`Filed July 14, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`APOTEX INC., APOTEX CORP., EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC., HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA, GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD., and MYLAN LABORATORIES
`LIMITED
`
`Petitioners
`
`V.
`
`ELI LILLY & COMPANY
`
`Patent Owner
`
`_____________________
`
`U.S. Patent No. 7,772,209
`Filed: July 11, 2007
`Issued: August 10, 2010
`Inventor: Clet Niyikiza
`
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`
`_____________________
`Inter Partes Review No.: IPR2016-01429
`————————————————
`
`PETITIONERS’ MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES .................................................................................... ii
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
`
`STATEMENT OF MATERIAL FACTS ........................................................ 3
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 4
`
`A.
`
`Reasons Why Joinder Is Appropriate .................................................... 6
`
`1.
`
`2.
`
`Substantively Identical Petitions ................................................. 6
`
`Consolidated Filings and Discovery ........................................... 7
`
`No New Grounds of Unpatentability .................................................... 8
`
`No Impact on IPR Trial Schedule ......................................................... 8
`
`Briefing and Discovery Will Be Simplified .......................................... 9
`
`Joinder Will Not Prejudice Lilly or Neptune ........................................ 9
`
`Expedited Briefing will Assist in Administering this
`Proceeding in a Just, Speedy and Efficient Manner ............................ 11
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
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`IV. PROPOSED ORDER .................................................................................... 11
`
`V.
`
`CONCLUSION .............................................................................................. 12
`
`
`
`i
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`
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`
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`Amneal Pharma., Inc. v. Yeda Res. and Dev. Co., Ltd.,
`IPR2015-01976 ....................................................................................................... 2
`
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385 ...................................................................................................5, 6
`
`In re Barr Labs., Inc.,
` 930 F.2d 72 (D.C. Cir. 1991) ..............................................................................10
`
`Kyocera Corp. et al. v. Softview LLC,
`IPR2013-00004 ....................................................................................................... 1
`
`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256 ....................................................................................................... 2
`
`Samsung Electronics Co., Ltd., v. Arendi S.A.R.L.,
`IPR2014-01144 .....................................................................................................11
`
`Sony Corp. v. Memory Integrity, LLC,
`IPR2015-01376 ....................................................................................................... 2
`
`STATUTES
`
`35 U.S.C. § 315(c) ............................................................................................. 1, 4, 5
`
`35 U.S.C. § 316(b) ..................................................................................................... 6
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.1(b) ..............................................................................................6, 11
`
`37 C.F.R. § 42.122(b) ......................................................................................... 1, 2, 4
`
`37 C.F.R. § 42.22 ............................................................................................... 1, 2, 4
`
`157 CONG. REC. S1376 (DAILY ED. MAR. 8, 2011) ........................................... 7
`
`
`
`ii
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`
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioners Apotex
`
`Inc.
`
`and Apotex Corp.
`
`(“Apotex”), Emcure
`
`Pharmaceuticals Ltd., Heritage Pharma Labs Inc. and Heritage Pharmaceuticals Inc.
`
`(“Emcure”), Glenmark Pharmaceuticals, Inc., USA, Glenmark Holding SA, and
`
`Glenmark Pharmaceuticals, Ltd. (“Glenmark”), and Mylan Laboratories Limited
`
`(“Mylan”) (the “Petitioners”) filed the present petition for inter partes review
`
`(“Petitioners’ IPR”) and respectfully submit this Motion for Joinder. Under 35 U.S.C.
`
`§ 315(c), 37 C.F.R. §§ 42.22, and 42.122(b), Petitioners request institution of an inter
`
`partes review concerning U.S. Patent No. 7,772,209 (“the ‘209 patent”) and joinder
`
`with the inter partes review concerning the same patent in Sandoz Inc. v. Eli Lilly &
`
`Co., assigned Case No. IPR2016-00318, (the “Sandoz IPR”), and instituted on June
`
`16, 2016. The Patent Trial and Appeal Board (“PTAB”) has also instituted petitions
`
`for IPR concerning the ’209 Patent IPR2016-00240 and IPR2016-00237 (“Neptune
`
`IPRs”).
`
`In accordance with the Board’s Representative Order identifying matters to be
`
`addressed in a motion for joinder (Kyocera Corp. et al. v. Softview LLC, Paper No. 15,
`
`IPR2013-00004, Apr. 24, 2013), Petitioners submit that: (1) joinder is appropriate
`
`because it will promote efficient determination of the validity of the ‘209 patent
`
`without prejudice to the prior petitioners, Sandoz Inc. (“Sandoz”), or to the owners of
`
`the ‘209 patent, Eli Lilly & Company (“Lilly”); (2) Petitioners’ Petition raises the
`
`
`
`1
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`
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`same ground of unpatentability over the same prior art as those instituted by the Board
`
`in the Sandoz IPR; (3) joinder would not affect the pending schedule in the Sandoz
`
`IPR nor increase the complexity of that proceeding, thereby minimizing costs; (4)
`
`joinder would not affect the schedule in the Neptune IPRs nor increase the complexity
`
`of those proceedings; and (5) Petitioners and Sandoz agree to submit consolidated
`
`filings to minimize the burden and the impact on the schedule. See, e.g., Motorola
`
`Mobility LLC v. Softview LLC, Paper No. 10, IPR2013-00256 (June 20, 2013) and
`
`Amneal Pharm., LLC v. Yeda Res. & Dev. Co., Ltd., Paper No. 9, IPR2015-01976
`
`(Dec. 28, 2015) (granting motions for joinder under similar circumstances). As
`
`explained below, Petitioners have agreed to work with Sandoz and take an
`
`“understudy” role in any joined IPR so long as Sandoz does not settle and dismiss
`
`the Sandoz IPR. See, e.g., Sony Corp. v. Memory Integrity, LLC, IPR2015-01376,
`
`Paper No. 12, Slip. Op. at 17-18 (Sept. 29, 2015) (“In light of [Petitioner’s] . . .
`
`understudy role . . ., we conclude they have demonstrated that joinder would not
`
`unduly complicate or delay [the earlier IPR].”).
`
`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 June 16, 2016, the date the Board instituted the
`
`Sandoz IPR. (Paper No. 14).
`
`
`
`2
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`
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`1.
`
`
`Lilly served Petitioner Apotex with a complaint asserting
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`infringement of the ‘209 patent on or about April 18, 2012. Eli Lilly & Co. v.
`
`Apotex Inc., Civ. A. No. 12-cv-499 (S.D. Ind., filed April 17, 2012).
`
`2.
`
`
`Lilly served Petitioner Mylan with a complaint asserting infringement
`
`of the ‘209 patent on or about July 31, 2016. Eli Lilly and Company v. Mylan
`
`Laboratories Limited et al. No. 15-cv-01083 (S.D. Ind., filed July 10,2015).
`
`3.
`
`
`Lilly served Petitioner Glenmark with a complaint asserting
`
`infringement of the ‘209 patent on or about January 23, 2014. Eli Lilly & Co. v.
`
`Glenmark Generics Inc., USA et al., Civ. A. No. 14-cv-00104 (S.D. Ind., filed
`
`January 23, 2014).
`
`4.
`
`
`Lilly served Petitioner Emcure with a complaint asserting
`
`infringement of the ‘209 patent on or about August 7, 2015. Eli Lilly & Co. v.
`
`Emcure Pharmaceuticals Ltd., Civ. A. No. 15-cv-1244 (S.D. Ind., filed August 7,
`
`2015).
`
`5.
`
`
`Each of
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`the above-captioned actions are either stayed or
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`administratively closed.
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`6.
`
`
`On June 16, 2016, the Board instituted trial on claims 1-22 of the ‘209
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`patent in the Sandoz IPR based on the grounds of unpatentability raised by Sandoz.
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`(Paper No. 14).
`
`
`
`3
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`
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`7.
`
`
`Petitioners filed the instant Petition and Motion for Joinder on July 13,
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`2016, within one month of the June 16, 2016 institution date of the Sandoz IPR.
`
`8.
`
`
`The instant petition for IPR filed by Petitioners challenges the same
`
`patent claims, contains the same instituted ground of unpatentability, and the
`
`ground is the same in all substantive aspects as the Sandoz IPR. Both petitions
`
`contain the same analysis and exhibits, and rely upon the same expert.
`
`9.
`
`
`Sandoz consents to joinder with Petitioners, and Petitioners have
`
`jointly-retained Sandoz’s expert, Dr. Ron D. Schiff, who submits a substantively
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`identical expert declaration on behalf of Petitioners in support of the instant
`
`Petition as he did in the Sandoz IPR.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`Petitioners respectfully request that the Board exercise its discretion and
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`grant joinder of the Petitioners’ IPR and the Sandoz IPR 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,
`
`Petitioners propose—and Sandoz has agreed—to consolidated filings and other
`
`procedural accommodations designed to streamline the proceedings. Petitioners
`
`and Sandoz have also agreed to rely on the same expert, and expert declaration, in
`
`support of their Petitions.
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`
`
`4
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`
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`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes
`
`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
`
`(c) JOINDER.—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 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., IPR2013-00385, Paper No. 17, Slip Op. at 3 (July 29, 2013). 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 Petitioners’ IPR with the Sandoz 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
`
`
`
`5
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`
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`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.
`
`A. Reasons Why Joinder Is Appropriate
`Joinder is appropriate here because it is the most expedient way to secure the
`
`just, speedy, and inexpensive resolution of the two related proceedings. See 35
`
`U.S.C. § 316(b); 37 C.F.R. § 42.1(b). In an intentional effort to avoid
`
`multiplication of issues before the Board, Petitioners’ IPR is substantively identical
`
`with respect to the ground instituted in the Sandoz IPR and is supported by
`
`identical expert testimony. Given the duplicative nature of these petitions, joinder
`
`of the related proceedings is appropriate and conserves Board resources. Further,
`
`Petitioners and Sandoz have agreed to consolidated filings and discovery, and have
`
`agreed to other procedural concessions, so that in this matter Petitioners will be
`
`bound by the schedule set forth in the Sandoz IPR.
`
`Substantively Identical Petitions
`
`1.
`Petitioners’ IPR challenges the same patent claims, contains the same
`
`
`
`instituted ground of unpatentability, and is the same in all substantive aspects as
`
`the Sandoz IPR. Both petitions contain the same analysis and exhibits, and
`
`Petitioners rely upon the same expert and expert declaration. Because the Board
`
`has already instituted trial in the Sandoz IPR (Paper No. 14), Petitioners’
`
`substantively identical IPR will not require additional Board resources to
`
`
`
`6
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`
`
`determine that institution on the same ground as in the Sandoz IPR institution
`
`decision is appropriate here. 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 to that proceeding, and thus
`
`allowed to file its own briefs and make its own arguments.”)
`
`Consolidated Filings and Discovery
`
`2.
`Because the ground of unpatentability and the prior art relied on in
`
`Petitioners’ IPR and the Sandoz IPR are the same, Petitioners and Sandoz agree to
`
`submit consolidated filings for all substantive papers in the proceeding (e.g., Reply
`
`to the Lilly’s Response, Opposition to Motion to Amend, Motion for Observation
`
`on Cross Examination Testimony of a Reply Witness, Objection to Evidence,
`
`Motion to Exclude Evidence, Opposition Motion to Exclude Evidence and Reply).
`
`For such consolidated filings, Petitioners and Sandoz do not request any increase in
`
`the ordinary one-party limit on length. These agreed-to consolidated filings avoid
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`lengthy and duplicative briefing.
`
`Consolidated discovery is also appropriate given that Petitioners and Sandoz
`
`will rely on the same expert and expert declaration in the two proceedings.
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`Petitioners agree to coordinate discovery with Sandoz, such that a single attorney
`
`will conduct cross-examination of any given witness produced by Lilly within the
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`
`
`7
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`
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`timeframe normally allotted by the rules for one party. Likewise, the redirect of
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`any given witness produced by Petitioners and Sandoz will be conducted by a
`
`single attorney on behalf of both Sandoz and Petitioners, and within the timeframe
`
`normally allotted by the rules for one party.
`
`The consolidated filings and coordinated discovery described above will
`
`minimize—if not eliminate—any burden from a joined proceeding.
`
`B. No New Grounds of Unpatentability
`Petitioners’ IPR contains the same ground of unpatentability instituted in the
`
`Sandoz IPR. In fact, the grounds of unpatentability are identical in all substantive
`
`respects. As a result, Petitioners’ IPR raises no new grounds of unpatentability
`
`from those of the Sandoz IPR.
`
`C. No Impact on IPR Trial Schedule
`The difference between the filing date of Petitioners’ IPR and the Sandoz
`
`IPR is without consequence should the proceedings be joined. The trial schedule
`
`for the Sandoz IPR would not need to be delayed to effect joinder based on Lilly’s
`
`preliminary response and Petitioners’ later-filed IPR. Indeed, Petitioners agree to
`
`follow the current schedule in the Sandoz IPR, as modified by Sandoz, Lilly,
`
`and/or the Board. Moreover, given that Petitioners’ IPR asserts the same ground of
`
`unpatentability as instituted in the Sandoz IPR, Lilly should be able to expedite
`
`filing their preliminary response—to the extent they do not choose to waive it
`
`
`
`8
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`
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`entirely. 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
`As discussed above, Petitioners agree to consolidated filings and discovery,
`
`which will simplify the briefing and discovery process. Moreover, because
`
`Petitioners and Sandoz rely on the same grounds, expert, and expert declaration,
`
`there need be no delay to the joined proceeding should Sandoz settle and withdraw
`
`the Sandoz IPR. Petitioners will simply continue on Sandoz’s place.1
`
`Joinder Will Not Prejudice Lilly or Neptune
`
`E.
`Permitting joinder will not prejudice Lilly or Sandoz. Sandoz consents to
`
`joinder. And Petitioners raise no issues not already before the Board, so joinder
`
`will not affect the timing of the Sandoz IPR. Moreover, because Petitioners’ and
`
`Sandoz’s petitions and evidence are substantively identical, the content of Lilly’s
`
`filings to-date (and going forward) in the Sandoz IPR apply equally to Petitioners’
`
`
`1 Should Sandoz settle and withdraw the Sandoz IPR, Petitioners agree to work
`
`with the parties to any other IPR joined with the Sandoz IPR and the Board to
`
`agree to similar procedures to avoid duplicative briefing and/or discovery. See,
`
`e.g., Teva Pharm. USA, Inc. v. Eli Lilly & Co., IPR2016-01340 (filed July 1, 2016).
`
`
`
`9
`
`
`
`IPR. Therefore no additional expense or delay need be incurred if joinder is
`
`granted.
`
`Furthermore, joinder will not impact the instituted Neptune IPRs, IPR2016-
`
`00240 and IPR2016-00237 because Petitioners would be joining the Sandoz IPR as
`
`an understudy relying on identical grounds for invalidity as those in the Sandoz
`
`IPR. And even if Sandoz settles and/or withdraws the Sandoz IPR, Petitioners can
`
`readily pick up where Sandoz left off given that the grounds for invalidity are
`
`identical and Petitioners have retained and will use the same expert as Sandoz.
`
`In contrast, Petitioners and the public interest may be prejudiced if joinder is
`
`denied. For example, allowing a joined inter partes review would avoid prejudice
`
`to Petitioners in the event that Sandoz and Lilly settle their dispute. 35 U.S.C. §
`
`317(a) provides that an inter partes review “shall be terminated with respect to any
`
`petitioner upon the joint request of the petitioner and the patent owner” unless the
`
`Board has already reached its decision on the merits. If no petitioner remains after
`
`settlement, “the Office may terminate the review.” Id. Joining Petitioners serves
`
`the public interest by ensuring the validity of the ‘209 patent continues to be tested
`
`in the event of a settlement and—if found wanting—will permit Petitioners’ to
`
`launch generic pemetrexed products. In re Barr Labs., Inc., 930 F.2d 72, 76 (D.C.
`
`Cir. 1991) (Congress enacted Hatch-Waxman precisely “to get generic drugs into
`
`the hands of patients at reasonable prices—fast.”).
`
`
`
`10
`
`
`
`F.
`
`Expedited Briefing will Assist in Administering this Proceeding in
`a Just, Speedy and Efficient Manner
`
`Petitioners respectfully request an expedited briefing schedule, requiring the
`
`patent owner’s preliminary response to be filed within one month. An expedited
`
`briefing schedule will not prejudice the patent owner because the grounds,
`
`references and expert declaration are identical to those in the Sandoz IPR, and
`
`Patent Owner chose not to address the merits of the petition in the Sandoz IPR in
`
`its preliminary response. See IPR2016-00318 Paper 19, at 9. Rather, an expedited
`
`briefing schedule “is not unduly burdensome and will assist in administering this
`
`proceeding in a just, speedy and efficient manner” pursuant to 37 C.F.R. § 42.1(b).
`
`Samsung Electronics Co., Ltd., v. Arendi S.A.R.L., IPR2014-01144, Paper 9, Slip
`
`Op. at 2 (Sept. 5, 2014).
`
`IV. PROPOSED ORDER
`Petitioners propose a joinder order for consideration by the Board as
`
`follows:
`
`• Petitioners’ IPR will be instituted and joined with the Sandoz IPR on
`
`the same grounds as those for which review was instituted in the
`
`Sandoz IPR.
`
`• The scheduling order entered in the Sandoz IPR will apply to the
`
`joined proceeding.
`
`
`
`11
`
`
`
`• Petitioners are bound by the procedural concessions set forth in their
`
`Motion for Joinder to the Sandoz IPR, or as otherwise agreed between
`
`the parties to the joined proceedings or ordered by the Board.
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`• An expedited briefing schedule, requiring
`
`the patent owner’s
`
`preliminary response to be filed within one month.
`
`V. CONCLUSION
`For the foregoing reasons, Petitioners respectfully requests that its Petition
`
`for inter partes review of U.S. Patent No. 7,772,209 be instituted and that the
`
`proceeding be joined with Sandoz Inc. v. Eli Lilly & Co., IPR2016-00318.
`
`Although no additional fee is believed to be required for this Motion, the
`
`Commissioner is hereby authorized to charge any additional fees which may be
`
`required for this Motion to Deposit Acct. No. 503626.
`
`
`
`
`
`12
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`
`
`July 14, 2016
`
`
`
` Thomas J. Parker
` Reg. No. 42,062
` thomas.parker@alston.com
` Alston & Bird LLP
` 90 Park Avenue, 15th Floor
` New York, NY 10016
` T: (212) 210-9529
` F: (212) 210-9444
`
`Counsel for Mylan Laboratories
`Limited
`
`
`
`Paul M. Zagar
`Reg. No. 52,392
`PZagar@BlankRome.com
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`T: 212-885-5290
`F: 917-332-3063
`
`Counsel for Emcure
`
`
`
`Respectfully submitted,
`
`/Deanne M. Mazzochi/
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500,
`Chicago, Illinois 60654
`Tel.: 312-222-6305
`
`Lead Counsel and Counsel to Apotex
`Corp. and Apotex Inc.
`
`
`Gerard A. Haddad
`Reg. No. 41,811
`GHaddad@BlankRome.com
`Blank Rome LLP
`
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`T: 212-885-5135
` F: 917-591-6921
`
`Counsel for Glenmark
`
`
`
`
`
`
`
`
`13
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on July 14, 2016, a copy of this Petitioner’s Motion for
`
`Joinder Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 and 42.122(b) was
`
`served via U.S.P.S. Priority Mail Express, on Eli Lilly & Company at the
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`correspondence address of record for the ‘209 patent as evidenced in Public PAIR
`
`on July 14, 2016, namely
`
`Elizabeth A. McGraw
`Eli Lilly and Company
`Patent Division
`P.O. Box 6288
`Indianapolis, Indiana 46206-6288
`
`Dov P. Grossman
`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
`dgrossman@wc.com
`dkrinsky@wc.com
`leeds_james@lilly.com
`
`Lead Counsel for Eli Lilly & Company
`in the Sandoz IPR
`
`
`
`/Deanne M. Mazzochi/
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`And electronically on:
`
`
`Ralph J. Gabric
`Brinks Gilson & Lione
`Suite 3600 NBC Tower
`455 Cityfront Plaza Drive
`Chicago IL 60611-5599
`rgabric@brinksgilson.com
`llydigsen@brinksgilson.com
`
`Lead Counsel for Sandoz
`in the Sandoz IPR
`
`
`Dated: July 14, 2016
`
`
`
`14