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Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`Paper 12
` Entered: June 8, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`GENZYME CORPORATION,
`Petitioner,
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owner.
`_______________
`
`Case IPR2016-00460
`Patent 6,331,415 B1
`_______________
`
`
`Before LORA M. GREEN, ERICA A. FRANKLIN, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`DECISION
`
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F.R. § 42.122(b)
`
`
`
`
`
`

`
`IPR2016-00460
`Patent No. 6,331,415 B1
`
`I.
`
`INTRODUCTION
`
`Genzyme Corporation (“Petitioner” or “Genzyme”) filed a Petition
`
`(Paper 2, “Pet.”) requesting an inter partes review of claims 1–4, 9, 11, 12,
`
`14–20, and 33 of U.S. Patent No. 6,331,415 B1 (Ex. 1001, “the ’415
`
`patent”). On February 26, 2016, Petitioner filed a Motion for Joinder (Paper
`
`10, “Mot.”). The Motion for Joinder seeks to join this proceeding with
`
`Sanofi-Aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. v.
`
`Genentech, Inc. and City of Hope, Case IPR2015-01624 (“the ’1624 IPR”).
`
`Mot. 1. In response, Genentech Inc. and City of Hope (collectively “Patent
`
`Owner” or “Genentech”) filed a Notice of Non-Opposition to Motion for
`
`Joinder and Waiver of Preliminary Response. Paper 11.
`
`For the reasons described below, we institute an inter partes review of
`
`challenged claims 1–4, 11, 12, 14, 18–20, and 33, and grant Petitioner’s
`
`Motion for Joinder.
`
`II.
`
`INSTITUION OF INTER PARTES REVIEW
`
`The Petition in this proceeding asserts the same grounds as those on
`
`which we instituted review in the ’1624 IPR. Specifically, based on the
`
`Petition filed by Sanofi-Aventis U.S. LLC and Regeneron Pharmaceuticals,
`
`Inc. (collectively “Sanofi-Aventis”), on February 5, 2016, we instituted a
`
`trial in the ’1624 IPR on the following grounds:
`
`
`
`2
`
`

`
`IPR2016-00460
`Patent No. 6,331,415 B1
`
`
`References
`
`Bujard1 and Riggs & Itakura2
`
`Bujard and Southern3
`
`Basis
`
`§ 103(a)
`
`§ 103(a)
`
`Claims Challenged
`
`1, 3, 4, 11, 12, 14,
`19, and 33
`1, 2, 18, 20, and 33
`
`Sanofi-Aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. v.
`
`Genentech, Inc. and City of Hope, Case IPR2015-01624, slip. op. at 26
`
`(PTAB February 5, 2016) (Paper 15).
`
`Petitioner proposes an order in its Motion for Joinder in which the
`
`instant inter partes review is instituted only on the grounds for which inter
`
`partes review was instituted in the ’1624 IPR. Mot. 8. In view of the fact
`
`that the challenges presented by the instant Petition and in the petition in the
`
`‘1624 IPR are identical, see Mot. 3, we institute an inter partes review in
`
`this proceeding on the same grounds and for the same reasons as those on
`
`which we instituted the ’1624 IPR. We do not institute inter partes review
`
`on any other grounds or as to any additional claims.
`
`III. GRANT OF MOTION FOR JOINDER
`
`An inter partes review may be joined with another inter partes
`
`review, subject to the provisions of 35 U.S.C. § 315(c), which governs
`
`joinder of inter partes review proceedings:
`
`
`1 Bujard et al., US 4,495,280, issued Jan. 22, 1985 (“Bujard”) (Ex. 1002).
`
`2 Arthur D. Riggs and Keiichi Itakura, Synthetic DNA and Medicine, 31 AM.
`J. HUM. GENET., 531–538 (1979) (“Riggs & Itakura”) (Ex. 1003).
`
`3 P.J. Southern and P. Berg, Transformation of Mammalian Cells to
`Antibiotic Resistance with a Bacterial Gene Under Control of the SV40
`Early Region Promoter, 1 J. MOLECULAR AND APPLIED GENETICS 327–341
`(1982) (“Southern”) (Ex. 1004).
`
`
`
`3
`
`

`
`IPR2016-00460
`Patent No. 6,331,415 B1
`
`
`(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.
`
`As the moving party, Genzyme bears the burden of proving that it is
`
`entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder
`
`should: (1) set forth the reasons joinder is appropriate; (2) identify any new
`
`grounds of unpatentability asserted in the petition; and (3) explain what
`
`impact (if any) joinder would have on the trial schedule for the existing
`
`review. See Frequently Asked Question H5, http://www.uspto.gov/patents-
`
`application-process/appealing-patent-decisions/trials/patent-review-
`
`processing-system-prps-0 (last visited June 2, 2016).
`
`The Petition in this proceeding has been accorded a filing date of
`
`January 15, 2016 (Paper 3), which is before the date of institution in the
`
`’1624 IPR, which was instituted on February 5, 2016 (’1624 IPR, Paper 15).
`
`The Petition, therefore, satisfies the joinder requirement of being filed within
`
`one month of our instituting a trial in the ’1624 IPR. 37 C.F.R. § 42.122(b).
`
`
`
`In its Motion for Joinder, Genzyme contends that the grounds asserted
`
`in the instant Petition are the same grounds of unpatentability asserted in the
`
`’1624 IPR. Mot. 1, 3, 8. Genzyme contends further that joinder is
`
`appropriate as it will promote efficient resolution of the challenges to the
`
`claims of the ’415 patent. Id. at 1. Genzyme represents that “joinder would
`
`not affect the pending schedule in the Sanofi-Aventis IPR nor increase the
`
`complexity of that proceeding, thereby minimizing costs,” stating that it
`
`agrees to consolidated filings with Sanofi-Aventis. Id. at 1–2. Patent Owner
`
`
`
`4
`
`

`
`IPR2016-00460
`Patent No. 6,331,415 B1
`
`does not oppose joinder, but lists several conditions that should be included
`
`in the decision ordering joinder to which Genzyme has agreed, such as the
`
`necessity for consolidated filing to avoid lengthy and duplicative briefing.
`
`Paper 11, 1–3.
`
`
`
`As discussed above, joinder is discretionary. In the instant
`
`proceeding, we agree with Genzyme that joinder of the instant proceeding
`
`with the ’1624 IPR would promote the efficient resolution of the
`
`proceedings. Genzyme has brought the same challenges as presented by the
`
`’1624 IPR, thus, the substantive issues in the ’1624 IPR would not be unduly
`
`complicated by joining with the instant IPR. In particular, joinder merely
`
`introduces the same grounds presented originally in the ’1624 IPR, where all
`
`of the prior art asserted in this Petition is of record. In addition, Genzyme
`
`agrees to be limited to the grounds on which trial was instituted in the
`
`’1624 IPR. Mot. 8. Moreover, the instant proceeding was filed timely
`
`before we instituted trial in the ’1624 IPR. Finally, Patent Owner will be
`
`able to address the challenges in a single proceeding, promoting efficiency.
`
`IV. ORDER
`
`In view of the foregoing, it is
`
`ORDERED that IPR2016-00460 is instituted and joined with
`
`IPR2015-01624;
`
`FURTHER ORDERED that the grounds on which IPR2015-01624
`
`was instituted are unchanged and no other grounds are instituted in the
`
`joined proceeding;
`
`FURTHER ORDERED that the Scheduling Order entered in
`
`IPR2015-01624 shall govern the schedule of the joined proceedings;
`
`
`
`5
`
`

`
`IPR2016-00460
`Patent No. 6,331,415 B1
`
`
`FURTHER ORDERED that, throughout the joined proceeding,
`
`Sanofi-Aventis or Genzyme will file papers, except for motions that do not
`
`involve the other party, as a single, consolidated filing; that the filing party
`
`(either Sanofi-Aventis or Genzyme) will identify each such filing as a
`
`consolidated filing;
`
`FURTHER ORDERED that, throughout the joined proceeding, Sanofi
`
`and Genzyme will designate an attorney to conduct the cross-examination of
`
`any witness produced by Patent Owner, as well as the redirect of any witness
`
`produced by Sanofi-Aventis and Genzyme within the time provided by
`
`37 C.F.R. § 42.53, and Genzyme will not receive any cross-examination or
`
`redirect time separate from that of Sanofi-Aventis;
`
`FURTHER ORDERED that IPR2016-00460 is terminated under
`
`37 C.F.R. § 42.72, and all further filings in the joined proceedings are to be
`
`made in IPR2015-01624;
`
`FURTHER ORDERED that a copy of this Decision will be entered
`
`into the record of IPR2015-01624; and
`
`FURTHER ORDERED that the case caption in IPR2015-01624 shall
`
`be changed to reflect joinder with this proceeding in accordance with the
`
`attached example.
`
`
`
`6
`
`
`
`

`
`IPR2016-00460
`Patent No. 6,331,415 B1
`
`FOR PETITIONER:
`
`Richard McCormick
`rmccormick@mayerbrown.com
`
`Brian Nolan
`bnolan@mayerbrown.com
`
`Ferri Lisa
`lferri@mayerbrown.com
`
`
`
`FOR PATENT OWNER:
`
`David Cavanaugh
`David.cavanaugh@wilmerhale.com
`
`Heather M. Petruzzi
`Heather.petruzzi@wilmerhale.com
`
`Adam R. Brausa
`abrasusa@durietangri.com
`
`Jeffrey P. Kushan
`iprnotices@sidley.com
`
`
`
`
`
`7
`
`

`
`Example Case Caption for Joined Proceeding
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`SANOFI-AVENTIS U.S. LLC,
`REGENERON PHARMACEUTICALS, INC., AND,
`GENZYME CORPORATION,
`Petitioners,
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
`_______________
`
`Case IPR2015-016241
`Patent 6,331,415 B1
`_______________
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2016-00460 has been joined with this proceeding.
`
`
`
`8

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