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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`
`v.
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`POZEN INC.
`Patent Owner
`______________
`
`Case No. IPR2015-00802
`Patent No. 8,557,285
`______________
`
`
`MANDATORY NOTICES
`37 C.F.R. § 42.8
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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. IPR2015-00802
`Patent No. 8,557,285
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`
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`Pozen Inc. (“Pozen”) and Horizon Pharma, Inc. (“Horizon”) hereby submit the
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`following mandatory notices in response to the Petition for Inter Partes Review of
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`U.S. Patent No. 8,557,285 (“the ’285 patent”), case number IPR2015-00802.
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`REAL PARTY-IN-INTEREST (37 C.F.R. § 42.8(b)(1))
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`The real parties-in-interest are Pozen Inc. and Horizon Pharma, Inc.
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`Pozen Inc. is the licensor and patent owner of the ’285 patent.
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`Horizon Pharma, Inc. is the exclusive licensee with the right to enforce and
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`defend the ’285 patent in this IPR proceeding.
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`Horizon obtained rights to the ’285 patent through an exclusive license
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`agreement between patent owner Pozen Inc. (“Pozen”) and Horizon relating to the
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`’285 patent (“the License Agreement”), a redacted version of which is submitted
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`with these mandatory notices.1 See Ex. 2001 (redacted version of the “License
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`Agreement”). Under the License Agreement, Pozen Inc. granted Horizon an
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`exclusive license in the Field of Use for the duration of the ’285 patent’s term,
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`which includes the right to sublicense, enforce, and defend the ’285 patent. See
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`Ex. 2001 at §§ 1.43, 1.44, 7.1 9.6.1, 9.6.2, and 9.10.2, and Schedule 1.43. These
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`rights specifically include the right to defend reexamination proceedings. See Ex.
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`2001 § 9.6.2.
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`1 The redacted version of the License Agreement was previously submitted as a
`public document to the Securities and Exchange Commission by Horizon.
`2
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`Specifically, the License Agreement defines “Licensed Patents” as
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`1.43 “Licensed Patents” means: (a) the Patents set forth on
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`Schedule 1.43, and any substitutions, divisions, continuations,
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`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
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`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
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`for
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`the Development, Manufacture or
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`Commercialization of a Product in the Territory. Notwithstanding
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`anything in this Section 1.43 to the contrary, Licensed Patents shall
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`not include any Patents Controlled by POZEN with Valid Claims that
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`do not cover any Product (e.g., any Patents with Valid Claims solely
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`directed to any product containing acetyl salicylic acid).
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`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
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`Patents.” Ex. 2001 Schedule 1.43. The ’285 patent falls within the scope of the
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`3
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`“Licensed Patents” as a divisional application of the licensed U.S. Appl. No.
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`11/129,320 and a continuation-in-part of U.S. Appl. No. 10/158,216.
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`The agreement also provides that Horizon is the exclusive licensee of the
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`“Licensed Technology,” which includes the ’285 patent under the term “Licensed
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`Patents.” Ex. 2001 § 1.44 (“‘Licensed Technology’ means the Licensed Patents
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`and the Licensed Know-How”). The exclusive grant of rights to Horizon for the
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`’285 patent under the License Agreement is as follows:
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`7.1 Licensed Technology. Subject to the terms and conditions of
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`this Agreement, POZEN hereby grants to Licensee an exclusive
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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
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`(Sublicenses), under the Licensed Technology to make, use, have
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`made, sell, offer for sale, import and export Products in the Field of
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`Use in the Territory. For the avoidance of doubt, Licensee shall have
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`no license or other right under the Licensed Technology to make, use,
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`have made, sell, offer for sale, import, and export any product
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`containing acetyl salicylic acid (including salts and derivatives
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`thereof).
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`Ex. 2001 at § 7.1.
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`4
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`The license agreement further gives Horizon the rights to enforce and defend
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`against challenges to the ’285 patent. These exclusive rights are set forth in section
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`9.6 of the License Agreement as follows:
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`9.6 Enforcement of Licensed Patents.
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`9.6.1 Infringement by Third Parties. Licensee and POZEN will
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`each, within [redacted]2 Business Days of learning of any alleged or
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`threatened infringement of the Licensed Patents or Joint Patents,
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`notify the other Party in writing. Licensee will have the first right, but
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`not the obligation, to prosecute any such infringement. If Licensee
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`does not commence an infringement action against the alleged or
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`threatened infringement (i) within [redacted] days following the
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`detection of the of alleged infringement, or (ii) [redacted] Business
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`Days before the time limit, if any, set forth in appropriate laws and
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`regulations for filing of such actions, whichever comes first, then
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`Licensee will so notify POZEN promptly, and POZEN may
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`commence litigation with respect to the alleged or threatened
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`infringement at its own expense. . . .
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`2 These designations identify redacted material that is not material to
`demonstrating that Horizon is an exclusive licensee with all substantial rights to
`the ’285 patent.
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`5
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`9.6.2 Challenge by Third Parties. Licensee and POZEN will each
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`notify the other Party in writing within [redacted] Business Days of
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`learning of any alleged or threatened opposition, reexamination
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`request, action for declaratory judgment, nullity action, interference or
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`other attack upon the validity, title or enforceability of the Licensed
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`Patents or Joint Patents by a Third Party. Licensee will have the first
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`right, but not the obligation, to defend any such challenge. If Licensee
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`does not commence Diligent Efforts to defend against the alleged or
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`threatened challenge (i) within [redacted] days following the detection
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`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
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`making a filing in defense of such a challenge, whichever comes first,
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`then Licensee will so notify POZEN promptly, and POZEN may take
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`action with respect to the alleged or threatened challenge at its own
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`expense. . . .
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`Ex. 2001 §§ 9.6.1, 9.6.2.
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`As the foregoing terms of the License Agreement demonstrate, Horizon has
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`obtained rights to the ’285 patent for purposes of this IPR through the License
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`Agreement with Pozen, and is a real party-in-interest with standing for purposes of
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`this Inter Partes Review proceeding.
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`6
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`Horizon Pharma plc is the corporate parent of Horizon.
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`RELATED MATTERS (37 C.F.R. § 42.8(b)(2))
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`Horizon Pharma, Inc. & Pozen Inc. v. Dr. Reddy’s Labs. Inc. & Dr. Reddy’s
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`Labs. Ltd., 3:11-cv-02317-MLC-DEA (D.N.J.). Horizon Pharma, Inc. & Pozen
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`Inc. v. Dr. Reddy’s Labs. Inc. & Dr. Reddy’s Labs. Ltd., 3:13-cv-00091-MLC-
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`DEA (D.N.J.). Horizon Pharma, Inc. & Pozen Inc. v. Lupin Ltd. & Lupin Pharms.,
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`Inc., 3:11-cv-04275-MLC-DEA (D.N.J.). Horizon Pharma, Inc. et al. v. Actavis
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`Labs. FL, Inc. & Actavis Pharma, Inc., 3:13-cv-03038-MLC-DEA (D.N.J.).
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`Horizon Pharma, Inc. & Pozen Inc. v. Mylan Pharms., Inc. et al., 3:13-cv-04022-
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`MLC-DEA (D.N.J.).
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`U.S. Patent Nos. 6,926,907, 8,206,741, 8,852,636, 8,858,996, and 8,865,190
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`and U.S. Patent Appl. Nos. 60/294,588, 10/158,216, 11/129,320, 12/553,804,
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`14/045,156, 14/231,971, 14/244,471, 14/515,627 claim, or may claim, the benefit
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`of priority to U.S. Provisional Application No. 60/294,588, filed on June 1, 2001,
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`the same application to which U.S. Patent No. 8,557,285 may claim priority.
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`Patent Owner does not concede that any of these applications or patents would
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`affect, or be affected by, a decision in the present inter partes review of U.S. Patent
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`No. 8,557,285.
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`7
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`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
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`
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`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
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`
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`8
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`Case No. IPR2015-00802
`Patent No. 8,557,285
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`SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
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`Please address all correspondence to the lead counsel at the above address.
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`
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`
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`Horizon and Pozen hereby consent to electronic service. Please direct all
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`correspondence to: IPR2015-00802@cooley.com, shash@velaw.com, and
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`msampson@velaw.com.
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`
`
`Date: March 17, 2015
`
`
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`Respectfully submitted,
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
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`
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`BY:
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`9
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`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e), 42.105(a))
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`I, Ricardo Rodriguez, hereby certify that on this 17th day of March, 2015,
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`Case No. IPR2015-00802
`Patent No. 8,557,285
`
`
`
`
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`the foregoing Patent Owner’s Mandatory Notices pursuant to 37 C.F.R. § 42.8 was
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`served electronically via email on the following:
`
`Alan H. Pollack
`apollack@buddlarner.com
`
`Louis H. Weinstein
`lweinstein@buddlarner.com
`
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
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`
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`Date: March 17, 2015
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`
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`114873386
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`BY:
`
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`10
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