Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 1 of 20 PageID #: 44
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 1:14-cv-00946-GMS
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`SALIX PHARMACEUTICALS, LTD., SALIX
`PHARMACEUTICALS, INC., and GLYCYX
`PHARMACEUTICALS, LTD.,
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`Plaintiffs,
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`
`v.
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`
`PAR PHARMACEUTICAL COMPANIES, INC. and
`PAR PHARMACEUTICAL, INC.,
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`Defendants.
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`
`DEFENDANTS PAR PHARMACEUTICAL COMPANIES, INC. AND
`PAR PHARMACEUTICAL, INC.’S ANSWER, SEPARATE DEFENSES,
`AND PAR PHARMACEUTICAL, INC.’S COUNTERCLAIMS
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`Defendants Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (together,
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`
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`“Par”), by and through their attorneys, for their Answer to the Complaint of Plaintiffs Salix
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`Pharmaceuticals, Ltd., Salix Pharmaceuticals, Inc., and Glycyx Pharmaceuticals, Ltd.
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`(collectively “Plaintiffs”), hereby declare as follows:
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`PARTIES
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`1.
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`Par is without knowledge and information sufficient to form a belief as to the state
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`of incorporation and principal place of business of Salix Pharmaceuticals, Ltd. Par thus denies
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`the allegations of Paragraph 1.
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`2.
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`Par is without knowledge and information sufficient to form a belief as to the state
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`of incorporation and principal place of business of Salix Pharmaceuticals, Inc. Par thus denies
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`the allegations of Paragraph 2.
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`Page 1 of 20
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 2 of 20 PageID #: 45
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`3.
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`Par is without knowledge and information sufficient to form a belief as to the state
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`of incorporation and principal place of business of Glycyx Pharmaceuticals, Ltd. Par thus denies
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`the allegations of Paragraph 3.
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`4.
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`Par admits that Par Pharmaceutical Companies, Inc. is a corporation organized
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`and existing under the laws of Delaware. Par avers that Par Pharmaceutical Companies, Inc. has
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`a principal place of business at One Ram Ridge Road, Spring Valley, New York 10977. Par
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`avers that Par Pharmaceutical Companies, Inc. is a pharmaceutical company engaged in
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`developing, manufacturing, and distributing, inter alia, generic pharmaceutical products
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`throughout the United States, including in this judicial district. Par denies the remaining
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`allegations of Paragraph 4.
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`5.
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`Par admits that Par Pharmaceutical, Inc. is a corporation organized and existing
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`under the laws of Delaware, having a principal place of business at One Ram Ridge Road, Spring
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`Valley, New York 10977. Par avers that Par Pharmaceutical, Inc. is a pharmaceutical company
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`engaged in developing, manufacturing, and distributing, inter alia, generic pharmaceutical
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`products throughout the United States, including in this judicial district. Par denies the
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`remaining allegations of Paragraph 5.
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`6.
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`Par admits that Par Pharmaceutical, Inc. is a wholly-owned subsidiary of Par
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`Pharmaceutical Companies, Inc. Par denies the remaining allegations of Paragraph 6.
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`7.
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`Par denies the allegations of Paragraph 7.
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`NATURE OF THE ACTION
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`8.
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`Paragraph 8 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par admits that the Complaint purports to be an action for patent
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`infringement of United States Patent No. 6,197,341 (the “’341 patent”) and U.S. Patent No.
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 3 of 20 PageID #: 46
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`8,497,256 (the “’256 patent”). Par further admits that the Complaint purports to be an action that
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`arises under the Patent Laws of the United States, 35 U.S.C. § 100 et seq.
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`JURISDICTION AND VENUE
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`9.
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`Paragraph 9 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par states, for the limited purposes of this action only, that Par
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`Pharmaceutical, Inc. does not contest jurisdiction in this judicial district. Par denies that it
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`engaged or is engaging in any act that violates the patent laws of the United States, or engaged in
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`or is engaging in any act resulting in liability for patent infringement. In addition, Par denies that
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`subject matter jurisdiction exists based on any acts by Par Pharmaceutical Companies, Inc. and
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`therefore denies that Par Pharmaceutical Companies, Inc. is a proper party in this case. Par
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`denies the remaining allegations of Paragraph 9.
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`10.
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`Paragraph 10 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par denies the allegations of Paragraph 10.
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`11.
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`12.
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`Par denies the allegations of Paragraph 11.
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`Paragraph 12 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par denies the allegations of Paragraph 12.
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`13.
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`Paragraph 13 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par states, for the limited purposes of this action only, that Par
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`Pharmaceutical, Inc. does not contest personal jurisdiction in this judicial district. Par denies the
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`remaining allegations of Paragraph 13.
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`14.
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`15.
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`Par denies the allegations of Paragraph 14.
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`Paragraph 15 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par states, for the limited purposes of this action only, that Par
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`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 4 of 20 PageID #: 47
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`Pharmaceutical, Inc. does not contest personal jurisdiction in this judicial district. Par denies the
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`remaining allegations of Paragraph 15.
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`16.
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`17.
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`Par denies the allegations of Paragraph 16.
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`Paragraph 17 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par admits that Plaintiffs purport to base venue on 28 U.S.C. §§
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`1391 and 1400(b). Par Pharmaceutical, Inc. does not contest venue in this judicial district for the
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`limited purpose of this action only. Par denies that venue is proper for Par Pharmaceutical
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`Companies, Inc. Par denies the remaining allegations of Paragraph 17.
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`THE PATENTS-IN-SUIT
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`18.
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`Par admits that the ’341 patent, on its face, is titled “Formulations of Balsalazide
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`and Its Derivatives,” and states its date of issue as March 6, 2001. Par further admits that what
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`appears to be a copy of the ’341 patent is attached to the Complaint as Exhibit A. Par denies that
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`’341 patent was duly and legally issued. Par denies the remaining allegations of Paragraph 18.
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`19.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 19 and thus denies the same.
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`20.
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`Par admits that the ’256 patent, on its face, is titled “Formulations and Uses of 2-
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`Hydroxy-5-Phenylazobenzoic Acid Derivatives for the Treatment of Males,” and states its date
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`of issue as July 30, 2013. Par further admits that what appears to be a copy of the ’256 patent is
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`attached to the Complaint as Exhibit B. Par denies that ’256 patent was duly and legally issued.
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`Par denies the remaining allegations of Paragraph 20.
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`21.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 21 and thus denies the same.
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 5 of 20 PageID #: 48
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`ACTS GIVING RISE TO THIS ACTION1
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`22.
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`Par admits New Drug Application (“NDA”) No. 022205 relates to oral tablets
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`containing 1.1 grams of balsalazide disodium associated with its trade name Giazo. Par admits
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`that Giazo is indicated for the treatment of mildly to moderately active ulcerative colitis in male
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`patients 18 years of age and older. Par is without knowledge and information sufficient to admit
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`or deny the remaining allegations of Paragraph 22 and thus denies the same.
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`23.
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`Par avers that the ’341 patent and the ’256 patent are listed in the FDA’s
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`publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (the
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`“Orange Book”) with reference to NDA No. 022205. Par is without knowledge and information
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`sufficient to admit or deny the remaining allegations of Paragraph 23 and thus denies the same.
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`24.
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`Par avers that Par Pharmaceutical, Inc. submitted Abbreviated New Drug
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`Application (“ANDA”) No. 206336 to the FDA pursuant to § 505(j) of the Federal Food, Drug,
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`and Cosmetic Act, 21 U.S.C. § 355(j), seeking FDA approval to engage in the commercial
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`manufacture, use, or sale of tablets containing 1.1 grams of balsalazide disodium (“Par’s ANDA
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`Product”) prior to the expiration of the ’341 and ’256 patents. Par denies the remaining
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`allegations of paragraph 24.
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`25.
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`Par avers that pursuant to § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and
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`Cosmetic Act, ANDA No. 206336 contained a certification stating that the claims of the ’341
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`patent and the ’256 patent are invalid, unenforceable, and/or will not be infringed by the
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`commercial manufacture, use, or sale of Par’s ANDA Product. Par denies the remaining
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`allegations of Paragraph 25.
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`1 Headings are reprinted here with the same language as used in Plaintiffs’ Complaint simply for
`ease of reference, and do not constitute an admission by Par.
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`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 6 of 20 PageID #: 49
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`26.
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`Par avers that Par Pharmaceutical, Inc. sent Plaintiffs a notice letter dated June 5,
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`2014, providing a written notification of Par Pharmaceutical, Inc.’s ANDA and its accompanying
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`certification. Par avers that this notice letter advised Plaintiffs that the claims of the ’341 and
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`’256 patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or
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`sale of Par’s ANDA Product. Par denies the remaining allegations of paragraph 26.
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`27.
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`Paragraph 27 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par avers that Plaintiffs filed their Complaint against Par within 45
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`days of the date of Par Pharmaceutical, Inc.’s Notice Letter.
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`FIRST COUNT
`INFRINGEMENT BY PAR OF U.S. PATENT NO. 6,197,341
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`28.
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`No response is required to the general reallegation and incorporation by reference
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`of the allegations set forth in Paragraphs 1 through 27 of the Complaint. To the extent a
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`response is required, Par hereby incorporates by reference its responses to Paragraphs 1 through
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`27.
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`29.
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`Paragraph 29 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par avers that Par Pharmaceutical, Inc.’s notice letter is self-evident
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`with respect to its content.
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`30.
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`Paragraph 30 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par avers that Par Pharmaceutical, Inc.’s notice letter is self-evident
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`with respect to its content.
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`31.
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`32.
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`33.
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`34.
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`Par denies the allegations of Paragraph 31.
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`Par denies the allegations of Paragraph 32.
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`Par denies the allegations of Paragraph 33.
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`Par denies the allegations of Paragraph 34.
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 7 of 20 PageID #: 50
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`35.
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`Par avers that Par Pharmaceutical, Inc. was aware of the existence of the ’341
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`patent. Par denies the remaining allegations of Paragraph 35.
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`SECOND COUNT
`INFRINGEMENT BY PAR OF U.S. PATENT NO. 8,497,256
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`36.
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`No response is required to the general reallegation and incorporation by reference
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`of the allegations set forth in Paragraphs 1 through 35 of the Complaint. To the extent a
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`response is required, Par hereby incorporates by reference its responses to Paragraphs 1 through
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`35.
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`37.
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`Paragraph 37 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par avers that Par Pharmaceutical, Inc.’s notice letter is self-evident
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`with respect to its content.
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`38.
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`Paragraph 38 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par avers that Par Pharmaceutical, Inc.’s notice letter is self-evident
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`with respect to its content.
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`39.
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`40.
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`41.
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`42.
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`43.
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`Par denies the allegations of Paragraph 39.
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`Par denies the allegations of Paragraph 40.
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`Par denies the allegations of Paragraph 41.
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`Par denies the allegations of Paragraph 42.
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`Par avers that Par Pharmaceutical, Inc. was aware of the existence of the ’256
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`patent. Par denies the remaining allegations of Paragraph 43.
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`ANSWER TO PLAINTIFFS’ PRAYER FOR RELIEF
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`Par denies that Plaintiffs are entitled to the relief they seek in Paragraphs A–F or any
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`relief at all for the allegations made in the Complaint.
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`Par Pharm. v. Horizon (fka Hyperion)
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 8 of 20 PageID #: 51
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`SEPARATE DEFENSES
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`Par pleads the following defenses in response to Plaintiffs’ allegations, undertaking the
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`burden of proof only as to those defenses deemed affirmative defenses by law, regardless of how
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`such defenses are denominated herein. Par reserves the right to allege additional defenses in the
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`event that discovery or other analysis indicates that additional affirmative or other defenses are
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`appropriate.
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`FIRST SEPARATE DEFENSE
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`Each purported claim for relief in the Complaint is barred for failure to state a
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`44.
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`claim upon which relief can be granted.
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`SECOND SEPARATE DEFENSE
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`45.
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`The claims of the ’341 and ’256 patents are invalid for failing to meet one or more
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`requirements for patentability under Title 35 of the United States Code.
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`THIRD SEPARATE DEFENSE
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`The manufacture, use, sale, offer for sale, and/or importation into the United
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`46.
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`States of Par ’s ANDA Product do not and will not infringe, induce infringement of, or
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`contribute to the infringement of any valid or enforceable claim of the ’341 and ’256 patents.
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`47.
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`The manufacture, use, sale, offer for sale, and/or importation into the United
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`States of Par’s ANDA Product do not and will not infringe, induce infringement of, or contribute
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`to the infringement of any valid or enforceable claim of the ’341 and ’256 patents under the
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`doctrine of equivalents.
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`FOURTH SEPARATE DEFENSE
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`48.
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`Par’s actions in defending this case do not constitute an exceptional case under 35
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`U.S.C. § 285.
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 9 of 20 PageID #: 52
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`RESERVATION OF ADDITIONAL SEPARATE DEFENSES
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`Par reserves the right to assert additional defenses in the event that discovery or other
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`analysis indicates that additional affirmative defenses are appropriate.
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`COUNTERCLAIMS
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`Counterclaimant Par Pharmaceutical, Inc. asserts the following Counterclaims against
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`Salix Pharmaceuticals, Ltd., Salix Pharmaceuticals, Inc., and Glycyx Pharmaceuticals, Ltd.
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`(collectively, “Plaintiffs”) that U.S. Patent Nos. 6,197,341 (the “’341 patent”), 7,452,872 (the
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`“’872 patent”), 7,625,884 (the “’884 patent”), and 8,497,256 (the “’256 patent”) are not infringed
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`by the product described in Abbreviated New Drug Application (“ANDA”) No. 206336, and/or
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`are invalid for violation of one or more provisions of Title 35 of the United States Code,
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`including 35 U.S.C. § 101 et seq.
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`THE PARTIES
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`1.
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`Defendant/Counterclaimant Par Pharmaceutical, Inc. is a corporation organized
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`and existing under the laws of Delaware with a principal place of business at One Ram Ridge
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`Road, Spring Valley, New York 10977.
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`2.
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`On information and belief, and based on Plaintiffs’ allegations, Counterclaim-
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`Defendant/Plaintiff Salix Pharmaceuticals, Ltd. is a corporation organized and existing under the
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`laws of the State of Delaware, having a principal place of business at 8510 Colonnade Center
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`Drive, Raleigh, North Carolina 27615.
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`3.
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`On information and belief, and based on Plaintiffs’ allegations, Counterclaim-
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`Defendant/Plaintiff Salix Pharmaceuticals, Inc. is a corporation organized and existing under the
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`laws of the State of California, having a principal place of business at 8510 Colonnade Center
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`Drive, Raleigh, North Carolina 27615.
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`01:15870778.1
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 10 of 20 PageID #: 53
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`4.
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`On information and belief, and based on Plaintiffs’ allegations, Counterclaim-
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`Defendant/Plaintiff Glycyx Pharmaceuticals, Ltd. is a corporation organized and existing under
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`the laws of the State of Delaware, having a principal place of business at 8510 Colonnade Center
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`Drive, Raleigh, North Carolina 27615.
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`NATURE OF THE ACTION
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`5.
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`These Counterclaims arise under the patent laws of the United States, 35 U.S.C. §
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`1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202. Par Pharmaceutical,
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`Inc. seeks declarations that the ’341, ’872, ’884, and ’256 patents are not infringed by the
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`product described in Par Pharmaceutical Inc.’s ANDA No. 206336 and/or are invalid for failure
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`to comply with one or more provisions of Title 35 of the United States Code, including 35
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`U.S.C. § 101 et seq.
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`JURISDICTION AND VENUE
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`6.
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`This Court has subject matter jurisdiction over these Counterclaims for
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`declaratory judgment pursuant to 28 U.S.C. §§ 1331, 1337(a), 1338(a), 2201(a) and (b), and
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`2202 based on an actual controversy among the parties, arising under the patent laws of the
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`United States, 35 U.S.C. § 1 et seq. This Court has original jurisdiction over the subject matter
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`of these claims under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202 as well as 21 U.S.C.
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`§ 355(c)(3)(D).
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`7.
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`This Court has personal jurisdiction over Plaintiffs based on, inter alia, Plaintiffs’
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`filing of this lawsuit in this jurisdiction.
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`8.
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`Venue is proper in this judicial district based on 28 U.S.C. § 1400(a) and/or 28
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`U.S.C. § 1391(b), (c), and (d).
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`BACKGROUND
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`9.
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`The ’341 patent, on its face, is titled “Formulations of Balsalazide and Its
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`Derivatives,” and states its date of issue as March 6, 2001.
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`10.
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`On information and belief, and based on Plaintiffs’ allegations, Glycyx
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`Pharmaceuticals, Ltd. currently owns the ’341 patent.
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`11.
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`The ’872 patent, on its face, is titled “Formulations and Uses of 2-Hydroxy-5-
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`Phenylazobenzoic Acid Derivatives,” and states its date of issue as November 18, 2008. A copy
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`of the ’872 patent is attached hereto as Exhibit 1.
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`12.
`
`On information and belief, Salix Pharmaceuticals, Inc. currently owns the ’872
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`patent.
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`13.
`
`The ’884 patent, on its face, is titled “Formulations and Uses of 2-Hydroxy-5-
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`Phenylazobenzoic Acid Derivatives,” and states its date of issue as December 1, 2009. A copy
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`of the ’884 patent is attached hereto as Exhibit 2.
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`14.
`
`The ’256 patent, on its face, is titled “Formulations and Uses of 2-Hydroxy-5-
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`Phenylazobenzoic Acid Derivatives for the Treatment of Males,” and states its date of issue as
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`July 30, 2013.
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`15.
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`On information and belief, Salix Pharmaceuticals, Ltd. currently owns the ’884
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`and ’256 patents.
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`16.
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`On information and belief, and based on Plaintiffs’ allegations, Salix
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`Pharmaceuticals, Inc. is the holder of New Drug Application (“NDA”) No. 022205 for
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`balsalazide disodium tablets in 1.1 grams strength, sold in the United States as Giazo.
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`17.
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`On information and belief, the FDA approved NDA No. 022205 on February 3,
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`2012.
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`18.
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`The ’341, ’872, ’884, and ’256 patents are listed in the Approved Drug Products
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`with Therapeutic Equivalence Evaluations (the “Orange Book”) listing of the United States Food
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`and Drug Administration (“FDA”) with respect to NDA No. 022205.
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`19.
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`Par Pharmaceutical, Inc. submitted ANDA No. 206336 to the FDA, requesting
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`approval to engage in the commercial manufacture, use, importation, sale, and/or offer for sale in
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`the United States of balsalazide disodium tablets in 1.1 grams dosage strength, before the stated
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`expiration date of the ’341, ’872, ’884, and ’256 patents. Par Pharmaceutical, Inc. made a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(a)(vii)(IV) (a “Paragraph IV Certification”) that
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`no valid or enforceable claim of the ’341, ’872, ’884, and ’256 patents would be infringed by the
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`commercial manufacture, use, importation, sale, and/or offer for sale of the products that are the
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`subject of ANDA No. 206336 (“Par’s ANDA Product”).
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`20.
`
`On July 17, 2014, Plaintiffs filed their Complaint alleging infringement by Par
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`Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. of the ’341 and ’256 patents.
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`21.
`
`By maintaining the listing of the ’872 and ’884 patents in the Orange Book,
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`Plaintiffs represent that the ’872 and ’884 patents “could reasonably be asserted if a person not
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`licensed by the owner engaged in the manufacture, use, or sale of the drug.” 21 U.S.C. §
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`355(b)(1)(g).
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`22.
`
`To date, Plaintiffs have not filed any actions alleging that the filing of Par
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`Pharmaceutical, Inc.’s ANDA No. 206336 infringes any claims of the ’872 and ’884 patents.
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`FIRST COUNT
`(Declaration of Invalidity of the ’341 Patent)
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`23.
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`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 22 as if
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`fully set forth herein.
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`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 13 of 20 PageID #: 56
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`
`
`24.
`
`The claims of the ’341 patent are invalid for failing to meet one or more
`
`requirements for patentability of Title 35 of the United States Code, including 35 U.S.C. § 101 et
`
`seq.
`
`25.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the validity of the ’341 patent, which
`
`is of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`26.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’341 patent is
`
`invalid.
`
`SECOND COUNT
`(Declaration of Noninfringement of the ’341 Patent)
`
`27.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 26 as if
`
`fully set forth herein.
`
`28.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’341 patent.
`
`29.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’341 patent under the
`
`doctrine of equivalents.
`
`30.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the alleged infringement by Par’s
`
`ANDA Product of the ’341 patent, which is of sufficient immediacy and reality to warrant the
`
`issuance of a declaratory judgment.
`
`01:15870778.1
`
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`– 13 –
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`Page 13 of 20
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`

`
`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 14 of 20 PageID #: 57
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`
`
`31.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’341 patent is
`
`not infringed.
`
`THIRD COUNT
`(Declaration of Invalidity of the ’872 Patent)
`
`32.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 31 as if
`
`fully set forth herein.
`
`33.
`
`The claims of the ’872 patent are invalid for failing to meet one or more
`
`requirements for patentability of Title 35 of the United States Code, including 35 U.S.C. § 101 et
`
`seq.
`
`34.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the validity of the ’872 patent, which
`
`is of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`35.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’872 patent is
`
`invalid.
`
`FOURTH COUNT
`(Declaration of Noninfringement of the ’872 Patent)
`
`36.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 35 as if
`
`fully set forth herein.
`
`37.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’872 patent.
`
`38.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`01:15870778.1
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`Page 14 of 20
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`

`
`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 15 of 20 PageID #: 58
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`
`
`contribute to the infringement of any valid or enforceable claim of the ’872 patent under the
`
`doctrine of equivalents.
`
`39.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the infringement by Par’s ANDA
`
`Product of the ’872 patent, which is of sufficient immediacy and reality to warrant the issuance
`
`of a declaratory judgment.
`
`40.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’872 patent is
`
`not infringed.
`
`FIFTH COUNT
`(Declaration of Invalidity of the ’884 Patent)
`
`41.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 40 as if
`
`fully set forth herein.
`
`42.
`
`The claims of the ’884 patent are invalid for failing to meet one or more
`
`requirements for patentability of Title 35 of the United States Code, including 35 U.S.C. § 101 et
`
`seq.
`
`43.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the validity of the ’884 patent, which
`
`is of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`44.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’884 patent is
`
`invalid.
`
`SIXTH COUNT
`(Declaration of Noninfringement of the ’884 Patent)
`
`45.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 44 as if
`
`fully set forth herein.
`
`01:15870778.1
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`– 15 –
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`Page 15 of 20
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`

`
`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 16 of 20 PageID #: 59
`
`
`
`46.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’884 patent.
`
`47.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’884 patent under the
`
`doctrine of equivalents.
`
`48.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the infringement by Par’s ANDA
`
`Product of the ’884 patent, which is of sufficient immediacy and reality to warrant the issuance
`
`of a declaratory judgment.
`
`49.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’884 patent is
`
`not infringed.
`
`SEVENTH COUNT
`(Declaration of Invalidity of the ’256 Patent)
`
`50.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 49 as if
`
`fully set forth herein.
`
`51.
`
`The claims of the ’256 patent are invalid for failing to meet one or more
`
`requirements for patentability of Title 35 of the United States Code, including 35 U.S.C. § 101 et
`
`seq.
`
`52.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the validity of the ’256 patent, which
`
`is of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`01:15870778.1
`
`
`– 16 –
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`Page 16 of 20
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`

`
`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 17 of 20 PageID #: 60
`
`
`
`53.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’256 patent is
`
`invalid.
`
`SIXTH COUNT
`(Declaration of Noninfringement of the ’256 Patent)
`
`54.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 53 as if
`
`fully set forth herein.
`
`55.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’256 patent.
`
`56.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Par’s ANDA Product does not and will not infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’256 patent under the
`
`doctrine of equivalents.
`
`57.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Plaintiffs concerning the alleged infringement by Par’s
`
`ANDA Product of the ’256 patent, which is of sufficient immediacy and reality to warrant the
`
`issuance of a declaratory judgment.
`
`58.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’256 patent is
`
`not infringed.
`
`PRAYER FOR RELIEF
`
`
`
`WHEREFORE, Par Pharmaceutical, Inc. requests the following relief:
`
`a)
`
`Dismissing Plaintiffs’ Complaint with prejudice and denying each request for
`
`relief made by Plaintiffs;
`
`b)
`
`Declaring all claims of the ’341 patent invalid;
`
`01:15870778.1
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`– 17 –
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`Page 17 of 20
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`Patent Owner Horizon Ex. 2003
`Par Pharm. v. Horizon (fka Hyperion)
`IPR2015-01117, IPR2015-01127
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`

`
`Case 1:14-cv-00946-GMS Document 9 Filed 08/07/14 Page 18 of 20 PageID #: 61
`
`
`
`c)
`
`Declaring all claims of the ’341 patent not infringed by the manufacturing, use,
`
`sale, offer for sale, or importation into the United States of Par’s ANDA Product;
`
`d)
`
`e)
`
`Declaring all claims of the ’872 patent invalid;
`
`Declaring all claims of the ’872 patent not infringed by the manufacturing, use,
`
`sale, offer for sale, or importation into the United States of Par’s ANDA Product;
`
`f)
`
`g)
`
`Declaring all claims of the ’884 patent invalid;
`
`Declaring all claims of the ’884 patent not infringed by the manufacturing, use,
`
`sale, offer for sale, or importation into the United States of the Par’s ANDA Product;
`
`h)
`
`i)
`
`Declaring all claims of the ’256 patent invalid;
`
`Declaring all claims of the ’256 patent not infringed by the manufacturing, use,
`
`sale, offer for sale, or importation into the United States of Par’s ANDA Product;
`
`j)
`
`Declaring tha