`———————————————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
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`TEVA PHARMACEUTICALS USA, INC.,
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`Petitioner,
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`v.
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`ALLERGAN, INC.,
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`Patent Owner
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`U.S. Patent No. 8,633,162
`Issued Date: January 21, 2014
`Title: Methods of Providing Therapeutic Effects
`Using Cyclosporin Components
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`———————————————
`IPR Case No.: IPR2017-00583
`Patent No. 8,633,162
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`1
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`TABLE OF CONTENTS
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`I.
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`II.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 2
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`STATEMENT OF MATERIAL FACTS ........................................................ 3
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`III.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 5
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`A. Legal Standard ........................................................................................ 5
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`B.
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`C.
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`Joinder Will Not Impact the Mylan IPR’s Case Schedule ..................... 7
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`Joinder Will Enhance Efficiency by Avoiding Duplicate
`Efforts and Inconsistencies ................................................................... 10
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`D. A Joined Proceeding Avoids Prejudice to Teva and Will
`Not Prejudice Mylan or Allergan .......................................................... 10
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`E.
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`Joinder will not prejudice Patent Owner or Mylan ............................... 11
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`IV. CONCLUSION .............................................................................................. 12
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`1
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`I.
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`
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. § 42.22, and 37 C.F.R.
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`§ 42.122(b), Teva Pharmaceuticals USA, Inc., (“Teva”) respectfully submits this
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`Motion for Joinder, together with a petition for inter partes review of U.S. Patent
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`No. 8,633,162 (“the ’162 patent”), seeking cancellation of claims 1-24 of the ’162
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`patent (“the Teva IPR”) and joinder of this proceeding with Mylan
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`Pharmaceuticals Inc., v. Allergan, Inc., Case IPR2016-01130 (the “Mylan IPR” or
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`“IPR 1130”).
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`
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b),
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`as it is submitted within one month of December 8, 2016, the date on which the
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`Mylan IPR was instituted. See Mylan IPR, Paper 8.
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`Teva submits that joinder is appropriate because it will: (1) promote efficient
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`determination of the validity of the ’162 patent in a single proceeding without
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`prejudice to first petitioner Mylan Pharmaceuticals Inc. (“Mylan”) or patent
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`owners Allergan, Inc. (“Allergan” or “Patent Owner”) because Teva’s petition
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`raises the identical grounds of unpatentability instituted by the Board in the Mylan
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`IPR (see, e.g., Motorola Mobility, Inc. v. Softview, Inc. IPR2013-00256, Paper No.
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`10 (granting motion for joinder under similar circumstances)); (2) not affect the
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`schedule in the Mylan IPR nor increase the complexity of that proceeding,
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`minimizing costs; and (3) minimize burden because Teva will agree to
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`2
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`consolidated filings1 and discovery and will accept a back-seat, “understudy” role
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`in the joint proceedings.2 Absent joinder, Teva could be prejudiced if the Mylan
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`IPR is terminated before a final written decision is issued, as Teva’s interests will
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`not be adequately represented before the Board. Accordingly, joinder should be
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`granted.
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`This Motion for Joinder and accompanying Petition are timely under 37
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`C.F.R. §§ 42.22 and 42.122(b), as they are submitted within one month of
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`December 8, 2016, the Mylan IPR’s institution date. See Mylan IPR, Paper 8
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`(Decision).
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`II.
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`STATEMENT OF MATERIAL FACTS
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`1.
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`Petitioner and other entities are involved in litigation over the ’162
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`patent and related patents in the action styled Allergan, Inc. v. Teva
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`Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455, filed by Allergan, Inc. in the
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`1 Teva agrees to consolidated filings for all substantive papers in the respective
`proceedings, except for motions that do not involve Mylan. Teva agrees to
`incorporate its filings with those of Mylan in a consolidated filing, subject to the
`ordinary rules for one party on page limits.
`2 To the extent the Board considers granting Teva’s motion for joinder, Teva is
`willing to take a passive role. For example, Teva agrees not file additional papers,
`not file additional pages to Mylan’s papers, not present any new, additional, or
`supplemental arguments, not cross-examine Allergan’s expert or attempt to offer a
`rebuttal expert of its own, and not present any arguments at oral hearings. See e.g.,
`Samsung Elec. Co., Ltd. v. Arendi S.A.R.L., IPR2014-01518, Paper 10 at 6 (PTAB
`Mar. 18, 2015) (allowing joinder where movants takes a “limited understudy role”
`without a separate opportunity to actively participate). Only if Mylan drops out of
`the proceedings for any reason, will Teva cease its passive role.
`3
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`Eastern District of Texas (EX1023). Petitioner also identifies the following
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`pending actions involving the ’162 patent: Allergan, Inc., v. Innopharma, Inc. and
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`Pfizer, Inc., No. 2:15cv1504, in the Eastern District of Texas.
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`2.
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`On June 3, 2016, Mylan filed its petition for inter partes review
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`seeking cancellation of claims 1-24 of the ’162 patent. (Mylan IPR, Paper 3.)
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`3.
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`The Mylan IPR petition included the following three grounds for
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`challenging the validity of the ’162 patent:
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`Ground 1: Claims 1-10, 12-14, 16-20, and 22-24 are obvious under 35
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`U.S.C. § 103 over Ding ’979 and Sall;
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`Ground 2: Claims 11 and 21 are obvious under 35 U.S.C. § 103 over Ding
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`’979, Sall and Acheampong; and
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`Ground 3: Claim 15 is obvious under 35 U.S.C. § 103 over Ding ’979, Sall,
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`and Glonek ’586.
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`4.
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`On September 9, 2016, Patent Owner filed a Preliminary Response.
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`(Mylan IPR, Paper No. 7)
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`5.
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`December 8, 2016, the Board instituted review of claims 1-24 of the
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`’162 patent in the Mylan IPR with respect to Grounds 1-3. (Mylan IPR, Paper 8.)
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`6.
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`On December 6, 2016, the Board entered a scheduling order in the
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`Mylan IPR setting various dates, including the oral argument set for August 17,
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`2017. (Mylan IPR, Paper 10).
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`4
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`7.
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`Teva’s petition in this proceeding proposes that claims 1-24 of the
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`’162 patent should be cancelled in view of Grounds 1-3, as set forth in the Mylan
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`IPR petition.
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`8.
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`Teva’s petition in this proceeding presents the identical grounds on
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`which the Mylan IPR was instituted.
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`9.
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`Teva’s petition in this proceeding proposes the same claim
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`construction positions as the petition in the Mylan IPR, and relies upon the same
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`exhibits.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
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`Joinder of this proceeding with the Mylan IPR will not enlarge the Mylan
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`IPR nor negatively affect its case schedule. But, a decision not to grant Teva’s
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`motion for joinder could severely prejudice Teva. Thus, joinder is appropriate and
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`warranted.
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`A.
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`Legal Standard
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`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
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`review proceedings. The statutory provision governing joinder of inter partes
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`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
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`(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,
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`5
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`determines warrants the institution of an inter partes review under
`section 314.
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`Under 35 U.S.C. § 315(c), the Board has authority to join a second inter
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`partes review proceeding to an instituted first inter partes review proceeding. The
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`motion for joinder must be filed within one month of institution of the first inter
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`partes review proceeding. 37 C.F.R. § 42.122(b).
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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
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`considerations, while being “mindful that patent trial regulations, including the
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`rules for joinder, must be construed to secure the just, speedy, and inexpensive
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`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
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`Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. The Board should
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`consider “the policy preference for joining a party that does not present new issues
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`that might complicate or delay an existing proceeding.” Id. at 10. Under this
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`framework, joinder of the present IPR with the Mylan IPR is appropriate.
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`“A motion for joinder should: (1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the
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`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 and Macronix Int’l Co. v. Spansion, IPR2014-00898,
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`Paper 15 at 4 (Aug. 13, 2014). The Board should also consider “the policy
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`6
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`preference for joining a party that does not present new issues that might
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`complicate or delay an existing proceeding.” See Dell, Inc. v. Network-1 Security
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`Solutions, Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. Under this
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`framework, joinder of the present Teva IPR with the Mylan IPR is appropriate.
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`B.
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`Joinder Will Not Impact the Mylan IPR’s Case Schedule
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`Joinder in this case will not impact the Board’s ability to complete its review
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`of the ’162 patent in a timely manner. 35 U.S.C. § 316(a)(11) and associated rule
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`37 C.F.R. § 42.100(c) provide that inter partes review proceedings should be
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`completed and the Board’s final decision issued within one year of institution of
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`the review. In this case, joinder will not affect the Board’s ability to issue the
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`decision within this required one-year timeframe because the Petition filed in the
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`present Teva IPR is substantially identical to the Mylan IPR. Indeed, in
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`circumstances such as these, the PTO anticipated that joinder would be granted as
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`a matter of right. See 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement
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`of Sen. Kyl) (“The Office anticipates that joinder will be allowed as of right – if an
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`inter partes review is instituted on the basis of a petition, for example, a party that
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`files an identical petition will be joined to that proceeding, and thus allowed to file
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`its own briefs and make its own arguments.”) (emphasis added).
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`As such, Teva raises no issues that are not already before the Board in the
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`Mylan IPR. Teva’s petition seeks review of claims 1-24 of the ’162 patent based
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`7
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`on the identical grounds and combination of prior art considered by the Board in
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`instituting review in the Mylan IPR. Indeed, Teva’s petition is substantially
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`identical to the corresponding Mylan IPR (Mylan IPR, Paper 3). There are no
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`substantive differences. Further, Teva’s petition proposes the same claim
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`construction positions as the petition in the Mylan IPR, and relies upon the same
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`exhibits.
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`Teva will agree to proceed in the instant IPR based only upon the arguments
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`and evidence advanced by Mylan and accept a back‐seat, “understudy” role in
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`those joined proceedings, without any right to separate or additional briefing or
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`discovery, unless authorized by the Board upon a request to address an issue that is
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`unique to Teva. Only if Mylan drops out of the proceedings for any reason, will
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`Teva cease its understudy role.
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`To the extent that Teva’s petition in this proceeding differs from the petition
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`that Mylan filed in IPR 1130, Teva agrees to withdraw all additional arguments, as
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`well as its supporting declaration of Dr. Chambliss, and proceed in IPR 1130 based
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`on the arguments and evidence provided by Mylan in IPR 1130. Teva agrees to
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`assume a primary role in IPR 1130 only if Mylan ceases to participate in IPR 1130.
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`In other words, Teva requests permission to be added to the case caption as a
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`petitioner in IPR 1130, without any active participation or involvement that is
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`8
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`separate from Mylan, unless authorized by the Board upon a request pertaining to
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`an issue unique to Teva alone.
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`Teva expects that any cross-examination(s) carried out by Mylan will occur
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`within the timeframe normally allotted by the rules to one party. As such, the time
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`will not need to be extended in light of the joinder.
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`In order to further simplify the proceeding, Teva will rely on the same expert
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`as Mylan, should Mylan permit it.3 If Mylan allows Teva to retain the same expert,
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`then Teva will withdraw its expert declaration of Dr. Chambliss and rely solely on
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`the declaration and testimony of Mylan’s expert, Dr. Amiji. The Board has
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`previously acknowledged that such concessions on the part of a party seeking to
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`join are sufficient to minimize the impact on the original proceeding (see SAP
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`America Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13, page 4).
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`Even if, through no fault of its own, Teva were required to proceed with its
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`own expert, there would be no impact on the Board’s ability to complete its review
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`in a timely manner. Moreover, there would be only a modest impact on the Patent
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`Owner, given that little additional preparation would be needed for the deposition
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`of Teva’s expert beyond that required for the deposition of Mylan’s expert.
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`3 In the event that Mylan does not agree to allow Teva to retain Mylan’s expert,
`and the Board determines it would not be able to complete these proceedings
`within the one-year timeframe as a result of having to provide the Patent Owners
`with the opportunity to additionally depose Dr. Chambliss, Teva would in that case
`agree to withdraw Dr. Chambliss’s declaration and instead rely solely on the
`declaration of Mylan’s expert, Dr. Amiji.
`9
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`C.
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`Joinder Will Enhance Efficiency by Avoiding Duplicate Efforts
`and Inconsistencies
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`Joinder is appropriate because it is the most expedient way to secure the just,
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`speedy, and inexpensive resolution of two related proceedings in a single inter
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`partes review. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Otherwise,
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`determining the same validity questions in separate concurrent proceedings could
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`duplicate efforts, and create a risk of inconsistent results and piecemeal review.
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`Accordingly, a joined inter partes review will avoid inefficiency and potential
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`inconsistency and result in a final written decision without any delay.
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b),
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`as it is submitted within one month of December 8, 2016, the date on which the
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`Mylan IPR was instituted. See Mylan IPR, Paper 8 (Decision).
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`D. A Joined Proceeding Avoids Prejudice to Teva and Will Not
`Prejudice Mylan or Allergan
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`Joinder is also warranted in order to permit Teva to protect its interests
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`related to the validity and interpretation of the ’162 patent claims, and Teva could
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`be prejudiced if it is not permitted to participate in the Mylan IPR. For example,
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`allowing a joined inter partes review would avoid potential inconsistency and
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`avoid prejudice to Teva in the event that Mylan and Allergan reach a resolution of
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`their disputes during the pendency of the Mylan IPR. 35 U.S.C. § 317(a) provides
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`that an inter partes review “shall be terminated with respect to any petitioner upon
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`10
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`the joint request of the petitioner and the patent owner” unless the Board has
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`already reached its decision on the merits. If no petitioner remains after settlement,
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`“the Office may terminate the review.” Id. Here, if Allergan and Mylan settled, the
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`Mylan IPR could terminate without proceeding to a final written decision,
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`prejudicing Teva.
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`Permitting joinder will not prejudice Allergan or Mylan. Teva raises no
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`issues not already before the Board, so joinder will not affect the timing of the
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`Mylan IPR or the content of Mylan’s Patent Owner response. Teva also believes
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`that given the procedural safeguards proposed below, any additional costs to
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`Allergan and Mylan associated with its participation in the Mylan IPR will be
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`minimal, and not so great as to justify the potential prejudice to Teva if the Mylan
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`IPR was otherwise terminated before a final written decision by the Board.
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`E.
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`Joinder will not prejudice Patent Owner or Mylan
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`Permitting joinder will not prejudice Allergan or Mylan. Teva’s proposed
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`grounds for instituting an IPR are identical to those proposed by Mylan in its
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`petition. Joinder will not affect the timing of the Mylan IPR, and any extension to
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`the schedule that may be required is permitted by law and the applicable rules. 35
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`U.S.C. § 316(a)(1); 37 C.F.R. § 42.100(c).
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`11
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`IV. CONCLUSION
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`For all the foregoing reasons, Teva respectfully requests this proceeding be
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`joined with the Mylan IPR.
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`Although Petitioner believes that no fee is required for this Motion, the
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`Commissioner may charge any additional fees which may be required for this
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`Motion to Deposit Account No. 502880.
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`Dated: January 6, 2017
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`Respectfully submitted,
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`/Gary J. Speier/
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Mark D. Schuman, Backup Counsel
`Reg. No. 31,197
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
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`12
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e), this is to certify that on January 6, 2017, I
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`caused to be served a true and correct copy of the foregoing “MOTION FOR
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`JOINDER PURSUANT TO 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 AND
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`42.122(b)” on this 6th day of January, 2017:
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`by FedEx Priority Overnight® on the Patent Owner at the correspondence
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`address of the Patent Owner as follows:
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`ALLERGAN, INC.
`2525 Dupont Drive, T2-7H
`Irvine, CA 92612-1599
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`and by FedEx Priority Overnight® on counsel of record for Allergan in
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`IPR2016-01130 for U.S. Patent No.: 8,633,162:
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`Dorothy P. Whelan
`Michael Kane
`FISH & RICHARDSON P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP2@fr.com
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`Dated: January 6, 2017
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`Respectfully submitted,
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`/Gary J. Speier/
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Attorney for Petitioner
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`13
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