Trials@uspto.gov
`571-272-7822
`
`Paper 35
`Date: December 28, 2015
`
`
`
`
`
`
`
`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 IPR2015-01976
`Patent 8,232,250 B2
`____________
`
`
`
`
`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)
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`

`

`IPR2015-01976
`Patent 8,232,250 B2
`
`
`I.
`INTRODUCTION
`On August 25, 2015, we instituted trial in Mylan Pharmaceuticals Inc. v.
`Yeda Research & Development Co. Ltd., IPR2015-00643, to review whether
`claims 1–20 of U.S. Patent No. 8,232,250 B2 (“the ’250 patent”) would have been
`obvious over (1) the combination of Pinchasi and 1996 SBOA, or (2) the
`combination of Pinchasi and Flechter. IPR2015-00643, Paper 13. On September
`25, 2015, Amneal Pharmaceuticals LLC (“Petitioner”) filed a Petition, seeking an
`inter partes review of claims 1–20 of the ’250 patent. Paper 1 (“Pet.”). Along
`with the Petition, Petitioner also filed a Motion for Joinder to join this proceeding
`with IPR2015-00643. Paper 3 (“Mot.”). During a conference call held on
`November 19, 2015, Yeda Research and Development Co. Ltd. (“Patent Owner”)
`stated that it does not oppose the joinder motion. Paper 7, 2. At the parties’
`request, we deemed the Patent Owner’s Preliminary Response filed in IPR2015-
`00643 as timely filed and served in the present case. Paper 8, 3.
`As explained further below, we institute trial on the same grounds as
`instituted in IPR2015-00643 and grant Petitioner’s Motion for Joinder.
`
`
`II. DISCUSSION
`In IPR2015-00643, Mylan Pharmaceuticals Inc. (“Mylan”) challenged
`claims 1–20 of the ’250 patent on the following four grounds:
`Claims
`Basis
`Reference(s)
`Pinchasi1
`1–13, 19, 20
`§ 102(b)
`1–20
`§ 103
`Pinchasi
`Pinchasi and the 1996 SBOA2
`1–20
`§ 103
`Pinchasi and Flechter3
`1–20
`§ 103
`
`1 Pinchasi, WO 2007/081975 A2, published July 19, 2007 (Ex. 1005).
`2 Summary Basis of Approval for the New Drug Application for 20 mg daily
`Copaxone ® (NDA #20-622) (Ex. 1007).
`2
`
`
`
`

`

`IPR2015-01976
`Patent 8,232,250 B2
`
`
`We instituted trial in IPR2015-00643 on two grounds: (1) obviousness over
`Pinchasi and 1996 SBOA; and (2) obviousness over Pinchasi and Flechter.
`IPR2015-00643, Paper 13, 17.
`The Petition in this case is substantively identical to the one in IPR2015-
`00643. Compare IPR2015-00643, Paper 2 with IPR2015-01976, Paper 1. For the
`same reasons stated in our Decision on Institution in IPR2015-00643, we institute
`trial in this proceeding on the same two grounds. See IPR2015-00643, Paper 13.
`Having determined that institution is appropriate, we now turn to Petitioner’s
`Motion for Joinder. Based on authority delegated to us by the Director, we have
`discretion to join an inter partes review to a previously instituted inter partes
`review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f 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.” Id. When determining whether to grant a motion for joinder
`we consider factors such as timing and impact of joinder on the trial schedule, cost,
`discovery, and potential simplification of briefing. Kyocera Corp. v. SoftView,
`LLC, Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15).
`Under the circumstances of this case, we determine that joinder is
`appropriate. Petitioner filed the Petition and Motion for Joinder in the present
`proceeding on September 25, 2015, within one month after we instituted trial in
`IPR2015-00643. See 37 C.F.R. § 42.122(b). Petitioner represents that the Petition
`in this case and the one in IPR2015-00643 include “identical grounds, analysis,
`and exhibits,” and rely on the same expert declarations. Mot. 5. Petitioner agrees
`
`
`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).
`3
`
`
`
`

`

`IPR2015-01976
`Patent 8,232,250 B2
`
`to consolidated filings and discovery with Mylan, and agrees not to be permitted
`any separate arguments. Id. at 6. Petitioner raises no new grounds of
`unpatentability from IPR2015-00643. Id. at 7. In addition, Petitioner contends
`that there will be no impact on the trial schedule of IPR2015-00643. Id. Patent
`Owner confirmed during the November 19, 2015, conference call that it does not
`oppose Petitioner’s Motion for Joinder. Paper 7, 2.
`In view of the foregoing, we find that joinder based upon the conditions
`stated by Petitioner in its Motion for Joinder will have little or no impact on the
`timing, cost, or presentation of the trial on the instituted ground. Discovery and
`briefing will be simplified if the proceedings are joined. Thus, there being no
`opposition to Petitioner’s Motion for Joinder from any of the parties, the Motion
`for Joinder is granted.
`
`
`III. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2015-01976 on the following
`grounds:
`Claims 1–20 as obvious over Pinchasi and 1996 SBOA; and
`1.
`Claims 1–20 as obvious over Pinchasi and Flechter;
`2.
`FURTHER ORDERED that Petitioner’s Motion for Joinder with IPR2015-
`00643 is granted;
`FURTHER ORDERED that IPR2015-01976 is terminated and joined to
`IPR2015-00643, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the conditions
`stated in Petitioner’s Motion for Joinder (Paper 3), as discussed above;
`FURTHER ORDERED that the Scheduling Order in place for IPR2015-
`00643 shall govern the joined proceedings;
`
`
`
`4
`
`

`

`IPR2015-01976
`Patent 8,232,250 B2
`
`
`FURTHER ORDERED that all future filings in the joined proceeding are to
`be made only in IPR2015-00643;
`FURTHER ORDERED that the case caption in IPR2015-00643 for all
`further submissions shall be changed to add Amneal as a named Petitioner after
`Mylan, and to indicate by footnote the joinder of IPR2015-01976 to that
`proceeding, as indicated in the attached form of caption;
`FURTHER ORDERED that the parties shall file an updated Protective
`Order to reflect the addition of Amneal as a named Petitioner; and
`FURTHER ORDERED that a copy of this Decision shall be entered into the
`record of IPR2015-00643.
`
`
`
`
`
`
`5
`
`

`

`IPR2015-01976
`Patent 8,232,250 B2
`
`FOR PETITIONER AMNEAL:
`Vincent Capuano
`vcapuano@duanemorris.com
`
`Christopher Kroon
`cskroon@duanemorris.com
`
`
`FOR PATENT OWNER:
`
`Elizabeth Holland
`eholland@goodwinprocter.com
`
`William James
`wjames@goodwinprocter.com
`
`Eleanor Yost
`eyost@goodwinprocter.com
`
`FOR PETITIONER MYLAN (IPR2015-00643):
`
`Jeffrey Guise
`jguise@wsgr.com
`
`Richard Torczon
`rtorczon@wsgr.com
`
`Brandon White
`bmwhite@perkinscoie.com
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`

`

`IPR2015-01976
`Patent 8,232,250 B2
`
`
`
`
`
`
`Sample Case Caption
`
`
`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.
`
`____________
`
`Case IPR2015-006431
`Patent 8,232,250 B2
`____________
`
`
`1 Case IPR2015-01976 has been joined with this proceeding.
`
`
`
`
`