UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`
`————————————————
`
`U.S. Patent No. 6,331,415
`Appl. No. 07/205,419, filed June 10, 1998
`Issued: Dec. 18, 2001
`
`Title: Methods of Producing Immunoglobulins, Vectors
`and Transformed Host Cells for Use Therein
`
`————————————————
`
`Inter Partes Review No.: IPR2016-00710
`
`————————————————
`
`PETITIONER’S MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`

`
`
`
`
`I. 
`
`II. 
`
`
`
`TABLE OF CONTENTS
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1 
`STATEMENT OF THE PRECISE RELIEF REQUESTED ........................ ..1
`
`TABLE OF CONTENTS
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2 
`
`STATEMENT OF MATERIAL FACTS ...................................................... ..2
`
`III. 
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3 
`STATEMENT OF REASONS FOR RELIEF REQUESTED ...................... ..3
`
`A. 
`A.
`
`Reasons Why Joinder Is Appropriate .................................................... 4 
`Reasons Why Joinder Is Appropriate .................................................. ..4
`
`1. 
`1.
`
`2. 
`2.
`
`Substantively Identical Petitions ................................................. 5 
`Substantively Identical Petitions ............................................... ..5
`
`Consolidated Filings and Discovery ........................................... 6 
`Consolidated Filings and Discovery ......................................... ..6
`
`No New Grounds of Unpatentability .................................................... 7 
`No New Grounds of Unpatentability .................................................. ..7
`
`No Impact on IPR Trial Schedule ......................................................... 8 
`No Impact on IPR Trial Schedule ....................................................... ..8
`
`Briefing and Discovery Will Be Simplified .......................................... 8 
`Briefing and Discovery Will Be Simplified ........................................ ..8
`
`Joinder Will Not Prejudice Patent Owners or Sanofi ........................... 8 
`Joinder Will Not Prejudice Patent Owners or Sanofi ......................... ..8
`
`B. 
`B.
`
`C. 
`C.
`
`D. 
`D.
`
`E. 
`E.
`
`IV.  PROPOSED ORDER ...................................................................................... 9 
`
`PROPOSED ORDER .................................................................................... ..9
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`IV.
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`V. 
`
`CONCLUSION ................................................................................................ 9 
`
`CONCLUSION .............................................................................................. ..9
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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 ....................................................................................................... 4
`
`Kyocera Corp. et al. v. Softview LLC,
`IPR2013-00004 ....................................................................................................... 1
`
`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256 ....................................................................................................... 2
`
`Sanofi-Aventis U.S. LLC et al. v. Genentech et al.,
`IPR2015-01624 ...................................................................................................1, 9
`
`Statutes 
`
`35 U.S.C. § 315(c) ..................................................................................................1, 3
`
`35 U.S.C. § 316(b) ..................................................................................................... 4
`
`Regulations 
`
`37 C.F.R. § 42.1(b) .................................................................................................... 4
`
`37 C.F.R. § 42.22 ............................................................................................... 1, 2, 3
`
`37 C.F.R. § 42.122(b) ......................................................................................... 1, 2, 3
`
`Other Authorities 
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 5
`
`
`
`
`
`ii
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`

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`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) filed the present petition for
`
`inter partes review (“the Mylan 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), Mylan
`
`requests institution of an inter partes review concerning U.S. Patent No. 6,331,415
`
`(“the ‘415 patent”) and joinder with the inter partes review concerning the same
`
`patent in Sanofi-Aventis U.S. LLC et al. v. Genentech et al., assigned Case No.
`
`IPR2015-01624, (the “Sanofi IPR”), which was instituted on February 5, 2016.
`
`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,
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`IPR2013-00004, Apr. 24, 2013), Mylan submits that: (1) joinder is appropriate
`
`because it will promote efficient determination of the validity of the ‘415 patent
`
`without prejudice to the prior petitioners, Sanofi-Aventis U.S. LLC (“Sanofi”) or
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`Regeneron Pharmaceuticals, Inc. (“Regeneron”), or to the owners of the ‘415 patent,
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`Genentech Inc. (“Genentech”) and City of Hope (collectively “Patent Owners”); (2)
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`Mylan’s Petition raises the same grounds of unpatentability over the same prior art as
`
`those instituted by the Board in the Sanofi IPR; (3) joinder would not affect the
`
`pending schedule in the Sanofi IPR nor increase the complexity of that proceeding,
`
`thereby minimizing costs; and (4) Mylan is willing to agree to consolidated filings
`
`with Sanofi and Regeneron to minimize the burden and the impact on the schedule.
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`
`
`1
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`

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`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,
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`IPR2015-01976 (Dec. 28, 2015) (granting motions for joinder under similar
`
`circumstances).
`
`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 February 5, 2016, the date on which the Sanofi IPR
`
`was instituted.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`Mylan requests institution of an inter partes review on the ‘415 patent and
`
`asserts the same grounds of unpatentability that were instituted in the Sanofi IPR.
`
`On February 5, 2016, the Board instituted trial on claims 1-4, 11, 12, 14, 18-
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`20, and 33 of the ‘415 patent in the Sanofi IPR based on two grounds of
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`unpatentability raised by Sanofi and Regeneron. The instant petition for IPR filed by
`
`Mylan challenges the same patent claims, contains the same instituted grounds of
`
`unpatentability, and those grounds are the same in all substantive aspects as the
`
`Sanofi IPR. Both petitions contain the same analysis and exhibits, and rely upon
`
`the same expert declaration.1
`
`
`1 As discussed in greater detail below, though Mylan submitted the Declaration of
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`Kathryn Calame, Ph.D. in connection with its IPR Petition, Mylan only seeks to
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`
`
`
`
`2
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`

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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`Mylan respectfully requests that the Board exercise its discretion and grant
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`joinder of the Mylan IPR and the Sanofi 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,
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`Mylan proposes consolidated filings and other procedural accommodations
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`designed to streamline the proceedings.
`
`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
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`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,
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`determines warrants the institution of an inter partes review under
`
`section 314.
`
`
`
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`preserve its rights in the event that the Sanofi IPR is settled or joinder is not
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`granted.
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`3
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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
`
`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, 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
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`framework, joinder of the present Mylan IPR with the Sanofi 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
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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.
`
`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 two related proceedings.
`
`See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Intentionally, the Mylan IPR is
`
`substantively identical with respect to the grounds instituted in the Sanofi IPR in an
`
`effort to avoid multiplication of issues before the Board. Given the duplicative
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`4
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`nature of these petitions, joinder of the related proceedings is appropriate and
`
`conserves Board resources. Further, Mylan will agree to consolidated filings and
`
`discovery, and procedural concessions, so that in this matter Mylan will be bound
`
`by the schedule set forth in the Sanofi IPR.
`
`Substantively Identical Petitions
`
`1.
`The instant petition for IPR filed by Mylan challenges the same patent
`
`
`
`claims, contains the same instituted grounds of unpatentability, and is the same in
`
`all substantive aspects as the Sanofi IPR. Both petitions contain the same analysis
`
`and exhibits, and Mylan intends to rely upon the same expert declaration. Because
`
`the Board has already instituted trial in the Sanofi IPR (Paper No. 15), the
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`substantively identical Mylan IPR will not require additional Board resources to
`
`determine that institution on the same grounds as in the Sanofi IPR institution
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`decision is appropriate here. Accordingly, maintaining the Mylan IPR proceeding
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`separate from that of the Sanofi IPR would entail duplication of effort, and could
`
`result in inconsistent results among these proceedings. 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
`
`
`
`5
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`

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`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 grounds of unpatentability and the prior art relied on in the
`
`Mylan IPR and the Sanofi IPR are the same, the case is amenable to consolidated
`
`filings. Mylan 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, Mylan will agree to incorporate its filings with those of
`
`Sanofi and Regeneron into a consolidated filing in the Sanofi IPR, including being
`
`subject to the ordinary rules for one party on page limits. Sanofi, Regeneron, and
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`Mylan will be jointly responsible for the consolidated filings.
`
`Mylan agrees not to be permitted any arguments separate from those
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`advanced by Sanofi and Regeneron in the consolidated filings. These limitations
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`avoid lengthy and duplicative briefing.
`
`Consolidated discovery is also appropriate given that Mylan, Sanofi, and
`
`Regeneron are using the same expert declaration in the two proceedings. Mylan,
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`Sanofi, and Regeneron will designate an attorney to conduct the cross-examination
`
`of any given witness produced by Genentech and City of Hope, and the redirect of
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`6
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`

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`any given witness produced by Mylan, Sanofi, and Regeneron within the
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`timeframe normally allotted by the rules for one party. Mylan will not receive any
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`separate cross-examination or redirect time from that of Sanofi and Regeneron.
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`Should joinder be granted, Mylan is prepared to rely solely on the testimony
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`of Sanofi’s expert, Dr. Foote, unless the Sanofi IPR is settled prior to a final
`
`written decision. Should the Sanofi IPR not reach a final decision, Mylan would
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`only then elect to rely on its own expert, Dr. Calame, who has reviewed and
`
`adopted the opinions set forth in the Foote Declaration relating to the instituted
`
`grounds of unpatentability. To be clear, as long as the Sanofi IPR remains pending
`
`following joinder, no additional discovery would be needed.
`
`Even if, through no fault of its own, Mylan were required to proceed with its
`
`own expert, there would be no impact on the Board’s ability to complete its review
`
`in a timely manner. Moreover, there would be only a modest impact on the Patent
`
`Owners, given that little additional preparation would be needed for the deposition
`
`of Mylan’s contingent expert beyond that required for the deposition of Sanofi’s
`
`expert.
`
`B. No New Grounds of Unpatentability
`The Mylan IPR contains the same grounds of unpatentability instituted in the
`
`Sanofi IPR. In fact, the grounds of unpatentability are identical in all substantive
`
`
`
`7
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`

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`respects. As a result, the Mylan IPR raises no new grounds of unpatentability from
`
`those of the Sanofi IPR.
`
`C. No Impact on IPR Trial Schedule
`The difference between the filing date of the Mylan IPR and the Sanofi IPR
`
`is without consequence should the proceedings be joined. The trial schedule for
`
`the Sanofi IPR would not need to be delayed to effect joinder based on Patent
`
`Owners’ preliminary response and later-filed Mylan IPR. Indeed, given that the
`
`Mylan IPR asserts substantively identical grounds of unpatentability as those
`
`instituted in the Sanofi IPR, there should be no need for the Patent Owners to
`
`submit a preliminary response. 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, Mylan is amenable to consolidated filings and
`
`discovery, which will simplify the briefing and discovery process.
`
`Joinder Will Not Prejudice Patent Owners or Sanofi
`
`E.
`Mylan proposes joinder to streamline the proceedings and reduce the costs
`
`and burdens on the parties and the Board. Mylan believes joinder will achieve
`
`these goals for 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
`8
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`

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`other discovery required in separate proceedings. Third, joinder eliminates the
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`possibility of conflicting rulings. Fourth, joinder creates case management
`
`efficiencies for the Board and parties without prejudice to Patent Owners.
`
`IV. PROPOSED ORDER
`Petitioner proposes a joinder order for consideration by the Board as
`
`follows:
`
` The Mylan IPR will be instituted and joined with the Sanofi IPR on
`
`the same grounds as those for which review was instituted in the
`
`Sanofi IPR.
`
` The scheduling order for the Sanofi IPR will apply to the joined
`
`proceeding.
`
` Mylan, Sanofi, and Regeneron will cooperate to avoid duplicative
`
`discovery and testimony.
`
`V. CONCLUSION
`For the foregoing reasons, Mylan respectfully requests that its Petition for
`
`inter partes review of U.S. Patent No. 6,331,415 be instituted and that the
`
`proceeding be joined with Sanofi-Aventis U.S. LLC et al. v. Genentech, Inc. et al.,
`
`IPR2015-01624. 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.
`
`
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`9
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`

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`Respectfully submitted,
`
` /Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`
`
`
`
`Dated: March 3, 2016
`
`
`
`10
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`

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`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that true and correct copies of the
`
`foregoing Petitioner’s Motion for Joinder Pursuant to 35 U.S.C. § 315(c) and 37
`
`C.F.R. §§ 42.22 and 42.122(b) were served on March 3, 2016, via FedEx Priority
`
`Overnight on the Patent Owners at the correspondence address of record for the
`
`‘415 patent as evidenced in Public PAIR on March 3, 2016, namely:
`
`JEFFREY P. KUSHAN, ESQ.
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C. 20005
`
`and
`
`SEAN JOHNSTON, ESQ.
`Genentech, Inc.
`1 DNA Way
`South San Francisco, CA 94080
`
`Respectfully submitted,
`
`
`
`Dated: March 3, 2016
`
`
`
` /Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325