IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`
`Adam R. Brausa
`Reg. No. 60,287
`Daralyn J. Durie
`Pro Hac Vice Application
`Pending
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`Jeffrey P. Kushan
`Reg. No. 43,401
`Peter S. Choi
`Reg. No. 54,033
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C.
`20005
`
`
`Filed on behalf of Patent Owners Genentech, Inc. and City of Hope by:
`
`David L. Cavanaugh
`Reg. No. 36,476
`Heather M. Petruzzi
`Reg. No. 71,270
`Robert J. Gunther, Jr.
`Pro Hac Vice Application
`Pending
`Wilmer Cutler Pickering
`Hale and Dorr LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`____________________________________________
`
`Case IPR2016-00710
`Patent 6,331,415
`____________________________________________
`
`PATENT OWNERS’ OPPOSITION TO MOTION FOR JOINDER
`
`
`
`
`Patent Owners’ Opposition to Motion for Joinder
`
`Adam R. Brausa
`Reg. No. 60,287
`Daralyn J. Durie
`Pro Hac Vice Application
`Pending
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`Jeffrey P. Kushan
`Reg. No. 43,401
`Peter S. Choi
`Reg. No. 54,033
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C.
`20005
`
`
`Filed on behalf of Patent Owners Genentech, Inc. and City of Hope by:
`
`David L. Cavanaugh
`Reg. No. 36,476
`Heather M. Petruzzi
`Reg. No. 71,270
`Robert J. Gunther, Jr.
`Pro Hac Vice Application
`Pending
`Wilmer Cutler Pickering
`Hale and Dorr LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`____________________________________________
`
`Case IPR2016-00710
`Patent 6,331,415
`____________________________________________
`
`PATENT OWNERS’ OPPOSITION TO MOTION FOR JOINDER
`
`
`
`
`
`IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`
`Patent Owners Genentech Inc. (“Genentech”) and City of Hope
`
`
`
`(collectively, “Patent Owners”) submit this Opposition to Petitioner Mylan
`
`Pharmaceuticals Inc.’s (“Mylan”) Motion for Joinder Pursuant to 35 U.S.C. §
`
`315(c) and 37 C.F.R. §§ 42.22 and 42.122(b) (“Motion for Joinder”) (Paper 3).
`
`
`
`Mylan seeks to join this inter partes review with IPR2015-01624 (“Sanofi
`
`IPR”), filed by Sanofi-Aventis U.S. LLC (“Sanofi”) and Regeneron
`
`Pharmaceuticals, Inc. (“Regeneron”) and relating to the same patent at issue here,
`
`U.S. Patent No. 6,331,415 (“the Cabilly ’415 patent”). Sanofi and Regeneron
`
`oppose Mylan’s Motion for Joinder on the ground that it unilaterally seeks to
`
`require them to cooperate with Mylan. Mylan’s attempt to force itself into the
`
`Sanofi IPR and to require Sanofi and Regeneron’s cooperation will be disruptive to
`
`the proceedings, and Patent Owners object to joinder on that basis.
`
`
`
`Mylan asserts that if the Board grants the Motion for Joinder, Mylan, Sanofi,
`
`and Regeneron together will (1) submit “consolidated filings for all substantive
`
`papers in the proceeding (e.g., Reply to the Patent Owner’s Response, Opposition
`
`to Motion to Amend, Motion for Observation on Cross Examination Testimony of
`
`a Reply Witness, Motion to Exclude Evidence, Opposition to Motion to Exclude
`
`Evidence and Reply)” (Id.at 6); (2) submit the same arguments in order to “avoid
`
`lengthy and duplicative briefing” (Id.); and (3) designate a single “attorney to
`
`conduct the cross-examination of any given witness produced by Genentech and
`- 1 -
`
`
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`
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`IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`City of Hope, and the redirect of any given witness produced by Mylan, Sanofi,
`
`and Regeneron within the timeframe normally allotted by the rules for one party.”
`
`(Id. at 6-7.)
`
`
`
`Far from such cooperation, however, Patent Owners understand that Sanofi
`
`and Regeneron oppose joinder. Given this lack of agreement, Patent Owners are
`
`concerned that joinder will interfere with the efficient administration of the Sanofi
`
`IPR. Indeed, the Sanofi IPR is already at an advanced stage – the Board issued its
`
`Institution Decision on February 5, 2016; the parties have scheduled the deposition
`
`of Sanofi-Aventis/Regeneron’s expert declarant, Dr. Foote, for April 21, 2016; and
`
`Patent Owners’ Response is due May 13, 2016. In addition, Mylan’s effort to join
`
`the Sanofi IPR may well interfere with settlement efforts between
`
`Sanofi/Regeneron and Patent Owners.
`
`
`
`While Patent Owners believe that Mylan’s motion should be denied, in the
`
`event that the Board decides to allow joinder, Mylan should be required to abide by
`
`the conditions set forth in its Motion for Joinder. These conditions are as follows:
`
`1. Mylan agrees to “consolidated filings for all substantive papers in the
`
`proceeding (e.g., Reply to the Patent Owner’s Response, Opposition
`
`to Motion to Amend, Motion for Observation on Cross Examination
`
`Testimony of a Reply Witness, Motion to Exclude Evidence,
`
`Opposition to Motion to Exclude Evidence and Reply). Specifically,
`
`- 2 -
`
`
`
`
`
`IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`Mylan will agree to incorporate its filings with those of Sanofi and
`
`Regeneron into a consolidated filing in the Sanofi IPR, including
`
`being subject to the ordinary rules for one party on page limits.”
`
`(Paper 3 at 6.) Mylan further agrees that “Sanofi, Regeneron and
`
`Mylan will be jointly responsible for the consolidated filings.” (Id. at
`
`6, 8.)
`
`2. Mylan agrees “not to be permitted any arguments separate from those
`
`advanced by Sanofi and Regeneron in the consolidated filings” in
`
`order to “avoid lengthy and duplicative briefing.” (Id. at 6.)
`
`3. Mylan agrees that “[c]onsolidated discovery is also appropriate given
`
`that Mylan, Sanofi, and Regeneron are using the same expert
`
`declaration in the two proceedings.” (Id. at 6.) Specifically, “Mylan,
`
`Sanofi, and Regeneron will designate an attorney to conduct the cross-
`
`examination of any given witness produced by Genentech and City of
`
`Hope, and the redirect of any given witness produced by Mylan,
`
`Sanofi, and Regeneron within the timeframe normally allotted by the
`
`rules for one party. Mylan will not receive any separate cross-
`
`examination or redirect time from that of Sanofi and Regeneron.” (Id.
`
`at 6-7.)
`
`- 3 -
`
`
`
`
`
`IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`4. Mylan agrees to “rely solely on the testimony of Sanofi’s expert, Dr.
`
`Foote, unless the Sanofi IPR is settled prior to a final written
`
`decision” and that “no additional discovery would be needed” as long
`
`as the Sanofi IPR remains pending following joinder. (Id. at 7.) In
`
`the event that the Sanofi IPR is settled prior to a final written decision,
`
`Mylan identifies Dr. Kathryn Calame as its expert. (Id.; see also
`
`Declaration of Kathryn Calame, Ph.D. (Ex. 1059).)
`
`5. Mylan agrees that “[t]he Mylan IPR [2016-00710] contains the same
`
`grounds of unpatentability instituted in the Sanofi IPR,” and that “the
`
`Mylan IPR raises no new grounds of unpatentability from those of the
`
`Sanofi IPR.” (Paper 3 at 7-8.)
`
`6. Mylan agrees that joinder will have “[n]o impact on [the] IPR trial
`
`schedule” and that “[t]he trial schedule for the Sanofi IPR would not
`
`need to be delayed to effect joinder . . . .” (Id. at 8.)
`
`In addition to the foregoing, because Mylan introduces the declaration of Dr.
`
`Calame in support of its petition and contingently relies on the testimony in the
`
`Foote declaration, Patent Owners seek clarity regarding the use of Dr. Foote’s
`
`deposition testimony if the Sanofi IPR terminates. Specifically, as a condition to
`
`any joinder, Patent Owner’s request the Panel direct that (1) any deposition
`
`testimony of Dr. Foote taken in this proceeding may be entered into the record and
`
`- 4 -
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`
`
`
`
`IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`cited in the parties’ filings irrespective of whether the Sanofi IPR is terminated; (2)
`
`once Dr. Foote is deposed in this proceeding, Mylan may not rely on Dr. Calame
`
`as a declarant supporting the Petition. These conditions are necessary to ensure the
`
`efficient disposition of the IPR and avoid any misunderstanding between the
`
`parties should the Sanofi IPR settle.
`
`The Patent Owners’ counsel are available for a telephone conference with
`
`the Board should the Board consider the issues related to Joinder amenable to be
`
`addressed by a conference call.
`
`
`
`Date: April 4, 2016
`
`
`
`Respectfully submitted,
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
`Counsel for Patent Owners
`
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`1875 PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20006
`TEL: 650-600-5036
`FAX: 650-858-6100
`EMAIL: david.cavanaugh@wilmerhale.com
`
`- 5 -
`
`
`
`
`
`IPR2016-00710
`Patent Owners’ Opposition to Motion for Joinder
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on April 4, 2016, I caused a true and correct copy of the
`foregoing materials:
`
`
` Patent Owners’ Opposition to Motion for Joinder
`
`to be served via electronic mail on the following attorneys of record:
`
`Deanne M. Mazzochi
`Paul J. Molino
`William A. Rakoczy
`Eric R. Hunt
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`dmazzochi@rmmslegal.com
`paul@rmmslegal.com
`wrakoczy@rmmslegal.com
`ehunt@rmmslegal.com
`Mylan_IPR_Service@rmmslegal.com
`
`
`
`_/Rebecca A. Whitfield/_
`Rebecca A. Whitfield
`Reg. No. 73,756
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`
`- 1 -
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