`
`
`
`
`
`
`
`
`Paper No. ___
`Filed: September 29, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN TECHNOLOGIES INC.,
`Petitioner,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`
`_____________________________
`
`Case IPR2017-00200
`Patent No. 8,603,514
`
`_____________________________
`
`JOINT MOTION TO TERMINATE PURSUANT TO
`35 U.S.C. § 317 AND 37 C.F.R. § 42.74
`
`
`
`
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`Pursuant to 35 U.S.C. § 317, 37 C.F.R. §§ 42.72 and 42.74, and the Board’s
`
`authorization of September 28, 2017, Petitioner Mylan Technologies, Inc.
`
`(“Mylan”) and Patent Owner MonoSol Rx, LLC jointly move to terminate the
`
`present inter partes review proceeding in light of the parties’ settlement of their
`
`dispute insofar as it relates to U.S. Patent No. 8,603,514 (“the ’514 patent”). The
`
`parties are filing, concurrently herewith, a true and complete copy of their written
`
`Settlement and License Agreement (“Settlement Agreement”) (Confidential
`
`Exhibit 1030) in connection with this matter as required by the statute. The
`
`Settlement Agreement completely settles the parties’ controversy and their dispute
`
`relating to the ’514 patent as between Patent Owner and Mylan, the Petitioner and
`
`real party-in-interest in the present proceeding, who was named as a defendant in
`
`the U.S. district court litigation captioned Indivior Inc., et al. v. Mylan
`
`Technologies Inc., et al., C.A. No. 1:15-01016-RGA (D. Del.). In the district court
`
`litigation, the parties will file a Consent Judgment in the district court litigation
`
`within one (1) business day after exchange of consideration (see Settlement
`
`Agreement (Confidential Exhibit 1030), para. 2.1 and Exhibit A).
`
`The parties further jointly certify that there are no other agreements or
`
`understandings, oral or written, between Patent Owner and Petitioner, including
`
`
`-1-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`any collateral agreements, made in connection with, or in contemplation of, the
`
`termination of the present proceeding as set forth in 35 U.S.C. § 317(b).
`
`The parties request that the Settlement Agreement (Confidential Exhibit
`
`1030) be treated as business confidential information and kept separate from the
`
`file of the ’514 patent. A joint request to treat the Settlement Agreement as
`
`business confidential information, kept separate from the file of the involved patent
`
`pursuant to 35 U.S.C. § 317(b), is being filed concurrently herewith.
`
`Termination of Inter Partes Review Proceeding
`
`A joint motion to terminate generally “must (1) include a brief explanation
`
`as to why termination is appropriate; (2) identify all parties in any related litigation
`
`involving the patents at issue; (3) identify any related proceedings currently before
`
`the Office, and (4) discuss specifically the current status of each such related
`
`litigation or proceeding with respect to each party to the litigation or proceeding.”
`
`Heartland Tanning, Inc. v. Sunless, Inc., IPR2014-00018, Paper No. 26, at *2
`
`(PTAB July 28, 2014). Each element is addressed below.
`
`
`
`As for requirement (1), termination is appropriate in this proceeding because
`
`the parties have settled their dispute with respect to the ’514 patent, and have
`
`agreed to terminate this inter partes review. The applicable statute, 35 U.S.C.
`
`§ 317(a), provides that an inter partes review proceeding “shall be terminated with
`
`respect to any petitioner upon the joint request of the petitioner and the patent
`
`-2-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`owner, unless the Office has decided the merits of the proceeding before the
`
`request for termination is filed.” In this case, the inter partes review has been
`
`instituted, but the parties’ filings are still in process and the oral hearing is set for
`
`January 10, 2018. The Office has made no final decision on the merits. Moreover,
`
`as recognized by the rules of practice before the Board:
`
`There are strong public policy reasons to favor settlement between the
`parties to a proceeding. The Board will be available to facilitate
`settlement discussions, and where appropriate, may require a
`settlement discussion as part of the proceeding. The Board expects
`that a proceeding will terminate after the filing of a settlement
`agreement, unless the Board has already decided the merits of the
`proceeding.
`
`Patent Office Trial Practice Guide, Fed. Register, Vol. 77, No. 157 at 48,768 (Aug.
`
`14, 2012). Moreover, no public interest or other factors militate against
`
`termination of this proceeding.
`
`As for requirements (2) and (4), the table below identifies parties in district
`
`court litigations that involve or involved the ’514 patent, and discusses the current
`
`status of these related litigations with respect to each party to the litigation. See
`
`Heartland Tanning, Inc., Paper No. 26, at *2. Petitioner and Patent Owner believe
`
`that all of the named defendants in the below-identified litigations are time-barred
`
`from filing IPR petitions challenging the ’514 patent. In particular, the defendant
`
`-3-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`in the most recently filed litigation, Actavis Laboratories UT, Inc., was previously
`
`named in the June 2015 Second Amended Complaint in Reckitt Benckiser
`
`Pharmaceuticals Inc., RB Pharmaceuticals Limited, and MonoSol Rx, LLC v.
`
`Watson Laboratories Inc. and Actavis, Inc., C.A. No. 1:13-cv-01674 (D. Del.)
`
`(original complaint filed on October 8, 2013).
`
`Case Caption
`
`Indivior Inc., et al. v. Actavis Laboratories
`UT, Inc., No. 1:16-cv-01009 (D. Del.) (filed on
`October 31, 2016)
`Indivior Inc., Indivior UK Limited, and
`Monosol Rx, LLC v. Teva Pharmaceuticals USA,
`Inc., C.A. No. 1:16-cv-00178 (D. Del.) (filed on
`March 21, 2016)
`Indivior Inc., Indivior UK Limited, and
`MonoSol Rx, LLC v. Sandoz Inc., C.A. No. 1:15-
`cv-01051 (D. Del.) (filed on November 13, 2015)
`Indivior Inc., Indivior UK Limited, and
`MonoSol Rx, LLC v. Mylan Technologies
`Inc., Mylan Pharmaceuticals Inc., and
`Mylan N.V., C.A. No. 1:15-cv-00209 (N.D.W.Va.)
`(filed on November 5, 2015)
`Indivior Inc., Indivior UK Limited, and
`MonoSol Rx, LLC v. Mylan Technologies
`Inc., Mylan Pharmaceuticals Inc., and
`Mylan N.V., C.A. No. 1:15-cv-01016 (D. Del.)
`(filed on November 4, 2015)
`Reckitt Benckiser Pharmaceuticals Inc., RB
`Pharmaceuticals Limited, and MonoSol Rx,
`LLC v. Alvogen Pine Brook, Inc., C.A. No. 1:15-
`cv-00477 (D. Del.) (filed on June 10, 2015)
`
`-4-
`
`Current Status of Each
`Related Litigation With
`Respect to Each Party to the
`Litigation or Proceeding
`Pending
`
`Stayed on May 3, 2016
`
`Closed on August 22, 2016
`
`Stayed on January 8, 2016
`
`Pending
`
`Pending
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`Case Caption
`
`Reckitt Benckiser Pharmaceuticals Inc., RB
`Pharmaceuticals Limited, and MonoSol Rx, LLC v.
`Teva Pharmaceuticals USA, Inc., C.A. No. 1:14-
`cv-01451 (D. Del.) (filed on December 2, 2014)
`Reckitt Benckiser Pharmaceuticals Inc., RB
`Pharmaceuticals Limited, and MonoSol Rx,
`LLC v. Par Pharmaceutical, Inc. and
`Intelgenx Technologies Corp., C.A. No. 1:14-cv-
`00422 (D. Del.) (filed on April 4, 2014)
`Reckitt Benckiser Pharmaceuticals Inc., RB
`Pharmaceuticals Limited, and MonoSol Rx,
`LLC v. Alvogen Pine Brook, Inc. and
`Alvogen Group, Inc., C.A. No. 1:13-cv-02003 (D. D
`(filed on December 6, 2013)
`Reckitt Benckiser Pharmaceuticals Inc., RB
`Pharmaceuticals Limited, and MonoSol Rx, LLC v.
`Watson Laboratories Inc. and
`Actavis, Inc., C.A. No. 1:13-cv-01674 (D. Del.)
`(filed on October 8, 2013)
`Reckitt Benckiser Pharmaceuticals, Inc.,
`RB Pharmaceuticals Ltd., and MonoSol Rx,
`LLC v. Par Pharmaceuticals, Inc.,
`Intelgenx Techs. Corp., and LTS Lohmann
`Therapy Sys. Corp., C.A. No. 1:13-cv-01461 (D.
`Del.) (filed on August 20, 2013)
`
`
`Current Status of Each
`Related Litigation With
`Respect to Each Party to the
`Litigation or Proceeding
`Pending
`
`Closed on June 28, 2016
`
`Closed on May 9, 2014
`
`Closed on June 28, 2016
`
`Closed on May 27, 2014
`
`As for requirements (3) and (4), the following related Inter Partes Review
`
`proceedings for the ’514 patent are currently before or were previously before the
`
`U.S. Patent & Trademark Office:
`
`-5-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`IPR Caption
`
`IPR2016-00281 - Teva Pharmaceuticals
`USA, Inc. v.
`MonoSol Rx, LLC
`
`IPR2016-01111 - Dr. Reddy’s
`Laboratories, Ltd. and Dr. Reddy’s
`Laboratories, Inc., v. MonoSol Rx, LLC
`IPR2017-00200 - Mylan Technologies,
`Inc. v. MonoSol Rx, LLC
`
`IPR2017-01557 - Par Pharmaceutical,
`Inc. and IntelGenx Corp. v. MonoSol Rx,
`LLC
`IPR2017-01582 - Dr. Reddy’s
`Laboratories, S.A. and Dr.
`Reddy’s Laboratories, Inc., v. MonoSol
`Rx, LLC
`
`
`Current Status of Each Related Inter
`Partes Review Proceeding With
`Respect to Each Party to the
`Proceeding
`Institution denied (petition filed
`December 4, 2015)
`
`Institution denied (petition filed May
`31, 2016)
`
`Pending Due Date 2 (Petitioner Reply
`due Oct. 2, 2017) (petition filed
`November 4, 2016)
`Pending Board decision on institution
`and joinder (petition filed June 9, 2017)
`
`Pending Board decision on institution
`and joinder (petition filed June 12,
`2017)
`
`Petitioner and Patent Owner believe that, in addition to this IPR proceeding,
`
`termination as to Petitioner MonoSol on all pending IPRs is appropriate, and
`
`therefore the pending joinder motions filed by Dr. Reddy’s Laboratories (IPR2017-
`
`01582) and Par Pharmaceutical, Inc. and IntelGenx Corp. (IPR2017-01552) should
`
`be denied. As the Board is aware, Dr. Reddy’s previously filed a petition
`
`challenging the ’514 patent in IPR2016-01111, for which institution was denied.
`
`In addition, as noted above, Par and IntelGenx were previously sued twice, in 2013
`
`and 2014, and failed to timely file IPR petitions challenging the ’514 patent in
`
`either instance.
`
`-6-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`
`Finally, as discussed above, the Settlement Agreement fully resolves all
`
`litigation and proceedings between the parties to this IPR proceeding relating to the
`
`’514 patent. The parties will file a Consent Judgment in the district court litigation
`
`involving Petitioner Mylan within one business day after the parties exchange
`
`consideration under the Settlement Agreement (see Confidential Exhibit 1030,
`
`para. 2.1 and Exhibit A).
`
`For the foregoing reasons, the parties jointly and respectfully request that the
`
`instant proceeding be terminated.
`
`
`Dated: September 28, 2017
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`By / Steven W. Parmelee /
`Steven W. Parmelee
`Reg. No. 31,990
`WILSON, SONSINI, GOODRICH &
`ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`Tel: (206)883-2500
`Fax: (206) 883-2699
`
`Attorneys for Petitioner
`
`
`
`
`
`
`
`
`
`-7-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`
`
`
`
`
`
`
`By /Harold H. Fox/ _____________
`Harold H. Fox
`Registration No. 41,498
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036-1795
`Tel: (202) 429-6284
`Fax: (202) 429-3902
`hfox@steptoe.com
`
`Attorneys for Patent Owner
`
`
`
`-8-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`
`
`Exhibit No
`
`List of Exhibits
`
`Description
`
`1001
`
`U.S. Patent No. 8,603,514 to Yang et al.
`
`1002
`
`Declaration of Graham Buckton, Ph.D.
`
`1003
`
`Curriculum Vitae of Graham Buckton, Ph.D.
`
`1004
`
`File history of U.S. Patent No. 8,603,514.
`
`1005
`
`Ilango et al., In-Vitro studies on Buccal strips of Glibenclamide
`using Chitosan, 59 Indian J. Pharm. Sci. 232-235 (1997).
`
`1006
`
`WO2000/42992 to Chen et al.
`
`1007
`
`1008
`
`Declaration of B. Arlie Bogue, Dated: March 13, 2013;
`Reexamination Control No. 95/002,170.
`
`Frankman et al., Clinical evaluation of C-Film, a vaginal
`contraceptive, 3 J. Int. Med. Res. 292-96 (1975).
`
`1009
`
`U.S. Patent No. 5,595,980 to Brode et al.
`
`Roddy et al., A controlled trial of nonoxynol 9 film to reduce
`male-to-female transmission of sexually transmitted
`diseases, 339 N. Engl. J. Med. 504-10 (1998).
`
`
`
`U.S. Patent No. 4,569,837 to Suzuki et al.
`
`1010
`
`1011
`
`
`-9-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`
`Exhibit No
`
`Description
`
`1012
`
`U.S. Patent No. 6,159,498 to Tapolsky et al.
`
`1013
`
`Yamamura et al., Oral mucosal adhesive film containing local
`anesthetics: in vitro and clinical evaluation. 43 J. Biomed.
`Mater. Res. 313-317 (1998).
`
`1014
`
`U.S. Patent No. 4,713,243 to Schiraldi et al.
`
`1015
`
`U.S. Patent No. 4,568,535 to Loesche et al.
`
`1016
`
`U.S. Patent No. 3,797,494 to Zaffaroni et al.
`
`1017
`
`U.S. Patent No. 4,249,531 to Heller et al.
`
`1018
`
`U.S. Patent No. 5,506,049 to Swei et al.
`
`1019
`
`U.S. Patent No. 7,067,116 to Bess et al.
`
`1020
`
`U.S. Patent No. 4,849,246 to Schmidt et al.
`
`1021
`
`European Patent No. 0241178 to Higashi et al.
`
`1022
`
`1023
`
`The United States Pharmacopeia: 20th Revision and the National
`Formulary, Fifteenth Edition. Rockville, Md: United States
`Pharmacopeial Convention, Inc., 1979.
`Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories,
`Inc. and Reckitt Benckiser Pharmaceuticals Inc. v. Par
`Pharmaceutical, Inc., C.A. No. 13-1674 and C.A. No. 14-
`422, District of Delaware, D.I. 446.
`
`-10-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`
`Exhibit No
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`Description
`Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories,
`Inc. and Reckitt Benckiser Pharmaceuticals Inc. v. Par
`Pharmaceutical, Inc., C.A. No. 13-1674 and C.A. No. 14-
`422, District of Delaware, D.I. 156.
`Reckitt Benckiser Pharmaceuticals Inc. v Teva Pharmaceuticals
`USA, Inc. and Reckitt Benckiser Pharmaceuticals Inc. v. Par
`Pharmaceutical, Inc., C.A. No. 14-1451 and C.A. No. 14-
`1573, District of Delaware, D.I. 175.
`Complaint; Indivior Inc. et al v. Mylan Technologies, Inc. et al.,
`No. 1:15-CV-00209, Northern District of West Virginia.
`
`Complaint; Indivior Inc. et al v. Mylan Technologies, Inc. et al.,
`No. 1:15-cv-01016, District of Delaware.
`
`Declaration of Tung-On Kong in support of Petitioner’s Motion
`for Pro Hac Vice Admission
`
`Declaration of Elham F. Steiner in support of Petitioner’s Motion
`for Pro Hac Vice Admission
`
`1030
`
`Confidential Settlement Agreement
`
`-11-
`
`
`
`Case IPR2017-00200
`Patent 8,603,514
`
`
`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Joint Motion to Terminate Pursuant to 35 U.S.C. § 317 and 37 C.F.R. §
`
`42.74 and Exhibit 1030, on this 29th day of September, 2017, on the Patent Owner
`
`at the correspondence address of the Patent Owner as follows:
`
`Harold Fox
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036-1795
`Email: hfox@steptoe.com
`Email: 514MIPR@steptoe.com
`
`
`John L. Abramic
`STEPTOE & JOHNSON LLP
`115 South LaSalle Street, Suite 3100
`Chicago, IL 60603
`Email: jabramic@steptoe.com
`
`
`
`
`
`Charanjit Brahma
`TROUTMAN SANDERS
`580 California Street, Suite 1100
`San Francisco, CA 94104
`Email:
`charanjit.brahma@troutmansanders.com
`
`Dustin B. Weeks
`TROUTMAN SANDERS
`600 Peachtree Street, NE, Suite 5200
`Atlanta, GA 30308
`Email:
`dustin.weeks@troutmansanders.com
`
`Dated: September 29, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`-12-
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
