UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO CORRECT
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO CORRECT
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s (“Mylan”) motion should be denied because the requested change
`
`to the Petition is substantive and would prejudice Patent Owner (“Sanofi”) by
`
`depriving Sanofi of the opportunity to respond. Alternatively, should the Board
`
`permit the correction, Sanofi requests authorization to file an amended Preliminary
`
`Response, limited to addressing the proposed correction, in order to mitigate the
`
`prejudice to Sanofi.
`
`I.
`
`REASONS FOR DENYING THE MOTION
`In determining whether to permit corrections to a petition, the Board has
`
`considered the following non-exclusive factors: (1) the nature of the error, whether
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`the party requesting relief provides adequate explanation for how the error occurred,
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`and how the error was discovered; (2) the length of time elapsed between learning
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`of the error and bringing the error to the Board’s attention; (3) prejudice to the other
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`party by allowing the proposed corrections; and (4) whether the proposed corrections
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`impact the proceeding. Ivantis, Inc. v. Glaukos Corp., IPR2018-01180, Paper 14 at
`
`9 (P.T.A.B. Dec. 6, 2018). Here, all four factors favor denial.
`
`1.
`
`The nature of the error, and whether the party requesting
`relief adequately explains how the error occurred, including
`how the error was discovered
`The nature of the error weighs against granting the motion. As Mylan admits,
`
`and stated in Sanofi’s Preliminary Response, the original citation on page 25 of the
`
`Petition did not support the argument for which it was proffered. See Ex. 1036, 7:18-
`
`1
`
`
`
`23. Other than a conclusory statement in its expert’s declaration, Mylan cited no
`
`evidence supporting the argument. Thus, though the error’s origin appears to be
`
`typographical, Mylan’s proposed correction would substantively change the Petition
`
`by providing different evidence to support an argument that previously had none.1
`
`That Mylan did not discover the error until Sanofi’s Preliminary Response
`
`alerted Mylan to it, even though Mylan filed a separate petition in IPR2019-00122
`
`on October 29, 2018 with an identical citation (see IPR2019-00122, Paper 2 at 28),
`
`further favors denying the motion. Ivantis, Paper 14 at 11.
`
`2.
`
`The length of time elapsed between learning of the error and
`bringing the error to the Board’s attention
` Mylan received Sanofi’s Preliminary Response on January 3, 2019, but did
`
`not bring the error to the Board’s or Sanofi’s attention prior to the conference call
`
`on January 15. Mylan does not explain its failure to bring the alleged error to the
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`Board’s attention for nearly two weeks, which impacted Sanofi’s ability to discuss
`
`the issue on the call. See Ex. 1036, 11:21-12:17. Thus, this factor favors denial.
`
`3.
`Prejudice to Patent Owner by allowing the correction
`The proposed correction would be prejudicial because Sanofi has already filed
`
`a Preliminary Response. As Mylan admits, Sanofi’s Preliminary Response addressed
`
`
`1 Should the correction be permitted, Sanofi will explain in an Amended Preliminary
`
`Response why the revised citation also fails to support the argument.
`
`2
`
`
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`the original citation by correctly noting that it does not relate to the subject matter
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`for which it was cited. Paper 12 at 38, n. 9; Ex. 1036, 7:18-23. Permitting the
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`correction would deprive Sanofi of an opportunity to rebut the new citation. See,
`
`e.g., 77 Fed. Reg. 48,680, 48,699 (Aug. 14, 2012) (the Board will consider “any
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`effect on the patent owner’s ability to file a preliminary response”). Because Mylan
`
`bears the burden of providing supporting evidence in its Petition, Sanofi, “in
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`formulating its Preliminary Response, should be able to rely on the Petition … as
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`being correct.” Ivantis, Paper 14 at 13. Thus, the prejudice to Sanofi favors denial.
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`For the same reasons, Sanofi should be allowed to file an amended
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`Preliminary Response if Mylan’s motion is granted. Indeed, Sanofi should not be
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`deprived of the ability to fully respond to the Petition due to an error and lack of
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`diligence by Mylan.
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`4.
`Impact on the proceeding
`As set forth above, the proposed change would substantively change the
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`content of the Petition without providing Sanofi with an opportunity to rebut the
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`newly cited evidence. Thus, this factor favors denial.
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`II. CONCLUSION
`For the above reasons, the Board should deny Mylan’s motion. In the
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`alternative, Sanofi should be permitted to file an amended Preliminary Response to
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`address the correction if the Board chooses to grant the motion.
`
`3
`
`
`
`Dated: February 6, 2019
`
`
`
`
`Respectfully submitted,
`
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`(Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Sudip K. Kundu (Reg. No. 74,193)
`Kathryn M. Kantha (Reg. No. 70,371)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`sudip.kundu@weil.com
`kathryn.kantha@weil.com
`
`William S. Ansley (Reg. No. 67,828)
`Matthew D. Sieger (Reg. No. 76,051)
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`sutton.ansley@weil.com
`matthew.sieger@weil.com
`
`Adrian C. Percer (Reg. No. 46,986)
`Brian C. Chang (Reg. No. 74,301)
`Weil, Gotshal & Manges LLP
`201 Redwood Shores Parkway
`Redwood Shores, CA 94065
`Phone: 650-802-300
`adrian.percer@weil.com
`brian.chang@weil.com
`
`Sanofi.IPR.Service@weil.com
`
`4
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`
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on February 6, 2019, the foregoing
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`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
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`CORRECT was served via electronic mail upon the following:
`
`Richard Torczon
`Wesley Derryberry
`Tasha Thomas
`Wilson Sonsini Goodrich & Rosati
`1700 K Street NW, 5th Floor
`Washington, D.C. 20006-3817
`rtorczon@wsgr.com
`wderryberry@wsgr.com
`tthomas@wsgr.com
`
`Douglas Carsten
`Jeffrey W. Guise
`Arthur Dykhuis
`Wilson Sonsini Goodrich & Rosati
`12235 El Camino Real
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
`
`Franklin Chu
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Ste. 5100
`Seattle, WA 98104
`ychu@wsgr.com
`
`Lorelei Westin
`Wilson Sonsini Goodrich & Rosati
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
`
`5
`
`
`
`Nicole W. Stafford
`Wilson Sonsini Goodrich & Rosati
`900 South Capital of Texas Highway
`Las Cimas, IV Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`
`
`
`
`
`Timothy J. Andersen
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`timothy.andersen@weil.com
`
`
`
`6
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`
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