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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PFIZER INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case IPR2019-00978
`Patent U.S. 8,603,044
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`PATENT OWNER’S RESPONSE TO PETITIONER’S MOTIONS FOR
`JOINDER
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`Patent Owner (“Sanofi”) respectfully submits this response to Petitioner’s
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`(“Pfizer”) Motions for Joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22,
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`42.122(b) of IPR Nos. 2019-00977, 2019-00978, 2019-00980, 2019-00981, 2019-
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`00982, 2019-00987, 2019-01022, and 2019-01023 (“Pfizer IPRs”), respectively, to
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`IPR Nos. 2018-01675, 2018-01676, 2018-01678, 2018-01679, 2019-00122, 2018-
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`01684, 2018-01680, and 2018-01682 filed by Mylan Pharmaceuticals Inc.
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`(collectively the “Mylan 044, 486, 008 and 844 IPRs”).1 Sanofi has also concurrently
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`filed a waiver of its Preliminary Response in the above Pfizer IPRs. As set forth
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`herein, Sanofi does not oppose joinder based on the representations made by Pfizer
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`in its Motion for Joinder, but submits that a 1-month extension of the schedule is
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`warranted in order to accommodate joinder of Pfizer to the Mylan 044, 486, 008 and
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`844 IPRs.
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`
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`In its Motion for Joinder, Pfizer represented to the Board that (1) its petitions
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`present the exact same grounds instituted in the Mylan 044, 486, 008, and 844 IPRs
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`and there are no new grounds of unpatentability; (2) its arguments and
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`accompanying expert declarations by Charles Clemens are substantively identical to
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`the arguments and expert declarations by Karl Leinsing in the Mylan 044, 486, 008,
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`1 A separate response has been filed in IPR2019-00979 (U.S. 8,679,069) which
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`Pfizer is seeking to join with IPR2018-01670.
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`1
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`and 844 IPRs; (3) it agrees to take an understudy role in these proceedings if joinder
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`is granted, and only assume a primary role if Mylan ceases to participate in the IPRs;
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`and (4) it will coordinate with Mylan to facilitate the elimination of repetitive briefs
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`and testimony. Sanofi has further confirmed with Pfizer that the above
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`representations mean that Pfizer, as an understudy to Mylan, will not seek time to
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`take the deposition of any Sanofi declarants.
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`
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`While Sanofi does not oppose Pfizer’s Motion for Joinder under the
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`conditions listed above, pursuant to 35 U.S.C. § 316(a)(11) and 37 C.F.R. §
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`42.100(c), a modest 1-month extension2 of the entire schedule is needed if joinder is
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`granted. Specifically, an extension is necessary to allow sufficient time to cross-
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`examine Mr. Clemens, and incorporate both his and Mr. Leinsing’s testimony into
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`Sanofi’s Patent Owner Responses, which are all currently due on June 25, 2019.
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`Even accepting Pfizer’s representations that the Pfizer IPRs present identical
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`grounds and substantively identical arguments as the Mylan 044, 486, 008, and 844
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`IPRs, and that Pfizer will take on an understudy role if the proceedings are joined,
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`2 Patent Owner proposes a 1-month extension, as opposed to a 2- or 3-week
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`extension, because of the intervening July 4th holiday and the fact that Patent Owner
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`will also be preparing opening expert reports in the co-pending litigation between
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`Sanofi and Mylan in the District of New Jersey currently due on July 15, 2019.
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`2
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`the parties must still coordinate scheduling for both Mr. Clemens and Mr. Leinsing
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`to be cross-examined on their respective opinions in nine IPR proceedings on five
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`patents. Assuming Pfizer agrees to make Mr. Clemens available for deposition in
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`accordance with the time limits that Patent Owner and Mylan have negotiated for
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`Mr. Leinsing’s depositions (35 hours of cross examination, 20 hours of redirect
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`examination, and 10 hours of re-cross examination), the parties will need to schedule
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`65 hours of deposition time sufficiently in advance of Due Date 1 so that Patent
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`Owner has a full and fair opportunity to incorporate the deposition testimony into its
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`Patent Owner Responses.
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`
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`Furthermore, extending only Due Date 1, while leaving the remaining dates
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`in the schedule in place would unnecessarily tighten the schedule. The Board’s rules
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`specifically contemplate and allow for extensions of the schedule because of joinder.
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`35 U.S.C. § 316(a)(11); 37 C.F.R. § 42.100(c). Moreover, Patent Owner anticipates
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`similar scheduling issues in connection with at least Due Dates 2 and 3 due to the
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`need to schedule numerous days of cross-examination on Patent Owner’s responsive
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`declarations and Pfizer’s and Mylan’s reply declarations. For example, extending
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`Due Date 1 to July 30, 2019 while leaving Due Date 2 on September 17, 2019 as
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`currently scheduled would require the parties to schedule depositions of Patent
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`Owner’s declarant on five patents in nine IPR proceedings during a period of less
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`than two months. Likewise, extending Due Date 2 by one month to October 22,
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`3
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`
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`2019 while leaving Due Date 3 on October 29, 2019 as currently scheduled would
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`require Patent Owner to depose Mylan’s and Pfizer’s reply declarants and prepare
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`sur-replies in each of the nine IPR proceedings within one week of receiving Mylan’s
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`and Pfizer’s replies. Thus, Patent Owner’s proposed one month extension of the
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`entire schedule is necessary in order to avoid compressing the time between
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`substantive due dates to the prejudice of the parties. The proposed extension is set
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`forth in the table below:
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`
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`Due Date 1
`- Patent Owner Response
`- Motion to Amend (“MTA”)
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`Due Date 2:
`- Petitioner Reply to POR
`- Petitioner Opposition to MTA
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`Due Date 3:
`- Patent Owner Sur-reply
`- Patent Owner Reply on MTA
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`Due Date 4
`- Request for Oral Argument
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`Due Date 5
`- Petitioner Sur-Reply on MTA
`- Motions to Exclude Evidence
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`Due Date 6
`- Oppositions to Mot. to Exclude
`- Request for Prehearing
`Conference
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`
`Current
`Schedule
`June 25, 2019
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`Revised
`Schedule
`July 30, 2019
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`September 17, 2019
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`October 22, 2019
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`October 29, 2019
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`December 3, 2019
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`November 19, 2019
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`December 20, 2019
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`December 6, 2019
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`January 10, 2020
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`December 13, 2019
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`January 17, 2020
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`4
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`Due Date 7
`- Reply on Mot. to Exclude
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`Due Date 8
`- Oral Argument
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`Final Written Decision
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`Current
`Schedule
`December 20, 2019
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`Revised
`Schedule
`January 24, 2020
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`January 14-15, 2020
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`~February 17-18,
`2020
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`~April 2-3, 2020
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`~May 4-5, 2020
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`Pursuant to the representations noted above and the requested extension of the
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`schedule, Sanofi does not oppose Pfizer’s Motion for Joinder and agrees that judicial
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`economy will be served by joining Pfizer to the Mylan 044, 486, 008, and 844 IPRs.
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`Patent Owner, however, submits that a 1-month extension of the schedule is
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`warranted in order to accommodate joinder of Pfizer to the Mylan 044, 486, 008,
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`and 844 IPRs.
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`Dated: June 3, 2019
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`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)
`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
`
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`5
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`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
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`6
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on June 3, 2019, the foregoing
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`PATENT OWNER RESPONSE TO PETITONER’S MOTION FOR
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`JOINDER was served via electronic mail upon the following:
`
`
`Jovial Wong
`Charles B. Klein
`Dan H. Hoang
`WINSTON & STRAWN LLP
`1700 K Street NW
`Washington, D.C., 20006
`PfizerIPRs@winston.com
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`
`
`/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
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`
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`7
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