UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________
`
`GENZYME CORPORATION,
`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, 1988
`Issued: Dec. 18, 2001
`
`Title: Methods of Producing Immunoglobulins, Vectors
`and Transformed Host Cells for Use Therein
`
`___________________________________
`
`IPR Trial No.
`
`IPR2016-00460
`___________________________________
`
`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 22313-14
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________
`
`GENZYME CORPORATION,
`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, 1988
`Issued: Dec. 18, 2001
`
`Title: Methods of Producing Immunoglobulins, Vectors
`and Transformed Host Cells for Use Therein
`
`___________________________________
`
`IPR Trial No.
`
`IPR2016-00460
`___________________________________
`
`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 22313-14
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`STATEMENT OF PRECISE RELIEF REQUESTED ..................................1
`
`STATEMENT OF MATERIAL FACTS .......................................................2
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED .......................3
`A.
`Reasons Why Joinder is Appropriate...................................................4
`1.
`Substantively Identical Petitions................................................5
`2.
`Consolidated Filings and Discovery..........................................6
`No New Grounds of Unpatentability ...................................................7
`B.
`No Impact on IPR Trial Schedule ........................................................7
`C.
`Briefing and Discovery Will Be Simplified.........................................7
`D.
`No Prejudice if Proceedings are Joined ...............................................8
`E.
`PROPOSED ORDER .....................................................................................8
`
`CONCLUSION.............................................................................................10
`
`-i-
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Amneal Pharma., Inc. v. Yeda Res. and Dev. Co., Ltd.,
`IPR2015-01976.....................................................................................................2
`
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`Case IPR2013-00385 ............................................................................................4
`
`Kyocera Corp. et al. v. Softview LLC,
`IPR2013-00004.....................................................................................................1
`
`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256.................................................................................................2, 7
`
`Statutes
`
`35 U.S.C. § 315(b) .....................................................................................................2
`
`35 U.S.C. § 315(c) .............................................................................................1, 3, 4
`
`35 U.S.C. § 316(b) .....................................................................................................5
`
`Leahy-Smith America Invents Act ............................................................................3
`
`Other Authorities
`
`37 C.F.R. § 42.1(b) ....................................................................................................5
`
`37 C.F.R. § 42.22 ...............................................................................................1, 2, 3
`
`37 C.F.R. § 42.122(a).................................................................................................3
`
`37 C.F.R. § 42.122(b) ........................................................................................1, 2, 3
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011)....................................................5
`
`-ii-
`
`
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`Genzyme Corporation (“Genzyme”) filed the present petition for inter partes
`
`review IPR2016-00460 (the “Genzyme 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),
`
`Genzyme requests institution of an inter partes review and joinder with the inter
`
`partes review concerning the same patent in Sanofi-Aventis U.S. LLC and
`
`Regeneron Pharmaceuticals, Inc. v. Genentech and City of Hope, which is assigned
`
`Case No. IPR2015-01624, (the “Sanofi-Aventis 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, IPR2013-00004, April 24, 2013), Genzyme submits that: (1) joinder is
`
`appropriate because it will promote efficient determination of the validity of the
`
`challenged patent, U.S. Patent No. 6,331,415 (the “’415 patent”) without prejudice
`
`to the prior petitioners, Sanofi-Aventis U.S. LLC (“Sanofi-Aventis”) or Regeneron
`
`Pharmaceuticals, Inc. (“Regeneron”), or to the owners of the challenged ’415 patent,
`
`Genentech Inc. (“Genentech”) and City of Hope (collectively “Patent Owners”); (2)
`
`Genzyme’s Petition raises the same grounds of unpatentability over the same prior
`
`art as the Sanofi-Aventis IPR; (3) joinder would not affect the pending schedule in
`
`the Sanofi-Aventis IPR nor increase the complexity of that proceeding, thereby
`
`
`
`minimizing costs; and (4) Genzyme is willing to agree to consolidated filings with
`
`Sanofi-Aventis and Regeneron 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 Pharma., Inc. v. Yeda Res. and Dev.
`
`Co., Ltd., Paper No. 9, IPR2015-01976 (granting motions for joinder under similar
`
`circumstances).
`
`This Motion for Joinder is timely filed under 37 C.F.R. §§ 42.22 and
`
`42.122(b), as it is filed less than one month after the Sanofi-Aventis IPR was
`
`instituted.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`The Sanofi-Aventis IPR and the Genzyme IPR both request institution on the
`
`’415 patent. Patent Owners have not asserted the ‘415 patent against any petitioning
`
`party in either IPR. Thus, the Sanofi-Aventis IPR and the Genzyme IPR were
`
`timely filed under 35 U.S.C. § 315(b).1
`
`1 Genzyme also filed IPR2016-00383 on December 30, 2015, in connection with the
`
`'415 patent. IPR2016-00383 is based on different prior art and different arguments
`
`supported by a different expert and a different expert declaration than in the Sanofi
`
`IPR and the instant Genzyme IPR. IPR2016-00383 is not part of the instant request
`
`for joinder.
`
`2
`
`
`
`The instant petition for IPR filed by Genzyme corresponds exactly to the
`
`petition filed by Sanofi-Aventis and Regeneron in IPR2015-01624. The instant
`
`petition challenges the same patent claims and is identical to the petition in
`
`IPR2015-01624 in all substantive aspects. Both petitions contain identical grounds,
`
`analysis, and exhibits, and rely upon the same expert declaration. Both petitions
`
`also involve the same real party in interest, Sanofi, which is the ultimate parent of
`
`Genzyme and Sanofi-Aventis.
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`Genzyme respectfully requests that the Board exercise its discretion and grant
`
`joinder of the Genzyme IPR and the Sanofi-Aventis 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, Genzyme proposes consolidated filings and other procedural
`
`accommodations designed to streamline the proceedings.
`
`The Leahy-Smith America Invents Act (“AIA”) permits the 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:
`
`the
`institutes an inter partes review,
`the Director
`If
`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
`
`3
`
`
`
`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 Genzyme’s present Petition with the Sanofi-Aventis 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.
`
`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 Genzyme IPR is
`
`4
`
`
`
`substantively identical to the corresponding Sanofi-Aventis 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 and conserves
`
`Board resources. Further, Genzyme, will agree to consolidated filings and
`
`discovery, and procedural concessions, so that in this matter Genzyme will be bound
`
`by the schedule set forth in the Sanofi-Aventis IPR.
`
`1.
`
`Substantively Identical Petitions
`
`Genzyme represents that the Genzyme IPR is identical to the Sanofi-Aventis
`
`IPR in all substantive respects. It includes identical grounds, analysis, and exhibits
`
`and relies upon the same expert declaration. Because the Board has already
`
`instituted trial in the Sanofi-Aventis IPR (Paper No. 15), the substantively identical
`
`Genzyme IPR will not require additional Board resources to determine that
`
`institution on the same grounds as in the Sanofi-Aventis IPR institution decision is
`
`appropriate here. Accordingly, maintaining the Genzyme IPR proceeding separate
`
`from that of the Sanofi-Aventis 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 identical
`
`5
`
`
`
`petition will be joined to that proceeding, and thus allowed to file its own briefs and
`
`make its own arguments.”)
`
`2.
`
`Consolidated Filings and Discovery
`
`Because the grounds of unpatentability and the prior art relied on in the
`
`Genzyme IPR and the Sanofi-Aventis IPR are the same, the case is amenable to
`
`consolidated filings. Genzyme 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, Genzyme will agree to incorporate its filings
`
`with those of Sanofi-Aventis and Regeneron into a consolidated filing in the Sanofi-
`
`Aventis IPR, including being subject to the ordinary rules for one party on page
`
`limits. Sanofi, Regeneron and Genzyme will be jointly responsible for the
`
`consolidated filings.
`
`Genzyme agrees not to be permitted any arguments separate from those
`
`advanced by Sanofi-Aventis and Regeneron in the consolidated filings. These
`
`limitations avoid lengthy and duplicative briefing.
`
`Consolidated discovery is also appropriate given that Genzyme, Sanofi-
`
`Aventis and Regeneron are using the same expert declaration in the two
`
`proceedings. Genzyme, Sanofi-Aventis and Regeneron will designate an attorney to
`
`6
`
`
`
`conduct the cross-examination of any given witness produced by Genentech and
`
`City of Hope, and the redirect of any given witness produced by Genzyme, Sanofi-
`
`Aventis and Regeneron within the timeframe normally allotted by the rules for one
`
`party. Genzyme will not receive any separate cross-examination or redirect time
`
`from that of Sanofi-Aventis and Regeneron.
`
`B.
`
`No New Grounds of Unpatentability
`
`The Genzyme IPR raises no new grounds of unpatentability from those of the
`
`Sanofi-Aventis 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 Genzyme IPR and the Sanofi-
`
`Aventis IPR is without consequence should the proceedings be joined. The trial
`
`schedule for the Sanofi-Aventis IPR would not need to be delayed to effect joinder
`
`based on Genentech and City of Hope’s preliminary response and the later-filed
`
`Genzyme IPR. The joint proceeding would allow the Board and parties to focus on
`
`the merits in one consolidated proceeding in a timely manner without unnecessary
`
`duplication of effort.
`
`D.
`
`Briefing and Discovery Will Be Simplified
`
`Joinder will simplify briefing and discovery because Genzyme seeks an order
`
`similar to that issued in Motorola Mobility LLC v. Softview LLC, IPR2013-00256
`
`7
`
`
`
`(PTAB June 20, 2013) (Paper 10). As discussed above, Genzyme, Sanofi-Aventis
`
`and Regeneron will engage in consolidated filings and discovery, which will
`
`simplify the briefing and discovery process.
`
`E.
`
`No Prejudice if Proceedings are Joined
`
`Genzyme proposes joinder to streamline the proceedings and reduce the costs
`
`and burdens on the parties. Genzyme 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 other discovery required in
`
`separate proceedings. Third, joinder eliminates the 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 Genzyme IPR will be instituted and joined with the Sanofi-Aventis
`
`IPR on the same grounds as those for which review was instituted in
`
`the Sanofi-Aventis IPR.
`
`The scheduling order for the Sanofi-Aventis IPR will apply to the
`
`joined proceeding.
`
`8
`
`
`
`"
`
`Throughout the proceeding, Genzyme, Sanofi-Aventis and Regeneron
`
`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 continue to participate in
`
`the merged proceeding, Genzyme, Sanofi-Aventis and Regeneron will
`
`identify each such filing as a Consolidated Filing and will be
`
`responsible for completing all consolidated filings.
`
`"
`
`Genzyme, Sanofi-Aventis and Regeneron will designate an attorney to
`
`conduct the cross examination of any given witness produced by Patent
`
`Owners and the redirect of any witness produced by Genzyme, Sanofi-
`
`Aventis and Regeneron within the timeframe normally allotted by the
`
`rules for one party. Genzyme will not receive any cross-examination or
`
`redirect time separate from that of Sanofi-Aventis and Regeneron.
`
`"
`
`Patent Owners will conduct any cross examination of any given witness
`
`jointly produced by Genzyme, Sanofi-Aventis and Regeneron and the
`
`redirect of any given witness produced by Patent Owners within the
`
`timeframe normally allotted by the rules for one cross-examination or
`
`redirect examination.
`
`9
`
`
`
`V.
`
`CONCLUSION
`
`For the foregoing reasons, Genzyme respectfully requests that the Board grant
`
`Petitioner’s Motion for Joinder of the Genzyme IPR and Sanofi-Aventis IPR
`
`proceedings.
`
`Dated: February 26, 2016
`
`Respectfully Submitted:
`
`/Richard J. McCormick/
`Richard J. McCormick (Reg No. 55,902)
`rmccormick@mayerbrown.com
`Lisa M. Ferri (pro hac vice motion pending)
`Brian W. Nolan (Reg. No. 45,821)
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Telephone: (212) 506-2382
`Fax: (212) 849 5682
`
`Counsel for Petitioner Genzyme Corporation
`
`10
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNERS
`
`I hereby certify that on February 26, 2016 a 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 electronic mail on the following counsel of record:
`
`David L. Cavanaugh, Reg. No. 36,476
`David.Cavanaugh@wilmerhale.com
`
`Robert J. Gunther, Jr., pro hac vice motion pending
`Robert.Gunther@wilmerhale.com
`
`Heather M. Petruzzi, Reg. No. 71,270
`Heather.Petruzzi@wilmerhale.com
`
`Adam R. Brausa, Reg. No. 60,287
`abrausa@durietangri.com
`
`Daralyn J. Durie, pro hac vice motion pending
`ddurie@durietangri.com
`
`Jeffrey P. Kushan, Reg. No. 43,401
`jkushan@sidley.com
`
`Dated: February 26, 2016
`
`Respectfully submitted,
`
`/Scott A. McMurry/
`Scott A. McMurry (Reg. No. 61,152)
`smcmurry@mayerbrown.com
`MAYER BROWN LLP
`1221 Avenue of the Americas
`New York, NY 10020-1001
`Telephone: (212) 506-2216
`Fax: (212) 849 5682
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