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Paper No. __
`Filed: July 1, 2016
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`IPR2015-01340
`Patent RE44,186
`_____________________________
`
`JOINT STIPULATION REGARDING JOINDER
`
`
`
`

`
`
`
`I.
`
`INTRODUCTION
`
`After a telephone hearing on June 17, 2016, the Board authorized the parties
`
`in IPR2015-01340, IPR2016-01029 and IPR2016-01104 to file a joint stipulation
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`“explaining the agreement between Petitioners Mylan, Wockhardt, Amneal and
`
`Sun with respect to the level of cooperation that will be maintained if the motions
`
`for joinder are granted IPR2016-01029, and IPR2016-01104.” Paper 22.
`
`AstraZeneca is the patent owner; Mylan, the original petitioner; Wockhardt,
`
`Amneal and Sun, the joining petitioners.
`
`AstraZeneca has advised the petitioners that it continues to oppose joinder of
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`these additional parties as time-barred and for reasons addressed in its Oppositions.
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`IPR2016-01029, Paper 8 (May 31, 2016); IPR2016-01140, Paper 12 (June 15,
`
`2016). The Board requested that the Parties propose a joint stipulation to ensure,
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`that if Joinder is granted, that Amneal, Sun, Wockhardt, and Mylan cooperate to
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`provide a single voice in the joined proceeding, whether at hearings, at depositions,
`
`in filings, or otherwise.
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`II. THE AGREEMENT
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`Amneal, Sun, and Wockhardt have agreed with Mylan, the “Lead
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`Petitioner”, to share the use and, after joinder, the pro rata costs of Mylan’s
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`experts in this IPR proceeding in exchange for continuing access to the experts in
`
`
`
`

`
`
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`the event that Mylan no longer participates in the review. As long as Mylan is a
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`party to the review, Amneal, Sun, and Wockhardt will:
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`• coordinate any communications with Mylan’s experts through Mylan;
`
`• not produce their own testifying witness ; and
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`• not file substantive papers (except for those associated with Board-
`
`approved motions that do not affect Mylan or Mylan’s position).
`
`Mylan, Amneal, Sun and Wockhardt will confer and cooperate on the
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`consolidated filings but, as long as Mylan is a party to the review, Mylan will make
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`all final decisions, will retain responsibility for oral argument (including telephone
`
`hearings and appeals) and Amneal, Sun, and Wockhardt will not receive separate
`
`time and will not separately argue during oral argument, including telephone
`
`hearings and appeals, except when addressing Board-approved motions that do not
`
`affect Mylan or Mylan’s position.
`
`
`
`Mylan, Amneal, Sun and Wockhardt have agreed to coordinate the
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`discovery and testimony relating to witnesses but, as long as Mylan is a party to
`
`the review, Mylan will make all final decisions. In particular, as long as Mylan is a
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`party to the review, Amneal, Sun, and Wockhardt will not separately file or serve
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`objections or discovery requests, will not receive separate cross examination or
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`redirect time, will not separately cross examine or redirect any witness, and they
`
`-2-
`
`

`
`
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`stipulate that cross examinations will occur within the timeframe normally allotted
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`to one party without a need for extension in light of the joinder.
`
`
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`Whether Mylan remains a party or not, Amneal, Sun and Wockhardt will not
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`actively seek to change the opinion of Mylan’s current expert (Dr. Rotella) or
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`present attorney arguments that are inconsistent with Dr. Rotella’s opinions or the
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`positions taken by Mylan in the copending litigation.
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`If either of the joining parties no longer participates in the reviews the
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`remaining parties will maintain this agreement. If Mylan is no longer a party to the
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`review, the remaining joined parties shall meet and confer to select a new Lead
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`Petitioner. Any such new Lead Petitioner will effectively take Mylan’s place in
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`this stipulation and all remaining petitioners will continue to be bound hereby.
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`Nothing is this Joint Stipulation Regarding Joinder is intended to limit the
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`evidence the Board may consider pursuant to Genzyme Therapeutic Partners
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`Products LP v. Biomarin Pharma, Ltd, ___ F.3d ____ (Fed. Cir. June 14, 2016).
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`III. PATENT OWNER’S VIEW ON THE LEVEL OF COOPERATION
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`AstraZeneca has advised the petitioners that it maintains that joinder is not
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`proper for the reasons provided in its respective oppositions to the motions for
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`joinder. If joinder is granted, AstraZeneca advises that it does not request any
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`additional level of cooperation other than that specified in the previous section.
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`
`
`-3-
`
`

`
`
`
`Dated: July 1, 2016
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Lead counsel for Mylan Pharmaceuticals, Inc.
` Reg. No. 31,990
`
`
`
`
`
`-4-
`
`

`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served a true and correct copy of the
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`foregoing JOINT STIPULATION REGARDING JOINDER on this 1st day of
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`July, 2016, on the Patent Owner at the electronic correspondence address of the
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`Patent Owner as follows:
`
`
`Charles E. Lipsey
`Finnegan, Henderson, Farabow,
`Garret & Dunner, L.L.P.
`charles.lipsey@finnegan.com
`
`Eric E. Grondahl
`McCarter & English LLP
`egrondahl@mccarter.com
`
`John D. Livingstone
`Finnegan, Henderson, Farabow,
`Garret & Dunner, L.L.P.
`john.livingstone@finnegan.com
`
`
`Anthony A. Hartmann
`Finnegan, Henderson, Farabow,
`Garret & Dunner, L.L.P.
`anthony.hartmann@finnegan.com
`
`M. David Weingarten
`Finnegan, Henderson, Farabow,
`Garret & Dunner, L.L.P.
`david.weingarten@finnegan.com
`
`
`
`And to counsel for Petitioners Wockhardt Bio AG in IPR2016-01029 and
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`Amneal Pharmaceuticals LLC in IPR2016-01104, as follows:
`
`Samuel Park
`spark@winston.com
`
`Andrew Sommer
`asommer@winston.com
`
`
`Patrick Gallager
`pcgallagher@duanemorris.com
`
`
`
`
`
`Dated: July 1, 2016
`
`
`
`
`
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`
`-5-

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