UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-008811
`Patent 9,254,338 B2
`____________
`
`RESPONSE TO PETITIONER’S IDENTIFICATION OF STATEMENTS
`SUPPORTED BY OBJECTED TO REFERENCES IN PATENT OWNER
`RESPONSES
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`

`

`In accordance with the Board’s order during the teleconference held on
`
`February 23, 2022, Patent owner hereby submits its response to Petitioner’s
`
`Identification of Statements Supported by Objected to References in Patent Owner
`
`Responses. Paper No. 44; see also Ex. 1100 Transcript of Teleconference
`
`Proceedings held on February 23, 2022, at 16:22-19:7.
`
`Petitioner’s Challenge
`
`IPR2021-00881, Patent
`No. 9,254,338
` Paper 40 (POR)
` Section VIII.B,
`(Paper 40, pp. 58-
`62, entitled
`“Objective
`Evidence
`Confirms the Non-
`Obviousness of
`the Claimed
`Dosing
`Regimen”).
` Ex. 2051, Do
`Decl. ¶¶98-133,
`135-170
`IPR2021-00881, Patent
`No. 9,254,338
` Paper 40 (POR)
` Section I, (Paper
`40, pp. 1-3,
`entitled
`“Introduction”).
` Section VIII.B,
`(Paper 40, pp. 54,
`58-62 entitled
`“Objective
`
`Patent Owner Response—Arguments and
`Evidence
`Nexus—Paper 40, pp. 58-60; see, e.g., id., p. 59 (“A
`nexus exists between the Challenged Claims and
`both EYLEA®’s approved dosing regimen (the
`“Eylea Label” or “EL”) and physicians’
`administration of EYLEA in practice (“Physicians’
`Practice” or PP, and together with EL, “EL&PP”)”);
`id., 58-59 (chart arguing that a nexus exists between
`each limitation of each challenged claims and the
`Eylea Label, Physicians’ Practice, or both).
`
`See also Ex. 2051 (Do Decl.), ¶¶98-133 (the United
`States prescribing information for Eylea
`demonstrates practice of the challenged claims); id.,
`¶¶134-170 (physicians’ administration of Eylea to
`patients practices the challenged claims).
`
`Commercial success—Paper 40, pp. 1-3, 54, 58-62;
`see, e.g., id., p. 1. (“Despite launching into a
`competitive market, EYLEA quickly became the
`preeminent treatment for angiogenic eye disorders
`including wAMD, diabetic macular edema, macular
`edema following retinal vein occlusion, and diabetic
`retinopathy.”); id., p. 2 (“EYLEA has enjoyed rapid
`clinical adoption and great commercial success.”);
`id., pp. 61-62 (“Regeneron’s U.S. sales of EYLEA,
`as well as EYLEA’s share of sales relative to other
`anti-VEGF treatments, have grown significantly
`
`–1–
`
`

`

`Petitioner’s Challenge
`
`Evidence
`Confirms the
`Non-Obviousness
`of the Claimed
`Dosing
`Regimen”).
` Ex. 2052,
`Manning Decl.
`¶¶29-42, 48-117
`
`IPR2021-00881, Patent
`No. 9,254,338
` Paper 40 (POR)
` Section VIII.B,
`(Paper 40, pp. 58-
`62, entitled
`“Objective
`Evidence
`Confirms the
`Non-Obviousness
`of the Claimed
`Dosing
`Regimen”).
` Ex.2050, Brown
`Declaration
`¶¶150-181
`
`Patent Owner Response—Arguments and
`Evidence
`since launch.”); id.(“[T]he ’338 Patent’s claimed
`dosing regimen has been an important factor driving
`demand for EYLEA.”); id., n. 18 (“EYELA’s
`commercial success does not appear to be due to
`marketing efforts….”).
`
`See also Ex. 2052 (Manning Decl.), ¶¶29-42
`(treatment options for angiogenic eye disorders); id.
`¶¶48-85 (Eylea was a commercial success); id.,
`¶¶89-104 (the claimed dosing regimen is a driver of
`the demand for Eylea); id., ¶¶105-117 (Eylea’s
`commercial success cannot be explained by factors
`not related to the claimed methods of treatment).
`Long-felt but unmet need, failure of others,
`unexpected benefit, and industry praise—Paper
`40, pp. 1-6, 13, 53-54, 58-62; see, e.g., id., p. 54
`(“[T]he long-felt need and failure in the art to
`develop an extended dosing regimen … confirm the
`non-obviousness of the claimed dosing regimen.”);
`id., 60-62 (“[T]he art was littered with failed efforts
`to extend dosing of anti-VEGF agents, which made
`Regeneron’s clinical trial results all the more
`unexpected.”); id. pp. 3-6 (“Numerous attempts
`were made to decrease injection or monitoring
`frequency with ranibizumab, including the PIER,
`PrONTO, SAILOR, EXCITE, and SUSTAIN
`clinical trials. Each of these efforts at extended
`dosing in the art failed ….”) (internal citations
`omitted); id., p. 13 (“[T]here remained a need in the
`art to reduce the burden of frequent injections and
`monitoring visits while maintaining the high level of
`efficacy….”).
`
`See also Ex. 2052 (Brown Decl.), ¶¶45, 75-85, 156-
`176 (satisfaction of a long felt but unmet need); id.,
`¶¶46-69, 110-113; 160-173: (failure of others); id.,
`¶¶75-90, 174-181 (unexpected benefits and industry
`praise).
`
`–2–
`
`

`

`Petitioner’s Challenge
`
`IPR2021-00880,
` Paper 39 (POR)
` Section V, (Paper
`39, pp. 7-9,
`entitled “Claim
`Construction”)
` Section V, (Paper
`39, p. 8 n. 5)
`
`Patent Owner Response—Arguments and
`Evidence
`Claim construction—Paper 39, pp. 7-9, n. 5; see,
`e.g., id., p. 8 (Claim construction “is not necessary
`to resolve the arguments presented in Mylan’s
`Petition.”); id., n. 5 (“[I]f the Board decides to
`construe ‘method of treating’ or “tertiary dose’ in
`this IPR, it should do so consistently with the
`constructions Regeneron has proposed in its
`contemporaneously filed Response in IPR2021-
`00881 relating to the ’338 Patent, since the ’069
`Patent was filed as a continuation from the ’338
`Patent.) (citing Samsung Elecs. Co. v. Elm 3DS
`Innovations, LLC, 925 F.3d 1373, 1378 (Fed. Cir.
`2019)).
`
`Dated: March 3, 2022
`
`
`
`Respectfully Submitted,
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`–3–
`
`

`

`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e)(4)(i) et seq. and 42.105(b), the undersigned
`
`Certifies that on March 3, 2022, a true and entire copy of this RESPONSE TO
`
`PETITIONER’S IDENTIFICATION OF STATEMENTS SUPPORTED BY
`
`OBJECTED TO REFERENCES IN PATENT OWNER RESPONSES was
`
`served via e-mail to the Petitioner at the following email addresses:
`
`MYL_REG_IPR@rmmslegal.com
`paul@ rmmslegal.com
`wrakoczy@ rmmslegal.com
`hsalmen@ rmmslegal.com
`nmclaughlin@rmmslegal.com
`lgreen@wsgr.com
`ychu@wsgr.com
`rcerwinski@geminilaw.com
`azalcenstein@geminilaw.com
`bmorris@geminilaw.com
`TRea@Crowell.com
`DYellin@Crowell.com
`SLentz@Crowell.com
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`–4–
`
`