UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-00880
`Patent No. 9,669,069 B2
`
`Case IPR2021-00881
`Patent No. 9,254,338 B2
`____________
`
`PATENT OWNER
`REGENERON PHARMACEUTICALS, INC.’S CONSOLIDATED
`SUR-REPLY TO PETITIONER’S REPLY TO PATENT OWNER
`PRELIMINARY RESPONSE
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-00880
`Patent No. 9,669,069 B2
`
`Case IPR2021-00881
`Patent No. 9,254,338 B2
`____________
`
`PATENT OWNER
`REGENERON PHARMACEUTICALS, INC.’S CONSOLIDATED
`SUR-REPLY TO PETITIONER’S REPLY TO PATENT OWNER
`PRELIMINARY RESPONSE
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`II.
`
`2.
`
`3.
`
`INTRODUCTION ........................................................................................... 1
`IPR2021-00881 SHOULD BE DENIED UNDER §325(D) ........................... 2
`A.
`The Examiner Considered Substantially the Same Art ......................... 2
`1.
`The Examiner Would Have Recognized the Thomson
`Reuters Publication as a September 28, 2008 Press Release ...... 2
`Mylan’s Relied-Upon Disclosures Are Substantially the
`Same as the 2008 Regeneron Press Release ............................... 5
`Mylan’s Secondary References Are Substantially the Same
`as the ’234 Application ............................................................... 6
`B. Mylan Fails to Show Examiner Error ................................................... 7
`IPR2021-00880 SHOULD ALSO BE DENIED UNDER §325(D) ............... 8
`A.
`The Examiner Considered the Same or Substantially the Same Art .... 8
`B. Mylan Fails to Show Examiner Error ................................................... 9
`IV. MYLAN’S BELATED §325(D) ARGUMENTS ARE
`PROCEDURALLY UNFAIR ....................................................................... 10
`CONCLUSION .............................................................................................. 10
`
`III.
`
`V.
`
`i
`
`
`
`I.
`
`INTRODUCTION
`
`Citing only pre-Advanced Bionics cases, Mylan argues that discretionary
`
`denial under §325(d) is inappropriate unless the same or substantially the same art
`
`was applied in a rejection by the Office. Advanced Bionics squarely rejected this
`
`argument and held that if the same or substantially the same art was previously
`
`presented to the Office (including in an IDS), then Petitioner must show that the
`
`Office materially erred. Advanced Bionics, LLC v. MED-EL Elektromedizinische
`
`Geräte GmbH, 2020 WL 740292, *3 (Feb. 13, 2020) (precedential). The Board
`
`adopted this framework as “a commitment to defer to previous Office evaluations
`
`of the evidence of record unless material error is shown.” Id.
`
`In IPR2021-00881 (the ’338 Patent), each of Mylan’s Grounds relies on a
`
`dosing regimen that was disclosed in a September 28, 2008 press release presented
`
`to the Office during prosecution. Mylan’s main response — that the Examiner
`
`thought the 2008 press release was from 2012 — is simply not credible.
`
`In IPR2021-00880 (the ’069 Patent), the same or substantially the same art
`
`was presented to the Office as well. Mylan raises for the first time the argument
`
`that only a single page of Dixon was disclosed to the Examiner. Yet, the face of the
`
`’069 Patent and the Examiner’s signature suggest that the Examiner considered
`
`Dixon in full and, in any event, Dixon’s relevant disclosures were cumulative of
`
`other disclosures before the Examiner during prosecution of the ’069 Patent.
`1
`
`
`
`Again ignoring Advanced Bionics, Mylan relies on the absence of a rejection
`
`on the cited art to allege error. But because the same or substantially the same art
`
`was before the Office, and because Mylan fails to show material error by the
`
`Examiner, discretionary denial is appropriate.
`
`II.
`
`IPR2021-00881 SHOULD BE DENIED UNDER §325(D)
`A.
`The Examiner Considered Substantially the Same Art
`
`Mylan argues that its asserted art is not the same or substantially the same as
`
`the Thomson Reuters press release because: (1) the Examiner would not have
`
`understood the Thomson Reuters press release to be prior art; and (2) Mylan’s art
`
`contains additional disclosures that are not in the press release. Neither has merit.
`
`1.
`
`The Examiner Would Have Recognized the Thomson
`Reuters Publication as a September 28, 2008 Press Release
`
`Regeneron presented a press release titled “VEGF Trap-Eye final phase II
`
`results in age-related macular degeneration presented at 2008 Retina Society
`
`Meeting” to the Office in an IDS, which was marked considered by the Examiner.
`
`Ex. 1017, 60 and 114. The IDS clearly identifies the title of the press release, the
`
`source as Thomas [sic] Reuters Integrity, and the date as September 28, 2008:
`
`Ex. 1017, 60. Nothing on the IDS suggests a 2012 date. Rather, the IDS and the
`
`face of the ’338 Patent report the document’s date as September 28, 2008. Ex. 1001.
`2
`
`
`
`Mylan does not dispute this. Instead, it argues that a 2012 copyright date on
`
`the publication would have indicated to the Examiner that the press release was
`
`from 2012, not 2008, and as a consequence, he would have disregarded it. But the
`
`document itself refutes this suggestion. Ex. 2007 identifies the “Reference” as
`
`“Regeneron Pharmaceuticals Press Release 2008, September 28” and the “Title” as
`
`“VEGF Trap-Eye final phase II results in age-related macular degeneration
`
`presented at 2008 Retina Society Meeting.” And the footer of Ex. 2007 shows that
`
`the printout was obtained from a Thomson website visited on “18-04-2012.”
`
`Thomson Reuters was a well-known source for retrieving literature citations (Ex.
`
`2043) and the 2012 copyright date would indicate to anyone familiar with the
`
`Internet the retrieval date of the publication, not the date of the press release itself.
`
`Furthermore, it defies common sense to assert that a press release reporting on a
`
`2008 Retina Society Meeting did not issue until 2012.
`
`Indeed, the international search report from EP-325 (European counterpart to
`
`the ’338 Patent), on which Mylan relies (’338 Pet. 10-11), confirms that this
`
`document was retrieved using Thomson Reuters Integrity on 2012-04-18:
`
`3
`
`
`
`It also confirms that exactly the same document that is marked “XP002674126” and
`
`cited as D13 in EP-325 was submitted during prosecution of the ’338 Patent (Ex.
`
`2007). Ex. 1063 at 62, 194, 196. Remarkably, in the context of EP-325, Mylan
`
`characterizes this same Thomson Reuters publication as a “September 28, 2008
`
`Press Release,”1 yet, Mylan incorrectly asserts that this same document was never
`
`provided to the Office during prosecution of the ’338 Patent. ’338 Pet. at 11.
`
`1 Mylan asserts the EPO Examiner rejected EP-325 over “prior art VEGF Trap-Eye
`
`dosing regimens (e.g., Regeneron Sept. 28, 2008 Press Release (Ex. 1056). See Ex.
`
`1063, EP-325-FH, 8/21/2014 Communication, 3-8.).” ’338 Pet. at 11. Yet, D13 (Ex.
`
`2007), and not Ex. 1056, was the only VEGF Trap-Eye dosing regimen art cited in
`
`the 8/21/2014 Communication. Ex. 1063, 190-200.
`
`4
`
`
`
`2. Mylan’s Relied-Upon Disclosures Are Substantially the
`Same as the 2008 Regeneron Press Release
`
`Each of Mylan’s Grounds relies on the same dosing regimen disclosure that
`
`is set forth in Ex. 2007. POPR at 12-14. Mylan nevertheless argues that its
`
`references contain disclosures not present in Ex. 2007. Reply at 7.
`
`As an initial matter, Mylan’s argument that different press releases, or
`
`different versions of press releases, contain different disclosures is a red herring.
`
`Id. at 5. Mylan does not dispute that Ex. 2007 was of record; thus, the relevant issue
`
`is whether Ex. 2007 contains substantially the same disclosures as Mylan’s cited
`
`art, not whether other press releases may contain more or different disclosures.
`
`Mylan says that Dixon discusses problems with monthly dosing of Lucentis
`
`in the prior art. But Mylan does not rely on this disclosure for its anticipation
`
`Grounds and, as to obviousness, it was known in the art that Lucentis® was dosed
`
`on a monthly basis and that there was a need in the art for less frequent dosing, as
`
`set forth in the “Background” section of the ’338 Patent. Ex. 1001, Col. 1:50-61.
`
`Mylan next argues that Regeneron (8-May-2008) includes efficacy endpoints and
`
`an inventor statement, but Mylan relies on neither of these passages in its Grounds.
`
`Finally, Mylan asserts that Adis and Dixon disclose that VEGF Trap-Eye is
`
`aflibercept,2 but, as the POPR explained, Mylan’s argument rests on the flawed
`
`2 Dixon never identifies aflibercept as the agent in Regeneron’s Phase III trials.
`
`5
`
`
`
`premise that these terms are synonymous. See POPR at 12, fn. 2.
`
`3. Mylan’s Secondary References Are Substantially the Same
`as the ’234 Application
`
`Mylan relies on the ’758 Patent and Dix as secondary references for
`
`obviousness (’338 Pet., Ground 6; ’069 Pet., Ground 5). Mylan argues that the ’758
`
`Patent is not substantially the same as the ’234 Application, a CIP child that was
`
`considered by the Office in prosecution of both patents, because it lacks sequence
`
`information. Reply at 7-8; Ex. 1017 at 66 and 112. Mylan ignores that the ’234
`
`Application specifically incorporates by reference the entirety of the ’758 Patent.
`
`Ex. 2009 at [0001] (“This application is a continuation-in-part of application Ser.
`
`No. 11/016,097 . . . which applications are herein specifically incorporated by
`
`reference in their entireties.”).3 Mylan also argues Dix is not cumulative of the ’234
`
`Application because it incorporates Holash. Reply at 8. But Holash (Ex. 1033),
`
`which lacks any sequence information, is not relied upon in Mylan’s Grounds.
`
`Also, Mylan’s contention that it presents arguments not previously considered
`
`by the Office ignores this Board’s consistent holding that “the first part of the 325(d)
`
`3 Mylan also points to the EYLEA PTE application in the file history as a difference
`
`(Reply at 8), but the ’758 file history is a different document (Ex. 1024) than the ’758
`
`patent (Ex. 1010), is not prior art, and is not relied upon in Mylan’s Grounds.
`
`6
`
`
`
`framework may be met when relied-upon art is presented in an IDS but never
`
`discussed or cited in a rejection by the Examiner….” Mylan Pharms. Inc. v. Merck
`
`Sharp & Dohme Corp., 2020 WL 2478503, *6 (May 12, 2020); Philip Morris Prods.,
`
`S.A. v. Rai Strategic Holdings, Inc., 2020 WL 6750120, *5 (Nov. 16, 2020); see also
`
`BMW of North Am., LLC v. Stragent, LLC, 2021 WL 3074671, *5 (Jul. 19, 2021).4
`
`B. Mylan Fails to Show Examiner Error
`
`Mylan argues that the Examiner erred by not rejecting claims based on prior
`
`art disclosures of Regeneron’s prospective Phase 3 dosing regimen. Reply at 9.
`
`However, the Board has consistently held that the absence of a rejection or a
`
`difference of opinion over treatment of art does not demonstrate Examiner error.
`
`See, e.g., Google LLC v. Kewazinga Corp., 2021 WL 3746361, *8 (Aug. 24, 2021)
`
`(“But whether a reference was a basis for a rejection is not dispositive… .”); Sony
`
`Interactive Entm’t LLC v. Terminal Realty, Inc., 2020 WL 6065188, *5 (Oct. 13,
`
`4 Mylan asserts that it “presents Dr. Albini’s opinions and analyses, further weighing
`
`against § 325(d) denial” in both Petitions. Reply at 9. But Mylan “does not explain
`
`how this testimony serves to show, if at all, that the Examiner erred.” Google, 2021
`
`WL 3746361, *8. Thus, Dr. Albini’s declaration is an insufficient basis to deny
`
`institution under §325(d). Id.; Medtronic CoreValve LLC v. Speyside Medical, LLC,
`
`2021 WL 3137302, *13 (Jul. 23, 2021).
`
`7
`
`
`
`2020) (argument that the asserted references were not evaluated by the examiner
`
`failed to sufficiently identify Examiner error); Universal Imaging v. Lexmark Int’l,
`
`Inc., 2020 WL 959375, *5 (the absence of a rejection based upon the petitioned
`
`grounds “is not the end of [the Board’s] analysis” on material error); Regeneron
`
`Pharms., Inc. v. Kymab Ltd., 2020 WL 2738613, *7 (May 26, 2020) (petitioner
`
`offered “a different interpretation” of prior art, which is not material error).
`
`III.
`
`IPR2021-00880 SHOULD ALSO BE DENIED UNDER §325(D)
`A.
`The Examiner Considered the Same or Substantially the Same Art
`Mylan relies on Dixon for each of the five Grounds in the ’069 Petition. Yet,
`
`Mylan argues for the first time in Reply that Dixon was not before the Office. Upon
`
`receipt of the Reply, Patent Owner promptly investigated Mylan’s allegations and
`
`agrees that only one page of Dixon, instead of the whole paper, was filed due to a
`
`clerical error. Mylan insinuates that Patent Owner “misdirected [the Examiner] from
`
`critical disclosures that anticipate and invalidate the claims.” Reply at 2. But Patent
`
`Owner was unaware that Dixon was submitted as a single page before Mylan’s Reply.
`
`Mylan also disregards that the full citation to the Dixon paper was presented
`
`in an IDS, the reference was publicly available, and was marked considered by the
`
`Examiner. Ex. 1017 at 121, 168. “The initials of the examiner placed adjacent to
`
`the citations . . . or its equivalent mean that the information has been considered by
`
`the examiner” in the same manner as other documents in Office search files are
`
`8
`
`
`
`considered. M.P.E.P. at § 609.05(b). The record does not suggest that the Examiner
`
`found Patent Owner’s disclosure of Dixon to be defective or incomplete, as the
`
`Examiner has not drawn a line through the citation on the IDS. Id. Further, Mylan’s
`
`reliance on Coolpad Techs., Inc. and Semiconductor Energy Lab’y Co. for its
`
`contention that the Examiner’s initials extend to only a portion of Dixon is misplaced.
`
`Reply at 4. In both cases, the references at issue required translation for the
`
`Examiner’s full consideration. Here, in contrast, Dixon is a publicly available,
`
`English-language reference that the Examiner could consider without translation.
`
`In any event, the Dixon disclosures relied upon by Mylan — namely, the
`
`CLEAR-IT-2 dosing regimen and results (’069 Pet. at 3-4) — are also disclosed in
`
`the Thomson Reuters press release (Ex. 2007), which was presented to and
`
`considered by the Examiner, and cited on the face of the ’069 Patent. Ex. 1017 at
`
`68, 114; Ex. 1001. Mylan’s secondary references, as discussed infra, are also
`
`cumulative of art that was considered by the Office. Thus, the same or substantially
`
`the same art was considered by the Examiner during prosecution of the ’069 Patent.
`
`B. Mylan Fails to Show Examiner Error
`
`Mylan asserts that the Examiner “materially erred” in not obtaining a
`
`complete copy of Dixon. Reply at 9. But Mylan assumes without basis that the
`
`Examiner did not obtain a copy of Dixon based on the full citation provided to the
`
`Examiner on the IDS. Yet, it cannot know that and, notwithstanding the one-page
`
`9
`
`
`
`submission, the file history of the ’069 Patent in view of M.P.E.P. § 609.05(b)
`
`otherwise supports that the Examiner fully considered the Dixon reference. Mylan
`
`also argues that the Examiner erred in not rejecting the claims over Dixon and/or
`
`other §102(b) references cited in the Petition. But, as discussed above, the absence
`
`of a prior art rejection does not establish Examiner error.
`
`IV. MYLAN’S BELATED §325(D) ARGUMENTS ARE PROCEDURALLY
`UNFAIR
`
`Mylan does not dispute that Ex. 2007 was before the Examiner during
`
`prosecution but chose to cast its Petition as Patent Owner failing to disclose to the
`
`Office. See, e.g., ’338 Pet. at 1, 11, 27-28, 31. Mylan should not be permitted to
`
`change its theory of its case on Reply to now parse the text of a 2008 Press Release,
`
`or worse yet, assert that it is not from 2008 at all. Likewise, Mylan knew that Dixon
`
`was cited in an IDS to the Examiner and listed on the face of the ’069 Patent. Yet,
`
`Mylan raised the argument that Dixon was not fully considered only on Reply.
`
`Permitting Mylan to lie in the weeds in its Petition and raise new arguments
`
`on Reply circumvents the Board’s word count rules, runs counter to General
`
`Plastics’ admonition against road-mapping from the POPR, flouts the good cause
`
`standard required for Reply, and is unfairly prejudicial to Patent Owner.
`
`V.
`
`CONCLUSION
`For the foregoing reasons, discretionary denial of IPR2021-00880 and
`
`IPR2021-00881 under §325(d) is warranted.
`10
`
`
`
`Dated: October 6, 2021
`
`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.
`
`11
`
`
`
`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 October 6, 2021, a true and entire copy of this PATENT OWNER
`
`REGENERON PHARMACEUTICALS, INC.’S CONSOLIDATED SUR
`
`REPLY TO PETITIONER’S REPLY TO PATENT OWNER PRELIMINARY
`
`RESPONSE, and all supporting exhibits, were 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
`
`/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.
`
`12
`
`
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