Case 3:15-cv-03327-MLC-DEA Document 32 Filed 02/10/16 Page 1 of 31 PageID: 365
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`
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`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 Blvd., Suite 1500
`Austin, TX 78701-4078
`(512) 322-2500
`
`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 (MLC) (DEA)
`
`
`
`SECOND AMENDED COMPLAINT FOR
`PATENT INFRINGEMENT
`
`
`HORIZON PHARMA, INC. and POZEN
`INC.,
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`MYLAN LABORATORIES LIMITED, and
`MYLAN, INC.,
`
`
`Defendants.
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`Page 1 of 31
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`Patent Owner Ex. 2004
`Mylan v. Pozen
`IPR2017-01995
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`Plaintiffs Horizon Pharma, Inc. and Pozen Inc. (collectively, “Plaintiffs”), by their
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`attorneys, for their Complaint against Mylan Pharmaceuticals Inc., Mylan Laboratories Limited,
`
`and Mylan, Inc. (collectively, “Defendants”), allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Horizon Pharma, Inc. (“Horizon”) is a corporation operating and existing
`
`under the laws of the State of Delaware, with its principal place of business at 520 Lake Cook
`
`Road, Suite 520, Deerfield, Illinois 60015.
`
`2.
`
`Plaintiff Pozen Inc. (“Pozen”) is a corporation operating and existing under the
`
`laws of the State of Delaware, with its principal place of business at 1414 Raleigh Road, Chapel
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`Hill, North Carolina 27517.
`
`3.
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc. is a corporation
`
`organized and existing under the laws of the State of West Virginia, with its principal place of
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`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,
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`including within this district.
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`4.
`
`On information and belief, Defendant Mylan Laboratories Limited (“Mylan
`
`Limited”) was formerly known as Matrix Laboratories Limited (“Matrix Limited”). On
`
`information and belief, Defendant Mylan Limited is a corporation organized and existing under
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`the laws of India, with its principal place of business at Plot No. 564/A/22, Road No. 92,
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`Hyderabad 500034 Andhra Pradesh, India. On information and belief, Mylan Limited is in the
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`
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`business of, inter alia, manufacturing, marketing, and selling generic copies of branded
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`pharmaceutical products throughout the United States, including within this district.
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`5.
`
`On information and belief, Defendant Mylan, Inc. is a corporation organized and
`
`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.
`
`6.
`
`On information and belief, Mylan, Inc. is the parent company of Mylan
`
`Pharmaceuticals Inc.
`
`7.
`
`8.
`
`On information and belief, Mylan, Inc. is the parent company of Mylan Limited.
`
`On information and belief, Mylan Pharmaceuticals Inc. and Mylan Limited are
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`within the control of Defendant Mylan, Inc. for purposes of responding to discovery in this
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`action.
`
`BACKGROUND
`
`The NDA
`
`9.
`
`Horizon is the holder of New Drug Application (“NDA”) No. 022511 for
`
`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.
`
`10.
`
`VIMOVO® Delayed-Release Tablets are prescription drugs approved for use to
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`relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
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`and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach
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`
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`ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Naproxen and
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`esomeprazole magnesium are the active ingredients in VIMOVO® Delayed-Release Tablets.
`
`The Patents-in-Suit
`
`11.
`
`United States Patent No. 8,852,636 (“the ’636 patent”), entitled “Pharmaceutical
`
`Compositions for the Coordinated Delivery of NSAIDs” was duly and legally issued by the
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`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.
`
`12.
`
`Pozen owns the ’636 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`under the ’636 patent. The ’636 patent will expire on May 31, 2022.
`
`13.
`
`The ’636 patent is listed in the FDA Orange Book in connection with NDA No.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`14.
`
`United States Patent No. 8,858,996 (“the ’996 patent”), entitled “Pharmaceutical
`
`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.
`
`15.
`
` Pozen owns the ’996 patent by assignment. Horizon is Pozen’s exclusive
`
`licensee under the ’996 patent. The ’996 patent will expire on May 31, 2022.
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`16.
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`The ’996 patent is listed in the FDA Orange Book in connection with NDA No.
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`022511 for VIMOVO® Delayed-Release Tablets.
`
`17.
`
`United States Patent No. 8,865,190 (“the ’190 patent”), entitled “Pharmaceutical
`
`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.
`
`18.
`
` Pozen owns the ’190 patent by assignment. Horizon is Pozen’s exclusive
`
`licensee under the ’190 patent. The ’190 patent will expire on May 31, 2022.
`
`19.
`
`United States Patent No. 9,161,920 (“the ’920 patent”), entitled “Pharmaceutical
`
`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
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`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.
`
`20.
`
`Pozen owns the ’920 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`under the ’920 patent. The ’920 patent will expire on May 31, 2022.
`
`21.
`
`The ’920 patent is listed in the FDA Orange Book in connection with NDA No.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`22.
`
`United States Patent No. 9,198,888 (“the ’888 patent”), entitled “Pharmaceutical
`
`Compositions for the Coordinated Delivery of NSAIDs,” was duly and legally issued by the
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`United States Patent and Trademark Office on December 1, 2015. The claims of the ’888 patent
`
`
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`4
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`are directed to a method of reducing the incidence of NSAID-associated gastric ulcers by
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`administering a pharmaceutical composition in unit dosage form comprising naproxen and
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`esomeprazole. A true and correct copy of the ’888 patent is attached as Exhibit E.
`
`23.
`
`Pozen owns the ’888 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`under the ’888 patent. The ’888 patent will expire on May 31, 2022.
`
`24.
`
`The ’888 patent is listed in the FDA Orange Book in connection with NDA No.
`
`022511 for VIMOVO® Delayed-Release Tablets.
`
`Related Patents
`
`25.
`
`United States Patent No. 6,926,907 (“the ’907 patent”), entitled “Pharmaceutical
`
`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).
`
`26.
`
`Pozen owns the ’907 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`under the ’907 patent. The ’907 patent will expire on February 28, 2023.
`
`27.
`
`The ’907 patent is listed in the FDA Orange Book in connection with NDA No.
`
`022511 for VIMOVO® drug product.
`
`28.
`
`United States Patent No. 8,557,285 (“the ’285 patent”), entitled “Pharmaceutical
`
`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.
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`29.
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`Pozen owns the ’285 patent by assignment. Horizon is Pozen’s exclusive licensee
`
`under the ’285 patent. The ’285 patent will expire on May 31, 2022.
`
`30.
`
`The ’285 patent is listed in the FDA Orange Book in connection with NDA No.
`
`022511 for VIMOVO® drug product.
`
`The ANDA
`
`31.
`
`On information and belief, Defendants filed ANDA No. 204920 (“Defendants’
`
`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
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`esomeprazole magnesium delayed-release tablets in 375 mg (naproxen)/20 mg (esomeprazole
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`magnesium) and 500 mg (naproxen)/20 mg (esomeprazole magnesium) strengths (“Mylan’s
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`ANDA Product”), which are generic versions of Plaintiffs’ VIMOVO® Delayed-Release Tablets
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`in 375 mg (naproxen)/20 mg (esomeprazole magnesium) and 500 mg (naproxen)/20 mg
`
`(esomeprazole magnesium) strengths, respectively.
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`32.
`
`By letter dated May 16, 2013 (the “May 2013 ANDA Notice Letter”), Defendants
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`notified AstraZeneca AB (Horizon’s predecessor-in-interest as holder of NDA No. 022511 and
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`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.
`
`33.
`
`On January 23, 2015, Plaintiffs requested that Defendants provide Paragraph IV
`
`certifications with respect to inter alia the ’285, ’636, and ’996 patents..
`
`34.
`
`By three letters each dated February 9, 2015 (the “February 2015 ANDA Notice
`
`Letters”), Defendants notified Horizon and Pozen that Defendants had filed ANDA No. 204920
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`seeking approval to market Mylan’s ANDA Product and that Defendants were providing
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`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.
`
`35.
`
`By a letter dated January 26, 2016 (the “January 2016 ANDA Notice Letter”),
`
`Defendants notified Horizon and Pozen that Defendants had filed ANDA No. 204920 seeking
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`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
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`patents.
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`JURISDICTION AND VENUE
`
`36.
`
`This action arises under the patent laws of the United States, 35 U.S.C. § 1 et seq.,
`
`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).
`
`37.
`
`On information and belief, Defendants have been and are engaging in activities
`
`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.
`
`38.
`
`Defendants’ ANDA May 2013 Notice Letter states Defendants’ intention to seek
`
`FDA approval to market a generic version of the VIMOVO® product before the related ’907
`
`patent expires on February 28, 2023.
`
`39.
`
`There is now an actual controversy between Defendants and Plaintiffs as to
`
`whether Defendants infringe the ’636, ’996,’190, ’920, and ’888 patents.
`
`40.
`
`This Court has personal jurisdiction over Defendants because, inter alia,
`
`Defendants, on information and belief, have purposely availed themselves of the benefits and
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`protections of the laws of New Jersey such that they should reasonably anticipate being haled
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`into court here; Defendants have had continuous and systematic contacts with this judicial
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`district, including, on information and belief, selling pharmaceutical products in New Jersey and
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`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
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`general jurisdiction in New Jersey.
`
`41.
`
`On information and belief, Defendants acted in concert to develop Mylan’s
`
`ANDA Product and to seek approval from the FDA to sell Mylan’s ANDA Product throughout
`
`the United States, including within this judicial district.
`
`42.
`
`On information and belief, the acts of Mylan Pharmaceuticals Inc. and Mylan
`
`Limited complained of herein were done at the direction of, with the authorization of, and with
`
`the cooperation, participation, and assistance of Mylan, Inc.
`
`43.
`
`On information and belief, Mylan Pharmaceuticals Inc., Mylan Limited, and
`
`Mylan, Inc. participated in the preparation and/or filing of ANDA No 204920.
`
`44.
`
`On information and belief and as stated in the May 2013 ANDA Notice Letter,
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`the FDA received ANDA No. 204920 from Defendants.
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`45.
`
`On information and belief, by virtue of, inter alia, Defendants’ continuous and
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`systematic contacts with New Jersey, including but not limited to the above-described contacts,
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`and the actions on behalf of Defendants in connection with ANDA No. 204920, this Court has
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`personal jurisdiction over Defendants. These activities satisfy due process and confer personal
`
`jurisdiction over Defendants consistent with New Jersey law.
`
`46.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b), 1391(c), and 1400(b).
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`COUNT I
`(INFRINGEMENT OF THE ’636 PATENT UNDER 35 U.S.C. § 271(e)(2))
`
`47.
`
`Plaintiffs incorporate by reference paragraphs 1–46 of this Complaint as if fully
`
`set forth herein.
`
`48.
`
`The ’636 patent is a patent with respect to which a claim of patent infringement
`
`could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,
`
`use, sale, or importation of the VIMOVO® product.
`
`49.
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`Accordingly, pursuant to 21 U.S.C. § 355(c)(2), Plaintiffs submitted patent
`
`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.
`
`50.
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) requires, inter alia,
`
`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 will not be infringed.” The FDA Rules and
`
`Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must
`
`include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent
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`is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i)
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`[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the
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`claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or
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`unenforceable, a full and detailed explanation of the grounds supporting the allegation.”
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`51.
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`On information and belief, Defendants were aware of the statutory provisions and
`
`regulations referred to in paragraph 50 above when they served the May 2013 ANDA Notice
`
`Letter regarding certain patents including the ’907 patent.
`
`52.
`
`On information and belief, Defendants have previously filed patent certifications
`
`in association with their ANDA No. 204920 seeking, inter alia, FDA final approval prior to
`
`February 28, 2023. The ’636 patent has an expiration date of May 31, 2022. Therefore, on
`
`further information and belief, Defendants are currently pursuing FDA final approval of ANDA
`
`No. 204920 before the ’636 patent expires.
`
`53.
`
`On information and belief, the making, using, selling, or offering for sale in the
`
`United States or the importation into the United States of Mylan’s ANDA Product infringes the
`
`’636 patent.
`
`54.
`
`Defendants have infringed, either literally or under the doctrine of equivalents, the
`
`’636 patent under 35 U.S.C. § 271(e)(2) by filing ANDA No. 204920 and continuing to seek
`
`approval from the FDA to engage in the commercial manufacture, use, sale, or importation of a
`
`drug claimed in the ’636 patent before the expiration of the ’636 patent.
`
`55.
`
`On information and belief, Mylan’s ANDA Product contains the pharmaceutical
`
`composition patented in the ’636 patent, is a material for use in practicing the methods patented
`
`in the ’636 patent, constitutes a material part of the inventions of the ’636 patent, is especially
`
`made or especially adapted for use in an infringement of the ’636 patent, and is not a staple
`
`article or commodity of commerce suitable for substantial noninfringing use. On information
`
`and belief, Defendants are aware that Mylan’s ANDA Product is so made or so adapted. On
`
`information and belief, Defendants are aware that Mylan’s ANDA Product, if approved, will be
`
`used in contravention of Plaintiffs’ rights under the ’636 patent.
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`56.
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`On information and belief, Defendants’ above-described activities are continuing
`
`and constitute an act of infringement of the ’636 patent under 35 U.S.C. § 271(e)(2).
`
`57.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`
`
`COUNT II
`(DECLARATORY JUDGMENT AS TO THE ’636 PATENT)
`
`58.
`
`Plaintiffs incorporate by reference paragraphs 1–57 of this Complaint as if fully
`
`set forth herein.
`
`59.
`
`The ’636 patent is a patent with respect to which a claim of patent infringement
`
`could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,
`
`use, sale, or importation of the VIMOVO® product.
`
`60.
`
`On information and belief, Mylan’s ANDA Product contains the pharmaceutical
`
`composition patented in the ’636 patent, is a material for use in practicing the methods patented
`
`in the ’636 patent, constitutes a material part of the inventions of the ’636 patent, is especially
`
`made or especially adapted for use in an infringement of the ’636 patent, and is not a staple
`
`article or commodity of commerce suitable for substantial noninfringing use. On information
`
`and belief, Defendants are aware that Mylan’s ANDA Product is so made or so adapted.
`
`61.
`
`On information and belief, the making, using, selling, or offering for sale in the
`
`United States or the importation into the United States of Mylan’s ANDA Product before the
`
`expiration of the ’636 patent constitutes infringement of the ’636 patent under 35 U.S.C.
`
`§§ 271(a), (b), and/or (c).
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`62.
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`On information and belief, Defendants have previously filed patent certifications
`
`in association with their ANDA No. 204920 seeking, inter alia, FDA final approval to market
`
`Mylan’s ANDA Product before February 28, 2023.
`
`63.
`
`The February 2015 ANDA Notice Letter shows Defendants’ intent to market
`
`Mylan’s ANDA Product before the ’636 patent expires on May 31, 2022.
`
`64.
`
`On information and belief, Defendants continue to seek FDA final approval for
`
`Mylan’s ANDA Product. On information and belief, Defendants are aware that the manufacture,
`
`use, sale, or offer for sale in the United States or the importation into the United States of
`
`Mylan’s ANDA Product, if approved, will infringe the ’636 patent under 35 U.S.C. §§ 271(a),
`
`(b), and/or (c).
`
`65.
`
`On information and belief, Defendants have made, and will continue to make,
`
`substantial preparation to manufacture, use, sell, or offer to sell in the United States or import
`
`into the United States Mylan’s ANDA Product before the ’636 patent expires.
`
`66.
`
`On information and belief, Defendants intend to engage in the commercial
`
`manufacture, use, sale, or offer for sale in the United States or importation into the United States
`
`of Mylan’s ANDA Product after receiving FDA final approval of ANDA No. 204920 and before
`
`the ’636 patent expires.
`
`67.
`
`Defendants maintain, on information and belief, and Plaintiffs deny that the ’636
`
`patent is invalid or unenforceable and that Mylan’s ANDA Product does not or will not infringe
`
`the ’636 patent. Accordingly, a definite and concrete, real and substantial, justiciable case or
`
`controversy exists between Plaintiffs and Defendants concerning infringement of the ’636 patent
`
`by Mylan’s ANDA Product.
`
`
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`
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`68.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`69.
`
`Plaintiffs are entitled to a declaration that the making, using, sale, or offer for sale
`
`in the United States or the importation into the United States of Mylan’s ANDA Product will
`
`infringe one or more claims of the ’636 patent.
`
`COUNT III
`(INFRINGEMENT OF THE ’996 PATENT UNDER 35 U.S.C. § 271(e)(2))
`
`
`
`70.
`
`Plaintiffs incorporate by reference paragraphs 1–69 of this Complaint as if fully
`
`set forth herein.
`
`71.
`
`The ’996 patent is a patent with respect to which a claim of patent infringement
`
`could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,
`
`use, sale, or importation of the VIMOVO® product.
`
`72.
`
`Accordingly, pursuant to 21 U.S.C. § 355(c)(2), Plaintiffs timely submitted patent
`
`information for the ’996 patent to the FDA in connection with NDA No. 022511 for the
`
`VIMOVO® product. This information has been published in the FDA’s Orange Book.
`
`73.
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV”) requires,
`
`inter alia,
`
`certification by the ANDA applicant that the subject patent in the Orange Book, here the ’996
`
`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 will not be infringed.” The FDA Rules and
`
`Regulations (21 C.F.R. § 314.95(c)) specify, inter alia, that a Paragraph IV notification must
`
`include “[a] detailed statement of the factual and legal basis of applicant’s opinion that the patent
`
`
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`
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`is not valid, unenforceable, or will not be infringed.” The detailed statement is to include “(i)
`
`[f]or each claim of a patent alleged not to be infringed, a full and detailed explanation of why the
`
`claim is not infringed” and “(ii) [f]or each claim of a patent alleged to be invalid or
`
`unenforceable, a full and detailed explanation of the grounds supporting the allegation.”
`
`74.
`
`On information and belief, Defendants were aware of the statutory provisions and
`
`regulations referred to in paragraph 73 above when they served the May 2013 ANDA Notice
`
`Letter regarding certain patents including the ’907 patent and when they served the February
`
`2015 ANDA Notice Letter regarding the ’285 patent.
`
`75.
`
`On information and belief, Defendants have previously filed patent certifications
`
`in association with their ANDA No. 204920 seeking, inter alia, FDA final approval prior to
`
`February 28, 2023. The ’996 patent has an expiration date of May 31, 2022. Therefore, on
`
`further information and belief, Defendants are currently pursuing FDA final approval of ANDA
`
`No. 204920 before the ’996 patent expires.
`
`76.
`
`On information and belief, the making, using, selling, or offering for sale in the
`
`United States or the importation into the United States of Mylan’s ANDA Product infringes the
`
`’996 patent.
`
`77.
`
`Defendants have infringed, either literally or under the doctrine of equivalents, the
`
`’996 patent under 35 U.S.C. § 271(e)(2) by filing ANDA No. 204920 and continuing to seek
`
`approval from the FDA to engage in the commercial manufacture, use, sale, or importation of a
`
`drug claimed in the ’996 patent before the expiration of the ’996 patent.
`
`78.
`
`On information and belief, Mylan’s ANDA Product contains the pharmaceutical
`
`composition patented in the ’996 patent, is a material for use in practicing the methods patented
`
`in the ’996 patent, constitutes a material part of the inventions of the ’996 patent, is especially
`
`
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`
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`made or especially adapted for use in an infringement of the ’996 patent, and is not a staple
`
`article or commodity of commerce suitable for substantial noninfringing use. On information
`
`and belief, Defendants are aware that Mylan’s ANDA Product is so made or so adapted. On
`
`information and belief, Defendants are aware that Mylan’s ANDA Product, if approved, will be
`
`used in contravention of Plaintiffs’ rights under the ’996 patent.
`
`79.
`
`On information and belief, Defendants’ above-described activities are continuing
`
`and constitute an act of infringement of the ’996 patent under 35 U.S.C. § 271(e)(2).
`
`80.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are precluded by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`
`
`COUNT IV
`(DECLARATORY JUDGMENT AS TO THE ’996 PATENT)
`
`81.
`
`Plaintiffs incorporate by reference paragraphs 1–80 of this Complaint as if fully
`
`set forth herein.
`
`82.
`
`The ’996 patent is a patent with respect to which a claim of patent infringement
`
`could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,
`
`use, sale, or importation of the VIMOVO® product.
`
`83.
`
`On information and belief, Mylan’s ANDA Product contains the pharmaceutical
`
`composition patented in the ’996 patent, is a material for use in practicing the methods patented
`
`in the ’996 patent, constitutes a material part of the inventions of the ’996 patent, is especially
`
`made or especially adapted for use in an infringement of the ’996 patent, and is not a staple
`
`article or commodity of commerce suitable for substantial noninfringing use. On information
`
`and belief, Defendants are aware that Mylan’s ANDA Product is so made or so adapted.
`
`
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`
`
`84.
`
`On information and belief, the making, using, selling, or offering for sale in the
`
`United States or the importation into the United States of Mylan’s ANDA Product before the
`
`expiration of the ’996 patent constitutes infringement of the ’996 patent under 35 U.S.C.
`
`§§ 271(a), (b), and/or (c).
`
`85.
`
`On information and belief, Defendants have previously filed patent certifications
`
`in association with their ANDA No. 204920 seeking, inter alia, FDA final approval to market
`
`Mylan’s ANDA Product before February 28, 2023.
`
`86.
`
`The May 2013 ANDA Notice Letter and the February 2015 ANDA Notice Letter
`
`show Defendants’ intent to market Mylan’s ANDA Product before the ’996 patent expires on
`
`May 31, 2022.
`
`87.
`
`On information and belief, Defendants continue to seek FDA final approval for
`
`Mylan’s ANDA Product. On information and belief, Defendants are aware that the manufacture,
`
`use, sale, or offer for sale in the United States or the importation into the United States of
`
`Mylan’s ANDA Product, if approved, will infringe the ’996 patent under 35 U.S.C. §§ 271(a),
`
`(b), and/or (c).
`
`88.
`
`On information and belief, Defendants have made, and will continue to make,
`
`substantial preparation to manufacture, use, sell, or offer to sell in the United States or import
`
`into the United States Mylan’s ANDA Product before the ’996 patent expires.
`
`89.
`
`On information and belief, Defendants intend to engage in the commercial
`
`manufacture, use, sale, or offer for sale in the United States or importation into the United States
`
`of Mylan’s ANDA Product after receiving FDA final approval of ANDA No. 204920 and before
`
`the ’996 patent expires.
`
`
`
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`
`
`90.
`
`Defendants maintain, on information and belief, and Plaintiffs deny that the ’996
`
`patent is invalid or