, and 26-28 of the
`’572 Patent under the Court’s Order on
`Claim Construction (ECF 427),
`Mylan’s Motion for summary
`judgment of noninfringement with
`respect to these claims is moot.
`TypeRight Keyboard Corp. v.
`Microsoft Corp., 374 F.3d 1151, 1157
`(Fed. Cir. 2004) (“[A] judgment of
`invalidity necessarily moots the issue
`of infringement.”).
`Yes (partially).
`
`Regeneron opposes summary judgment
`of invalidity as to claims 6, 7, 12, 13,
`18, 19, 22, and 23 of the ’572 Patent.
`
`
`

`

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`and 9 of the ’601 patent,
`in view of Dixon.” Mot.
`2.1
`
`Regeneron understands
`this ground to be limited
`to the claims
`enumerated in Mylan’s
`Motion and brief:
`claims 1-14 and 26-28
`of the ’572 patent; and
`claims 5-6 and 9 of the
`’601 patent. Mot. 2; Br.
`22.
`
`6 and 9 of the ’601 patent2
`and claims 1-5, 8-11, 14,
`and 26-28 of the ’572
`patent under the Court’s
`claim construction.
`
`The Court may enter summary
`judgment of invalidity as to claims 5-6
`and 9 of the ’601 patent and claims 1-5,
`8-11, 14, and 26-28 of the ’572 patent.
`
`To the extent Mylan seeks an
`additional judgment of
`noninfringement as to claims 5-6 and 9
`of the ’601 patent and claims 1-5, 8-11,
`14, and 26-28 of the ’572 patent, such a
`request would be moot in view of the
`stipulated judgment of invalidity.
`TypeRight, 374 F.3d at 1157.
`
`C. Mylan Has Not Moved for Summary Judgment on Various Asserted Claims.
`
`Wholly apart from the substantive problems with Mylan’s remaining summary judgment
`
`arguments, addressed below, Mylan’s request for blanket relief as to the asserted “patents” must
`
`be denied because it has not moved for summary judgment with respect to all asserted claims. It
`
`is black-letter law that both infringement and validity are claim-by-claim inquiries, not patent-by-
`
`patent inquiries. DSW, Inc. v. Shoe Pavilion, Inc., 537 F.3d 1342, 1346 (Fed. Cir. 2008)
`
`(“Infringement occurs when a properly construed claim of an issued patent covers an accused
`
`
`1 It is not clear what Mylan means by seeking summary judgment on “at least” claims 1-14 and 26-28 of
`the ’572 patent and claims 5-6 and 9 of the ’601 patent. Mot. 2. Mylan’s Brief asserts that “[s]ummary
`judgment in Mylan’s favor on claims 1-14 and 26-28 of the ’572 patent and claims 5-6 and 9 of the ’601
`patent is appropriate.” Br. 16 (Section VII, “The ’572 and ’601 Patents Are Invalid for Anticipation.”).
`Federal Rule of Civil Procedure 56(a) requires that a party identify “each” claim or defense on which
`summary judgment is sought. Absent further specificity, Regeneron takes Mylan’s Motion to be limited to
`the enumerated claims.
`
`2 Mylan’s Motion purports to seek a judgment of no induced infringement as to these claims, but that ground
`is not addressed in substance in Mylan’s brief. Section VI of Mylan’s brief (argument 4 in the table above)
`is addressed to certain claims of the ’572 patent only, and Section VII (argument 5) does not address the
`sufficiency of Regeneron’s inducement evidence except to assert that if Regeneron proves inducement,
`invalidity must follow. Regeneron does not understand Mylan’s argument to seek judgment of no
`infringement with respect to the enumerated ’601 patent claims. Regardless, such a request would be moot:
`Regeneron has accepted summary judgment of invalidity of the only ’601 patent claims to which Section
`VII (argument 5) is directed (claims 5-6 and 9). TypeRight, 374 F.3d at 1157.
`
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`4
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`“uncontroverted” evidence of non-infringement as Mylan baselessly asserts, ECF 432-1 ¶ 22; Facts
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`¶¶ 21-22.
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`
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`, as claim
`
`18 requires. To the extent summary judgment on this factual infringement dispute is warranted, it
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`should issue in Regeneron’s favor.
`
`The Federal Circuit’s Conoco decision further supports infringement. Like the limitation
`
`reciting that “the formulation does not contain phosphate,” Conoco involved the phrase “consisting
`
`of,” which in patent law “signifies restriction and exclusion of unrecited steps or components.”
`
`Conoco, 460 F.3d at 1360 (emphasis added). In Conoco, the court addressed claims reciting a
`
`“suspending material selected from the group consisting of water and water-alcohol mixtures.” Id.
`
`at 1353. Like Mylan here, the Conoco defendant argued that the presence of an impurity (called
`
`MIBK) precluded infringement, since it was outside the closed group recited in the claim. Id. The
`
`Federal Circuit disagreed, because “impurities that a person of ordinary skill in the relevant art
`
`would ordinarily associate with a component on the ‘consisting of’ list do not exclude the accused
`
`product or process from infringement.” Id. at 1360 (emphasis added); see also Norian Corp. v.
`
`Stryker Corp., 363 F.3d 1321, 1331-32 (Fed. Cir. 2004). There, “MIBK [was] a common impurity
`
`in industrial alcohols in order to prevent a liquor tax from being applied” and was not added to
`
`“adjust the stability” or “prevent agglomeration.” Conoco, 460 F.3d at 1360-61. Here,
`
`
`
` Just as the presence of the impurity did not negate infringement in
`
`Conoco, notwithstanding the use of the closed-off phrase “consisting
`
`
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` cannot preclude infringement of the claim 18 limitation that the
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`8
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`“formulation” does not contain phosphate.
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`Mylan infringes under Sunovion. Separately,
`
`
`
` conclusively establish infringement pursuant to 35 U.S.C. § 271(e)(2).
`
`Under that provision, if the “product that [the] applicant is asking the FDA to approve for sale falls
`
`within the scope of an issued patent, a judgment of infringement must necessarily ensue.”
`
`Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1278 (Fed. Cir. 2013).4 In other
`
`words, because
`
`
`
`
`
` a judgment of infringement under § 271(e) must issue, without
`
`regard to whether actual samples of Mylan’s product would infringe.
`
`. Indeed, that result obtains even if a biosimilar applicant shows that
`
`particular lots would fall outside a claim. In Sunovion, for example, the defendant relied on “batch
`
`records” indicating that tested lots of its product fell outside the claims, and the district court
`
`granted summary judgment of noninfringement. Sunovion Pharm. Inc. v. Teva Pharm. USA, Inc.,
`
`2013 WL 211289, at *5-6 (D.N.J. Jan. 17, 2013). The Federal Circuit reversed, because what
`
`ultimately mattered was not the characteristics of individual lots or samples, but what the applicant
`
`“ask[ed] the FDA to approve.” 731 F.3d at 1278 (emphasis added). Because
`
`
`
`
`
`, and
`
`Mylan’s Motion should thus be denied for this reason as well.
`
`
`4 Sunovion addressed § 271(e)(2) infringement by Abbreviated New Drug Applications (“ANDAs”). Just
`as in the ANDA context, § 271(e)(2) makes submitting a BLA seeking approval of an infringing product
`an act of infringement, and courts thus have held unanimously that Sunovion applies to BLAs. Amgen Inc.
`v. Apotex Inc., 712 F. App’x 985, 991-992 (Fed. Cir. 2017) (applying Sunovion in BLA context).
`
`
`
`9
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`

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`III. THE METHOD OF TREATMENT PATENTS
`
`Mylan’s motion with respect to the ’572 and ’601 patents is fatally flawed. Mylan’s
`
`arguments are at odds with the Court’s Markman Order, misstate the standard for inducement, and
`
`utterly ignore critical claim limitations search of anticipation. Mylan’s theories must fail.
`
`First, in seeking judgment of no inducement of the ’572 patent claims containing a “visual
`
`acuity” limitation, Mylan impermissibly construes the asserted claims for infringement purposes
`
`in a manner wholly inconsistent with the construction it urged and obtained via the Court’s
`
`Markman Order (ECF 427). At Mylan’s request, the Court held that “visual acuity” language in
`
`certain claims of the ’572 and ’601 patents does not “change the manipulative steps of the claim”
`
`and is thus non-limiting. ECF 427 at 39. In the instant motion, Mylan does an about face—it asks
`
`the Court to treat the exact same language as limiting for purposes of infringement. Indeed, Mylan
`
`acknowledges that “[f]or purposes of this Motion, Mylan treats these claim elements as limiting.”
`
`Br. 6 n.1. This is flatly impermissible. The Federal Circuit expressly forbids this “heads we win,
`
`tails you lose” approach. See, e.g., WL Gore & Associates, Inc. v. Garlock, Inc., 842 F. 2d 1275,
`
`1279 (Fed. Cir. 2003) (“Having construed the claims one way for determining their validity, it is
`
`axiomatic that the claims must be construed in the same way for infringement.”), abrogated on
`
`other grounds by eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006).
`
`Even were Mylan permitted to toggle the limiting nature of claim language on and off on
`
`a whim—and to be clear, the Federal Circuit prohibits such gamesmanship—Mylan’s theory of no
`
`inducement would still fail. Regeneron will establish at trial that Mylan induces physicians to
`
`perform every step of the claimed methods, even if the Court were to ignore the import of its
`
`Markman ruling and determine those steps include “visual acuity” limitations. Regardless of claim
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`construction, there is no aspect of the claimed methods that Mylan does not encourage doctors to
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`perform, direct, or control. Mylan’s suggestion that patients in fact perform the non-step of gaining
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`Case 1:22-cv-00061-TSK-JPM Document 443 *SEALED* Filed 05/08/23 Page 16 of 32 Case 1:22-cv-00061-TSK-JPM Document 632 Filed 09/01/23 Page 16 of 219 PageID #:
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`PageID #: 3186149785
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`visual acuity independently of their physicians’ treatment (Br. §§ VI.A-VI.B) defies law and
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`logic—as does the suggestion that Mylan’s label and presentation of study results does not
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`encourage, recommend, or promote the same. GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7
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`F.4th 1320, 1327 (Fed. Cir. 2021). Mylan’s argument that the label need do more than that—i.e.,
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`that the label must “require” and “ensure” that doctors infringe, Br. 9-15—is simply not the law,
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`GSK, 7 F.4th 1327; Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1368 (Fed. Cir.
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`2017). At a minimum, genuine issues of material fact preclude summary judgment regarding
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`inducement of the asserted claims of the ’572 patent. Facts ¶¶ 37, 39-47.
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`Finally, Mylan’s contention that asserted claims 6, 7 ,12, and 13 of the ’572 patent (along
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`with unasserted claims from both the ’572 and ’601 patents) are invalid if Regeneron can prove
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`inducement is rife with error. Each of claims 6, 7, 12, and 13 of the ’572 patent (M. Ex. 18)
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`requires aflibercept formulated in an isotonic solution or with a nonionic surfactant—Mylan
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`cannot (and does not) allege any such limitations are disclosed by its supposedly anticipatory
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`Dixon reference, M. Ex. 26. Neither Mylan’s brief (ECF 432) nor its twenty-five pages of “facts”
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`(ECF 432-1) even attempt to address these limitations. Mylan simply has not supplied any basis
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`to grant summary judgment in its favor with respect to these claims. Union Carbide v. Shell Oil
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`Co., 308 F.3d 1167, 1188 (Fed. Cir. 2002) (anticipation requires defendant “to prove by clear and
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`convincing evidence that every limitation of [the] asserted claims was contained, either expressly
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`or inherently, in a single prior art reference.”).
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`A. Mylan’s Motion Does Not Address All Asserted Claims of the Method of
`Treatment Patents.
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`Mylan has not moved for summary judgment with respect to asserted claims 11, 19, and
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`27 of the ’601 Patent nor claim 25 of the ’572 patent on any grounds. See Br. 13, 16 (limiting
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`Section VI of Mylan’s argument to claims 1-14, 16-23, and 26-28 of the ’572 Patent); Br. 22
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`(limiting Section VII of Mylan’s argument to claims 1-14 and 26-28 of the ’572 patent and claims
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`5-6 and 9 of the ’601 patent). There is thus no basis for entry of judgment as to these claims.
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`B. Mylan’s “Direct Infringement” Ground Targets a Theory that Regeneron Is
`Not Advancing. (Responsive to Section V of Mylan’s Brief)
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`Mylan asserts that it is entitled to summary judgment of no direct infringement of the ’601
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`and ’572 Patents under 35 U.S.C. § 271(a). Br. § V. But Regeneron’s theory of infringement as
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`to its method of treatment claims is not direct infringement under 35 U.S.C. § 271(a), it is (and
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`always has been) indirect infringement. See ECF 1 ¶¶ 133-142 (’601 Patent), ¶¶ 223-232 (’572
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`Patent). Specifically, Regeneron’s complaint asserts under 35 U.S.C. § 271(e) that “the sale of
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`M710 pursuant to the label proposed in Mylan’s aBLA will contribute to and induce infringement
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`of, inter alia, claim 1 of the ’572 patent.” See id. at ECF 1 ¶¶ 139 (’601 Patent), 229 (’572 Patent).
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`The report of one of Regeneron’s experts, Dr. Karl Csaky, is consistent. M. Ex. 19 ¶ 5 (addressing
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`induced infringement). Mylan’s Motion on this issue thus requests an advisory opinion from the
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`Court on a theory that is not a part of the case. It should be denied on that basis.
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`C. Mylan Is Not Entitled to Summary Judgment of No Inducement with
`Respect to Claims 1-14, 16-23, and 26-28 of the ’572 Patent.
`(Responsive to Section VI of Mylan’s Brief)
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`Mylan moves for summary judgment that it does not induce infringement of any claims
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`containing a “visual acuity” limitation.5 In view of Regeneron’s stipulation (ECF 433), Mylan’s
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`motion is directed only to a limited subset of the asserted claims. Regardless, Mylan’s motion
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`must fail, because it ignores the Court’s claim construction, rewrites the legal standard for
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`inducement, and ignores a mountain of evidence that Mylan encourages, recommends, and
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`5 Mylan includes in its arguments claim 14, which does not contain any “visual acuity” limitation, but does
`contain an “exclusion criteria” limitation. Regeneron has stipulated to the invalidity of claim 14 under the
`Court’s Markman Order, and there is no basis to address Mylan’s arguments as to that claim.
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`promotes performance of the visual acuity measurements recited in the asserted claims.
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`1.
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`Overview of Claims Implicated by Mylan’s “Visual Acuity”
`Inducement Arguments. (’572 Claims 6, 7, 12, 13, 18, 19, 22, and 23)
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`While it requires effort to ascertain which claims of the ’572 Patent are the subject of
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`Mylan’s argument, the answer arrives in the final sentences of subsection VI.C.2.b. There, Mylan
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`specifies that it is seeking summary judgment of no inducement with respect to “claims 1-14, 16-
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`23, and 26-28.” Br. 13. Mylan cannot expand the scope of its requested relief or introduce new
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`arguments on reply. United States v. Smalls, 720 F.3d 193, 197 (4th Cir. 2013); Zurich Am. Ins.
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`Co. v. Dove Enter., Inc., 2020 WL 4926171, at *3 (N.D.W. Va. June 12, 2020).
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`After Mylan filed its motion, Regeneron stipulated (subject to its rights of appeal) to the
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`invalidity of claims 1-5, 8-11, 14, and 26-28 of the ’572 patent, thereby mooting Mylan’s motion
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`for judgment of noninfringement of those claims.6 TypeRight Keyboard Corp. v. Microsoft Corp.,
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`374 F.3d 1151, 1157 (Fed. Cir. 2004) (“[A] judgment of invalidity necessarily moots the issue of
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`infringement.”); Sandt Tech., 264 F.3d at 1356.
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`Thus, the only claims of the ’572 patent that remain subject to Mylan’s Motion for
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`summary judgment are claims 6, 7, 12, 13, 18, 19, 22, and 23 of the ’572 patent, each of which,
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`by virtue of dependency, incorporates language reciting “wherein the patient gains at least [7, 8,
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`or 9] letters Best Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic
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`Retinopathy Study (ETDRS) letter score.” M. Ex. 18 at 23:1-24:23; ECF 427 at 26-29, 37-39.
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`Mylan’s only argument for summary judgment as to non-inducement of these claims is based on
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`the visual acuity language they contain. E.g., Br. 6, 7, 9, 13.
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`6 Even were it not for Regeneron’s stipulation of invalidity as to these claims, claims 1-5, 8-11 and 26-28
`each contain a “visual acuity” limitation just like claims 6, 7, 12, 13, 18, 19, 22, and 23, and Mylan’s request
`for a non-infringement judgment as to them is improper in view of the Court’s Markman ruling.
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`2.
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`The Court’s Claim Construction Order Forecloses Mylan’s Argument
`Regarding Inducement. (Responsive to Section VI of Mylan’s Brief)
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`Mylan dedicates Section VI of its brief to arguing it does not infringe various claims of the
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`’572 patent because doctors do not perform, and Mylan does not induce, the recited visual acuity
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`language. Mylan is thus attempting to wield on summary judgment claim language that only two
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`weeks ago—at Mylan’s behest—the Court found non-limiting. ECF 427 at 26-29, 37-39.
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`This position squarely violates black letter law. “Having construed the claims one way
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`for determining their validity, it is axiomatic that the claims must be construed in the same way
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`for infringement.” W.L. Gore, 842 F. 2d at 1279.7 Mylan cannot assert that claim language is non-
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`limiting to advance i