UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner
`v.
`
`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
`
`____________________________________________
`
`__________________________________________________________________
`
`PETITIONER’S MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. § 42.22 AND § 42.122(b)
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`DM2\6159769.3
`
`

`
`
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
`
`II.
`
`STATEMENT OF MATERIAL FACTS ...................................................... ..2
`
`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 
`
`IV.
`
`PROPOSED ORDER .................................................................................... ..8
`
`V.
`
`CONCLUSION .............................................................................................. . .9
`
`
`
`
`
`
`DM2\6159769.3
`DM2\6159769.3
`
`i
`i
`
`

`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Dell, Inc. v. Network-1 Security Solutions, Inc., Case IPR2013-00385 .................... 4
`
`In re Copaxone 40 mg Consolidated Cases, C.A. No. 14-1171-GMS ...................... 2
`
`Motorola Mobility LLC v. Softview LLC, IPR2013-00256 (PTAB June 20,
`2013) ..................................................................................................................... 7
`
`Mylan Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd.,
`Case No. IPR2015-00644 ..................................................................................... 1
`
`Statutes
`
`35 U.S.C. § 315(b) ..................................................................................................... 2
`
`35 U.S.C. § 315(c) ................................................................................................. 1, 3
`
`35 U.S.C. § 316(b) ..................................................................................................... 5
`
`Other Authorities
`
`37 C.F.R. § 42.1(b) .................................................................................................... 5
`
`37 C.F.R. § 42.22 ....................................................................................................... 3
`
`37 C.F.R. § 42.22 ....................................................................................................... 1
`
`37 C.F.R. § 42.122(a) ................................................................................................. 3
`
`37 C.F.R. § 42.122(b) ............................................................................................ 1, 3
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 5
`
`U.S. Patent No. 8,232,250 .......................................................................................... 2
`
`U.S. Patent No. 8,399,413 ...................................................................................... 1-2
`
`U.S. Patent No. 8,969,302 .......................................................................................... 2
`
`
`DM2\6159769.3
`
`ii
`
`

`
`
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`Amneal Pharmaceuticals LLC (“Amneal”) filed the present petition for inter
`
`partes review IPR2015-01980 (the “Amneal IPR”) and respectfully submits this
`
`Motion for Joinder. Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and
`
`42.122(b), Amneal requests institution of an inter partes review and joinder with
`
`the inter partes review concerning the same patent in Mylan Pharmaceuticals Inc.
`
`v. Yeda Research & Development Co. Ltd., which is assigned Case No. IPR2015-
`
`00644, (the “Mylan IPR”), which was instituted on August 25, 2015.
`
`In accordance with the Board’s Representative Order identifying matters to
`
`be addressed in a motion for joinder (Paper No. 15, IPR2013-00004, April 24,
`
`2013), Amneal submits that: (1) joinder is appropriate because it will promote
`
`efficient determination of the validity of the ’413 Patent without prejudice to
`
`Mylan Pharmaceuticals Inc. (“Mylan”) or Yeda Research & Development Co. Ltd
`
`(“Yeda”) (See, e.g., Paper No. 10, IPR2013-00256, June 20, 2013 (granting motion
`
`for joinder under similar circumstances)); (2) Amneal’s Petition raises the same
`
`grounds of unpatentability as Mylan’s IPR; (3) joinder would not affect the
`
`pending schedule in the Mylan IPR nor increase the complexity of that proceeding,
`
`minimizing costs; and (4) Amneal is willing to agree to consolidated filings with
`
`Mylan to minimize burden and schedule impact.
`
`DM2\6159769.3
`
`

`
`
`
`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b),
`
`as it is submitted within one month of August 25, 2015, the date on which the
`
`Mylan IPR was instituted.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`The Amneal IPR and Mylan IPR are among a family of inter partes review
`
`(“IPR”) proceedings relating to three patents that are being asserted by Yeda
`
`Research and Development Co., Ltd. (“Yeda”), along with Teva Pharmaceuticals
`
`USA, Inc., Teva Pharmaceuticals Industries Ltd., and Teva Neuroscience, Inc.,
`
`against numerous defendants in the following litigation: In re Copaxone 40 mg
`
`Consolidated Cases, C.A. No. 14-1171-GMS (consolidated). Accordingly, all
`
`petitions for inter partes review that have been filed by defendant Mylan and
`
`Amneal are timely as prescribed by 35 U.S.C. § 315(b).
`
`Currently, the family of Mylan IPR proceedings relating to the three Yeda
`
`patents consists of the following proceedings: IPR2015-00643 (relating to claims
`
`1–20 of U.S. Patent No. 8,232,250); IPR2015-00644 (relating to claims 1–20 of
`
`U.S. Patent No. 8,399,413); and IPR2015-00830 (relating to claims 1–12 of U.S.
`
`Patent No. 8,969,302).
`
`The petitions for IPR filed by Amneal correspond exactly to the petitions
`
`first filed by Mylan against the same patent claims, and are identical to the Mylan
`
`
`DM2\6159769.3
`
`2
`
`

`
`
`
`petitions in all substantive respects. They include identical grounds, analysis, and
`
`exhibits and rely upon the same expert declarations.
`
`In addition to this motion, Amneal is presently filing motions for joinder of
`
`each of their IPR petitions with the corresponding petitions first filed by Mylan,
`
`subject to the same conditions sought by this motion. Mylan does not oppose the
`
`Amneal motions.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`Amneal respectfully requests that the Board exercise its discretion to grant
`
`joinder of the Amneal IPR and Mylan IPR proceedings pursuant to 35 U.S.C.
`
`§ 315(c), 37 C.F.R. § 42.22, and 37 C.F.R. § 42.122(b). In support of this motion,
`
`Amneal proposes consolidated filings and other procedural accommodations
`
`designed to streamline the proceedings.
`
`The Leahy-Smith America Invents Act (“AIA”) permits joinder of like
`
`review proceedings, e.g., an inter partes review (“IPR”) may be joined with
`
`another inter partes review. 37 C.F.R. § 42.122(a). The statutory provision
`
`governing joinder of inter partes review proceedings is 35 U.S.C. § 315(c), which
`
`reads as follows:
`
`If the Director institutes an inter partes review, the
`
`Director, in his or her discretion, may join as a party to
`
`that inter partes review any person who properly files a
`
`
`DM2\6159769.3
`
`3
`
`

`
`
`
`petition under section 311 that the Director, after
`
`receiving a preliminary response under section 313 or the
`
`expiration of the time for filing such a response,
`
`determines warrants the institution of an inter partes
`
`review under section 314.
`
`In exercising its discretion to grant joinder, the Board considers the impact
`
`of substantive and procedural issues on the proceedings, as well as other
`
`considerations, while being “mindful that patent trial regulations, including the
`
`rules for joinder, must be construed to secure the just, speedy, and inexpensive
`
`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
`
`Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. The Board should
`
`consider “the policy preference for joining a party that does not present new issues
`
`that might complicate or delay an existing proceeding.” Id. at 10. Under this
`
`framework, joinder of the present Petition with the Mylan IPR is appropriate.
`
`“A motion for joinder should: (1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
`
`may be simplified.” Id. at 4. Each of these is addressed fully below.
`
`
`DM2\6159769.3
`
`4
`
`

`
`
`
`A. Reasons Why Joinder is Appropriate
`Joinder is appropriate in this case because it is the most expedient way to
`
`secure the just, speedy, and inexpensive resolution of the related proceedings. See
`
`35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Intentionally, the Amneal IPR is
`
`substantively identical to the corresponding Mylan IPR in an effort to avoid
`
`multiplication of issues before the Board. Given the duplicative nature of these
`
`petitions, joinder of the related proceedings is appropriate. Further, Amneal will
`
`agree to consolidated filings and discovery, and procedural concessions, which
`
`Mylan does not oppose.
`
`Substantively Identical Petitions
`
`1.
`Amneal represents that the Amneal IPR is identical to the Mylan IPR in all
`
`substantive respects. It includes identical grounds, analysis, and exhibits and relies
`
`upon the same expert declarations. Accordingly, if instituted, maintaining the
`
`Amneal IPR proceeding separate from that of Mylan would entail needless
`
`duplication of effort. Indeed, in circumstances such as these, the PTO anticipated
`
`that joinder would be granted as a matter of right. See 157 CONG. REC. S1376
`
`(daily ed. Mar. 8, 2011) (statement of Sen. Kyl) (“The Office anticipates that
`
`joinder will be allowed as of right – if an inter partes review is instituted on the
`
`basis of a petition, for example, a party that files an identical petition will be joined
`
`
`DM2\6159769.3
`
`5
`
`

`
`
`
`to that proceeding, and thus allowed to file its own briefs and make its own
`
`arguments.”) (emphasis added).
`
`Consolidated Filings and Discovery
`
`2.
`Because the grounds of unpatentability in the Amneal IPR and Mylan IPR
`
`are the same, the case is amenable to consolidated filings. Amneal will agree 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, Amneal will agree to incorporate its filings with those of Mylan in a
`
`consolidated filing, subject to the ordinary rules for one party on page limits.
`
`Mylan and Amneal will be jointly responsible for the consolidated filings.
`
`Amneal agrees not to be permitted any arguments separate from those
`
`advanced by Amneal and Mylan in the consolidated filings. These limitations
`
`avoid lengthy and duplicative briefing.
`
`Consolidated discovery is also appropriate given that Amneal and Mylan are
`
`using the same expert declarations in the two proceedings. Amneal and Mylan will
`
`designate an attorney to conduct the cross-examination of any given witness
`
`produced by Yeda and the redirect of any given witness produced by Amneal or
`
`
`DM2\6159769.3
`
`6
`
`

`
`
`
`Mylan within the timeframe normally allotted by the rules for one party. Amneal
`
`and Mylan will not receive any separate cross-examination or redirect time.
`
`B. No New Grounds of Unpatentability
`The Amneal IPR raises no new grounds of unpatentability from those of the
`
`Mylan IPR because, in fact, the petitions are identical in all substantive respects.
`
`C. No Impact on IPR Trial Schedule
`The difference between the filing date of the Amneal IPR and the Mylan IPR
`
`is without consequence should the proceedings be joined. The trial schedule for
`
`the Mylan IPR would not need to be delayed to effect joinder based on Yeda’s
`
`preliminary response and later-filed Amneal IPR. The joint proceeding would
`
`allow the Board and parties to focus on the merits in one consolidated proceeding
`
`without unnecessary duplication of effort, and in a timely manner.
`
`D. Briefing and Discovery Will Be Simplified
`Joinder will simplify briefing and discovery because Amneal seeks an order
`
`similar to that issued in Motorola Mobility LLC v. Softview LLC, IPR2013-00256
`
`(PTAB June 20, 2013) (Paper 10). As discussed above, Amneal and Mylan will
`
`engage in consolidated filings and discovery, which will simplify the briefing and
`
`discovery process.
`
`E. No Prejudice to Yeda if Proceedings are Joined
`Amneal proposes joinder to streamline the proceedings and reduce the costs
`
`and burdens on the parties. Amneal believes joinder will achieve these goals for
`
`
`DM2\6159769.3
`
`7
`
`

`
`
`
`several reasons. First, joinder will most certainly decrease the number of papers
`
`the parties must file, by eliminating a duplicative proceeding. Second, joinder will
`
`also reduce by half the time and expense for depositions and other discovery
`
`required in separate proceedings. Third, joinder creates case management
`
`efficiencies for the Board and parties without any prejudice to Yeda.
`
`IV. PROPOSED ORDER
`Petitioner proposes a joinder order for consideration by the Board as
`
`follows, which Mylan does not oppose:
`
` The Amneal IPR will be instituted and will be joined with the Mylan IPR
`
`on the same grounds as those for which review has been instituted in the
`
`Mylan IPR.
`
` The scheduling order for the Mylan IPR will apply for the joined
`
`proceeding.
`
` Throughout the proceeding, Mylan and Amneal will file papers as
`
`consolidated filings, except for motions that do not involve the other
`
`party, in accordance with the Board's established rules regarding page
`
`limits. So long as they both continue to participate in the merged
`
`proceeding, Mylan and Amneal will identify each such filing as a
`
`Consolidated Filing and will be responsible for completing all
`
`consolidated filings.
`
`
`DM2\6159769.3
`
`8
`
`

`
`
`
` Mylan and Amneal will designate an attorney to conduct the cross
`
`examination of any given witness produced by Yeda and the redirect of
`
`any given witness produced by Mylan or Amneal within the timeframe
`
`normally allotted by the rules for one party. Mylan and Amneal will not
`
`receive any separate cross-examination or redirect time.
`
` Yeda will conduct any cross examination of any given witness jointly
`
`produced by Mylan or Amneal and the redirect of any given witness
`
`produced by Yeda within the timeframe normally allotted by the rules for
`
`one cross-examination or redirect examination.
`
`V. CONCLUSION
`For the foregoing reasons, Amneal respectfully requests that the Board grant
`
`joinder of the Amneal IPR and Mylan IPR proceedings.
`
`
`Dated: September 25, 2015
`
`
`DM2\6159769.3
`
`9
`
`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
`
`Lead Counsel for Petitioner Amneal
`Pharmaceuticals LLC
`
`

`
`
`
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`
` The undersigned certifies that on the 25th day of September 2015, a complete
`
`copy of the foregoing Petitioner’s Motion for Joinder Under 35 U.S.C. § 315(c)
`
`And 37 C.F.R. § 42.22 AND § 42.122(b) was served via FEDEX® to the Patent
`
`Owner by serving the correspondence address of record for the ’413 Patent:
`
`Yeda Research & Development Co., Ltd.
`c/o COOPER & DUNHAM, LLP
`30 Rockefeller Plaza
`20th Floor
`New York, NY 10112
`Attn: John P. White
`
`A courtesy copy of the foregoing will also be served on counsel for Patent
`
`
`
`Owner as follows:
`
`VIA ELECTRONIC DELIVERY
`
`Elizabeth J. Holland (EHolland@goodwinprocter.com)
`William G. James (WJames@goodwinprocter.com)
`Eleanor H. Yost (eyost@goodwinprocter.com)
`GOODWIN PROCTOR LLP
`
`
`
`
`
`
`
`
`
`DM2\6159769.3
`
`

`
`
`
`Respectfully submitted,
`
`
`Duane Morris LLP
`
`
`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
`
`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
`
`
`DM2\6159769.3
`
`2