Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 1 of 34 PageID #: 47791
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`
`OUTSIDE COUNSEL EYES ONLY
`
`FILED UNDER SEAL
`
`
`
`Defendant.
`
`
`
`
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S MEMORANDUM IN SUPPORT
`OF ITS MOTION FOR SUMMARY JUDGMENT OR PARTIAL SUMMARY
`JUDGMENT ON U.S. PATENT NOS. 11,104,715 (PROCESS PATENT); 11,084,865
`(FORMULATION PATENT); and 10,888,601 & 11,253,572 (DOSING PATENTS)
`
`
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 2 of 34 PageID #: 47792
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ......................................................................................................... iii
`
`TABLE OF ABREVIATIONS ...................................................................................................... vi
`
`TABLE OF RECORD CITATIONS ............................................................................................ vii
`
`I.
`
`II.
`
`INTRODUCTION. ............................................................................................................. 1
`
`LEGAL STANDARDS - GENERAL. ............................................................................... 2
`
`III. MYLAN’S PROCESS FOR MAKING YESAFILITM DOES NOT INFRINGE
`THE ‘715 PATENT’S CDM PROCESS STEPS. .............................................................. 3
`
`IV.
`
`THE YESAFILITM FORMULATION DOES NOT INFRINGE CLAIM 18 OF
`THE ‘865 PATENT. ........................................................................................................... 5
`
`V.
`
`MYLAN DOES NOT DIRECTLY INFRINGE THE ‘572 AND ‘601 PATENTS. .......... 5
`
`VI. MYLAN DOES NOT INDUCE INFRINGEMENT OF ANY VALID CLAIM OF
`THE ‘572 PATENT. ........................................................................................................... 6
`
`A.
`
`B.
`
`C.
`
`Regeneron lacks proof of direct infringement by a single entity. ........................... 6
`
`There can be no induced infringement absent a direct infringer. ........................... 7
`
`Regeneron’s theories are legally insufficient to prove inducement. ....................... 7
`
`1.
`
`2.
`
`Interchangeability/biosimilarity statements in YESAFILITM’s label
`are legally insufficient to prove Mylan actively induces. ........................... 8
`
`No YESAFILITM label instructions require or encourage doctors or
`patients to achieve particular visual acuity results, including in
`comparison to ranibizumab, by the 52-week mark. .................................... 9
`
`a.
`
`b.
`
`Even assuming that some doctors test for visual acuity, or
`some patients reach visual acuity metrics, this is legally
`insufficient proof of induced infringement. .................................... 9
`
`The clinical trial data in the YESAFILITM label also are
`legally insufficient proof of induced infringement ....................... 11
`
`3.
`
`Statements at scientific conferences about the Accused Product
`also are legally insufficient evidence for inducement............................... 13
`
`D.
`
`Regeneron’s theories of “inevitable” infringement, if accepted for
`inducement purposes, must apply equally to invalidate the claims. ..................... 14
`
`i
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 3 of 34 PageID #: 47793
`
`VII. THE ‘572 AND ‘601 PATENTS ARE INVALID FOR ANTICIPATION. .................... 16
`
`A.
`
`B.
`
`C.
`
`Dixon undisputedly disclosed the drug, dose, diseases, and schedules, as
`well as various efficacy outcomes. ....................................................................... 18
`
`Dixon anticipates the claims of the ‘601 patent and the ‘572 patent for the
`same reasons set forth by the PTAB on the undisputed facts. .............................. 19
`
`Because claims must be construed and applied the same way for
`infringement and for invalidity, Dixon anticipates, particularly if this
`Court accepts Regeneron’s infringement theories of the case. ............................. 22
`
`VIII. CONCLUSION ................................................................................................................. 25
`
`
`
`
`
`
`
`ii
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 4 of 34 PageID #: 47794
`
`TABLE OF AUTHORITIES
`
`Federal Cases
`
`Abbott Lab’ys v. Geneva Pharms., Inc.,
`182 F.3d 1315 (Fed. Cir. 1999) ................................................................................................ 17
`
`Akamai Techs., Inc. v. Limelight Networks, Inc.,
`797 F.3d 1020 (Fed. Cir. 2015) .................................................................................................. 7
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) ................................................................................................ 16
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) ................................................................................................ 14
`
`Athletic Alts., Inc. v. Prince Mfg., Inc.,
`73 F.3d 1573 (Fed. Cir. 1996) .................................................................................................... 4
`
`Atlas Powder Co. v. Ireco Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) .................................................................................................. 3
`
`Barwick v. Celotex Corp.,
`736 F.2d 946 (4th Cir. 2013) .................................................................................................... 16
`
`Bayer AG v. Elan Pharm. Rsch. Corp.,
`212 F.3d 1241 (Fed. Cir. 2000) .................................................................................................. 2
`
`Bayer Schering Pharma AG v. Lupin, Ltd.,
`676 F.3d 1315 (Fed. Cir. 2012) ................................................................................................ 12
`
`Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ...................................................................................... 3, 18, 24
`
`Dealertrack, Inc. v. Huber,
`674 F.3d 1315 (Fed. Cir. 2012) .................................................................................................. 4
`
`Eli Lilly & Co. v. Teva Parenteral Meds., Inc.,
`845 F.3d 1357 (Fed. Cir. 2017) .................................................................................................. 8
`
`E-Pass Techs., Inc. v. 3Com Corp.,
`473 F.3d 1213 (Fed. Cir. 2007) .................................................................................................. 2
`
`GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.,
`7 F.4th 1320 (Fed. Cir. 2021) ..................................................................................................... 8
`
`Grunenthal GmbH v. Alkem Lab’ys Ltd.,
`919 F.3d 1333 (Fed. Cir. 2019) .......................................................................................... 11, 14
`
`iii
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 5 of 34 PageID #: 47795
`
`HZNP Medicines LLC v. Actavis Laboratories UT, Inc.,
`940 F.3d 680 (Fed. Cir. 2019) .................................................................................................. 10
`
`In re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) .................................................................................................. 17
`
`In re Oxycontin Antitrust Litig.,
`994 F. Supp. 2d 367 (S.D.N.Y. 2014) ...................................................................................... 18
`
`Jeneric/Pentron, Inc. v. Dillon Co.,
`205 F.3d 1377 (Fed. Cir. 2000) .................................................................................................. 6
`
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) ................................................................................................ 17
`
`Limelight Networks, Inc. v. Akamai Techs., Inc.,
`572 U.S. 915 (2014) .................................................................................................................... 7
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) .................................................................................................................... 2
`
`Mas-Hamilton Grp. v. LaGard, Inc.,
`156 F.3d 1206 (Fed. Cir. 1998) .................................................................................................. 5
`
`Medtronic, Inc. v. Mirowski Family Ventures,
`571 U.S. 191 (2014) .................................................................................................................... 2
`
`MEHL/Biophile Int’l Corp. v. Milgraum,
`192 F.3d 1362 (Fed. Cir. 1999) ................................................................................................ 25
`
`Novartis Corp. v. Ben Venue Lab’ys, Inc.,
`271 F.3d 1043 (Fed. Cir. 2001) .................................................................................................. 5
`
`Qualcomm Inc. v. Apple Inc.,
`24 F.4th 1367 (Fed. Cir. 2022) ................................................................................................. 17
`
`Schering Corp. v. Geneva Pharms.,
`339 F.3d 1373 (Fed. Cir. 2003) ............................................................................................ 3, 17
`
`Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.,
`785 F.3d 625 (Fed. Cir. 2015) ........................................................................................ 8, 10, 14
`
`Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.,
`72 F. Supp. 3d 539 (D. Del. 2014) ............................................................................................ 12
`
`Telectronics Pacing Sys., Inc. v. Ventritex, Inc.,
`982 F.2d 1520 (Fed. Cir. 1992) ................................................................................................ 13
`
`iv
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 6 of 34 PageID #: 47796
`
`Teva Pharm. Indus. Ltd. v. AstraZeneca Pharms. LP,
`661 F.3d 1378 (Fed. Cir. 2011) ............................................................................................ 3, 23
`
`U.S. Ethernet Innovations, LLC v. Acer, Inc.,
`646 F. App’x 929 (Fed. Cir. 2016) ........................................................................................... 22
`
`Vanmoor v. Wal-Mart Stores, Inc.,
`201 F.3d 1363 (Fed. Cir. 2000) ................................................................................................ 23
`
`Verdegaal Bros., Inc. v. Union Oil Co. of Cal.,
`814 F.2d 628 (Fed. Cir. 1987) .................................................................................................. 17
`
`Warner-Lambert Co. v. Apotex Corp.,
`316 F.3d 1348 (Fed. Cir. 2003) ........................................................................................ 2, 7, 10
`
`Zenith Lab’ys, Inc. v. Bristol-Myers Squibb Co.,
`19 F.3d 1418 (Fed. Cir. 1994) .................................................................................................... 9
`
`Federal Statutes
`
`35 U.S.C. § 102 ..................................................................................................................... 1, 3, 18
`
`35 U.S.C. § 102(b) ........................................................................................................................ 17
`
`35 U.S.C. § 271(a) .......................................................................................................................... 5
`
`35 U.S.C. § 271(b) .......................................................................................................................... 7
`
`35 U.S.C. § 271(e)(1) .................................................................................................................... 13
`
`
`
`
`
`
`
`v
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 7 of 34 PageID #: 47797
`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 7 of 34 PagelD #: 47797
`
`Response Patent Trial and Appeals Board
`
`YESAFILI™,the aflibercept-containing productthat is the subject of
`Biologics License Application No. 761274
`February 2, 2023 Opening Expert Report of Karl G. Csaky, M.D., Ph.D
`Regarding Infringement of U.S. Patent Nos. 11,253,572 and 10,888,601
`March 3, 2023 Response Expert Report of Dr. Karl Csak
`Transcript of April 14, 2023 Deposition of Karl Csaky, M.D., Ph.D.
`United States Food and Drug Administration
`United States Patent and Trademark Office
`Chemically Defined Media or Chemically Defined Medium
`
`Exhibit 57 to Mylan’s Opening Claim Construction Brief, James A Dixon
`et al., VEGF Trap-Eyefor the Treatment ofNeovascular Age-Related
`Macular Degeneration, 18 EXPERT OPINION ON INVESTIGATIONAL DRUGS
`
`YESAFILI™
`
`‘601 Patent Owner
`
`YESAFILI™,the accused product, whichis the aflibercept-containing
`productthat is the subject of Biologics License Application No. 761274.
`Patent Owner Response, Mylan Pharms. Inc. v. Regeneron Pharms., Inc.,
`IPR2021-01226, Paper 45 (P.T.A.B.
`
`TABLE OF ABREVIATIONS
`
`Description
`
`U.S. Patent No. 11,084,865
`
`U.S. Patent No. 10,888,601
`U.S. Patent No. 11,253,572
`U.S. Patent Nos. 10,888,601 and 11,253,572
`
`USS. Patent No. 11,104,715
`
`Abbreviation
`the ‘865 patentor the
`Formulation Patent
`the ‘601 patent
`the ‘572 patent
`Dosing Patents
`the ‘715 patent or the
`Process Patent
`
`Accused Product
`
`Csaky Resp.
`C
`saky
`Tr.
`FD
`o
`PT
`DMCc
`
`A O
`
`PTAB
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 8 of 34 PageID #: 47798
`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 8 of 34 PagelD #: 47798
`
`TABLE OF RECORD CITATIONS
`
`Abbreviation
`Dkt. 254-2, ‘601 patent|Mylan Pharms. Inc. v. Regeneron Pharms., Inc., 1PR2021-01226, Paper 22
`Inst. Decision
`P.T.A.B.Jan. 11, 2023
`Dkt. 254-3, ‘338 FWD Mylan Pharms. Inc. v. Regeneron Pharms., Inc. , T?R2021-00881, Paper 94
`P.T.A.B. Nov. 9, 2022
`Dkt. 306, Mylan
`soa:
`.
`.
`.
`Proposed Findines
`Mylan’s Findings of Fact and Conclusions ofLaw on Claim Construction
`
`April 19, 2023 Order on Claim Construction
`
`Proposed Findings
`Dkt. 350-1, ‘572
`Institution Decision
`
`On27, Markman
`
`Conclusions of Law
`Institution Decision, Apotex Inc. v. Regeneron Pharms., Inc., IPR2022-
`01524, Paper 9 (P.T.A.B. Mar. 10, 2023
`
`Vii
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 9 of 34 PageID #: 47799
`
`I.
`
`INTRODUCTION.
`
`Mylan Pharmaceuticals Inc. (“Mylan”) moves for summary judgment under Rule 56, Fed.
`
`R. Civ. P., and LR Civ. P. 7.02 that the accused aflibercept product, YESAFILITM, and its use do
`
`not infringe multiple patents that Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) asserts;
`
`and that several asserted claims also are invalid under 35 U.S.C. § 102.
`
`Process patent. Mylan seeks summary judgment of non-infringement for the ‘715 process
`
`patent. The Court construed the asserted claims to require harvesting aflibercept from cells
`
`cultured in a chemically defined medium (CDM) throughout, not merely at “some point in time.”
`
`(Dkt. 427, Markman Order at 57, 75).
`
`
`
`
`
`
`
` Thus, summary judgment of non-infringement for Mylan is
`
`proper for all asserted claims.
`
`Formulation patent. Mylan seeks summary judgment of non-infringement of claim 18 of
`
`the ‘865 formulation patent. Claim 18 requires a formulation that “does not contain phosphate.”
`
`
`
`
`
`
`
`
`
`
`
` Thus, summary judgment of
`
`non-infringement for Mylan is proper for claim 18.
`
`Dosing patents. The ‘572 and ‘601 patents (together, the “Dosing Patents”) involve
`
`treatment methods that dose the drug aflibercept on particular schedules. Mylan seeks summary
`
`judgment of non-infringement and/or invalidity. First, Regeneron does not dispute Mylan will not
`
`directly infringe the Dosing Patents. Second, Mylan cannot induce infringement without the claim
`
`also being invalid for anticipation. Neither the YESAFILITM labeling, nor any other statements
`
`that Regeneron calls “inducement” meet the legal standard of inevitably requiring doctors or
`
`patients to meet the claims. But, under the principle, “that which infringes, if later, anticipates, if
`
`earlier,” if such statements inevitably induce infringement, then their counterpart statements in the
`
`
`
`1
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 10 of 34 PageID #:
`47800
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`prior art operate to inevitably anticipate. Either approach justifies summary judgment for Mylan.
`
`Third, under this Court’s claim construction (Dkt. 427), the BCVA and exclusion criteria in the
`
`Dosing Patents lack patentable weight.
`
`Thus, for much the same reasons already set forth by the PTAB, each and every element
`
`of the Dosing Patent claims are expressly or inherently found in the prior art, e.g., the Dixon
`
`publication; and are invalid for anticipation. Summary judgment for Mylan is appropriate for this
`
`further independent reason.
`
`Concurrent herewith, pursuant to Local Rule 7.02(a), Mylan also submits its Statement of
`
`Uncontroverted Facts. (“SUF”).
`
`II.
`
`LEGAL STANDARDS - GENERAL.
`
`There are “two elements of a simple patent case, construing the patent and determining
`
`whether infringement occurred.” Markman v. Westview Instruments, Inc., 517 U.S. 370, 384
`
`(1996). Now that the Court has now construed the claims (Dkt. 427), “the burden of proving
`
`infringement generally rests upon the patentee.” Medtronic, Inc. v. Mirowski Fam. Ventures, LLC,
`
`571 U.S. 191, 198 (2014). Regeneron must show that YESAFILITM’s aflibercept is made (the
`
`‘715 process patent); formulated (the ‘865 formulation patent); and used (the ‘572 and ‘601 dosing
`
`patents) in such a way that meets “each limitation of the asserted claim(s).” Bayer AG v. Elan
`
`Pharm. Rsch. Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). “If any claim limitation is absent from
`
`the accused device, there is no literal infringement as a matter of law.” Id.; see also E-Pass Techs.,
`
`Inc. v. 3Com Corp., 473 F.3d 1213, 1222-23 (Fed. Cir. 2007).
`
`Inducement to infringe “requires proof that the accused infringer knowingly aided and
`
`abetted another’s direct infringement of the patent.” Warner-Lambert Co. v. Apotex Corp., 316
`
`F.3d 1348, 1363 (Fed. Cir. 2003). Mere “knowledge of the acts alleged to constitute infringement”
`
`are legally insufficient to prove inducement. Id.
`
`2
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 11 of 34 PageID #:
`47801
`
`A patent is invalid for anticipation under 35 U.S.C. § 102 if a single prior art reference
`
`expressly or inherently discloses what is claimed. See Schering Corp. v. Geneva Pharms., 339
`
`F.3d 1373, 1377 (Fed. Cir. 2003). A century-old patent law axiom holds that a product or process
`
`“which would literally infringe if later in time anticipates if earlier.” Id. at 1379 (quoting Bristol-
`
`Myers Squibb Co. v. Ben Venue Lab’ys, Inc., 246 F.3d 1368, 1378 (Fed. Cir. 2001) (treatment
`
`method patent). The principle is based on common sense and fairness. If “granting patent
`
`protection on the disputed claim would allow the patentee to exclude the public from practicing
`
`the prior art, then that claim is anticipated.” Schering, 339 F.3d at 1379. This rule applies even
`
`when the prior art did not expressly disclose the efficacy of the method of using a drug. “Newly
`
`discovered results of known processes directed to the same purpose are not patentable because
`
`such results are inherent.” Bristol-Myers, 246 F.3d at 1376. “The public remains free to make,
`
`use, or sell prior art compositions or processes, regardless of whether or not they understand their
`
`complete makeup or the underlying scientific principles which allow them to operate,” and the
`
`inherency doctrine “enforces that basic principle.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342,
`
`1348 (Fed. Cir. 1999).
`
`Patentees thus cannot accuse of infringement dosing steps identical to those already found
`
`in the prior art without creating invalidity problems. Regeneron’s own infringement allegations
`
`here allow Mylan to demonstrate invalidity. See, e.g., Teva Pharm. Indus. Ltd. v. AstraZeneca
`
`Pharms. LP, 661 F.3d 1378, 1382 (Fed. Cir. 2011) (Teva’s infringement allegations treated as
`
`admitted facts for summary judgment invalidity purposes).
`
`III. MYLAN’S PROCESS FOR MAKING YESAFILITM DOES NOT INFRINGE THE
`‘715 PATENT’S CDM PROCESS STEPS.
`
`Every asserted claim in the ‘715 patent is tied to independent claims 1 and 16, both of
`
`which require a “method of producing aflibercept harvested from a host cell cultured in a
`
`3
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 12 of 34 PageID #:
`47802
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`chemically defined medium (CDM).” (SUF ¶¶ 1-4).
`
`Regeneron’s infringement theory depended upon a construction for its claims wherein
`
`aflibercept could be made in a host cell cultured in CDM at some point in time before harvesting.
`
`(SUF ¶¶ 5-14; see also Dkt. 313, Regeneron Proposed Findings ¶¶ 148, 150-54). The Court
`
`rejected Regeneron’s proposed claim construction (see, e.g., Dkt. 427, Markman Order at 57, 59,
`
`65, 74-75), in favor of one where the cell culturing occurs in CDM throughout, (see, e.g., id. at 57-
`
`58, 65, 67-69, 75). Because “the parties do not dispute any relevant facts” about the process, but
`
`only “disagree . . . over which of [the] possible meanings of [particular claims at issue] is the
`
`proper one, the question of literal infringement collapses to one of claim construction and is thus
`
`amenable to summary judgment.” Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1320 (Fed. Cir.
`
`2012) (quoting Athletic Alts., Inc. v. Prince Mfg., Inc., 73 F.3d 1573, 1578 (Fed. Cir. 1996)). Thus,
`
`now that the Court has construed the claims in Mylan’s favor to require culturing the aflibercept-
`
`producing host cells in CDM throughout,
`
`
`
` summary judgment of non-infringement for Mylan is proper for the ‘715
`
`patent.
`
`4
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 13 of 34 PageID #:
`47803
`
`IV.
`
`THE YESAFILITM FORMULATION DOES NOT INFRINGE CLAIM 18 OF THE
`‘865 PATENT.
`
`Regeneron asserts dependent claim 18 of the ‘865 patent, which requires a formulation that
`
`“does not contain phosphate.” (SUF ¶¶ 15-17). Regeneron has to establish that the YESAFILITM
`
`formulation includes “every limitation in the asserted claims”; there is no infringement “[i]f even
`
`one limitation”—here the no-phosphate requirement—“is missing or not met as claimed.” Mas-
`
`Hamilton Grp. v. LaGard, Inc., 156 F.3d 1206, 1211 (Fed. Cir. 1998).
`
`
`
`
`
`
`
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`
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`
`
`
`
` Because Dr. Trout’s analysis does not “rise above the level
`
`of a self-serving conclusion,” or create a fact issue, this “entitles [Mylan] to summary judgment”
`
`on claim 18. Novartis Corp. v. Ben Venue Lab’ys, Inc., 271 F.3d 1043, 1050 (Fed. Cir. 2001).
`
`V. MYLAN DOES NOT DIRECTLY INFRINGE THE ‘572 AND ‘601 PATENTS.
`
`Regeneron asserts claims 1-14, 16-23, and 25-28 of the ‘572 patent; and claims 5-6, 9, 11-
`
`12, 15-17, 19, 21, 23-25, 27-28, and 31-33 of the ‘601 patent. (SUF ¶¶ 29, 31). Both patents are
`
`method of use patents: dosing 2 mg of aflibercept to patients on a particular schedule. (SUF ¶¶
`
`30, 32). Direct infringement of a method patent occurs when someone “without authority . . .
`
`uses . . . any patented invention” in the U.S. during its term. 35 U.S.C. § 271(a). Mylan is a
`
`5
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 615 Filed 09/01/23 Page 14 of 34 PageID #:
`47804
`
`pharmaceutical manufacturer; Mylan does not dose or otherwise treat patients. (SUF ¶¶ 35-36).
`
`Thus, summary judgment of no direct infringement by Mylan is warranted.
`
`VI. MYLAN DOES NOT INDUCE INFRINGEMENT OF ANY VALID CLAIM OF
`THE ‘572 PATENT.
`
`Regeneron’s induced infringement theories do not comply with legal thresholds necessary
`
`to show inducement, particularly given Regeneron’s expert admissions here. But, even if they did,
`
`then the claims are invalid as a matter of law. Either way, the Court should grant summary
`
`judgment for Mylan.
`
`The ‘572 patent’s claims are directed to a “method of treating” that involves someone (e.g.,
`
`a doctor) dosing aflibercept on a particular schedule; the asserted claims then list further efficacy
`
`and timing criteria that “the patient” is to achieve.1 Independent claim 1, from which claims 2-14
`
`depend, states, “the patient achieves a gain in visual acuity within 52 weeks following the initial
`
`dose;” claim 16, from which claims 17-23 depend, adds this same language as well, to a method
`
`limited to treating diabetic macular edema. (SUF ¶¶ 30, 34). Independent claim 26, from which
`
`claims 27-28 depend, states, “wherein the method is as effective in achieving a gain in visual acuity
`
`as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects
`
`with age-related macular degeneration at 52 weeks following the initial dose.” (Id.) If claims 1,
`
`16, and 26 are not directly infringed, neither are their associated dependent claims.
`
`Jeneric/Pentron, Inc. v. Dillon Co., 205 F.3d 1377, 1383 (Fed. Cir. 2000).
`
`A.
`
`Regeneron lacks proof of direct infringement by a single entity.
`
`Direct infringement requires all steps of a claimed method to be performed by or
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`1 For purposes of this Motion, Mylan treats these claim elements as limiting; should these claims
`be presented at trial, Mylan reserves the right to demonstrate that these elements are non-limiting
`under the Court’s claim construction in view of positions Regeneron took in its expert reports.
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`6
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`attributable to a single entity. Akamai Techs., Inc. v. Limelight Networks, Inc., 797 F.3d 1020,
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`1022 (Fed. Cir. 2015) (en banc). Here, the claims by their terms preclude one person, whether
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`doctor or patient, from complying with all elements in claims 1, 16, and 26. Only the doctor
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`“administers”; yet only the patient can “achieve” any degree of efficacy. Regeneron has not met
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`the legal standards for imposing the acts of one onto the other, which precludes finding direct
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`infringement for this independent reason.
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`B.
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`There can be no induced infringement absent a direct infringer.
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`35 U.S.C. § 271(b) states that whoever “actively induces infringement of a patent shall be
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`liable as an infringer.” 35 U.S.C. § 271(b). Regeneron alleges that “Mylan Induces Infringement”
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`of the Dosing Patents. (Ex. 3, Csaky Opn. at 28, 180). But “case law leaves no doubt that
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`inducement liability may arise if, but only if, there is direct infringement.” Limelight Networks,
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`Inc. v. Akamai Techs., Inc., 572 U.S. 915, 921 (2014) (cleaned up). As noted in Section VI(A),
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`for the ‘572 patent claims, there is no one direct infringer; and without one, Mylan cannot induce
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`infringement.
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`C.
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`Regeneron’s theories are legally insufficient to prove inducement.
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`Even assuming in Regeneron’s favor that the doctors and patients meet the Akamai
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`standard, Regeneron lacks “any evidence that [Mylan] has or will promote or encourage doctors
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`to infringe” the claim language in claims 1, 16, or 26 of the ‘572 patent. Warner-Lambert, 316
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`F.3d at 1364. The relevant language in claims 1, 16, and 26 requires the patient to have
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`“achieve[d]” particular results, or use a method that is as effective as monthly dosing of 0.5 mg
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`ranibizumab, and reach such results by the 52-week mark. Regeneron’s induced infringement
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`theories do not comply with the legal thresholds necessary to show inducement, particularly given
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`Regeneron’s expert admissions here. But, even if they did, then the claims would be invalid, as
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`Section VI(D) below explains.
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`Inducement proofs in pharmaceutical cases usually turn on the labeling that FDA requires
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`for a drug product—the label “must encourage, recommend, or promote infringement.” Eli Lilly
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`& Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1368 (Fed. Cir. 2017). Regeneron’s
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`inducement theories involve statements or acts that fail to meet this threshold.
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`1.
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`Interchangeability/biosimilarity statements in YESAFILITM’s label are
`legally insufficient to prove Mylan actively induces.
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`Regeneron incorrectly alleges that the YESAFILITM label statements describing it as
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`biosimilar to, and interchangeable with, Eylea® proves inducement. (SUF ¶¶ 40, 39). The Federal
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`Circuit emphasized that it was “not our holding” that “calling a product a ‘generic version’ or
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`‘generic equivalent’—is now enough” to prove induced infringement. GlaxoSmithKline LLC v.
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`Teva Pharms. USA, Inc., 7 F.4th 1320, 1336 (Fed. Cir. 2021). This theory thus is legally
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`insufficient.
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`Regeneron tries to argue that these statements are sufficient because “ophthalmologists
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`have administered Eylea®—consistent with Regeneron’s instructions—in a manner that practices
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`the Asserted Claims.” (SUF ¶ 41).
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`First, asserting that the practice of ophthalmology is “consistent with” label instructions,
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`or that assessing patients for efficacy is a standard of care beyond the label, applies the wrong legal
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`standard. Off-label activity, or even a label that merely describes an infringing use, is “not the
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`same as ‘recommend[ing],’ ‘encourag[ing]’ or ‘promot[ing]” that use. Takeda Pharms. U.S.A.,
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`Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015) (citations omitted). Only
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`from the latter categories can a court “infer from those instructions an affirmative intent to infringe
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`the patent.” Id.
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`Second, it “is error for a court to compare in its infringement analysis the accused product
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`or process with the patentee’s commercial embodiment or other version of the product or process;
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`the only proper comparison is with the claims of the patent.” Zenith Lab’ys, Inc. v. Bristol-Myers
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`Squibb Co., 19 F.3d 1418, 1423 (Fed. Cir. 1994). Even so, when it comes to the Eylea® labeling,
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`Regeneron’s 30(b)(6) witness admitted that Eylea®’s dosing instructions do not instruct doctors or
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`patients to reach particular visual acuity outcomes or mandate performing visual acuity
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`measurements. (SUF ¶ 48). Thus, this theory fails as a matter of law.
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`2.
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`No YESAFILITM label instructions require or encourage doctors or
`patients to achieve particular visual acuity results, including in
`comparison to ranibizumab, by the 52-week mark.
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`The YESAFILITM label lacks statements that require, obligate, or encourage doctors to
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`perform visual acuity tests as a condition of using the drug on their patients; require, obligate, or
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`encourage doctors to keep their patients dosed for 52 weeks; or require, obligate, or encourage
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`patients to reach any particular visual acuity outcomes, including in comparison to ranibizumab.
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`a.
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`Even assuming that some doctors test for visual acuity, or some
`patients reach visual acuity metrics, this is legally insufficient
`proof of induced infringement.
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`Regeneron’s expert argues that some physicians carrying out the 2 mg aflibercept dosing
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`regimen will “also perform the step of measuring a gain in the visual acuity of the patient to whom
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`the physician administered aflibercept no more than 52 weeks after administering the initial dose
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`of aflibercept to that patient.” (Ex. 3, Csaky Opn. ¶ 124 (‘572 patent, claim 1); id. ¶ 236 (same,
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`for claim 16); id. ¶ 302 (must measure a gain at least as great as ranibizumab for claim 26)). Yet,
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`he also reiterates that he “do[es] not agree that the measurement of the visual acuity gains specified
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`in the Asserted Claims necessarily or inevitably results from performing the other steps of the
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`Asserted Claims.” (Ex. 4, Csaky Resp. ¶ 43).
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`These assertions by Regeneron’s expert, even if presumed true, simply say in a dressed-up
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`way that independent of the labeling, some doctors may perform visual acuity tests in clinical
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`practice, and some patients may reach the claimed visual acuity gains. But mere knowledge that
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`9
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`an infringing act may occur is legally insufficient evidence of inducement. Takeda, 785 F.3d at
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`631; Warner-Lambert, 316 F.3d at 1364. The legally relevant eviden