Case 3:15-cv-03327-MLC-DEA Document 33 Filed 02/19/16 Page 1 of 47 PageID: 508
`
`Melody K. Glazer
`(MGlazer@perkinscoie.com)
`PERKINS COIE LLP
`1 East Main Street, Suite 201
`Madison, Wisconsin 53703-5118
`(608) 663-7460 (telephone)
`(608) 663-7499 (facsimile)
`
`Bryan D. Beel
`(BBeel@perkinscoie.com)
`PERKINS COIE LLP
`1120 N.W. Couch Street, Tenth Floor
`Portland, Oregon 97209-4128
`(503) 727-2000 (telephone)
`(503) 727-2222 (facsimile)
`
`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, NJ 07601-7021
`(201) 287-2460 (telephone)
`(201) 489-0495 (facsimile)
`
`Shannon M. Bloodworth
`(SBloodworth@perkinscoie.com)
`Brandon M. White
`(BMWhite@perkinscoie.com)
`PERKINS COIE LLP
`700 Thirteenth Street N.W., Suite 600
`Washington, D.C. 20005-3960
`(202) 654-6200 (telephone)
`(202) 654-9135 (facsimile)
`
`Attorneys for Defendants/Counterclaim Plaintiffs
`Mylan Pharmaceuticals Inc., Mylan Laboratories Limited and Mylan Inc.
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`HORIZON PHARMA, INC., and POZEN,
`INC.,
`
`Plaintiffs/
`Counterclaim
`Defendants,
`
`v.
`
`MYLAN PHARMACEUTICALS, INC.,
`MYLAN LABORATORIES LIMITED, and
`MYLAN, INC.,
`
`Defendants/
`Counterclaim
`Plaintiffs.
`
`No. 3:15-cv-03327-MLC-DEA
`
`ANSWER TO SECOND AMENDED
`COMPLAINT, SEPARATE DEFENSES,
`AND COUNTERCLAIMS BY
`DEFENDANTS MYLAN
`PHARMACEUTICALS INC.,
`MYLAN LABORATORIES LIMITED
`AND MYLAN INC.
`
`DOCUMENT ELECTRONICALLY FILED
`
`
`
`Page 1 of 47
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`
`
`
`Mylan Pharmaceuticals Inc., Mylan Laboratories Limited, and Mylan Inc. (collectively,
`
`“Mylan”), by their undersigned attorneys, answer and respond to the Second Amended
`
`Complaint of Horizon Pharma, Inc., and Pozen, Inc. (collectively, “Plaintiffs”) on behalf of
`
`Mylan and no other parties, as follows:
`
`THE PARTIES
`
`Plaintiff Horizon Pharma, Inc. (“Horizon”) is a corporation operating and existing
`1.
`
`under the laws of the State of Delaware, with its principal place of business at 520 Lake Cook
`Road, Suite 520, Deerfield, Illinois 60015.
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations of paragraph 1, and, therefore, denies those allegations.
`
`Plaintiff Pozen Inc. (“Pozen”) is a corporation operating and existing under the
`2.
`
`laws of the State of Delaware, with its principal place of business at 1414 Raleigh Road, Chapel
`Hill, North Carolina 27517.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations of paragraph 2, and, therefore, denies those allegations.
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc. is a corporation
`3.
`
`organized and existing under the laws of the State of West Virginia, with its principal place of
`business at 781 Chestnut Ridge Rd., Morgantown, West Virginia 26505. On information and
`belief, Mylan Pharmaceuticals Inc. is in the business of, inter alia, manufacturing, marketing,
`and selling generic copies of branded pharmaceutical products throughout the United States,
`including within this district.
`
`
`
`ANSWER: Mylan admits that Mylan Pharmaceuticals Inc. is a corporation organized
`
`and existing under the laws of West Virginia, having its principal place of business at 781
`
`Chestnut Ridge Road, Morgantown, West Virginia 26505. Mylan denies the remaining
`
`allegations set forth in paragraph 3.
`
`On information and belief, Defendant Mylan Laboratories Limited (“Mylan
`4.
`
`Limited”) was formerly known as Matrix Laboratories Limited (“Matrix Limited”). On
`information and belief, Defendant Mylan Limited is a corporation organized and existing under
`the laws of India, with its principal place of business at Plot No. 564/A/22, Road No. 92,
`Hyderabad 500034 Andhra Pradesh, India. On information and belief, Mylan Limited is in the
`
`
`
`
`
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`business of, inter alia, manufacturing, marketing, and selling generic copies of branded
`pharmaceutical products throughout the United States, including within this district.
`
`
`
`ANSWER: Mylan admits that Mylan Laboratories Limited is a corporation operating
`
`and existing under the laws of India with its principal place of business at Plot No. 564/A/22,
`
`Road No. 92, Jubilee Hills 500034, Hyderabad, India. Mylan denies the remaining allegations
`
`set forth in paragraph 4.
`
`On information and belief, Defendant Mylan, Inc. is a corporation organized and
`5.
`
`existing under the laws of Pennsylvania, with its principal place of business at 1000 Mylan
`Blvd., Canonsburg, Pennsylvania 15317. On information and belief, Mylan, Inc. is in the
`business of, inter alia, manufacturing, marketing, and selling generic copies of branded
`pharmaceutical products throughout the United States, including within this district.
`
`
`
`ANSWER: Mylan admits that Mylan Inc. is a corporation organized and existing
`
`under the laws of Pennsylvania. Mylan Inc.’s principal place of business is at 1000 Mylan
`
`Boulevard, Canonsburg, PA 15317. Mylan denies the remaining allegations set forth in
`
`paragraph 5.
`
`On information and belief, Mylan, Inc. is the parent company of Mylan
`6.
`
`Pharmaceuticals Inc.
`
`
`
`ANSWER: Mylan admits that Mylan Inc. is the parent company of Mylan
`
`Pharmaceuticals Inc.
`
`
`
`
`
`7.
`
`On information and belief, Mylan, Inc. is the parent company of Mylan Limited.
`
`ANSWER: Mylan admits that Mylan Inc. is the parent company of Mylan
`
`Laboratories Limited.
`
`
`On information and belief, Mylan Pharmaceuticals Inc. and Mylan Limited are
`8.
`within the control of Defendant Mylan, Inc. for purposes of responding to discovery in this
`action.
`
`
`
`ANSWER: Paragraph 8 sets forth legal conclusions for which no answer is required.
`
`To the extent that an answer is deemed required, however, Mylan denies the allegations in
`
`paragraph 8.
`
`
`
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`
`BACKGROUND
`
`The NDA
`
`Horizon is the holder of New Drug Application (“NDA”) No. 022511 for
`9.
`
`VIMOVO® (naproxen and esomeprazole magnesium) Delayed-Release Tablets, in 375 mg
`(naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg (esomeprazole
`magnesium) dosage forms.
`
`
`
`ANSWER: Mylan
`
`admits
`
`that
`
`there
`
`is
`
`an NDA No.
`
`022511
`
`for
`
`naproxen/esomeprazole magnesium products marketed under the trade name VIMOVO®. Mylan
`
`is without sufficient knowledge or information to form a belief as to the remaining allegations set
`
`forth in paragraph 9, and, therefore, denies those allegations.
`
`VIMOVO® Delayed-Release Tablets are prescription drugs approved for use to
`10.
`
`relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
`and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach
`ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Naproxen and
`esomeprazole magnesium are the active ingredients in VIMOVO® Delayed-Release Tablets.
`
`
`
`ANSWER: Mylan admits that there are naproxen/esomeprazole magnesium products
`
`marketed under the trade name VIMOVO®. Mylan is without sufficient knowledge or
`
`information to form a belief as to the remaining allegations set forth in paragraph 10, and,
`
`therefore, denies those allegations.
`
`The Patents-In-Suit
`
`United States Patent No. 8,852,636 (“the ’636 patent”), entitled “Pharmaceutical
`11.
`
`Compositions for the Coordinated Delivery of NSAIDs” was duly and legally issued by the
`United States Patent and Trademark Office on October 7, 2014. The claims of the ’636 patent
`are directed to pharmaceutical compositions in unit dosage form comprising esomeprazole and
`naproxen (claims 1–4, 7–10, 13–18) and methods of treating a patient for pain or inflammation
`comprising administration of the aforementioned compositions (claims 5–6, 11–12). A true and
`correct copy of the ’636 patent is attached as Exhibit A.
`
`
`
`ANSWER: Mylan admits that the ’636 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs.” Mylan recognizes
`
`that what purports to be a copy of the ’636 patent was attached as Exhibit A to Horizon and
`
`
`
`
`
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`
`Pozen’s Second Amended Complaint, which patent is the best source for its content. Mylan
`
`denies that the ’636 patent was duly and legally issued by the U.S. Patent and Trademark Office
`
`on October 7, 2014. Paragraph 11 also contains allegations that call for legal conclusions to
`
`which no answer is required. To the extent an answer is deemed required, Mylan is without
`
`sufficient knowledge or information to form a belief as to the remaining allegations set forth in
`
`paragraph 11, and, therefore, denies those allegations.
`
`Pozen owns the ’636 patent by assignment. Horizon is Pozen’s exclusive licensee
`12.
`
`under the ’636 patent. The ’636 patent will expire on May 31, 2022.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 12, and, therefore, denies those allegations.
`
`The ’636 patent is listed in the FDA Orange Book in connection with NDA No.
`13.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 13, and, therefore, denies those allegations.
`
`United States Patent No. 8,858,996 (“the ’996 patent”), entitled “Pharmaceutical
`14.
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`United States Patent and Trademark Office on October 14, 2014. The claims of the ’996 patent
`are directed to pharmaceutical compositions in unit dosage form comprising esomeprazole and
`naproxen (claims 1–9, 12–15) and methods of treating a patient for pain or inflammation
`comprising administration of the aforementioned compositions (claims 10–11, 16–19). A true
`and correct copy of the ’996 patent is attached as Exhibit B.
`
`
`
`ANSWER: Mylan admits that the ’996 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs.” Mylan recognizes
`
`that what purports to be a copy of the ’996 patent was attached as Exhibit B to Horizon and
`
`Pozen’s Second Amended Complaint, which patent is the best source for its content. Mylan
`
`denies that the ’996 patent was duly and legally issued by the U.S. Patent and Trademark Office
`
`on October 14, 2014. Paragraph 14 also contains allegations that call for legal conclusions to
`
`which no answer is required. To the extent an answer is deemed required, Mylan is without
`
`
`5
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`sufficient knowledge or information to form a belief as to the remaining allegations set forth in
`
`paragraph 14, and, therefore, denies those allegations.
`
`Pozen owns the ’996 patent by assignment. Horizon is Pozen’s exclusive licensee
`15.
`
`under the ’996 patent. The ’996 patent will expire on May 31, 2022.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 15, and, therefore, denies those allegations.
`
`The ’996 patent is listed in the FDA Orange Book in connection with NDA No.
`16.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 16, and, therefore, denies those allegations.
`
`United States Patent No. 8,865,190 (“the ’190 patent”), entitled “Pharmaceutical
`17.
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`United States Patent and Trademark Office on October 21, 2014. The claims of the ’190 patent
`are directed to a process for preparing pharmaceutical compositions in unit dosage form
`comprising esomeprazole and naproxen. A true and correct copy of the ’190 patent is attached
`as Exhibit C.
`
`
`
`ANSWER: Mylan admits that the ’190 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs.” Mylan recognizes
`
`that what purports to be a copy of the ’190 patent was attached as Exhibit C to Horizon and
`
`Pozen’s Second Amended Complaint, which patent is the best source for its content. Mylan
`
`denies that the ’190 patent was duly and legally issued by the U.S. Patent and Trademark Office
`
`on October 21, 2014. Paragraph 17 also contains allegations that call for legal conclusions to
`
`which no answer is required. To the extent an answer is deemed required, Mylan is without
`
`sufficient knowledge or information to form a belief as to the remaining allegations set forth in
`
`paragraph 17, and, therefore, denies those allegations.
`
`Pozen owns the ’190 patent by assignment. Horizon is Pozen’s exclusive licensee
`18.
`
`under the ’190 patent. The ’190 patent will expire on May 31, 2022.
`
`
`
`
`
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`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 18, and, therefore, denies those allegations.
`
`United States Patent No. 9,161,920 (“the ’920 patent”), entitled “Pharmaceutical
`19.
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`United States Patent and Trademark Office on October 20, 2015. The claims of the ’920 patent
`are directed to methods of reducing the incidence of NSAID-associated gastric ulcers by
`administering a pharmaceutical composition in unit dose form comprising naproxen and
`esomeprazole. A true and correct copy of the ’920 patent is attached as Exhibit D.
`
`
`
`ANSWER: Mylan admits that the ’920 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs.” Mylan recognizes
`
`that what purports to be a copy of the ’920 patent was attached as Exhibit D to Horizon and
`
`Pozen’s Second Amended Complaint, which patent is the best source for its content. Mylan
`
`denies that the ’920 patent was duly and legally issued by the U.S. Patent and Trademark Office
`
`on October 20, 2015. Paragraph 19 also contains allegations that call for legal conclusions to
`
`which no answer is required. To the extent an answer is deemed required, Mylan is without
`
`sufficient knowledge or information to form a belief as to the remaining allegations set forth in
`
`paragraph 19, and, therefore, denies those allegations.
`
`Pozen owns the ’920 patent by assignment. Horizon is Pozen’s exclusive licensee
`20.
`
`under the ’920 patent. The ’920 patent will expire on May 31, 2022.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 20, and, therefore, denies those allegations.
`
`The ’920 patent is listed in the FDA Orange Book in connection with NDA No.
`21.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 21, and, therefore, denies those allegations.
`
`United States Patent No. 9,198,888 (“the ’888 patent”), entitled “Pharmaceutical
`22.
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`United States Patent and Trademark Office on December 1, 2015. The claims of the ’888 patent
`
`
`
`
`
`7
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`are directed to a method of reducing the incidence of NSAID-associated gastric ulcers by
`administering a pharmaceutical composition in unit dosage form comprising naproxen and
`esomeprazole. A true and correct copy of the ’888 patent is attached as Exhibit E.
`
`
`
`ANSWER: Mylan admits that the ’888 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs.” Mylan recognizes
`
`that what purports to be a copy of the ’888 patent was attached as Exhibit E to Horizon and
`
`Pozen’s Second Amended Complaint, which patent is the best source for its content. Mylan
`
`denies that the ’888 patent was duly and legally issued by the U.S. Patent and Trademark Office
`
`on December 1, 2015. Paragraph 22 also contains allegations that call for legal conclusions to
`
`which no answer is required. To the extent an answer is deemed required, Mylan is without
`
`sufficient knowledge or information to form a belief as to the remaining allegations set forth in
`
`paragraph 22, and, therefore, denies those allegations.
`
`Pozen owns the ’888 patent by assignment. Horizon is Pozen’s exclusive licensee
`23.
`
`under the ’888 patent. The ’888 patent will expire on May 31, 2022.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 23, and, therefore, denies those allegations.
`
`The ’888 patent is listed in the FDA Orange Book in connection with NDA No.
`24.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 24, and, therefore, denies those allegations.
`
`Related Patents
`
`
`United States Patent No. 6,926,907 (“the ’907 patent”), entitled “Pharmaceutical
`25.
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`United States Patent and Trademark Office on August 9, 2005. The claims of the ’907 patent are
`directed to pharmaceutical compositions that provide for the coordinated release of an acid
`inhibitor and an NSAID (claims 1–21, and 53–55) and methods of treating a patient for pain or
`inflammation comprising administration of the aforementioned compositions (claims 22–52).
`
`
`
`
`
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`
`
`ANSWER: Mylan admits that the ’907 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDS.” Mylan denies that
`
`the ’907 patent was duly and legally issued by the U.S. Patent and Trademark Office on August
`
`9, 2005. Mylan is without sufficient knowledge or information to form a belief as to the
`
`remaining allegations set forth in paragraph 25, and, therefore, denies those allegations.
`
`Pozen owns the ’907 patent by assignment. Horizon is Pozen’s exclusive licensee
`26.
`
`under the ’907 patent. The ’907 patent will expire on February 28, 2023.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 26, and, therefore, denies those allegations.
`
`The ’907 patent is listed in the FDA Orange Book in connection with NDA No.
`27.
`
`022511 for VIMOVO® drug product.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 27, and, therefore, denies those allegations.
`
`United States Patent No. 8,557,285 (“the ’285 patent”), entitled “Pharmaceutical
`28.
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
`United States Patent and Trademark Office on October 15, 2013. The claims of the ’285 patent
`are directed to pharmaceutical compositions in unit dosage form comprising esomeprazole and
`naproxen.
`
`
`
`ANSWER: Mylan admits that the ’285 patent states on its face that it is entitled
`
`“Pharmaceutical Compositions for the Coordinated Delivery of NSAIDS.” Mylan denies that
`
`the ’285 patent was duly and legally issued by the U.S. Patent and Trademark Office on October
`
`15, 2013. Mylan is without sufficient knowledge or information to form a belief as to the
`
`remaining allegations set forth in paragraph 28, and, therefore, denies those allegations.
`
`Pozen owns the ’285 patent by assignment. Horizon is Pozen’s exclusive licensee
`29.
`
`under the ’285 patent. The ’285 patent will expire on May 31, 2022.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 29, and, therefore, denies those allegations.
`
`
`
`
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`
`The ’285 patent is listed in the FDA Orange Book in connection with NDA No.
`30.
`
`022511 for VIMOVO® drug product.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 30, and, therefore, denies those allegations.
`
`The ANDA
`
`On information and belief, Defendants filed ANDA No. 204920 (“Defendants’
`31.
`
`ANDA”) with the FDA under 21 U.S.C. § 355(j) to obtain FDA approval for the commercial
`manufacture, use, import, offer for sale, and sale in the United States of naproxen and
`esomeprazole magnesium delayed-release tablets in 375 mg (naproxen)/20 mg (esomeprazole
`magnesium) and 500 mg (naproxen)/20 mg (esomeprazole magnesium) strengths (“Mylan’s
`ANDA Product”), which are generic versions of Plaintiffs’ VIMOVO® Delayed-Release Tablets
`in 375 mg (naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg
`(esomeprazole magnesium) strengths, respectively.
`
`
`
`ANSWER: Mylan Pharmaceuticals Inc. admits that it filed with FDA an ANDA
`
`pursuant to 21 U.S.C. § 355(j) seeking FDA approval for naproxen/esomeprazole magnesium
`
`delayed-release
`
`tablets, 375 mg/20 mg and 500 mg/20 mg
`
`(“Mylan’s proposed
`
`naproxen/esomeprazole product”), which FDA assigned ANDA No. 204920. Mylan denies the
`
`remaining allegations set forth in paragraph 31.
`
`By letter dated May 16, 2013 (the “May 2013 ANDA Notice Letter”), Defendants
`32.
`
`notified AstraZeneca AB (Horizon’s predecessor-in-interest as holder of NDA No. 022511 and
`as exclusive licensee for the ’907 patent and the ’285 patent) and Pozen that Defendants had filed
`ANDA No. 204920 seeking approval to market Mylan’s ANDA Product and that Defendants
`were providing information pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. § 314.95
`regarding certain patents including the ’907 patent.
`
`
`
`ANSWER: Mylan Pharmaceuticals Inc. admits that in a letter dated May 16, 2013, it
`
`notified AstraZeneca AB and Pozen of the filing of Mylan Pharmaceuticals Inc.’s ANDA and
`
`that the ANDA included a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with
`
`respect to the ’504, ’424, ’085, ’872, ’070, ’907, and ’466 patents. Mylan denies the remaining
`
`allegations set forth in paragraph 32.
`
`On January 23, 2015, Plaintiffs requested that Defendants provide Paragraph IV
`33.
`
`certifications with respect to inter alia the ’285, ’636, and ’996 patents.
`
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`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 33, and, therefore, denies those allegations.
`
`By three letters each dated February 9, 2015 (the “February 2015 ANDA Notice
`34.
`
`Letters”), Defendants notified Horizon and Pozen that Defendants had filed ANDA No. 204920
`seeking approval to market Mylan’s ANDA Product and that Defendants were providing
`information pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. § 314.95 regarding the ’285,
`’636, and ’996 patents.
`
`
`
`ANSWER: Mylan Pharmaceuticals Inc. admits that in letters dated February 9, 2015,
`
`it notified Horizon and Pozen of the filing of Mylan Pharmaceuticals Inc.’s ANDA and that the
`
`ANDA included a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the
`
`’285, ’636, and ’996 patents. Mylan denies the remaining allegations set forth in paragraph 34.
`
`By a letter dated January 26, 2016 (the “January 2016 ANDA Notice Letter”),
`35.
`
`Defendants notified Horizon and Pozen that Defendants had filed ANDA No. 204920 seeking
`approval to market Mylan’s ANDA Product and that Defendants were providing information
`pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) and 21 C.F.R. § 314.95 regarding the ’920 and ’888
`patents.
`
`
`
`ANSWER: Mylan Pharmaceuticals Inc. admits that in a letter dated January 26, 2016,
`
`it notified Horizon and Pozen of the filing of Mylan Pharmaceuticals Inc.’s ANDA and that the
`
`ANDA included a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the
`
`’920 and ’888 patents. Mylan denies the remaining allegations set forth in paragraph 35.
`
`JURISDICTION AND VENUE
`
`This action arises under the patent laws of the United States, 35 U.S.C. § 1 et seq.,
`36.
`
`including 35 U.S.C. § 271, and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`
`
`ANSWER: Paragraph 36 contains allegations and legal conclusions to which no
`
`answer is required. To the extent an answer is deemed required, Mylan Pharmaceuticals Inc.
`
`admits its Notice Letters notified Plaintiffs of the filing of Mylan Pharmaceuticals Inc.’s ANDA
`
`and that the ANDA included patent certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
`
`
`
`
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`IPR2017-01995
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`To the extent this Court finds it has subject matter jurisdiction over this action, it is limited to
`
`claims asserted pursuant to 35 U.S.C. § 271(e). Mylan denies the remaining allegations set forth
`
`in paragraph 36.
`
`On information and belief, Defendants have been and are engaging in activities
`37.
`
`directed toward infringement of the ’636, ’996, ’190, ’920, and ’888 patents (collectively, the
`“patents-in- suit”) by, inter alia, submitting to the FDA ANDA No. 204920 and continuing to
`seek approval for Mylan’s ANDA Product.
`
`
`
`ANSWER: Mylan Pharmaceuticals Inc. admits that it filed ANDA No. 204920
`
`seeking FDA approval for Mylan’s proposed naproxen/esomeprazole product. Mylan denies the
`
`remaining allegations set forth in paragraph 37.
`
`Defendants’ ANDA May 2013 Notice Letter states Defendants’ intention to seek
`38.
`
`FDA approval to market a generic version of the VIMOVO® product before the related ’907
`patent expires on February 28, 2023.
`
`
`
`ANSWER: Mylan Pharmaceuticals Inc. admits its Notice Letter dated May 16, 2013,
`
`states inter alia that it “submitted to the Food and Drug Administration … an Abbreviated New
`
`Drug Application … under § 505(j) of the Act seeking approval … prior to the expiration of the
`
`[’907] patent[].” Mylan denies the remaining allegations set forth in paragraph 38.
`
`There is now an actual controversy between Defendants and Plaintiffs as to
`39.
`
`whether Defendants infringe the ’636, ’996, ’190, ’920, and ’888 patents.
`
`
`
`ANSWER: Mylan admits that there is a justiciable controversy between the parties
`
`regarding the ’636, ’996, ’920, and ’888 patents. Mylan denies the remaining allegations set
`
`forth in paragraph 39.
`
`This Court has personal jurisdiction over Defendants because, inter alia,
`40.
`
`Defendants, on information and belief, have purposely availed themselves of the benefits and
`protections of the laws of New Jersey such that they should reasonably anticipate being haled
`into court here; Defendants have had continuous and systematic contacts with this judicial
`district, including, on information and belief, selling pharmaceutical products in New Jersey and
`deriving substantial revenues from those sales; and, on information and belief, Mylan, Inc. and
`Mylan Limited are licensed to do business within New Jersey. Thus, Defendants are subject to
`general jurisdiction in New Jersey.
`
`
`
`
`
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`
`
`ANSWER: Mylan denies the allegations set forth in paragraph 40.
`
`On information and belief, Defendants acted in concert to develop Mylan’s
`41.
`
`ANDA Product and to seek approval from the FDA to sell Mylan’s ANDA Product throughout
`the United States, including within this judicial district..
`
`
`
`ANSWER: Mylan denies the allegations set forth in paragraph 41.
`
`On information and belief, the acts of Mylan Pharmaceuticals Inc. and Mylan
`42.
`
`Limited complained of herein were done at the direction of, with the authorization of, and with
`the cooperation, participation, and assistance of Mylan, Inc.
`
`
`
`ANSWER: Mylan denies the allegations set forth in paragraph 42.
`
`On information and belief, Mylan Pharmaceuticals Inc., Mylan Limited, and
`43.
`
`Mylan, Inc. participated in the preparation and/or filing of ANDA No 204920.
`
`
`
`ANSWER: Mylan denies the allegations set forth in paragraph 43.
`
`On information and belief and as stated in the May 2013 ANDA Notice Letter,
`44.
`
`the FDA received ANDA No. 204920 from Defendants.
`
`
`
`ANSWER: Mylan denies the allegations set forth in paragraph 44.
`
`On information and belief, by virtue of, inter alia, Defendants’ continuous and
`45.
`
`systematic contacts with New Jersey, including but not limited to the above-described contacts,
`and the actions on behalf of Defendants in connection with ANDA No. 204920, this Court has
`personal jurisdiction over Defendants. These activities satisfy due process and confer personal
`jurisdiction over Defendants consistent with New Jersey law.
`
`
`
`
`
`
`
`ANSWER: Mylan denies the allegations set forth in paragraph 45.
`
`46.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391(b), 1391(c), and 1400(b).
`
`ANSWER: Mylan denies the allegations set forth in paragraph 46.
`
`COUNT I
`(INFRINGEMENT OF THE ’636 PATENT UNDER 35 U.S.C. § 271(e)(2))
`
`Plaintiffs incorporate by reference paragraphs 1–46 of this Complaint as if fully
`47.
`
`set forth herein.
`
`
`
`ANSWER: Mylan incorporates its foregoing responses to paragraphs 1-46 as if fully
`
`set forth herein.
`
`
`
`
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`Case 3:15-cv-03327-MLC-DEA Document 33 Filed 02/19/16 Page 14 of 47 PageID: 521
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`The ’636 patent is a patent with respect to which a claim of patent infringement
`48.
`
`could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,
`use, sale, or importation of the VIMOVO® product.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 48, and, therefore, denies those allegations.
`
`Accordingly, pursuant to 21 U.S.C. § 355(c)(2), Plaintiffs submitted patent
`49.
`
`information for the ’636 patent to the FDA in connection with NDA No. 022511 for the
`VIMOVO® product. On information and belief, this information will be published in the FDA’s
`Orange Book.
`
`
`
`ANSWER: Mylan is without sufficient knowledge or information to form a belief as
`
`to the allegations set forth in paragraph 49, and, therefore, denies those allegations.
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) requires, inter alia,
`50.
`
`certification by the ANDA applicant that the subject patent in the Orange Book, here the ’636
`patent, “is invalid or will not be infringed by the manufacture, use, or sale of the new drug for
`which the application is submitted . . . .” The statute (21 U.S.C. § 355(j)(2)(B)(iv)) also requires
`a Paragraph IV notice to “include a detailed statement of the factual and legal basis of the
`opinion of the applicant that the patent is not valid or w