`
`John E. Flaherty
`Jonathan M.H. Short
`McCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Horizon Pharma, Inc.
`and Pozen Inc.
`
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5000
`
`Of Counsel for Plaintiff Horizon Pharma, Inc.
`
`Stephen M. Hash
`BAKER BOTTS LLP
`98 San Jacinto Boulevard, Suite 1500
`Austin, Texas 78701-4078
`(512) 542-8400
`
`Of Counsel for Plaintiff Pozen Inc.
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`Civil Action No. 3:15-cv-03327
`
`PLAINTIFFS’ DISCLOSURE OF
`ASSERTED CLAIMS PURSUANT TO
`L. PAT. R. 3.6(B)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`HORIZON PHARMA, INC. and POZEN INC.,
`
`Plaintiffs,
`
`v.
`
`
`MYLAN PHARMACEUTICALS, INC.,
`MYLAN LABORATORIES LIMITED, and
`MYLAN, INC.
`
`
`Defendants.
`
`
`
`
`
`
`
`
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 1 of 9
`
`
`
`Pursuant to Local Patent Rule 3.6(b), Plaintiffs Horizon Pharma Inc. and Pozen,
`
`Inc. (collectively, “Plaintiffs”) hereby disclose the asserted claims of U.S. Patent Nos.
`
`9,161,920 (“the ’920 patent”), 9,198,888 (“the ’888 patent”), and 9,220,698 (“the ’698
`
`patent”) (collectively, “the asserted patents”) to Mylan Pharmaceuticals Inc., Mylan
`
`Laboratories Limited, and Mylan Inc. (collectively, “Mylan Defendants”).
`
`U.S. PATENT NO. 9,161,920
`
`1.
`
`Mylan Defendants infringed claims 1-9, 11-14 of the ’920 patent under 35
`
`U.S.C. § 271(e)(2) by filing Abbreviated New Drug Application No. 202654 and seeking
`
`approval from the FDA to engage in the commercial manufacture, use or sale of a drug
`
`claimed in the ’920 patent prior to the expiration of the ’920 patent.
`
`2.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will directly infringe at least claims 1-9, 11-14 of the ’920 patent (either
`
`literally or under the Doctrine of Equivalents), upon receiving FDA approval, by making,
`
`using, offering to sell, importing, and/or selling their naproxen and esomeprazole
`
`magnesium delayed-release tablet product in the United States in violation of 35 U.S.C.
`
`§ 271(a).
`
`3.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will induce the infringement of at least claims 1-9, 11-14 of the ’920 patent,
`
`upon receiving FDA approval, by actively and intentionally encouraging, aiding, and
`
`abetting the manufacture, offer for sale, sale, and use in the United States and/or import
`
`into the United States of Mylan Defendants’ naproxen and esomeprazole magnesium
`
`delayed-release tablet product by others, including manufacturers, distributors, and/or
`
`consumers, with knowledge that such infringing acts are in contravention of Plaintiffs’
`
`rights under the ’920 patent and in violation of 35 U.S.C. § 271(b).
`
`
`
`2
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 2 of 9
`
`
`
`4.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will induce the infringement of at least claims 1-9, 11-14 of the ’920 patent by
`
`actively and intentionally encouraging, through their label, the infringing use of Mylan
`
`Defendants’ naproxen and esomeprazole magnesium delayed-release tablet product in the
`
`United States, by others, including distributors, prescribers, and/or consumers, in
`
`contravention of Plaintiffs’ rights under the ’920 patent and in violation of 35 U.S.C.
`
`§ 271(b).
`
`5.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will contribute to the infringement of at least claims 1-9, 11-14 of the ’920
`
`patent by knowingly and intentionally selling materials and/or apparatuses, including
`
`chemical precursors of Mylan Defendants’ naproxen and esomeprazole magnesium
`
`delayed-release tablet product or equipment for the manufacture of Mylan Defendants’
`
`naproxen and esomeprazole magnesium delayed-release tablet product to others, including
`
`manufacturers and distributors, where such materials and apparatuses are not staple articles
`
`or commodities of commerce suitable for non-infringing use, and are made or adapted
`
`especially for use in the manufacture, use, sale, or offer for sale of Mylan Defendants’
`
`naproxen and esomeprazole magnesium delayed-release tablet product in contravention of
`
`Plaintiffs’ rights under the ’920 patent in violation of 35 U.S.C. § 271(c).
`
`U.S. PATENT NO. 9,198,888
`
`1.
`
`Mylan Defendants infringed claims 1-2, 4-7, and 9 of the ’888 patent under
`
`35 U.S.C. § 271(e)(2) by filing Abbreviated New Drug Application No. 202654 and
`
`seeking approval from the FDA to engage in the commercial manufacture, use or sale of a
`
`drug claimed in the ’888 patent prior to the expiration of the ’888 patent.
`
`
`
`3
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 3 of 9
`
`
`
`2.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will directly infringe at least claims 1-2, 4-7, and 9 of the ’888 patent (either
`
`literally or under the Doctrine of Equivalents), upon receiving FDA approval, by making,
`
`using, offering to sell, importing, and/or selling their naproxen and esomeprazole
`
`magnesium delayed-release tablet product in the United States in violation of 35 U.S.C.
`
`§ 271(a).
`
`3.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will induce the infringement of at least claims 1-2, 4-7, and 9 of the ’888
`
`patent, upon receiving FDA approval, by actively and intentionally encouraging, aiding,
`
`and abetting the manufacture, offer for sale, sale, and use in the United States and/or
`
`import into the United States of Mylan Defendants’ naproxen and esomeprazole
`
`magnesium delayed-release tablet product by others, including manufacturers, distributors,
`
`and/or consumers, with knowledge that such infringing acts are in contravention of
`
`Plaintiffs’ rights under the ’888 patent and in violation of 35 U.S.C. § 271(b).
`
`4.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will induce the infringement of at least claims 1-2, 4-7, and 9 of the ’888
`
`patent by actively and intentionally encouraging, through their label, the infringing use of
`
`Mylan Defendants’ naproxen and esomeprazole magnesium delayed-release tablet product
`
`in the United States, by others, including distributors, prescribers, and/or consumers, in
`
`contravention of Plaintiffs’ rights under the ’888 patent and in violation of 35 U.S.C.
`
`§ 271(b).
`
`5.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will contribute to the infringement of at least claims 1-2, 4-7, and 9 of the ’888
`
`patent by knowingly and intentionally selling materials and/or apparatuses, including
`
`
`
`4
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 4 of 9
`
`
`
`chemical precursors of Mylan Defendants’ naproxen and esomeprazole magnesium
`
`delayed-release tablet product or equipment for the manufacture of Mylan Defendants’
`
`naproxen and esomeprazole magnesium delayed-release tablet product to others, including
`
`manufacturers and distributors, where such materials and apparatuses are not staple articles
`
`or commodities of commerce suitable for non-infringing use, and are made or adapted
`
`especially for use in the manufacture, use, sale, or offer for sale of Mylan Defendants’
`
`naproxen and esomeprazole magnesium delayed-release tablet product in contravention of
`
`Plaintiffs’ rights under the ’888 patent in violation of 35 U.S.C. § 271(c).
`
`U.S. PATENT NO. 9,220,698
`
`1.
`
`Mylan Defendants infringed claims 1-7 of the ’698 patent under 35 U.S.C.
`
`§ 271(e)(2) by filing Abbreviated New Drug Application No. 204470 and seeking approval
`
`from the FDA to engage in the commercial manufacture, use or sale of a drug claimed in
`
`the ’698 patent prior to the expiration of the ’698 patent.
`
`2.
`
`Upon information and belief, unless Mylan is enjoined by this Court, patients
`
`will directly infringe at least claims 1-7 of the ’698 patent (either literally or under the
`
`Doctrine of Equivalents), upon Mylan’s receipt of FDA approval, by using Mylan’s
`
`naproxen and esomeprazole magnesium delayed-release tablet product in the United States
`
`in violation of 35 U.S.C. § 271(a).
`
`3.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will induce the infringement of at least claims 1-7 of the ’698 patent, upon
`
`receiving FDA approval, by actively and intentionally encouraging, aiding, and abetting
`
`the manufacture, offer for sale, sale, and use in the United States and/or import into the
`
`United States of Mylan Defendants’ naproxen and esomeprazole magnesium delayed-
`
`release tablet product by others, including manufacturers, distributors, and/or consumers,
`
`
`
`5
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 5 of 9
`
`
`
`with knowledge that such infringing acts are in contravention of Plaintiffs’ rights under the
`
`’698 patent and in violation of 35 U.S.C. § 271(b).
`
`4.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will induce the infringement of at least claims 1-7 of the ’698 patent by
`
`actively and intentionally encouraging, through their label, the infringing use of Mylan
`
`Defendants’ naproxen and esomeprazole magnesium delayed-release tablet product in the
`
`United States, by others, including distributors, prescribers, and/or consumers, in
`
`contravention of Plaintiffs’ rights under the ’698 patent and in violation of 35 U.S.C.
`
`§ 271(b).
`
`5.
`
`Upon information and belief, unless enjoined by this Court, Mylan
`
`Defendants will contribute to the infringement of at least claims 1-7 of the ’698 patent by
`
`knowingly and intentionally selling materials and/or apparatuses, including chemical
`
`precursors of Mylan Defendants’ naproxen and esomeprazole magnesium delayed-release
`
`tablet product or equipment for the manufacture of Mylan Defendants’ naproxen and
`
`esomeprazole magnesium delayed-release tablet product to others, including manufacturers
`
`and distributors, where such materials and apparatuses are not staple articles or
`
`commodities of commerce suitable for non-infringing use, and are made or adapted
`
`especially for use in the manufacture, use, sale, or offer for sale of Mylan Defendants’
`
`naproxen and esomeprazole magnesium delayed-release tablet product in contravention of
`
`Plaintiffs’ rights under the ’698 patent in violation of 35 U.S.C. § 271(c).
`
`
`
`
`
`
`
`
`
`
`
`6
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 6 of 9
`
`
`
`
`Dated: March 31, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`By: s/ John E. Flaherty
`John E. Flaherty
`Jonathan M.H. Short
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Counsel for Plaintiffs Horizon Pharma,
`Inc. and Pozen Inc.
`
`Stephen M. Hash
`BAKER BOTTS LLP
`98 San Jacinto Boulevard, Suite 1500
`Austin, Texas 78701-4078
`(512) 542-8400
`
`Of Counsel for Plaintiff Pozen Inc.
`
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5000
`
`Of Counsel for Plaintiff Horizon Pharma,
`Inc.
`
`
`
`
`
`
`7
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 7 of 9
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the foregoing
`
`PLAINTIFFS’ DISCLOSURE OF ASSERTED CLAIMS PURSUANT TO L. PAT. R.
`
`3.6(B) was caused to be served on March 31, 2016 by electronic mail to the following counsel of
`
`record:
`
`Gregory D. Miller (Gregory.Miller@rivkin.com)
`Nancy A. Del Pizzo (Nancy.Delpizzo@rivkin.com)
`Gene Y. Kang (Gene.Kang@rivkin.com)
`RIVKIN RADLER LLP
`21 Main Street, Court Plaza South
`West Wing, Suite 158
`Hackensack, N.J. 07601-7021
`Phone: (201) 287-2460
`
`Shannon M. Bloodworth (sbloodworth@perkinscoie.com)
`Brandon M. White (bmwhite@perkinscoie.com)
`PERKINS COIE LLP
`700 Thirteenth Street NW, Suite 600
`Washington, D.C. 20005-3960
`Phone: (202) 654-6200
`
`Melody K. Glazer (MGlazer@perkinscoie.com)
`PERKINS COIE LLP
`One East Main Street, Suite 201
`Madison, WI. 53703-5118
`Phone: (608) 663-7460
`
`Bryan D. Beel (bbeel@perkinscoie.com)
`PERKINS COIE LLP
`1120 NW Couch Street, 10th Floor
`Portland, OR 97209
`Phone: (503) 727-2000
`
`Attorneys for Defendants Mylan Pharmaceuticals Inc.,
`Mylan Laboratories Limited, and Mylan Inc.
`
`
`
`
`
`
`
`
`
`
`8
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 8 of 9
`
`
`
`
`
`
`
`
`
`
`
`Dated: March 31, 2016
`
`
`
`
`
`
`
`
`By: /s/ John E. Flaherty
`John E. Flaherty
`Jonathan M.H. Short
`MCCARTER & ENGLISH, LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Counsel for Plaintiffs Horizon Pharma,
`Inc. and Pozen Inc.
`
`9
`
`Patent Owner's Ex. 2072
`IPR2017-01995
`Page 9 of 9
`
`
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