Trials@uspto.gov
`571.272.7822
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`Paper No. 9
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` Filed: December 28, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01980
`Patent 8,399,413 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, 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)
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`

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`Case IPR2015-01980
`Patent 8,399,413 B2
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`I.
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`INTRODUCTION
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`Amneal Pharmaceuticals LLC (“Amneal”) filed a Petition, seeking an
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`inter partes review of claims 1–20 of U.S. Patent No. 8,399,413 B2 (“the
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`’413 patent,” Ex. 1001). Paper 1 (“Pet”). Along with the Petition, Amneal
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`filed a Motion for Joinder to join this proceeding with Mylan
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`Pharmaceuticals Inc. v. Yeda Research & Development Co. Ltd., IPR2015-
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`00644. Paper 3 (“Mot”). Amneal filed the Petition and Motion for Joinder
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`in the present proceeding on September 25, 2015, within one month after we
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`instituted trial in IPR2015-00644. 37 C.F.R. § 42.122(b). On December 7,
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`2015, the parties requested that we deem the Patent Owner Preliminary
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`Response filed in IPR2015-00644 as filed and served in the present case.
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`The panel granted the parties’ request. Paper 8.
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`As explained further below, we institute trial on the same grounds as
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`instituted in IPR2015-00644 and grant Amneal’s Motion for Joinder.
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`II. DISCUSSION
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`In IPR2015-00644, Mylan Pharmaceuticals Inc. (“Mylan”) challenged
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`claims 1–20 of the ’413 patent on the following four grounds:
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`References
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`Pinchasi1
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`Pinchasi
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`Basis
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`§ 102
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`§ 103
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`Pinchasi and the 1996 SBOA2
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`§ 103
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`
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`Claims challenged
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`1–6 and 8–20
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`1–20
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`1–20
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`1 Irit Pinchasi, WO 2007/081975 A2, published July 19, 2007 (Ex. 1005).
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`2 Summary Basis of Approval (“SBOA”) for the New Drug Application for
`20 mg daily Copaxone ® (NDA #20-622) (Ex. 1007).
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`Case IPR2015-01980
`Patent 8,399,413 B2
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`References
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`Pinchasi and Flechter3
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`
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`Basis
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`§ 103
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`Claims challenged
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`1–20
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`After considering the Petition and the Patent Owner Preliminary
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`Response, we instituted trial in IPR2015-00644 on two grounds:
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`(1) obviousness over Pinchasi and 1996 SBOA; and (2) obviousness over
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`Pinchasi and Flechter. IPR2015-00644, Paper 14, 15–16.
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`Amneal’s Petition is substantively identical to Mylan’s Petition,
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`challenging the same claims based on the same art and the same grounds.
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`Compare IPR2015-00644, Paper 2 with IPR2015-01980, Paper 1. For the
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`same reasons stated in our Decision on Institution in IPR2015-00644, we
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`institute trial in this proceeding on the same two grounds. See IPR2015-
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`00644, Paper 14.
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`Having determined that institution is appropriate, we now turn to
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`Amneal’s Motion for Joinder. Based on authority delegated to us by the
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`Director, we have discretion to join an inter partes review to a previously
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`instituted inter partes review. 35 U.S.C. § 315(c). Section 315(c) provides,
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`in relevant part, that “[i]f 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
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`review any person who properly files a petition under section 311.” Id.
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`When determining whether to grant a motion for joinder we consider factors
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`such as timing and impact of joinder on the trial schedule, cost, discovery,
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`
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`3 S. Flechter et al., Copolymer 1 (Glatiramer Acetate) in Relapsing Forms of
`Multiple Sclerosis: Open Multicenter Study of Alternate-Day
`Administration, 25 CLINICAL NEUROPHARM. 11–15 (2002) (Ex. 1008).
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`Case IPR2015-01980
`Patent 8,399,413 B2
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`and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC,
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`Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15).
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`Under the circumstances of this case, we determine that joinder is
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`appropriate. As Amneal notes, the Petition in IPR2015-00644 is
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`substantively identical to the grounds, analysis, exhibits, and expert
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`declaration relied on in the instant proceeding. Mot. 5. Amneal has also
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`agreed to consolidated filings and discovery with Mylan, and has agreed not
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`“to be permitted any arguments separate from those advanced by Amneal
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`and Mylan in the consolidated filings.” Id. at 6. Amneal raises no new
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`grounds of unpatentability from IPR2015-00644. Id. at 7. And Amneal
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`contends that there will be no impact on the trial schedule of IPR2015-
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`00644. Id. As confirmed during the conference call held November 19,
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`2015, Patent Owner does not oppose Amneal’s Motion for Joinder.
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`Paper 7, 2.
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`In view of the foregoing, we find that joinder based upon the
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`conditions stated in Amneal’s Motion for Joinder will have little or no
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`impact on the timing, cost, or presentation of the trial on the instituted
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`grounds. Moreover, discovery and briefing will be simplified if the
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`proceedings are joined. Thus, without opposition to the Motion for Joinder
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`from any of the parties, the Motion is granted.
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`Case IPR2015-01980
`Patent 8,399,413 B2
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`III. ORDER
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`Accordingly, it is
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`ORDERED that trial is instituted in IPR2015-01980 on the following
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`grounds:
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`A. Claims 1–20 as obvious over Pinchasi and 1996 SBOA; and
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`B. Claims 1–20 as obvious over Pinchasi and Flechter;
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`FURTHER ORDERED that Amneal’s Motion for Joinder with
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`IPR2015-00644 is granted;
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`FURTHER ORDERED that IPR2015-01980 is terminated and joined
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`to IPR2015-00644, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
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`conditions stated in Amneal’s Motion for Joinder (Paper 3), as discussed
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`above;
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`FURTHER ORDERED that the Scheduling Order in place for
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`IPR2015-00644 shall govern the joined proceedings;
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`FURTHER ORDERED that all future filings in the joined proceeding
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`are to be made only in IPR2015-00644;
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`FURTHER ORDERED that the case caption in IPR2015-00644 for all
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`further submissions shall be changed to add Amneal as a named Petitioner
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`after Mylan, and to indicate by footnote the joinder of IPR2015-01980 to
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`that proceeding, as indicated in the attached sample case caption;
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`FURTHER ORDERED that the parties shall file an updated
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`Protective Order to reflect the addition of Amneal as a named Petitioner; and
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`FURTHER ORDERED that a copy of this Decision shall be entered
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`into the record of IPR2015-00644.
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`Case IPR2015-01980
`Patent 8,399,413 B2
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`FOR PETITIONER AMNEAL:
`
`Vincent Capuano
`Christopher Kroon
`DUANE MORRIS LLP
`VCapuano@duanemorris.com
`cskroon@duanemorris.com
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`FOR PATENT OWNER:
`
`Elizabeth J. Holland
`William G. James
`Eleanor Yost
`GOODWIN PROCTER LLP
`eholland@goodwinprocter.com
`wjames@goodwinprocter.com
`eyost@goodwinprocter.com
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`
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`FOR PETITIONER MYLAN (IPR2015-00644):
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`
`Jeffrey Guise
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`
`Brandon White
`David Anstaett
`Shannon Bloodworth
`PERKINS COIE
`BMWhite@perkinscoie.com
`SBloodworth@perkinscoie.com
`DAnstaett@perkinscoie.com
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`Sample Case Caption
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC. and AMNEAL
`PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
`Patent Owner.
`____________
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`Case IPR2015-006441
`Patent 8,399,413 B2
`____________
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`1 Case IPR2015-01980 has been joined with this proceeding.
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