UNITED STATES PATENT AND TRADEMARK OFFICE
`———————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`
`Patent Owner
`
`U.S. Patent No. RE44,186
`Issued Date: April 30, 2013
`Title: Cyclopropyl-Fused Pyrrolidine-Based
`Inhibitors of Dipeptidyl Peptidase IV and Method
`
`———————————————
`IPR Case No.: Unassigned
`Patent No. RE44,186
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
`
`
`
`1
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`———————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`
`Patent Owner
`
`U.S. Patent No. RE44,186
`Issued Date: April 30, 2013
`Title: Cyclopropyl-Fused Pyrrolidine-Based
`Inhibitors of Dipeptidyl Peptidase IV and Method
`
`———————————————
`IPR Case No.: Unassigned
`Patent No. RE44,186
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
`
`
`
`1
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`Table of Contents
`
`I. STATEMENT OF THE PRECISE RELIEF REQUESTED ........................2
`
`II. STATEMENT OF MATERIAL FACTS .......................................................3
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ....................6
`
`A. Legal standard .............................................................................................6
`
`B. Joinder will not impact the Mylan IPR’s case schedule …..……………8
`
`C. Joinder will promote efficiency by avoiding duplicative efforts and
`
`inconsistencies .............................................................................................10
`
`D. A joined proceeding avoids prejudice to Teva and will not prejudice
`
`Mylan or AstraZeneca ……………………...............................................11
`
`E. Joinder will not prejudice Patent Owner or Mylan ................................12
`
`IV. CONCLUSION ...............................................................................................13
`
`
`
`1
`
`
`
`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. RE44,186 (“the ’186 patent”), seeking cancellation of claims 1, 2, 4, 6-22, 25-
`
`30, 32-37 and 39-42 of the ‘186 patent (“the Teva IPR”) and joinder of this
`
`proceeding with Mylan Pharmaceuticals Inc., v. AstraZeneca AB, Case IPR2015-
`
`01340 (the “Mylan IPR” or “IPR 340”).
`
`
`
`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 May 2, 2016, the date on which the
`
`Mylan IPR was instituted. See Mylan IPR, Paper 16.
`
`Teva submits that joinder is appropriate because it will: (1) promote efficient
`
`determination of the validity of the ’186 patent in a single proceeding without
`
`prejudice to first petitioner Mylan Pharmaceuticals Inc. (“Mylan”) or patent
`
`owners AstraZeneca AB (“AstraZeneca” 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
`
`
`
`2
`
`
`
`consolidated filings and discovery and will accept a back-seat, “understudy” role in
`
`the joint proceedings.1 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
`
`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 May 2,
`
`2016, the Mylan IPR’s institution date. See Mylan IPR, Paper 16 (Decision).
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`
`
`1.
`
`AstraZeneca has not sued Teva for allegedly infringing the ’186
`
`patent. As such, there is no current underlying patent litigation between
`
`AstraZeneca and Teva, with respect to the ’186 patent.
`
`
`
`2.
`
`The ’186 patent is involved in AstraZeneca AB v. Mylan
`
`Pharmaceuticals Inc., 14-cv-00696 (D. Del. 2014); AstraZeneca AB v. Mylan
`
`Pharmaceuticals Inc., 14-cv-00094 (D.W. Va. 2014); AstraZeneca AB v.
`
`
`1 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 AstraZeneca’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
`
`
`
`Aurobindo Pharma Ltd. et al., 14-cv-014696 and 14-cv-00664 (D. Del. 2014);
`
`AstraZeneca AB v. Actavis Laboratories FL, Inc., 14-cv-01356 (D. Del. 2014);
`
`AstraZeneca AB v. Sun Pharma Global FZE et al., 14-cv-00694 (D. Del. 2014);
`
`AstraZeneca AB v. Amneal Pharmaceuticals LLC., 14-cv-00697 (D. Del. 2014);
`
`and AstraZeneca AB v. Wockhardt Bio AG et al., 14-cv-00696 (D. Del. 2014);
`
`none of which involve Teva.
`
`
`
`3.
`
`On June 4, 2015, Mylan filed its petition for inter partes review
`
`seeking cancellation of claims 1, 2, 4, 6-22, 25-30, 32-37 and 39-42 of the ‘186
`
`patent. (Mylan IPR, Paper 3.)
`
`
`
`4.
`
`The Mylan IPR petition included the following four grounds for
`
`challenging the validity of the ’186 patent:
`
`
`
`Ground 1: Claims 1, 2, 4, 6-11, 25-28, 32-35, 39 and 40 are obvious over
`
`Ashworth, Villhauer, Raag and Hanessian;
`
`
`
`Ground 2: Claims 12-16, 29, 30, 36, 37, 41 and 42 are obvious over
`
`Ashworth, Villhauer, Raag, Hanessian, Bachovchin and the GLUCOPHAGE
`
`Label;
`
`
`
`Ground 3: Claims 12, 17, 18 and 22 are obvious over Ashworth, Villhauer,
`
`Raag, Hanessian, Bachovchin and the XENICAL Label; and
`
`
`
`Ground 4: Claims 12 and 19-21 are obvious over Ashworth, Villhauer,
`
`Raag, Hanessian, Bachovchin and the MEVACOR Label.
`
`
`
`4
`
`
`
`
`
`5.
`
`On September 25, 2015, Patent Owner filed a Preliminary Response.
`
`(Mylan IPR, Paper No. 7)
`
`
`
`6.
`
`On November 6, 2015, Mylan filed a reply to Patent Owner’s
`
`Preliminary Response. (Mylan IPR, Paper No. 11).
`
`5.
`
`On December 9, 2015, the Board denied Mylan’s petition. (Mylan
`
`IPR, Paper No. 12)
`
`
`
`6.
`
`On January 8, 2016, Mylan filed the request for rehearing. (Mylan
`
`IPR, Paper No. 13)
`
`
`
`7.
`
`On May 2, 2016, the Board granted Mylan’s request for rehearing.
`
`(Mylan IPR, Paper No. 15)
`
`
`
`8.
`
`On May 2, 2016, the Board instituted review of claims 1, 2, 4, 6–22,
`
`25–30, 32–37, and 39–42 of the ‘186 patent in the Mylan IPR with respect to
`
`Grounds 1-4. (Mylan IPR, Paper 16.)
`
`
`
`9.
`
`On May 2, 2016, the Board entered a scheduling order in the Mylan
`
`IPR setting various dates, including the oral argument set for January 25, 2017.
`
`(Mylan IPR, Paper 17)
`
`
`
`8.
`
`Teva’s petition in this proceeding proposes that claims 1, 2, 4, 6–22,
`
`25–30, 32–37, and 39–42 of the ’186 patent should be cancelled in view of
`
`Grounds 1-4, as set forth in the Mylan IPR petition.
`
`9.
`
`Teva’s petition in this proceeding presents the identical
`
`5
`
`
`
`
`
`
`
`grounds on which the Mylan IPR was instituted.
`
`
`
`10. 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.
`
`
`
`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,
`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
`
`
`
`6
`
`
`
`motion for joinder must be filed within one month of institution of the first inter
`
`partes review proceeding. 37 C.F.R. § 42.122(b).
`
`In exercising its discretion to grant joinder, the Board considers the impact
`
`of substantive and procedural issues on the proceedings, as well as other
`
`considerations, while being “mindful that patent trial regulations, including the
`
`rules for joinder, must be construed to secure the just, speedy, and inexpensive
`
`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
`
`Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. The Board should
`
`consider “the policy preference for joining a party that does not present new issues
`
`that might complicate or delay an existing proceeding.” Id. at 10. Under this
`
`framework, joinder of the present IPR with the Mylan IPR is appropriate.
`
`“A motion for joinder should: (1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
`
`may be simplified.” Id. at 4 and Macronix Int’l Co. v. Spansion, IPR2014-00898,
`
`Paper 15 at 4 (Aug. 13, 2014). The Board should also consider “the policy
`
`preference for joining a party that does not present new issues that might
`
`complicate or delay an existing proceeding.” See Dell, Inc. v. Network-1 Security
`
`
`
`7
`
`
`
`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.
`
`
`
`
`
`B.
`
`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 ’186 patent in a timely manner. 35 U.S.C. § 316(a)(11) and associated rule
`
`37 C.F.R. § 42.100(c) provide that inter partes review proceedings should be
`
`completed and the Board’s final decision issued within one year of institution of
`
`the review. In this case, joinder will not affect the Board’s ability to issue the
`
`decision within this required one-year timeframe because the Petition filed in the
`
`present Teva IPR is substantially identical to the Mylan IPR. Indeed, in
`
`circumstances such as these, the PTO anticipated that joinder would be granted as
`
`a matter of right. See 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement
`
`of Sen. Kyl) (“The Office anticipates that joinder will be allowed as of right – if an
`
`inter partes review is instituted on the basis of a petition, for example, a party that
`
`files an identical petition will be joined to that proceeding, and thus allowed to file
`
`its own briefs and make its own arguments.”) (emphasis added).
`
`
`
`As such, Teva raises no issues that are not already before the Board in the
`
`Mylan IPR. Teva’s petition seeks review of claims 1, 2, 4, 6–22, 25–30, 32–37,
`
`and 39–42 of the ‘186 patent based on the identical grounds and combination of
`
`prior art considered by the Board in instituting review in the Mylan IPR. Indeed,
`
`
`
`8
`
`
`
`Teva’s petition is substantially 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. Additionally, the Teva IPR and Mylan IPR
`
`include the same “lead compound” theories.
`
`
`
`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
`
`those joined proceedings, without any right to separate or additional briefing or
`
`discovery, unless authorized by the Board upon a request to address an issue that is
`
`unique to Teva. Only if Mylan drops out of the proceedings for any reason, will
`
`Teva cease its understudy role.
`
`To the extent that Teva’s petition in this proceeding differs from the
`
`petition that Mylan filed in IPR 340, Teva agrees to withdraw all additional
`
`arguments, as well as its supporting declaration of Dr. Muthyala, and proceed in
`
`IPR 340 based on the arguments and evidence provided by Mylan in
`
`IPR 340. Teva agrees to assume a primary role in IPR 340 only if Mylan ceases to
`
`participate in IPR 340. In other words, Teva requests permission to be
`
`added to the case caption as a petitioner in IPR 340, without any active
`
`participation or involvement that is separate from Mylan, unless authorized
`
`by the Board upon a request pertaining to an issue unique to Teva alone.
`
`
`
`9
`
`
`
`
`
`In order to further simplify the proceeding, Teva will rely on the same expert
`
`as Mylan, should Mylan permit it.2 If Mylan allows Teva to retain the same expert,
`
`then Teva will withdraw its expert declaration of Dr. Muthyala and rely solely on
`
`the declaration and testimony of Mylan’s expert, Dr. Rotella. The Board has
`
`previously acknowledged that such concessions on the part of a party seeking to
`
`join are sufficient to minimize the impact on the original proceeding (see SAP
`
`America Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13, page 4).
`
`Even if, through no fault of its own, Teva were required to proceed with its
`
`own expert, there would be no impact on the Board’s ability to complete its review
`
`in a timely manner. Moreover, there would be only a modest impact on the Patent
`
`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.
`
`C.
`
`Joinder Will Enhance Efficiency by Avoiding Duplicate Efforts
`and Inconsistencies
`
`
`
`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,
`
`
`2 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. Muthyala, Teva would in that case
`agree to withdraw Dr. Muthyala’s declaration and instead rely solely on the
`declaration of Mylan’s expert, Dr. Rotella.
`
`
`
`10
`
`
`
`determining the same validity questions in separate concurrent proceedings could
`
`duplicate efforts, and create a risk of inconsistent results and piecemeal review.
`
`Accordingly, a joined inter partes review will avoid inefficiency and potential
`
`inconsistency and result in a final written decision without any delay.
`
`
`
`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 May 2, 2016, the date on which the
`
`Mylan IPR was instituted. See Mylan IPR, Paper 16 (Decision). Absent joinder,
`
`Teva’s petition is not otherwise time-barred.3 35 U.S.C. § 315(b). Teva has an
`
`independent right to file an IPR, having not been previously sued for allegedly
`
`infringing AstraZeneca’s RE 44,186 patent (“the ’186 patent”). Absent joinder, the
`
`Board may otherwise be burdened with two proceedings.
`
`D. A Joined Proceeding Avoids Prejudice to Teva and Will Not
`Prejudice Mylan or AstraZeneca
`
`Joinder is also warranted in order to permit Teva to protect its interests
`
`related to the validity and interpretation of the ’186 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 AstraZeneca reach a resolution
`
`
`3 The Board has repeatedly denied joinder for an otherwise time-barred petition.
`Teva Pharms., IPR2015-00550, Paper 11; Samsung Elec., IPR2014-01142, Paper
`11; Microsoft Corp. v. Surfcast, Inc., IPR2014-00271, Paper 20 at 7 (PTAB June
`13, 2014).
`
`
`
`11
`
`
`
`of their disputes during the pendency of the Mylan IPR. 35 U.S.C. § 317(a)
`
`provides that an inter partes review “shall be terminated with respect to any
`
`petitioner upon the joint request of the petitioner and the patent owner” unless the
`
`Board has already reached its decision on the merits. If no petitioner remains after
`
`settlement, “the Office may terminate the review.” Id. Here, if AstraZeneca and
`
`Mylan settled, the Mylan IPR could terminate without proceeding to a final written
`
`decision, prejudicing Teva.
`
`
`
`Permitting joinder will not prejudice AstraZeneca or Mylan. Teva raises no
`
`issues not already before the Board, so joinder will not affect the timing of the
`
`Mylan IPR or the content of AstraZeneca’s Patent Owner response. Teva also
`
`believes that given the procedural safeguards proposed below, any additional costs
`
`to AstraZeneca and Mylan associated with its participation in the Mylan IPR will
`
`be minimal, and not so great as to justify the potential prejudice to Teva if the
`
`Mylan IPR was otherwise terminated before a final written decision by the Board.
`
`E.
`
`Joinder will not prejudice Patent Owner or Mylan
`
`Permitting joinder will not prejudice AstraZeneca or Mylan. Teva’s
`
`proposed 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 the schedule that may be required is permitted by law and the
`
`applicable rules. 35 U.S.C. § 316(a)(1); 37 C.F.R. § 42.100(c).
`
`
`
`12
`
`
`
`IV. CONCLUSION
`
`
`
`For all the foregoing reasons, Teva respectfully requests this proceeding be
`
`joined with the Mylan IPR.
`
`
`
`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
`
`Motion to Deposit Account No. 502880.
`
`
`Dated: June 1, 2016
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`Respectfully submitted,
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`
`/Gary J. Speier/
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Iain M. McIntyre, Backup Counsel
`Reg. No. 40,337
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`
`
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`13
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`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), this is to certify that on June 1, 2016, I
`
`caused to be served a true and correct copy of the foregoing “MOTION FOR
`
`JOINDER PURSUANT TO 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 AND
`
`42.122(b)” by EXPRESS MAIL on counsel of record for AstraZeneca AB in
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`IPR2015-10340 for Re44186 at its correspondence address as follows:
`
`Mr. Charles E. Lipsey
`Finnegan, Henderson, Farabow, Garrett and Dunner,
`11955 Freedom Drive
`Reston VA 20190
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`
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`Respectfully submitted,
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`Dated: June 1, 2016
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`/Gary J. Speier/
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Attorney for Petitioner
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`14
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