UNITED STATES PATENT AND TRADEMARK OFFICE
`———————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`
`Patent Owner
`
`U.S. Patent No. 8,629,111
`Issued Date: January 14, 2014
`Title: Methods of Providing Therapeutic Effects
`Using Cyclosporin Components
`
`———————————————
`IPR Case No.: IPR2017-00578
`Patent No. 8,629,111
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 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 22313-1450
`
`
`
`
`1
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`
`———————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`
`Patent Owner
`
`U.S. Patent No. 8,629,111
`Issued Date: January 14, 2014
`Title: Methods of Providing Therapeutic Effects
`Using Cyclosporin Components
`
`———————————————
`IPR Case No.: IPR2017-00578
`Patent No. 8,629,111
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 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 22313-1450
`
`
`
`
`1
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`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 2
`
`STATEMENT OF MATERIAL FACTS ........................................................ 3
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 5
`
`A. Legal Standard ........................................................................................ 5
`
`B.
`
`C.
`
`Joinder Will Not Impact the Mylan IPR’s Case Schedule ..................... 7
`
`Joinder Will Enhance Efficiency by Avoiding Duplicate
`Efforts and Inconsistencies ................................................................... 10
`
`D. A Joined Proceeding Avoids Prejudice to Teva and Will
`Not Prejudice Mylan or Allergan .......................................................... 10
`
`E.
`
`Joinder will not prejudice Patent Owner or Mylan ............................... 11
`
`IV. CONCLUSION .............................................................................................. 11
`
`
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`1
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`
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`I.
`
`
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. § 42.22, and 37 C.F.R.
`
`§ 42.122(b), Teva Pharmaceuticals USA, Inc., (“Teva”) respectfully submits this
`
`Motion for Joinder, together with a petition for inter partes review of U.S. Patent
`
`No. 8,629,111 (“the ’111 patent”), seeking cancellation of claims 1-27 of the ’111
`
`patent (“the Teva IPR”) and joinder of this proceeding with Mylan
`
`Pharmaceuticals Inc., v. Allergan, Inc., Case IPR2016-01128 (the “Mylan IPR” or
`
`“IPR 1128”).
`
`
`
`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b),
`
`as it is submitted within one month of December 8, 2016, the date on which the
`
`Mylan IPR was instituted. See Mylan IPR, Paper 8.
`
`Teva submits that joinder is appropriate because it will: (1) promote efficient
`
`determination of the validity of the ’111 patent in a single proceeding without
`
`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
`
`raises the identical grounds of unpatentability instituted by the Board in the Mylan
`
`IPR (see, e.g., Motorola Mobility, Inc. v. Softview, Inc. IPR2013-00256, Paper No.
`
`10 (granting motion for joinder under similar circumstances)); (2) not affect the
`
`schedule in the Mylan IPR nor increase the complexity of that proceeding,
`
`minimizing costs; and (3) minimize burden because Teva will agree to
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`
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`2
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`
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`consolidated filings1 and discovery and will accept a back-seat, “understudy” role
`
`in the joint proceedings.2 Absent joinder, Teva could be prejudiced if the Mylan
`
`IPR is terminated before a final written decision is issued, as Teva’s interests will
`
`not be adequately represented before the Board. Accordingly, joinder should be
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`granted.
`
`
`
`This Motion for Joinder and accompanying Petition are timely under 37
`
`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
`
`(Decision).
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`1.
`
`Petitioner and other entities are involved in litigation over the ’111
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`patent and related patents in the action styled Allergan, Inc. v. Teva
`
`Pharmaceuticals USA, Inc., et al., No. 2:15-cv-01455, filed by Allergan, Inc. in the
`
`
`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
`
`
`
`
`
`Eastern District of Texas (EX1023). Petitioner also identifies the following
`
`pending actions involving the ’111 patent: Allergan, Inc., v. Innopharma, Inc. and
`
`Pfizer, Inc., No. 2:15cv1504, in the Eastern District of Texas.
`
`2.
`
`On June 3, 2016, Mylan filed its petition for inter partes review
`
`seeking cancellation of claims 1-27 of the ’111 patent. (Mylan IPR, Paper 3.)
`
`3.
`
`The Mylan IPR petition included the following three grounds for
`
`challenging the validity of the ’111 patent:
`
`
`
`Ground 1: Claims 1-27 are anticipated under 35 U.S.C. § 102(b) by Ding
`
`’979;
`
`
`
`Ground 2: Claims 1-27 are obvious under 35 U.S.C. § 103 over Ding ’979
`
`and Sall; and
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`
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`Ground 3: Claims 11 and 16 are obvious under 35 U.S.C. § 103 over Ding
`
`’979, Sall, and Acheampong.
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`4.
`
`On September 9, 2016, Patent Owner filed a Preliminary Response.
`
`(Mylan IPR, Paper No. 7)
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`5.
`
`December 8, 2016, the Board instituted review of claims 1-27 of the
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`’111 patent in the Mylan IPR with respect to Grounds 1-3. (Mylan IPR, Paper 8.)
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`6.
`
`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,
`
`2017. (Mylan IPR, Paper 10).
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`
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`4
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`
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`7.
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`Teva’s petition in this proceeding proposes that claims 1-27 of the
`
`’111 patent should be cancelled in view of Grounds 1-3, as set forth in the Mylan
`
`IPR petition.
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`8.
`
`Teva’s petition in this proceeding presents the identical grounds on
`
`which the Mylan IPR was instituted.
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`9.
`
`Teva’s petition in this proceeding proposes the same claim
`
`construction positions as the petition in the Mylan IPR, and relies upon the same
`
`exhibits.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`
`
`Joinder of this proceeding with the Mylan IPR will not enlarge the Mylan
`
`IPR nor negatively affect its case schedule. But, a decision not to grant Teva’s
`
`motion for joinder could severely prejudice Teva. Thus, joinder is appropriate and
`
`warranted.
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`
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`A.
`
`Legal Standard
`
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes
`
`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
`
`(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,
`
`
`
`5
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`
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`determines warrants the institution of an inter partes review under
`section 314.
`
`Under 35 U.S.C. § 315(c), the Board has authority to join a second inter
`
`
`
`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).
`
`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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`
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`6
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`
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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
`
`framework, joinder of the present Teva IPR with the Mylan IPR is appropriate.
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`
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`
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`B.
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`Joinder Will Not Impact the Mylan IPR’s Case Schedule
`
`Joinder in this case will not impact the Board’s ability to complete its review
`
`of the ’111 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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`
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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 1-27 of the ’111 patent based
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`
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`7
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`
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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
`
`substantive differences. Further, Teva’s petition proposes the same claim
`
`construction positions as the petition in the Mylan IPR, and relies upon the same
`
`exhibits.
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`
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`Teva will agree to proceed in the instant IPR based only upon the arguments
`
`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 1128, Teva agrees to withdraw all additional arguments, as
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`well as its supporting declaration of Dr. Chambliss, and proceed in IPR 1128 based
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`on the arguments and evidence provided by Mylan in IPR 1128. Teva agrees to
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`assume a primary role in IPR 1128 only if Mylan ceases to participate in IPR 1128.
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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 1128, 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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`
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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
`
`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,
`
`speedy, and inexpensive resolution of two related proceedings in a single inter
`
`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
`
`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),
`
`as it is submitted within one month of December 8, 2016, the date on which the
`
`Mylan IPR was instituted. See Mylan IPR, Paper 8 (Decision).
`
`D. A Joined Proceeding Avoids Prejudice to Teva and Will Not
`Prejudice Mylan or Allergan
`
`Joinder is also warranted in order to permit Teva to protect its interests
`
`related to the validity and interpretation of the ’111 patent claims, and Teva could
`
`be prejudiced if it is not permitted to participate in the Mylan IPR. For example,
`
`allowing a joined inter partes review would avoid potential inconsistency and
`
`avoid prejudice to Teva in the event that Mylan and Allergan reach a resolution of
`
`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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`
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`10
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`
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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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`
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`Permitting joinder will not prejudice Allergan or Mylan. Teva raises no
`
`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
`
`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.
`
`Joinder will not prejudice Patent Owner or Mylan
`
`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
`
`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).
`
`IV. CONCLUSION
`
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`11
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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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`
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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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`IPR2016-01128 for U.S. Patent No. 8,629,111:
`
`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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