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`____________________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________________________________
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`AMNEAL PHARMACEUTICALS LLC,
`Petitioner
`v.
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`YEDA RESEARCH AND DEVELOPMENT CO., LTD.,
`Patent Owner
`
`Case IPR2015-01980
`U.S. PATENT NO. 8,399,413 B2
`Issue Date: March 19, 2013
`Title: LOW FREQUENCY GLATIRAMER ACETATE THERAPY
`
`____________________________________________
`
`__________________________________________________________________
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`PETITIONER’S MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. § 42.22 AND § 42.122(b)
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`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`DM2\6159769.3
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`TABLE OF CONTENTS
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`TABLE OF CONTENTS
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`II.
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`STATEMENT OF MATERIAL FACTS ...................................................... ..2
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`STATEMENT OF PRECISE RELIEF REQUESTED ................................... 1
`I.
`STATEMENT OF PRECISE RELIEF REQUESTED ................................. ..l
`I.
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`II.
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3
`III.
`STATEMENT OF REASONS FOR RELIEF REQUESTED ...................... ..3
`A.
`Reasons Why Joinder is Appropriate .................................................... 5
`A.
`Reasons Why Joinder is Appropriate .................................................. ..5
`1.
`Substantively Identical Petitions ................................................. 5
`1.
`Substantively Identical Petitions ............................................... ..5
`2.
`Consolidated Filings and Discovery ........................................... 6
`2.
`Consolidated Filings and Discovery ......................................... ..6
`B. No New Grounds of Unpatentability .................................................... 7
`B.
`No New Grounds of Unpatentability .................................................. ..7
`C. No Impact on IPR Trial Schedule ......................................................... 7
`C.
`No Impact on IPR Trial Schedule ....................................................... ..7
`D.
`Briefing and Discovery Will Be Simplified .......................................... 7
`D.
`Briefing and Discovery Will Be Simplified ........................................ ..7
`E.
`No Prejudice to Yeda if Proceedings are Joined ................................... 7
`E.
`No Prejudice to Yeda if Proceedings are Joined ................................. ..7
`IV. PROPOSED ORDER ...................................................................................... 8
`V.
`CONCLUSION ................................................................................................ 9
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`IV.
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`PROPOSED ORDER .................................................................................... ..8
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`V.
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`CONCLUSION .............................................................................................. . .9
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`TABLE OF AUTHORITIES
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`Cases
`Dell, Inc. v. Network-1 Security Solutions, Inc., Case IPR2013-00385 .................... 4
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`In re Copaxone 40 mg Consolidated Cases, C.A. No. 14-1171-GMS ...................... 2
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`Motorola Mobility LLC v. Softview LLC, IPR2013-00256 (PTAB June 20,
`2013) ..................................................................................................................... 7
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`Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd.,
`Case No. IPR2015-00644 ..................................................................................... 1
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`Statutes
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`35 U.S.C. § 315(b) ..................................................................................................... 2
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`35 U.S.C. § 315(c) ................................................................................................. 1, 3
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`35 U.S.C. § 316(b) ..................................................................................................... 5
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`Other Authorities
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`37 C.F.R. § 42.1(b) .................................................................................................... 5
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`37 C.F.R. § 42.22 ....................................................................................................... 3
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`37 C.F.R. § 42.22 ....................................................................................................... 1
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`37 C.F.R. § 42.122(a) ................................................................................................. 3
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`37 C.F.R. § 42.122(b) ............................................................................................ 1, 3
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`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 5
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`U.S. Patent No. 8,232,250 .......................................................................................... 2
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`U.S. Patent No. 8,399,413 ...................................................................................... 1-2
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`U.S. Patent No. 8,969,302 .......................................................................................... 2
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`I.
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`STATEMENT OF PRECISE RELIEF REQUESTED
`Amneal Pharmaceuticals LLC (“Amneal”) filed the present petition for inter
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`partes review IPR2015-01980 (the “Amneal IPR”) and respectfully submits this
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`Motion for Joinder. Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and
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`42.122(b), Amneal requests institution of an inter partes review and joinder with
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`the inter partes review concerning the same patent in Mylan Pharmaceuticals Inc.
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`v. Yeda Research & Development Co. Ltd., which is assigned Case No. IPR2015-
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`00644, (the “Mylan IPR”), which was instituted on August 25, 2015.
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`In accordance with the Board’s Representative Order identifying matters to
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`be addressed in a motion for joinder (Paper No. 15, IPR2013-00004, April 24,
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`2013), Amneal submits that: (1) joinder is appropriate because it will promote
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`efficient determination of the validity of the ’413 Patent without prejudice to
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`Mylan Pharmaceuticals Inc. (“Mylan”) or Yeda Research & Development Co. Ltd
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`(“Yeda”) (See, e.g., Paper No. 10, IPR2013-00256, June 20, 2013 (granting motion
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`for joinder under similar circumstances)); (2) Amneal’s Petition raises the same
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`grounds of unpatentability as Mylan’s IPR; (3) joinder would not affect the
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`pending schedule in the Mylan IPR nor increase the complexity of that proceeding,
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`minimizing costs; and (4) Amneal is willing to agree to consolidated filings with
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`Mylan to minimize burden and schedule impact.
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b),
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`as it is submitted within one month of August 25, 2015, the date on which the
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`Mylan IPR was instituted.
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`II.
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`STATEMENT OF MATERIAL FACTS
`The Amneal IPR and Mylan IPR are among a family of inter partes review
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`(“IPR”) proceedings relating to three patents that are being asserted by Yeda
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`Research and Development Co., Ltd. (“Yeda”), along with Teva Pharmaceuticals
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`USA, Inc., Teva Pharmaceuticals Industries Ltd., and Teva Neuroscience, Inc.,
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`against numerous defendants in the following litigation: In re Copaxone 40 mg
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`Consolidated Cases, C.A. No. 14-1171-GMS (consolidated). Accordingly, all
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`petitions for inter partes review that have been filed by defendant Mylan and
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`Amneal are timely as prescribed by 35 U.S.C. § 315(b).
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`Currently, the family of Mylan IPR proceedings relating to the three Yeda
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`patents consists of the following proceedings: IPR2015-00643 (relating to claims
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`1–20 of U.S. Patent No. 8,232,250); IPR2015-00644 (relating to claims 1–20 of
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`U.S. Patent No. 8,399,413); and IPR2015-00830 (relating to claims 1–12 of U.S.
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`Patent No. 8,969,302).
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`The petitions for IPR filed by Amneal correspond exactly to the petitions
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`first filed by Mylan against the same patent claims, and are identical to the Mylan
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`petitions in all substantive respects. They include identical grounds, analysis, and
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`exhibits and rely upon the same expert declarations.
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`In addition to this motion, Amneal is presently filing motions for joinder of
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`each of their IPR petitions with the corresponding petitions first filed by Mylan,
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`subject to the same conditions sought by this motion. Mylan does not oppose the
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`Amneal motions.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`Amneal respectfully requests that the Board exercise its discretion to grant
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`joinder of the Amneal IPR and Mylan IPR proceedings pursuant to 35 U.S.C.
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`§ 315(c), 37 C.F.R. § 42.22, and 37 C.F.R. § 42.122(b). In support of this motion,
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`Amneal proposes consolidated filings and other procedural accommodations
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`designed to streamline the proceedings.
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`The Leahy-Smith America Invents Act (“AIA”) permits joinder of like
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`review proceedings, e.g., an inter partes review (“IPR”) may be joined with
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`another inter partes review. 37 C.F.R. § 42.122(a). The statutory provision
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`governing joinder of inter partes review proceedings is 35 U.S.C. § 315(c), which
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`reads as follows:
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`If the Director institutes an inter partes review, the
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`Director, in his or her discretion, may join as a party to
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`that inter partes review any person who properly files a
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`petition under section 311 that the Director, after
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`receiving a preliminary response under section 313 or the
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`expiration of the time for filing such a response,
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`determines warrants the institution of an inter partes
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`review under section 314.
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`In exercising its discretion to grant joinder, the Board considers the impact
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`of substantive and procedural issues on the proceedings, as well as other
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`considerations, while being “mindful that patent trial regulations, including the
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`rules for joinder, must be construed to secure the just, speedy, and inexpensive
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`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
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`Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. The Board should
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`consider “the policy preference for joining a party that does not present new issues
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`that might complicate or delay an existing proceeding.” Id. at 10. Under this
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`framework, joinder of the present Petition with the Mylan IPR is appropriate.
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`“A motion for joinder should: (1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the
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`petition; (3) explain what impact (if any) joinder would have on the trial schedule
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`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Id. at 4. Each of these is addressed fully below.
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`A. Reasons Why Joinder is Appropriate
`Joinder is appropriate in this case because it is the most expedient way to
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`secure the just, speedy, and inexpensive resolution of the related proceedings. See
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`35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Intentionally, the Amneal IPR is
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`substantively identical to the corresponding Mylan IPR in an effort to avoid
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`multiplication of issues before the Board. Given the duplicative nature of these
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`petitions, joinder of the related proceedings is appropriate. Further, Amneal will
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`agree to consolidated filings and discovery, and procedural concessions, which
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`Mylan does not oppose.
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`Substantively Identical Petitions
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`1.
`Amneal represents that the Amneal IPR is identical to the Mylan IPR in all
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`substantive respects. It includes identical grounds, analysis, and exhibits and relies
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`upon the same expert declarations. Accordingly, if instituted, maintaining the
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`Amneal IPR proceeding separate from that of Mylan would entail needless
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`duplication of effort. Indeed, in circumstances such as these, the PTO anticipated
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`that joinder would be granted as a matter of right. See 157 CONG. REC. S1376
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`(daily ed. Mar. 8, 2011) (statement of Sen. Kyl) (“The Office anticipates that
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`joinder will be allowed as of right – if an inter partes review is instituted on the
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`basis of a petition, for example, a party that files an identical petition will be joined
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`to that proceeding, and thus allowed to file its own briefs and make its own
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`arguments.”) (emphasis added).
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`Consolidated Filings and Discovery
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`2.
`Because the grounds of unpatentability in the Amneal IPR and Mylan IPR
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`are the same, the case is amenable to consolidated filings. Amneal will agree to
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`consolidated filings for all substantive papers in the proceeding (e.g., Reply to the
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`Patent Owner’s Response, Opposition to Motion to Amend, Motion for
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`Observation on Cross Examination Testimony of a Reply Witness, Motion to
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`Exclude Evidence, Opposition to Motion to Exclude Evidence and Reply).
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`Specifically, Amneal will agree to incorporate its filings with those of Mylan in a
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`consolidated filing, subject to the ordinary rules for one party on page limits.
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`Mylan and Amneal will be jointly responsible for the consolidated filings.
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`Amneal agrees not to be permitted any arguments separate from those
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`advanced by Amneal and Mylan in the consolidated filings. These limitations
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`avoid lengthy and duplicative briefing.
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`Consolidated discovery is also appropriate given that Amneal and Mylan are
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`using the same expert declarations in the two proceedings. Amneal and Mylan will
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`designate an attorney to conduct the cross-examination of any given witness
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`produced by Yeda and the redirect of any given witness produced by Amneal or
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`Mylan within the timeframe normally allotted by the rules for one party. Amneal
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`and Mylan will not receive any separate cross-examination or redirect time.
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`B. No New Grounds of Unpatentability
`The Amneal IPR raises no new grounds of unpatentability from those of the
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`Mylan IPR because, in fact, the petitions are identical in all substantive respects.
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`C. No Impact on IPR Trial Schedule
`The difference between the filing date of the Amneal IPR and the Mylan IPR
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`is without consequence should the proceedings be joined. The trial schedule for
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`the Mylan IPR would not need to be delayed to effect joinder based on Yeda’s
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`preliminary response and later-filed Amneal IPR. The joint proceeding would
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`allow the Board and parties to focus on the merits in one consolidated proceeding
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`without unnecessary duplication of effort, and in a timely manner.
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`D. Briefing and Discovery Will Be Simplified
`Joinder will simplify briefing and discovery because Amneal seeks an order
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`similar to that issued in Motorola Mobility LLC v. Softview LLC, IPR2013-00256
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`(PTAB June 20, 2013) (Paper 10). As discussed above, Amneal and Mylan will
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`engage in consolidated filings and discovery, which will simplify the briefing and
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`discovery process.
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`E. No Prejudice to Yeda if Proceedings are Joined
`Amneal proposes joinder to streamline the proceedings and reduce the costs
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`and burdens on the parties. Amneal believes joinder will achieve these goals for
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`several reasons. First, joinder will most certainly decrease the number of papers
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`the parties must file, by eliminating a duplicative proceeding. Second, joinder will
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`also reduce by half the time and expense for depositions and other discovery
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`required in separate proceedings. Third, joinder creates case management
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`efficiencies for the Board and parties without any prejudice to Yeda.
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`IV. PROPOSED ORDER
`Petitioner proposes a joinder order for consideration by the Board as
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`follows, which Mylan does not oppose:
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` The Amneal IPR will be instituted and will be joined with the Mylan IPR
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`on the same grounds as those for which review has been instituted in the
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`Mylan IPR.
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` The scheduling order for the Mylan IPR will apply for the joined
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`proceeding.
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` Throughout the proceeding, Mylan and Amneal will file papers as
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`consolidated filings, except for motions that do not involve the other
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`party, in accordance with the Board's established rules regarding page
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`limits. So long as they both continue to participate in the merged
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`proceeding, Mylan and Amneal will identify each such filing as a
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`Consolidated Filing and will be responsible for completing all
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`consolidated filings.
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` Mylan and Amneal will designate an attorney to conduct the cross
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`examination of any given witness produced by Yeda and the redirect of
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`any given witness produced by Mylan or Amneal within the timeframe
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`normally allotted by the rules for one party. Mylan and Amneal will not
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`receive any separate cross-examination or redirect time.
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` Yeda will conduct any cross examination of any given witness jointly
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`produced by Mylan or Amneal and the redirect of any given witness
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`produced by Yeda within the timeframe normally allotted by the rules for
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`one cross-examination or redirect examination.
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`V. CONCLUSION
`For the foregoing reasons, Amneal respectfully requests that the Board grant
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`joinder of the Amneal IPR and Mylan IPR proceedings.
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`Dated: September 25, 2015
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`Respectfully Submitted:
`
`/s/ Vincent L. Capuano
`Vincent L. Capuano (Reg. No. 42385)
`Duane Morris LLP
`100 High Street, Suite 2400
`Boston, MA 02110
`Telephone: (857) 488-4250
`Facsimile: (857) 488-4201
`E-mail: vcapuano@duanemorris.com
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`Lead Counsel for Petitioner Amneal
`Pharmaceuticals LLC
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`CERTIFICATION OF SERVICE ON PATENT OWNER
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` The undersigned certifies that on the 25th day of September 2015, a complete
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`copy of the foregoing Petitioner’s Motion for Joinder Under 35 U.S.C. § 315(c)
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`And 37 C.F.R. § 42.22 AND § 42.122(b) was served via FEDEX® to the Patent
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`Owner by serving the correspondence address of record for the ’413 Patent:
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`Yeda Research & Development Co., Ltd.
`c/o COOPER & DUNHAM, LLP
`30 Rockefeller Plaza
`20th Floor
`New York, NY 10112
`Attn: John P. White
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`A courtesy copy of the foregoing will also be served on counsel for Patent
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`Owner as follows:
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`VIA ELECTRONIC DELIVERY
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`Elizabeth J. Holland (EHolland@goodwinprocter.com)
`William G. James (WJames@goodwinprocter.com)
`Eleanor H. Yost (eyost@goodwinprocter.com)
`GOODWIN PROCTOR LLP
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`Respectfully submitted,
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`Duane Morris LLP
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`By: /s/ Vincent L. Capuano______________
`
`
`Vincent L. Capuano
`Reg. No. 42,385
`Duane Morris LLP
`100 High Street, Suite 2400
`Boston, MA 02110
`Telephone: (857) 488-4250
`Facsimile: (857) 488-4201
`E-mail: vcapuano@duanemorris.com
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`Christopher S. Kroon (Reg. No.
`54,241)
`DUANE MORRIS LLP
`100 High Street, Suite 2400
`Boston, MA 02110
`Telephone: (857) 488-4276
`Facsimile: (857) 401-3008
`E-mail: cskroon@duanemorris.com
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