UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner
`
`v.
`
`POZEN INC.,
`Patent Owner
`______________
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`______________
`
`
`
`MANDATORY NOTICES
`37 C.F.R. § 42.8
`
`
`
`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
`______________
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner
`
`v.
`
`POZEN INC.,
`Patent Owner
`______________
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`______________
`
`
`
`MANDATORY NOTICES
`37 C.F.R. § 42.8
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.8, the real parties-in-interest for this proceeding
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`
`
`
`hereby submit the following mandatory notices in response to the Petition for Inter
`
`Partes Review of U.S. Patent No. 6,926,907 (“the ’907 patent”), case number
`
`IPR2015-01241.
`
`REAL PARTY-IN-INTEREST (37 C.F.R. § 42.8(b)(1))
`
`The real parties-in-interest are:
`
`Pozen Inc.;
`
`Horizon Pharma, Inc., a corporation organized and existing under the laws
`
`of the State of Delaware having its principal place of business at 520 Lake Cook
`
`Road, Suite 520, Deerfield, Illinois, 60015, which is wholly owned by;
`
`Horizon Pharma Finance S.á r.l., an entity organized and existing under the
`
`laws of Luxembourg, having its principal place of business at 19 Rue de Bitbourg,
`
`Luxembourg, which is wholly owned by;
`
`Horizon Pharma Capital Limited, a corporation organized and existing under
`
`the laws of Ireland, having its principal place of business at Connaught House, 1st
`
`Floor, 1 Burlington Road, Dublin 4, Ireland, which is wholly owned by;
`
`Horizon Pharma Holdings Limited, a corporation organized and existing
`
`under the laws of Ireland, having its principal place of business at Connaught
`
`House, 1st Floor, 1 Burlington Road, Dublin 4, Ireland, which is wholly owned by;
`
`
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`2
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`
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`Horizon Pharma plc, a corporation organized and existing under the laws of
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
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`Ireland, having its principal place of business at Connaught House, 1st Floor, 1
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`Burlington Road, Dublin 4, Ireland; and
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`Horizon Pharma USA, Inc., a corporation organized and existing under the
`
`laws of the State of Delaware having its principal place of business at 520 Lake
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`Cook Road, Suite 520, Deerfield, Illinois, 60015, which is wholly owned by
`
`Horizon Pharma, Inc.
`
`Pozen Inc. (“Pozen”) is the licensor and patent owner of the ’907 patent.
`
`Horizon Pharma USA, Inc. (“Horizon”) is the exclusive licensee with the
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`right to enforce and defend the ’907 patent in this IPR proceeding.
`
`Horizon obtained rights to the ’907 patent through an exclusive license
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`agreement between patent owner Pozen and Horizon relating to the ’907 patent
`
`(“the License Agreement”), a redacted version of which is submitted with these
`
`mandatory notices.1 See Ex. 2001 (redacted version of the “License Agreement”).
`
`Under the License Agreement, Pozen granted Horizon an exclusive license in the
`
`Field of Use for the duration of the ’907 patent’s term, which includes the right to
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`sublicense, enforce, and defend the ’907 patent. See Ex. 2001 at §§ 1.43, 1.44, 7.1
`
`
`1 The redacted version of the License Agreement was previously submitted as a
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`public document to the Securities and Exchange Commission by Horizon.
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`
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`3
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`
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`9.6.1, 9.6.2, and 9.10.2, and Schedule 1.43. These rights specifically include the
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`Case No. IPR2015-01241
`Patent No. 6,926,907
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`right to defend reexamination proceedings. See Ex. 2001 § 9.6.2.
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`Specifically, the License Agreement defines “Licensed Patents” as:
`
`1.43 “Licensed Patents” means: (a) the Patents set forth on
`
`Schedule 1.43, and any substitutions, divisions, continuations,
`
`continuations-in-part, reissues, renewals, registrations, confirmations,
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`re-examinations, or extensions of such Patents, (b) any Patents in the
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`Territory Controlled by POZEN or any of its Affiliates as of the
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`Effective Date or during the Term that claim Inventions (including
`
`without limitation POZEN’s interest in Joint Inventions), and (c) all
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`other Patents in the Territory Controlled by POZEN or any of its
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`Affiliates as of the Effective Date or during the Term that are
`
`necessary or useful
`
`for
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`the Development, Manufacture or
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`Commercialization of a Product in the Territory. Notwithstanding
`
`anything in this Section 1.43 to the contrary, Licensed Patents shall
`
`not include any Patents Controlled by POZEN with Valid Claims that
`
`do not cover any Product (e.g., any Patents with Valid Claims solely
`
`directed to any product containing acetyl salicylic acid).
`
`Ex. 2001 § 1.43. Schedule 1.43 to the License Agreement identifies U.S. Patent
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`Appl. Nos. 10/158,216 and 11/129,320 as being within the scope of the “Licensed
`
`
`
`4
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`
`
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`Patents.” Ex. 2001 Schedule 1.43. The ’907 patent falls within the scope of the
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
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`“Licensed Patents” as it a Patent explicitly set forth on Schedule 1.43 of the
`
`License Agreement.
`
`The License Agreement also provides that Horizon is the exclusive licensee
`
`of the “Licensed Technology,” which includes the ’907 patent under the term
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`“Licensed Patents.” Ex. 2001 § 1.44 (“‘Licensed Technology’ means the
`
`Licensed Patents and the Licensed Know-How”). The exclusive grant of rights to
`
`Horizon for the ’907 patent under the License Agreement is as follows:
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`7.1 Licensed Technology. Subject to the terms and conditions of
`
`this Agreement, POZEN hereby grants to Licensee an exclusive
`
`(including with regard to POZEN and its Affiliates), royalty-bearing
`
`license, with the right to grant sublicenses as described in Section 7.3
`
`(Sublicenses), under the Licensed Technology to make, use, have
`
`made, sell, offer for sale, import and export Products in the Field of
`
`Use in the Territory. For the avoidance of doubt, Licensee shall have
`
`no license or other right under the Licensed Technology to make, use,
`
`have made, sell, offer for sale, import, and export any product
`
`containing acetyl salicylic acid (including salts and derivatives
`
`thereof).
`
`Ex. 2001 at § 7.1.
`
`
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`5
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`The license agreement further gives Horizon the rights to enforce and defend
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`against challenges to the ’907 patent. These exclusive rights are set forth in section
`
`9.6 of the License Agreement as follows:
`
`9.6 Enforcement of Licensed Patents.
`
`9.6.1 Infringement by Third Parties. Licensee and POZEN will
`
`each, within [redacted]2 Business Days of learning of any alleged or
`
`threatened infringement of the Licensed Patents or Joint Patents,
`
`notify the other Party in writing. Licensee will have the first right, but
`
`not the obligation, to prosecute any such infringement. If Licensee
`
`does not commence an infringement action against the alleged or
`
`threatened infringement (i) within [redacted] days following the
`
`detection of the of alleged infringement, or (ii) [redacted] Business
`
`Days before the time limit, if any, set forth in appropriate laws and
`
`regulations for filing of such actions, whichever comes first, then
`
`Licensee will so notify POZEN promptly, and POZEN may
`
`commence litigation with respect to the alleged or threatened
`
`infringement at its own expense. . . .
`
`2 These designations
`identify redacted material
`
`that
`
`is not material
`
`to
`
`demonstrating that Horizon is an exclusive licensee with all substantial rights to
`
`the ’907 patent.
`
`
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`6
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`
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`Case No. IPR2015-01241
`Patent No. 6,926,907
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`9.6.2 Challenge by Third Parties. Licensee and POZEN will each
`
`notify the other Party in writing within [redacted] Business Days of
`
`learning of any alleged or threatened opposition, reexamination
`
`request, action for declaratory judgment, nullity action, interference or
`
`other attack upon the validity, title or enforceability of the Licensed
`
`Patents or Joint Patents by a Third Party. Licensee will have the first
`
`right, but not the obligation, to defend any such challenge. If Licensee
`
`does not commence Diligent Efforts to defend against the alleged or
`
`threatened challenge (i) within [redacted] days following the detection
`
`of the alleged challenge, or (ii) [redacted] Business Days before the
`
`time limit, if any, set forth in appropriate laws and regulations for
`
`making a filing in defense of such a challenge, whichever comes first,
`
`then Licensee will so notify POZEN promptly, and POZEN may take
`
`action with respect to the alleged or threatened challenge at its own
`
`expense. . . .
`
`Ex. 2001 §§ 9.6.1, 9.6.2.
`
`As the foregoing terms of the License Agreement demonstrate, Horizon has
`
`obtained rights to the ’907 patent for purposes of this IPR through the License
`
`Agreement with Pozen, and is a real party-in-interest with standing for purposes of
`
`this Inter Partes Review proceeding.
`
`
`
`7
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`
`
`
`
`RELATED MATTERS (37 C.F.R. § 42.8(b)(2))
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`Horizon Pharma, Inc. & Pozen Inc. v. Dr. Reddy’s Labs. Inc. & Dr. Reddy’s
`
`Labs. Ltd., 3:11-cv-02317-MLC-DEA (D.N.J.). Horizon Pharma, Inc. & Pozen
`
`Inc. v. Dr. Reddy’s Labs. Inc. & Dr. Reddy’s Labs. Ltd., 3:13-cv-00091-MLC-
`
`DEA (D.N.J.). Horizon Pharma, Inc. & Pozen Inc. v. Lupin Ltd. & Lupin Pharms.,
`
`Inc., 3:11-cv-04275-MLC-DEA (D.N.J.). Horizon Pharma, Inc. et al. v. Actavis
`
`Labs. FL, Inc. & Actavis Pharma, Inc., 3:13-cv-03038-MLC-DEA (D.N.J.).
`
`Horizon Pharma, Inc. & Pozen Inc. v. Mylan Pharms., Inc. et al., 3:13-cv-04022-
`
`MLC-DEA (D.N.J.).
`
`U.S. Patent Nos. 8,206,741, 8,852,636, 8,557,285, 8,858,996, and 8,865,190
`
`and U.S. Patent Appl. Nos. 60/294,588, 10/158,216, 11/129,320, 12/553,804,
`
`13/215,855, 14/045,156, 14/231,971, 14/244,471, 14/515,627 claim, or may claim,
`
`the benefit of priority to U.S. Provisional Application No. 60/294,588, filed on
`
`June 1, 2001, the same application to which U.S. Patent No. 6,926,907 may claim
`
`priority. Additional proceedings involving patents related to 6,926,907 include
`
`Horizon Pharma, Inc. v. Actavis Labs. FL, Inc., 3:15-cv-03322 (D.N.J.); Horizon
`
`Pharma, Inc. v. Dr. Reddy’s Labs., Inc., 3:15-cv-03324 (D.N.J.); Horizon Pharma,
`
`Inc. v. Lupin Ltd., 3:15-cv-03326 (D.N.J.); Horizon Pharma, Inc., v. Mylan
`
`Pharmas., Inc. 3:15-cv-03327 (D.N.J.); and Dr. Reddy’s Labs., Inc. v. Pozen Inc.,
`
`IPR2015-00802 (P.T.A.B.). Patent Owner does not concede that any of these
`
`
`
`8
`
`
`
`
`applications or patents would affect, or be affected by, a decision in the present
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`inter partes review of U.S. Patent No. 6,926,907.
`
`LEAD AND BACK-UP COUNSEL (37 C.F.R. § 42.8(b)(3))
`
`Counsel for Horizon Pharma, Inc.:
`
`Lead Counsel
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`Tel: (650) 843-5046
`Fax: (650) 843-7400
`rr@cooley.com
`
`USPTO Reg. No. 40,789
`
`
`
`Counsel for Pozen Inc.:
`
`Lead Counsel
`Stephen M. Hash, Ph.D.
`VINSON & ELKINS LLP
`2801 Via Fortuna
`Suite 100
`Austin, TX 78746-7568
`Tel +1.512.542.8504
`Fax +1.512.236.3278
`shash@velaw.com
`
`USPTO Reg. No. 45,490
`
`
`
`
`Back-up Counsel
`Thomas A. Blinka, Ph. D.
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W,
`Suite 700
`Washington, DC 20004-2400
`Tel: (202) 842-7800
`Fax: (202) 842-7899
`tblinka@cooley.com
`
`USPTO Reg. No. 44,541
`
`Back-up Counsel
`Margaret J. Sampson, Ph.D.
`VINSON & ELKINS LLP
`2801 Via Fortuna
`Suite 100
`Austin, TX 78746-7568
`Tel +1.512.542.8569
`Fax +1.512.236.3264
`msampson@velaw.com
`
`USPTO Reg. No. 47,052
`
`
`
`9
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`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
`
`Horizon and Pozen hereby consent to electronic service. Please direct all
`
`
`
`
`
`correspondence
`
`to:
`
`
`
`IPR2015-01241@cooley.com, shash@velaw.com, and
`
`msampson@velaw.com.
`
`
`
`Date: June 11, 2015
`
`
`
`Respectfully submitted,
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`
`
`BY:
`
`
`
`
`
`
`10
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`
`
`
`
`
`
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e), 42.105(a))
`
`I, Ricardo Rodriguez, hereby certify that on this 11th day of June, 2015, the
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`
`
`
`
`foregoing Patent Owner’s Mandatory Notices pursuant to 37 C.F.R. § 42.8 and
`
`Pozen Exhibit 2001 were served electronically via email on the following:
`
`Amy E. LaValle
`alavalle@conleyrose.com
`
`Jerry C. Harris, Jr.
`jcharris@conleyrose.com
`
`Rodney B. Carroll
`rcarroll@conleyrose.com
`
`Conley Rose, P.C.
`5601 Granite Parkway, Suite 500
`Plano, Texas 75024
`
`
`
`
`
`Date: June 11, 2015
`
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`BY:
`
`
`
`
`11
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