`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.
`Petitioner
`
`v.
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`GENENTECH, INC. AND CITY OF HOPE
`Patent Owners
`____________
`
`U.S. Patent No. 6,331,415
`
`“Methods of Producing Immunoglobulins, Vectors and
`Transformed Host Cells for Use Therein”
`____________
`
`Inter Partes Review No. IPR2017-00047
`
`PETITIONER’S MOTION FOR JOINDER PURSUANT TO
`35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`
`
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`I.
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`II.
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`TABLE OF CONTENTS
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`Page
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`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
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`BACKGROUND AND RELATED PROCEEDINGS ................................... 2
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 4
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`A.
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`B.
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`Legal Standard ....................................................................................... 4
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`Joinder Is Appropriate ........................................................................... 5
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`1.
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`Joinder Will Not Introduce Any New Grounds of
`Unpatentability ............................................................................ 6
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`2.
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`Joinder Will Not Impact the Mylan IPR’s Trial Schedule ......... 9
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`3. Merck Agrees to Consolidated Filings and Discovery .............10
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`IV. PROPOSED ORDER ....................................................................................12
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`V.
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`CONCLUSION ..............................................................................................13
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`
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`i
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`TABLE OF AUTHORITIES
`
`Cases
`Amneal Pharm., LLC v. Yeda Res. & Dev. Co., Ltd.,
`IPR2015-01976, Paper 9 (Dec. 28, 2015) ............................................................... 6
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385, Paper 17 (July 29, 2013) .........................................................4, 5
`Kyocera Corp. et al. v. Softview LLC,
`IPR2013-00004, Paper 15 (Apr. 24, 2013) ............................................................. 5
`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256, Paper 10 (June 20, 2013) ............................................................. 6
`Mylan Pharmaceuticals Inc. v. Novartis AG et al.,
`IPR2015-00268, Paper 17 (April 10, 2015)..................................................... 6, 12
`Statutes & Regulations
`35 U.S.C. § 315(c) .................................................................................................1, 4
`35 U.S.C. § 316(a) ..................................................................................................... 9
`35 U.S.C. § 316(b) ..................................................................................................... 5
`37 C.F.R. § 42.1(b) .................................................................................................... 5
`37 C.F.R. § 42.100(c) ................................................................................................. 9
`37 C.F.R. § 42.122(b) ............................................................................................2, 4
`37 C.F.R. § 42.22 ...................................................................................................2, 4
`Other Authorities
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 8
`
`
`
`
`ii
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Petitioner Merck Sharp & Dohme Corp. (“Merck”) submits concurrently
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`herewith a Petition for inter partes review (“IPR”) of U.S. Patent No. 6,331,415
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`(“Petition”) based on grounds identical to those that formed the basis for pending
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`IPR proceedings in Mylan Pharmaceuticals Inc. v. Genentech Inc., et al., IPR2016-
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`00710, (the “Mylan IPR”). See Paper 13 (Institution of Inter Partes Review, 37
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`C.F.R. §42.108) (Sept. 8, 2016), at 2. Pursuant to 35 U.S.C. § 315(c), Merck
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`respectfully requests and moves that its Petition be instituted and joined with the
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`Mylan IPR, for the exact same reasons previously considered by the Patent Trial
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`and Appeal Board (“Board”), on the exact same trial schedule. Mylan consents to
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`Merck’s request for joinder.
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`Merck submits that joinder is appropriate because: (a) Merck does not seek
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`to add to or alter the grounds of unpatentability that the Board has already
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`instituted in the Mylan IPR; (b) joinder will have no impact on the existing
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`schedule in the Mylan IPR; and (c) joinder will promote the efficient resolution of
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`issues related to the ’415 patent, specifically whether U.S. Patent No. 6,331,415
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`(“the ’415 patent”) is obvious over well-known prior art.
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`Absent joinder, Merck may be prejudiced as it has a significant interest in
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`the underlying validity determination at issue in the Mylan IPR, given the potential
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`impact on litigation proceedings between Merck and the owners of the ’415 patent,
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`1
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`Genentech Inc. (“Genentech”) and City of Hope (collectively “Patent Owners”)
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`involving related patent, U.S. Patent No. 7,923,221 (the ’221 patent), which is a
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`continuation patent and involves the same recombinant antibody technology
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`claimed by the ’415 patent. Joinder would protect Merck’s interests without
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`affecting the scheduling or complexity of the pending Mylan IPR, and without
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`prejudice to the prior petitioner, Mylan, or to Patent Owners. In light of the fact
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`that Merck’s petition raises the same grounds of unpatentability over the same
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`prior art, and that Merck is willing to agree to consolidated filings with Mylan,
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`joinder with the Mylan IPR is appropriate.
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`Merck’s present motion for joinder is timely under 37 C.F.R. §§ 42.22 and
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`42.122(b) because it is submitted within one month of September 8, 2016, the date
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`on which the Mylan IPR was instituted.
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`II. BACKGROUND AND RELATED PROCEEDINGS
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`In its Petition, Merck requests institution of an IPR on challenged claims 1-
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`4, 11, 12, 14, 18-20, and 33 of the ’415 patent and asserts the same two grounds of
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`unpatentability that were instituted in the Mylan IPR. These are all of the claims
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`for which an IPR was instituted previously in the Mylan IPR. See Paper 13, at 2.
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`Prior to the Mylan IPR, the Board instituted an IPR of the same claims of the ’415
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`patent based on the same grounds in Sanofi-Aventis U.S. LLC, et al. v. Genentech,
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`Inc., et al., IPR2015-01624 (the “Sanofi IPR”). See Paper 15 (Institution of Inter
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`2
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`
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`Partes Review, 37 C.F.R. §42.108) (Feb. 5, 2016), at 22-23. A separate IPR
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`petition filed by Petitioner Genzyme Corporation was subsequently instituted on
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`the same grounds and joined to the Sanofi IPR. See Genzyme Corp. v. Genentech,
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`Inc., et al., IPR2016-00460 (the “Genzyme IPR”), Paper 12 (June 8, 2016); Sanofi
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`IPR, Paper 35 (March 28, 2016). Mylan then challenged the then-instituted claims
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`on the then-instituted grounds and, while its Petition was pending, the Sanofi IPR
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`was terminated (along with the joined Genzyme IPR). See Paper 43 (Termination
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`of the Proceeding, 37 C.F.R. § 42.73) (Sept. 2, 2016), at 1-2. Thereafter, the
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`Mylan IPR was instituted on those same two previously-instituted grounds. See
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`Mylan IPR, Paper 13, at 13-14. Merck’s Petition challenges the same patent
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`claims on grounds that are the same in all substantive aspects as the Mylan IPR.
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`Both petitions contain the same analysis and exhibits, and effectively rely upon the
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`same underlying expert opinions―as described further below.
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`As noted supra, Merck and Patent Owners are currently engaged in related
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`district court litigation in Merck Sharp & Dohme Corp. v. Genentech, Inc., et al.,
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`No. 16-cv-4992 (C.D. Cal.) (filed July 7, 2016) concerning the ’221 patent, a
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`continuation patent that involves the same recombinant antibody technology as
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`the ’415 patent. In addition, Merck and Patent Owners are currently engaged in
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`related proceedings related to the ’415 patent and the subject matter in this
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`Petition. Merck has a separate, pending petition for IPR of the ’415 patent in
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`3
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`Merck Sharp & Dohme Corp. v. Genentech, Inc., et al., IPR2016-01373 (filed July
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`7, 2016).
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
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`Merck respectfully requests that the Board exercise its discretion and grant
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`joinder of the instant Petition and the Mylan IPR proceedings pursuant to 35
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`U.S.C. § 315(c), 37 C.F.R. § 42.22, and 37 C.F.R. § 42.122(b). In support of this
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`Motion, Merck proposes
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`consolidated
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`filings
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`and other procedural
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`accommodations designed to streamline the proceedings.
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`A. Legal Standard
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`The Leahy-Smith America Invents Act permits joinder of IPR proceedings.
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`The statutory provision governing joinder of IPR proceedings is 35 U.S.C. §
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`315(c), which reads as follows:
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`(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.
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`Motions 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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`4
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`may be simplified.” Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-
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`00385, Paper 17 (July 29, 2013), at 4; Kyocera Corp. et al. v. Softview LLC,
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`IPR2013-00004, Paper 15 (Apr. 24, 2013). Under its discretion, the Board
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`considers the impact of substantive and procedural issues on the proceedings, as
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`well as other considerations, while being “mindful that patent trial regulations,
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`including the rules for joinder, must be construed to secure the just, speedy, and
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`inexpensive resolution of every proceeding.” Dell, Inc., IPR2013-00385, Paper 17,
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`at 3. The Board may also consider “the policy preference for joining a party that
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`does not present new issues that might complicate or delay an existing
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`proceeding.” Id. at 10. Under this framework, for the reasons set forth in the
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`Petition and the present motion, joinder of the present instant Petition with the
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`Mylan IPR is appropriate.
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`B.
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`Joinder Is Appropriate
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`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 two related proceedings.
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`See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). The Instant Petition is substantively
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`identical with respect to the grounds instituted in the Mylan IPR. Given the
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`duplicative nature of these petitions and Merck’s significant interest in the
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`underlying validity determination at issue, joinder of the related proceedings is
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`appropriate and conserves Board resources. Further, Merck will agree to
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`5
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`consolidated filings and discovery, and procedural concessions, so that in this
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`matter Merck will be bound by the schedule set forth in the Mylan IPR.
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`In other proceedings, the Board has found joinder is appropriate where (1)
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`no new grounds of unpatentability are introduced, (2) the party joining the
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`proceeding agrees to consolidated filings and discovery, (3) joinder will not affect
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`the schedule in the pending IPR, and (4) joinder will streamline the proceedings
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`and increase efficiency without prejudicing the parties. See, e.g., Amneal Pharm.,
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`LLC v. Yeda Res. & Dev. Co., Ltd., IPR2015-01976, Paper 9 (Dec. 28, 2015)
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`(granting motion for joinder where petitioner limited the grounds of unpatentatility
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`to those already instituted, relied on the same expert testimony, agreed to “assume
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`a limited ‘understudy’ role,” and submitted that joinder would not affect the
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`pending schedule); Mylan Pharmaceuticals Inc. v. Novartis AG, et al., IPR2015-
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`00268, Paper 17 (April 10, 2015) (granting motion for joinder of substantially
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`identical petition where petitioner agreed to consolidated filings and discovery and
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`relied on the same expert declarations); Motorola Mobility LLC v. Softview LLC,
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`IPR2013-00256, Paper 10 (June 20, 2013) (granting motion for joinder under
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`similar circumstances). This Petition is no different.
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`1.
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`Joinder Will Not Introduce Any New Grounds of
`Unpatentability
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`The instant Petition contains the same grounds of unpatentability instituted
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`in the Mylan IPR. In fact, the grounds of unpatentability are identical in all
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`6
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`substantive respects. Merck’s Petition challenges the same patent claims, contains
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`the same instituted grounds of unpatentability, and is the same in all substantive
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`aspects as the instituted Mylan IPR. Merck’s Petition contains the same analysis
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`and exhibits, and effectively relies on the same expert opinions—those of Dr.
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`Jefferson Foote as adopted by Kathryn Calame.1
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`If joinder is granted, Merck is prepared to rely solely on the testimony of
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`Mylan’s expert, Dr. Calame, who “fully agree[s] with, and hereby adopt[s], the
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`opinions set forth in the Foote Declaration.” See Calame Declaration at ¶ 16. Only
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`if the Mylan IPR settles prior to a final written decision, Merck would elect to rely
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`on its own expert, Dr. Margaret H. Baron, who has submitted a declaration
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`1
`Previously, in its Motion for Joinder with the Sanofi IPR, Mylan agreed to
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`“rely solely on the testimony of Sanofi’s expert, Dr. Foote, unless the Sanofi IPR is
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`settled prior to a final written decision” and that “no additional discovery would be
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`needed” as long as the Sanofi IPR remains pending following joinder. See Mylan
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`IPR, Paper 3 (March 3, 2016), at 2, 7. Mylan also retained its own expert, Dr.
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`Kathryn Calame, to preserve its position in the event that the Sanofi IPR settled
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`before a final decision; Dr. Calame simply adopted Dr. Foote’s opinions in the
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`Sanofi IPR. Id.; see also Ex. 1059 (Declaration of Kathryn Calame, Ph.D., in
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`Support of Mylan Pharmaceuticals Inc.’s Petition for Inter Partes Review of U.S.
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`Patent No. 6,331,415) (“Calame Declaration”).
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`7
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`identical to Dr. Calame’s declaration in all material respects. See Merck Petition,
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`IPR2017-00047, Ex. 1006 (Declaration of Margaret H. Baron, M.D., Ph.D., in
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`Support of Merck Sharp & Dohme Corp.’s Petition for Inter Partes Review of U.S.
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`Patent No. 6,331,415) (“Baron Declaration”).
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`Dr. Baron’s Declaration in the instant Petition is substantively identical to
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`Dr. Foote’s opinion in the Sanofi IPR, which Mylan submitted in support of its
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`petition for IPR and which Mylan’s expert Dr. Calame expressly incorporates as
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`her own opinion. The Baron Declaration does not alter or otherwise seek to
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`supplement the opinions offered by Dr. Foote, nor does Dr. Baron intend to offer
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`opinions beyond those expressed by Dr. Foote in connection with the Sanofi IPR
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`and adopted by Dr. Calame in the connection with the Mylan IPR.
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`Because the Board has already instituted trial in the Mylan IPR, the
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`substantively identical instant Petition and supporting exhibits will not require
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`additional Board resources to determine that institution on the same grounds as in
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`the Mylan IPR and joinder of the instant petition with the Mylan IPR is appropriate
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`here. Indeed, in circumstances such as these, the PTO anticipated that joinder of
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`proceedings 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 IPR is instituted on the basis of a petition,
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`8
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`for example, a party that files an identical petition will be joined to that
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`proceeding, and thus allowed to file its own briefs and make its own arguments.”).
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`2.
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`Joinder Will Not Impact the Mylan IPR’s Trial Schedule
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`Joinder will not impact the Board’s ability to complete its review in a timely
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`manner. 35 U.S.C. § 316(a)(11) and 37 C.F.R. § 42.100(c) provide that IPR
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`proceedings should be completed and the Board’s final decision issued within one
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`year of institution of the review. The same provisions provide the Board with
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`flexibility to extend the one-year period by up to six months for good cause, or in
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`the case of joinder. See 35 U.S.C. § 316(a)(11); 37 C.F.R. § 42.100(c). In this
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`case, joinder should not affect the Board’s ability to issue its final determination
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`within one year because Merck does not raise any issues that are not already before
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`the Board and the Mylan IPR was instituted only one month ago. See Mylan IPR,
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`Paper 13.
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`Merck agrees that the Scheduling Order issued in the Mylan IPR will apply
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`to the joined proceeding. See Mylan IPR, Paper 14 (Scheduling Order) (Sept. 8,
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`2016). The first deadline is the Initial Conference Call, which has not yet occurred
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`and which deadline is “Upon Request” by the parties. Id. at 7. Mylan does not
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`object to Merck’s participation on this call and Merck’s involvement will not delay
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`the timing of the as-yet-unscheduled call.
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`The next deadline in the Mylan IPR is Patent Owner’s response to the
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`petition and any motion to amend the petition, which is currently set for December
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`8, 2016―almost two months from the date of this motion. Should the Board grant
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`Merck’s request for joinder, Patent Owners will have ample time to complete its
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`submission by its deadline, particularly given that Patent Owners’ response would
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`not require any analysis beyond what they are already required to undertake to
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`respond to Mylan’s petition. None of the other deadlines would need to be
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`extended following joinder of Merck’s Petition to those proceedings. In sum, no
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`aspect of the trial schedule for the Mylan IPR would need to be impacted to effect
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`joinder. Rather, a joint proceeding would allow the Board and parties to focus on
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`the merits in one consolidated proceeding without unnecessary duplication of
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`effort, and in a timely manner.
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`3. Merck Agrees to Consolidated Filings and Discovery
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`Because the grounds of unpatentability and the prior art relied on in the
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`instant Petition and the Mylan IPR are the same, the case is amenable to
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`consolidated filings and discovery, which will simplify the briefing and discovery
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`process.
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`Merck will agree to consolidated filings for all substantive papers in the
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`proceedings (e.g., Reply to the Patent Owner’s Response, Opposition to Motion to
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`Amend, Motion for Observation on Cross Examination Testimony of a Reply
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`10
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`Witness, Motion to Exclude Evidence, Opposition to Motion to Exclude Evidence
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`and Reply). Specifically, Merck will agree to incorporate its filings with those of
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`Mylan into a consolidated filing in the Mylan IPR, including being subject to the
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`ordinary rules for one party on page limits. Mylan and Merck will be jointly
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`responsible for the consolidated filings. Merck agrees not to be permitted any
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`arguments separate from those advanced by Mylan in the consolidated filings, thus
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`avoiding lengthy and duplicative briefing.2
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`Consolidated discovery is also appropriate given that Merck agrees to take a
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`subordinate role in the proceedings and have Mylan take the lead in all discovery
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`matters. Merck agrees to work with Mylan to manage any depositions within an
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`ordinary time limit and to allow Mylan to take the lead in designating an attorney
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`to conduct the cross-examination of any given witness produced by Patent Owners,
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`and the redirect of any given witness produced by Merck and Mylan within the
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`ordinary time limits normally allotted by the rules for one party. Merck will not
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`receive any separate cross-examination or redirect time from that of Mylan, unless
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`2
`In the event that an issue arises that is directed to Merck alone, although
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`none is anticipated at this time, Merck proposes an arrangement where any
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`separate filing by Merck would be limited to no more than seven pages, and Patent
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`Owners would be allowed a corresponding number of pages to respond separately.
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`Mylan does not oppose this arrangement.
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`11
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`Mylan wishes otherwise or until Mylan terminates its involvement in the joined
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`deposition or oral hearing time.
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`If joinder is granted, Merck is also willing to agree to any other procedural
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`concessions that will minimize complication or delay and result in a speedy trial
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`with little to no impact on the Mylan IPR or the Board. In short, as long as the
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`Mylan IPR remains pending following joinder, no additional discovery would be
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`needed. Merck will adopt an “understudy” or “second chair” role and would only
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`assume the primary role if Mylan ceases to participate in the IPR. See, e.g.,
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`Novartis AG, IPR2015-00268, Paper 17, at 5.3
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`IV. PROPOSED ORDER
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`Merck proposes a joinder order for consideration by the Board as follows:
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`•
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`The instant Petition will be instituted and joined with the Mylan IPR on
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`the same grounds as those for which review was instituted in the Mylan
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`IPR;
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`3
`In the event that Mylan ceases to participate and Merck is required to rely on
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`Dr. Baron, there would be no impact on the Board’s ability to complete its review
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`in a timely manner. Moreover, there would only be a modest impact on the Patent
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`Owners, given that Merck’s contingent expert’s opinions are virtually identical to
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`those already introduced and relied upon by Mylan’s expert.
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`12
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`•
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`•
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`The scheduling order for the Mylan IPR will apply to the joined
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`proceeding.
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`Merck and Mylan will cooperate to avoid duplicative discovery and
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`testimony.
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`V. CONCLUSION
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`For the foregoing reasons, Merck respectfully requests that its Petition be
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`instituted and the proceeding joined with Mylan Pharmaceuticals Inc. v.
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`Genentech, Inc. et al., IPR2016-00710. Although no additional fee is believed to
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`be required for this Motion, the Commissioner is hereby authorized to charge any
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`additional fees which may be required for this Motion to Deposit Acct. No.
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`503626.
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`13
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`DATED: October 11, 2016
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`Respectfully submitted,
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`By s/Matthew A. Traupman
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`Matthew A. Traupman (Reg. No. 50,832)
`matthewtraupman@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`Katherine A. Helm (pro hac vice to be filed)
`khelm@stblaw.com
`SIMPSON THACHER & BARTLETT LLP
`425 Lexington Avenue
`New York, NY 10017
`Telephone: (212) 455-2000
`Facsimile: (212) 455-2502
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`Attorneys for Petitioner Merck Sharp &
`Dohme Corp.
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`14
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`CERTIFICATE OF SERVICE
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`I hereby certify that true and correct copies of the foregoing PETITIONER’S
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`MOTION FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§
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`42.22 AND 42.122(b) were served on October 11, 2016 via FEDERAL EXPRESS
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`to the attorneys of record for U.S. Patent No. 6,331,415 as evidenced on Public
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`PAIR on October 11, 2016, namely:
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`JEFFREY P. KUSHAN, ESQ.
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C. 20005
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`and
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`SEAN JOHNSTON, ESQ.
`Genentech, Inc.
`1 DNA Way
`South San Francisco, CA 94080
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`DATED: October 11, 2016
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`Respectfully submitted,
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`By s/Matthew A. Traupman
`Matthew A. Traupman (Reg. No. 50,832)
`matthewtraupman@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`
`15