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. IPR2015-01680
`Patent No. 8,852,636
`______________
`
`
`
`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
`
`
`
`120672381 v2
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`
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner
`
`v.
`
`POZEN INC.,
`Patent Owner
`______________
`
`Case No. IPR2015-01680
`Patent No. 8,852,636
`______________
`
`
`
`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
`
`
`
`120672381 v2
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`
`
`
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`Pursuant to 37 C.F.R. § 42.8, the real parties-in-interest for this proceeding
`
`Case No. IPR2015-01680
`Patent No. 8,852,636
`
`
`
`
`hereby submit the following mandatory notices in response to the Petition for Inter
`
`Partes Review of U.S. Patent No. 8,852,636 (“the ’636 patent”), case number
`
`IPR2015-01680.
`
`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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`Horizon Pharma plc, a corporation organized and existing under the laws of
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`Case No. IPR2015-01680
`Patent No. 8,852,636
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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
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`Horizon Pharma, Inc.
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`Pozen Inc. (“Pozen”) is the licensor and patent owner of the ’636 patent.
`
`Horizon Pharma USA, Inc. (“Horizon”) is the exclusive licensee with the
`
`right to enforce and defend the ’636 patent in this IPR proceeding.
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`Horizon obtained rights to the ’636 patent through an exclusive license
`
`agreement between patent owner Pozen and Horizon relating to the ’636 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 ’636 patent’s term, which includes the right to
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`sublicense, enforce, and defend the ’636 patent. See Ex. 2001 at §§ 1.43, 1.44, 7.1
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`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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`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. IPR2015-01680
`Patent No. 8,852,636
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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
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`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
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`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.
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`Schedule 1.43 to the License Agreement identifies U.S. Patent Appl. Nos.
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`Case No. IPR2015-01680
`Patent No. 8,852,636
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`10/158,216 (U.S. Pat. No. 6,926,907) and 11/129,320 (now U.S. Pat. No.
`
`8,206,741) as being within the scope of the “Licensed Patents.” Ex. 2001 Schedule
`
`1.43. The ’636 patent issued from U.S. Pat. Appl. No. 14/045,156, which is a
`
`continuation application of U.S. Pat. Appl. No. 13/215,855 (now U.S. Pat. No.
`
`8,557,285), which is a divisional application of U.S. Pat. Appl. No. 12/553,804
`
`(abandoned), which is a divisional application of U.S. Pat. Appl. No. 11/129,320
`
`(now U.S. Pat. No. 8,206,741), which is a continuation-in-part application of U.S.
`
`Pat. Appl. No. 10/158,216 (now U.S. Pat. No. 6,926,907). Accordingly, the ’636
`
`patent falls within the scope of the “Licensed Patents” as it is a continuation
`
`application of a divisional application of a divisional application of a continuation-
`
`in-part application of U.S. Pat. No. 6,926,907, which is 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 ’636 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 ’636 patent under the License Agreement is as follows:
`
`7.1 Licensed Technology. Subject to the terms and conditions of
`
`this Agreement, POZEN hereby grants to Licensee an exclusive
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`Case No. IPR2015-01680
`Patent No. 8,852,636
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`(including with regard to POZEN and its Affiliates), royalty-bearing
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`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.
`
`The License Agreement further gives Horizon the rights to enforce and
`
`defend against challenges to the ’636 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,
`
`2 These designations
`identify redacted material
`
`is not material
`
`that
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`to
`
`demonstrating that Horizon is an exclusive licensee with all substantial rights to
`
`the ’636 patent.
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`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
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`Licensee will so notify POZEN promptly, and POZEN may
`
`commence litigation with respect to the alleged or threatened
`
`infringement at its own expense. . . .
`
`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
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`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 ’636 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.
`
`RELATED MATTERS (37 C.F.R. § 42.8(b)(2))
`
`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.). Lupin Ltd. and Lupin Pharms. Inc.,
`
`IPR2015-01774 (P.T.A.B.).
`
`U.S. Patent Nos. 6,926,907, 8,206,741, 8,858,996, 8,557,285, and 8,865,190
`
`and U.S. Patent Appl. Nos. 12/553,804, 13/475,446, 14/515,627, and 14/753,195
`
`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.
`
`120672381 v2
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`8,852,636 may claim priority. Additional proceedings involving patents related to
`
`Case No. IPR2015-01680
`Patent No. 8,852,636
`
`8,852,636 include:
`
`• 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.);
`
`• Dr. Reddy’s Labs., Inc. v. Pozen Inc., IPR2015-00802 (P.T.A.B.);
`
`• Coalition for Affordable Drugs VII LLC v. Pozen Inc., IPR2015-
`
`01241 (P.T.A.B.);
`
`• Coalition for Affordable Drugs VII LLC v. Pozen Inc., IPR2015-
`
`01344 (P.T.A.B.);
`
`• Lupin Ltd. and Lupin Pharms. Inc. v. Pozen Inc., IPR2015-01773
`
`(P.T.A.B.); and
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`120672381 v2
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`Patent No. 8,852,636
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`• Lupin Ltd. and Lupin Pharms. Inc. v. Pozen Inc., IPR2015-01775
`
`(P.T.A.B.).
`
`Patent Owner does not concede that any of these applications or patents
`
`would affect, or be affected by, a decision in the present inter partes review of U.S.
`
`Patent No. 8,852,636.
`
`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
`
`Back-up Counsel
`Dennis Bennett
`GLOBAL PATENT GROUP, LLC
`1005 N. Warson Road, Suite 404
`St. Louis, MO 63132
`Tel: (314) 812-8018
`Fax: (314) 685-2300
`dennisbennett@globalpatentgroup.com
`
`USPTO Reg. No. 34,547
`
`
`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
`Lauren L. Stevens, Ph.D.
`GLOBAL PATENT GROUP, LLC
`1005 N. Warson Road, Suite 404
`St. Louis, MO 63132
`Tel: (650) 387-3813
`Fax: (314) 685-2300
`lstevens@globalpatentgroup.com
`
`USPTO Reg. No. 36,691
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`120672381 v2
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`10
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`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
`
`Case No. IPR2015-01680
`Patent No. 8,852,636
`
`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
`
`Jeffrey S. Gritton
`VINSON & ELKINS LLP
`2801 Via Fortuna
`Suite 100
`Austin, TX 78746-7568
`Tel +1.512.542.8531
`Fax +1.512.236.3315
`jgritton@velaw.com
`
`USPTO Reg. No. 65,314
`
`
`
`
`
`SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
`
`Horizon and Pozen hereby consent to electronic service. Please direct all
`
`correspondence to: zIPR2015-01680@cooley.com,
`
`dennisbennett@globalpatentgroup.com, lstevens@globalpatentgroup.com,
`
`shash@velaw.com, msampson@velaw.com, and jgritton@velaw.com.
`
`11
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`120672381 v2
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`Case No. IPR2015-01680
`Patent No. 8,852,636
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`Respectfully submitted,
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`
`
`BY:
`
`
`
`
`
`Date: August 28, 2015
`
`
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`120672381 v2
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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 28th day of August, 2015,
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`Case No. IPR2015-01680
`Patent No. 8,852,636
`
`
`
`
`
`the 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: Aug. 28, 2015
`
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`BY:
`
`
`
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`120672381 v2
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`13
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