Case 1:13-cv-03284-TPG Document 30 Filed 08/07/13 Page 1 of 19
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`ENDO PHARMACEUTICALS INC.,
`Plaintiff,
`
`v.
`
`C.A. No. 1:13-cv-3284
`
`PAR PHARMACEUTICAL COMPANIES,
`INC., and PAR PHARMACEUTICAL, INC.
`Defendants.
`
`DEFENDANTS PAR PHARMACEUTICAL COMPANIES, INC.’S
`AND PAR PHARMACEUTICAL, INC.’S ANSWER, SEPARATE DEFENSES, AND
`PAR PHARMACEUTICAL, INC.’S COUNTERCLAIMS
`
`Defendants Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (together,
`
`“Par”), by and through their attorneys, for their Answer to the Complaint of Plaintiff Endo
`
`Pharmaceuticals Inc. (“Endo”), hereby declare as follows:
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`PARTIES
`
`1.
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`Par is without knowledge and information sufficient to form a belief as to the
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`location of organization and existence, principal place of business, nature of business, marketing
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`profile, and product distribution information of Endo Pharmaceuticals Inc. Par thus denies the
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`allegations of Paragraph 1.
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`2.
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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 the State of Delaware, having a principal place of business located
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`at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677.
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`3.
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`Par avers that Par Pharmaceutical Companies, 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 3.
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`JAZZ EXHIBIT 2027
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
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`4.
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`Par admits that Par Pharmaceutical, Inc. is a corporation organized and existing
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`under the laws of the State of Delaware, having a principal place of business located at 300 Tice
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`Boulevard, Woodcliff Lake, New Jersey 07677.
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`5.
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`Par avers that Par Pharmaceutical, Inc. is wholly owned by Sky Growth Holdings
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`Corporation. Par denies the remaining allegations of Paragraph 5.
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`6.
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`7.
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`Par denies the allegations of Paragraph 6.
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`NATURE OF ACTION
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`Paragraph 7 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 arising under the patent laws of the United States, 35 U.S.C. § 100, et seq., and the
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`Declaratory Judgment Act, 28 U.S.C. § 2201, et seq. Par denies the remaining allegations of
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`Paragraph 7.
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`JURISDICTION AND VENUE
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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 Endo purports to base subject matter jurisdiction on
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`28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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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 admits that Endo purports to base venue on 28 U.S.C. §§
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`1391(b) and 1400(b).
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`10.
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`Paragraph 10 states legal conclusions to which no response is required. To the
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`extent a response is required, Par denies that it engaged in tortious conduct in the State of New
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`York that has led to harm to Plaintiff. Par denies the remaining allegations of Paragraph 10.
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`11.
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`Par admits that Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc.
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`are registered with the New York State Department of State as corporations. Par denies the
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`remaining allegations of Paragraph 11.
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`12.
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`13.
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`Par denies the allegations of Paragraph 12.
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`Par states that Par Pharmaceutical Companies, Inc.’s website is self-evident with
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`respect to its content.
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`14.
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`Par admits that after Abbreviated New Drug Application (“ANDA”) No. 20-
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`0792’s approval by the Food and Drug Administration (“FDA”), it may distribute and sell the
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`product as described the ANDA (the “ANDA Product”) in this judicial district. Par denies the
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`remaining allegations of Paragraph 14.
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`15.
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`16.
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`Paragraph 15 states a legal conclusion to which no response is required.
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`Par states that its website is self-evident with respect to the products it has
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`manufactured and sold. Par denies the remaining allegations of Paragraph 16.
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`17.
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`Par admits that Par Pharmaceutical Companies, Inc. is registered with the New
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`York State Department of State as an active corporation.
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`18.
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`Par admits that Par Pharmaceutical, Inc. is registered as a Pharmacy
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`Establishment in the State of New York, by the New York State Department of Education Office
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`of the Professions, under Registration Nos. 027015, 029055, and 101405 through November 30,
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`2013, July 31, 2014, and October 31, 2015, respectively. Par denies the remaining allegations of
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`Paragraph 18.
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`19.
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`Paragraph 19 states a conclusion related to future events to which Par is unable to
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`confirm.
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`20.
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`Paragraph 20 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 20.
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`21.
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`Paragraph 21 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 21.
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`FACTUAL BACKGROUND
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`Endo’s OPANA® ER CRF NDA
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`22.
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`Par admits that New Drug Application (“NDA”) No. 21-610 was approved on
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`June 22, 2006 and lists Endo as the applicant. Par is without knowledge and information
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`sufficient to admit or deny the remaining allegations of Paragraph 22 and thus denies the same.
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`23.
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`Par admits that Supplemental New Drug Application (“sNDA”) No. 201655 was
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`approved on December 9, 2011 and lists Endo as the applicant. Par is without knowledge and
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`information sufficient to admit or deny the remaining allegations of Paragraph 23 and thus denies
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`the same.
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`24.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 24 and thus denies the same.
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`25.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 25 and thus denies the same.
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`26.
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`Par avers that OPANA® ER is indicated for relief of moderate to severe pain. Par
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`is without knowledge and information sufficient to admit or deny the remaining allegations of
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`Paragraph 26 and thus denies the same.
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`ENDO’S PATENTS
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`27.
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`Par admits that US Patent No. 7,851,482 (the “’482 patent”), on its face, is titled
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`“Method for Making Analgesics,” and lists its date of issue as December 14, 2010. Par admits
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`that the ’482 patent, on its face, identifies Jen-Sen Dung, Erno M. Keskeny, and James J. Mencel
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`as its inventors, and Johnson Matthey Public Limited Company as its assignee. Par further
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`admits that what appears to be a copy of the ’482 patent is attached to the Complaint as Exhibit
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`A. Par denies that the United States Patent and Trademark Office duly and legally issued the
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`’482 patent and the remaining allegations of Paragraph 27.
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`28.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 28 and thus denies the same.
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`29.
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`Par admits that US Patent No. 8,309,122 (the “’122 patent”), on its face, is titled
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`“Oxymorphone Controlled Release Formulations,” and lists its date of issue as November 13,
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`2012. Par admits that the ’122 patent, on its face, identifies Huai-Hung Kao, Anand R.
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`Baichwal, Troy McCall, and David Lee as its inventors, and Endo Pharmaceuticals, Inc. as its
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`assignee. Par further admits that what appears to be a copy of the ’122 patent is attached to the
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`Complaint as Exhibit B. Par denies that the United States Patent and Trademark Office duly and
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`legally issued the ’122 patent and the remaining allegations of Paragraph 29.
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`30.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 30 and thus denies the same.
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`31.
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`Par admits that US Patent No. 8,329,216 (the “’216 patent”), on its face, is titled
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`“Oxymorphone Controlled Release Formulations,” and lists its date of issue as December 11,
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`2012. Par admits that the ’216 patent, on its face, identifies Huai-Hung Kao, Anand R.
`
`Baichwal, Troy McCall, and David Lee as its inventors, and Endo Pharmaceuticals Inc. as its
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`assignee. Par further admits that what appears to be a copy of the ’216 patent is attached to the
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`Complaint as Exhibit C. Par denies that the United States Patent and Trademark Office duly and
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`legally issued the ’216 patent and the remaining allegations of Paragraph 31.
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`32.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 32 and thus denies the same.
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`33.
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`Paragraph 33 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 in paragraph 33.
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`34.
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`Par avers that the ’482, ’122, and ’216 patents appear listed in the Orange Book
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`with reference to OPANA® ER. Par admits that U.S. Patent Nos. 8,114,383 (the “’383 patent”),
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`8,192,722 (the “’722 patent”), and 8,309,060 (the “’060 patent”) are also listed with reference to
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`OPANA® ER. Par is without knowledge and information sufficient to admit or deny the
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`remaining allegations of Paragraph 34 and thus denies the same.
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`DEFENDANTS’ INFRINGING PRODUCT1
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`35.
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`Par avers that Watson Laboratories, Inc. filed ANDA No. 20-0792 with the FDA,
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`seeking approval of its Oxymorphone Hydrochloride extended release tablets. Par is without
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`knowledge and information sufficient to admit or deny the allegations of Paragraph 35 and thus
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`denies the same.
`
`36.
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`Par avers that on March 4, 2010, Endo and Penwest Pharmaceuticals Co. appear
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`to have filed a lawsuit against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and
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`Watson Pharma, Inc. in the United States District Court for the District of New Jersey, Docket
`
`No. 2:10-cv-1242-KSH-PS. Par further admits that the Court appears to have dismissed this case
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`with prejudice on October 21, 2010. The rest of Paragraph 36 states legal conclusions to which
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`no response is required. To the extent a response is required, Par denies the remaining
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`allegations of Paragraph 36.
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`1 Headings are reprinted here with the same language as used in Endo’s Complaint simply for
`ease of reference, and do not constitute an admission.
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`37.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 37 and thus denies the same.
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`38.
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`Par admits it purchased ANDA No. 20-0792 in 2012. Par states that the United
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`States Federal Trade Commission’s website is self-evident with respect to its content.
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`39.
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`Par admits that before November 8, 2012, Par Pharmaceutical, Inc. submitted an
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`ANDA to FDA pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act, 21
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`U.S.C. § 355(j), seeking approval to engage in the commercial manufacture, use, and sale of
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`crush-resistant oxymorphone hydrochloride extended-release tablets. Par denies the remaining
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`allegations of Paragraph 39.
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`40.
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`Par avers that Par Pharmaceutical, Inc. sent to Endo a notice letter dated
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`November 8, 2012 regarding an ANDA that is not at issue in this case. Par admits that this
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`notice letter represented that Par Pharmaceutical, Inc. had filed with FDA ANDA No. 20-4340,
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`and that Par Pharmaceutical, Inc. seeks approval to market the product as described in ANDA
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`No. 20-4340 before the ’482, ’383, and ’722 patents expire. Par admits that this notice letter
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`stated that ANDA No. 20-4340 contained a written certification pursuant to 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) for the ’482, ’383, and ’722 patents, and
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`advised Endo that the claims of the ’482, ’383, and ’722 patents are invalid, unenforceable,
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`and/or will not be infringed by the proposed manufacture, importation, use, sale, or offer for sale
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`of the product as described in ANDA No. 20-4340. Par denies the remaining allegations of
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`Paragraph 40.
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`41.
`
`Par avers that Endo and Grünenthal GmbH filed a lawsuit against Par in the
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`Southern District of New York, Docket No. 12-cv-9261-TPG, on December 19, 2012. Par
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`further admits the Complaint in that case purports to allege that Par infringed the ’482, ’383,
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`’722, ’122, ’216, and ’060 patents, based on Par’s filing of ANDA No. 20-4340. Par further
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`admits that the ’122, ’216, and ’060 patents appear to have issued after Par sent its notice letters
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`to Endo. Par denies the remaining allegations of Paragraph 41.
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`42.
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`Par admits that upon FDA approval it may market the ANDA No. 20-0792
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`Product. Par denies the remaining allegations of Paragraph 42.
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`43.
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`Par is without knowledge and information sufficient to admit or deny the
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`allegations of Paragraph 43 and thus denies the same.
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`44.
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`Par denies the allegations of Paragraph 44.
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`COUNT I
`(INFRINGEMENT OF THE ’482 PATENT)
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`45.
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`No response is required to the general reallegation and incorporation by reference
`
`of the allegations of Paragraphs 1-44 of the Complaint. To the extent a response is required, Par
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`hereby incorporates by reference its responses to Paragraphs 1-44.
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`46.
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`47.
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`48.
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`Par denies the allegations of Paragraph 46.
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`Par denies the allegations of Paragraph 47.
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`Par admits that it is aware of the existence of the ’482 patent. Par denies the
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`remaining allegations of Paragraph 48.
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`COUNT II
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’482 PATENT)
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`49.
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`No response is required to the general reallegation and incorporation by reference
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`of the allegations of Paragraphs 1-48 of the Complaint. To the extent a response is required, Par
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`hereby incorporates by reference its responses to Paragraphs 1-48.
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`50.
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`Paragraph 50 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par denies the remaining allegations of Paragraph 50.
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`51.
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`52.
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`53.
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`54.
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`55.
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`Par denies the allegations of Paragraph 51.
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`Par denies the allegations of Paragraph 52.
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`Par denies the allegations of Paragraph 53.
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`Par denies the allegations of Paragraph 54.
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`Par denies the allegations of Paragraph 55.
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`COUNT III
`(INFRINGEMENT OF THE ’122 PATENT)
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`56.
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`No response is required to the general reallegation and incorporation by reference
`
`of the allegations of Paragraphs 1-55 of the Complaint. To the extent a response is required, Par
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`hereby incorporates by reference its responses to Paragraphs 1-55.
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`57.
`
`58.
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`59.
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`Par denies the allegations of Paragraph 57.
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`Par denies the allegations of Paragraph 58.
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`Par admits that it is aware of the existence of the ’122 patent. Par denies the
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`remaining allegations of Paragraph 59.
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`COUNT IV
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’122 PATENT)
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`60.
`
`No response is required to the general reallegation and incorporation by reference
`
`of the allegations of Paragraphs 1-59 of the Complaint. To the extent a response is required, Par
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`hereby incorporates by reference its responses to Paragraphs 1-59.
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`61.
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`Paragraph 61 states a legal conclusion to which no response is required. To the
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`extent a response is required, Par denies the remaining allegations of Paragraph 61.
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`62.
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`63.
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`64.
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`Par denies the allegations of Paragraph 62.
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`Par denies the allegations of Paragraph 63.
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`Par denies the allegations of Paragraph 64.
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`65.
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`66.
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`Par denies the allegations of Paragraph 65.
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`Par denies the allegations of Paragraph 66.
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`COUNT V
`(INFRINGEMENT OF THE ’216 PATENT)
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`67.
`
`No response is required to the general reallegation and incorporation by reference
`
`of the allegations of Paragraphs 1-66 of the Complaint. To the extent a response is required, Par
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`hereby incorporates by reference its responses to Paragraphs 1-66.
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`68.
`
`69.
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`70.
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`Par denies the allegations of Paragraph 68.
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`Par denies the allegations of Paragraph 69.
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`Par admits that it is aware of the existence of the ’216 patent. Par denies the
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`remaining allegations of Paragraph 70.
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`COUNT VI:
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’216 PATENT)
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`71.
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`No response is required to the general reallegation and incorporation by reference
`
`of the allegations of Paragraphs 1-70 of the Complaint. To the extent a response is required, Par
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`hereby incorporates by reference its responses to Paragraphs 1-70.
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`72.
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`Paragraph 72 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 72.
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`73.
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`74.
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`75.
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`76.
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`77.
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`Par denies the allegations of Paragraph 73.
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`Par denies the allegations of Paragraph 74.
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`Par denies the allegations of Paragraph 75.
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`Par denies the allegations of Paragraph 76.
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`Par denies the allegations of Paragraph 77.
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`ANSWER TO ENDO’S PRAYER FOR RELIEF
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`Par denies that Plaintiffs are entitled to the relief they seek in Paragraphs A–J or any
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`relief at all for the allegations made in the Complaint.
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`SEPARATE DEFENSES
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`Par pleads the following defenses in response to Endo’s 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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`78.
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`Each purported claim for relief in the Complaint is barred for failure to state a
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`claim upon which relief can be granted.
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`SECOND SEPARATE DEFENSE
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`79.
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`The claims of the ’482, ’122, and ’216 patents are invalid for failing to meet one
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`or more requirements for patentability under Title 35 of the United States Code.
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`THIRD SEPARATE DEFENSE
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`80.
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`The manufacture, use, sale, offer for sale, and/or importation into the United
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`States of the ANDA Product does not and will not infringe, induce infringement of, or contribute
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`to the literal infringement of any valid or enforceable claim of the ’482, ’122, and ’216 patents.
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`81.
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`The manufacture, use, sale, offer for sale, and/or importation into the United
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`States of the ANDA Product does 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 ’482, ’122, and ’216 patents under
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`the doctrine of equivalents.
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`FOURTH SEPARATE DEFENSE
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`82.
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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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`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
`
`Counterclaimant Par Pharmaceutical Inc. asserts the following Counterclaims against
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`Endo Pharmaceuticals Inc., that U.S. Patent Nos. 7,851,482 (the “’482 patent”), 8,309,122 (the
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`“’122 patent”), and 8,329,216 (the “’216 patent”) are not infringed by the product described in
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`Abbreviated New Drug Application (“ANDA”) No. 20-0792, and/or are invalid for violation of
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`one or more provisions of Title 35 of the United States Code, including 35 U.S.C. § 101 et seq.
`
`THE PARTIES
`
`1.
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`Par Pharmaceutical, Inc. is a corporation organized and existing under the laws of
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`Delaware with a principal place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey
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`07677.
`
`2.
`
`On information and belief, and based on Plaintiff’s allegations, Counterclaim-
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`Defendant/Plaintiff Endo Pharmaceuticals Inc. (“Endo”) is a corporation organized and existing
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`under the laws of the State Delaware, having a principal place of business at 1400 Atwater Drive,
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`Malvern, Pennsylvania 19355.
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`NATURE OF THE ACTION
`
`3.
`
`These Counterclaims arise under the patent laws of the United States, 35 U.S.C. §
`
`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 ’482, ’122, and ’216 patents are not infringed by the product
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`described in Par Pharmaceutical, Inc.’s ANDA No. 20-0792 and/or are invalid for failure to
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`comply with one or more provisions of Title 35 of the United States Code, including 35 U.S.C.
`
`§ 101 et seq.
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`JURISDICTION AND VENUE
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`4.
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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 of
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`these claims under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202 as well as 21 U.S.C.
`
`§ 355(c)(3)(D).
`
`5.
`
`This Court has personal jurisdiction over Endo based on, inter alia, Endo’s filing
`
`of this lawsuit in this jurisdiction.
`
`6.
`
`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).
`
`BACKGROUND
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`7.
`
`The ’482 patent, on its face, is titled “Method for Making Analgesics,” and lists
`
`its date of issue as December 14, 2010.
`
`8.
`
`The ’122 patent, on its face, is titled “Oxymorphone Controlled Release
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`Formulations,” and lists its date of issue as November 13, 2012.
`
`9.
`
`The ’216 patent, on its face, is titled “Oxymorphone Controlled Release
`
`Formulations,” and lists its date of issue as December 11, 2012.
`
`10.
`
`On information and belief, and based on Endo’s allegations, Endo owns the ’482,
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`’122, and ’216 patents.
`
`11.
`
`On March 4, 2010, Endo and Penwest Pharmaceuticals Co. filed a lawsuit against
`
`Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. in the United
`
`States District Court for the District of New Jersey, Docket No. 2:10-cv-1242-KSH-PS,
`
`regarding ANDA No. 20-0792. The Court dismissed the case with prejudice on October 21,
`
`2010.
`
`12.
`
`Endo and Watson settled their dispute and executed a Settlement and License
`
`Agreement in 2012.
`
`13.
`
`14.
`
`In 2012, Par Pharmaceutical, Inc. purchased ANDA No. 20-0792 from Watson.
`
`Par Pharmaceutical Inc. is the owner of Watson ANDA No. 20-0792 and its
`
`proposed products.
`
`15.
`
`On information and belief, on May 10, 2013, FDA denied Endo’s citizen petition
`
`requesting FDA to not approve ANDAs based on non-crush resistant oxymorphone
`
`hydrochloride extended release tablets, including ANDA No. 20-0792.
`
`16.
`
`On May 15, 2013, Endo filed its Complaint alleging infringement by Par
`
`Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. of the ’482, ’122, and ’216 patents.
`
`COUNT I
`(Declaration of Invalidity of the ’482 Patent)
`
`17.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 16 as if
`
`fully set forth herein.
`
`18.
`
`The claims of the ’482 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.
`
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`Case 1:13-cv-03284-TPG Document 30 Filed 08/07/13 Page 15 of 19
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`19.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Endo concerning the validity of the ’482 patent, which is
`
`of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`20.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’482 patent is
`
`invalid.
`
`COUNT II
`(Declaration of Noninfringement of the ’482 Patent)
`
`21.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 20 as if
`
`fully set forth herein.
`
`22.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the ANDA Product does not and will not literally infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’482 patent.
`
`23.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the ANDA Product does not and will not infringe, induce infringement of, or contribute
`
`to the infringement of any valid or enforceable claim of the ’482 patent under the doctrine of
`
`equivalents.
`
`24.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Endo concerning the alleged infringement by the ANDA
`
`Product of the ’482 patent, which is of sufficient immediacy and reality to warrant the issuance
`
`of a declaratory judgment.
`
`25.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’482 patent is
`
`not infringed.
`
`15
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`Case 1:13-cv-03284-TPG Document 30 Filed 08/07/13 Page 16 of 19
`
`COUNT III
`(Declaration of Invalidity of the ’122 Patent)
`
`26.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 25 as if
`
`fully set forth herein.
`
`27.
`
`The claims of the ’122 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.
`
`28.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Endo concerning the validity of the ’122 patent, which is
`
`of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`29.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’122 patent is
`
`invalid.
`
`COUNT IV
`(Declaration of Noninfringement of the ’122 Patent)
`
`30.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 29 as if
`
`fully set forth herein.
`
`31.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the ANDA Product does not and will not literally infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’122 patent.
`
`32.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the ANDA Product does not and will not infringe, induce infringement of, or contribute
`
`to the infringement of any valid or enforceable claim of the ’122 patent under the doctrine of
`
`equivalents.
`
`16
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`Case 1:13-cv-03284-TPG Document 30 Filed 08/07/13 Page 17 of 19
`
`33.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Endo concerning the alleged infringement by the ANDA
`
`Product of the ’122 patent, which is of sufficient immediacy and reality to warrant the issuance
`
`of a declaratory judgment.
`
`34.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’122 patent is
`
`not infringed.
`
`COUNT V
`(Declaration of Invalidity of the ’216 Patent)
`
`35.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 34 as if
`
`fully set forth herein.
`
`36.
`
`The claims of the ’216 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.
`
`37.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Endo concerning the validity of the ’216 patent, which is
`
`of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.
`
`38.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’216 patent is
`
`invalid.
`
`COUNT VI
`(Declaration of Noninfringement of the ’216 Patent)
`
`39.
`
`Par Pharmaceutical, Inc. incorporates by reference Paragraphs 1 through 38 as if
`
`fully set forth herein.
`
`17
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`Page 17 of 19
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`Case 1:13-cv-03284-TPG Document 30 Filed 08/07/13 Page 18 of 19
`
`40.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the ANDA Product does not and will not literally infringe, induce infringement of, or
`
`contribute to the infringement of any valid or enforceable claim of the ’216 patent.
`
`41.
`
`The manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of the ANDA Product does not and will not infringe, induce infringement of, or contribute
`
`to the infringement of any valid or enforceable claim of the ’216 patent under the doctrine of
`
`equivalents.
`
`42.
`
`A definite and concrete, real and substantial, justiciable controversy exists
`
`between Par Pharmaceutical, Inc. and Endo concerning the alleged infringement by the ANDA
`
`Product of the ’216 patent, which is of sufficient immediacy and reality to warrant the issuance
`
`of a declaratory judgment.
`
`43.
`
`Par Pharmaceutical, Inc. is entitled to a judicial declaration that the ’216 patent is
`
`not infringed.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Par Pharmaceutical, Inc. requests the following relief:
`
`a)
`
`Dismissing Endo’s Complaint with prejudice and denying each request for relief
`
`made by Plaintiffs;
`
`b)
`
`c)
`
`Declaring all claims of the ’482 patent invalid;
`
`Declaring all claims of the ’482 patent not infringed by the making, use, sale,
`
`offer for sale, marketing, or importation into the United States of the ANDA Product;
`
`d)
`
`e)
`
`Declaring all claims of the ’122 patent invalid;
`
`Declaring all claims of the ’122 patent not infringed by the making, use, sale,
`
`offer for sale, marketing, or importation into the United States of the ANDA Product;
`
`f)
`
`Declaring all claims of the ’216 patent invalid;
`18
`
`Page 18 of 19
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`

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`Case 1:13-cv-03284-TPG Document 30 Filed 08/07/13 Page 19 of 19
`
`g)
`
`Declaring all claims of the ’216 patent not infringed by the making, use, sale,
`
`offer for sale, marketing, or importation into the United States of the ANDA Product;
`
`h)
`
`Declaring that Par has a lawful right to obtain FDA approval for the products as
`
`described in ANDA No. 20-0792, and that Par has a lawful right to manufacture, import, use,
`
`sell, and/or offer to sell the products as described in ANDA No. 20-0792;
`
`i)
`
`Declaring that this is an exceptional case under 35 U.S.C. § 285 and awarding Par
`
`Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. their attorneys’ fees, costs, and
`
`expenses in this action; and
`
`j)
`
`Awarding Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. such
`
`other and further relief as the Court deems just and proper.
`
`Dated: August 7, 2013
`
`OF COUNSEL:
`Richard J. Berman
`Janine A. Carlan
`Aziz Burgy
`Taniel E. Anderson
`Stephen Yang
`ARENT FOX LLP
`1717 K STREET, NW
`Washington, DC 20036-5342
`(202) 857-6000
`
`/s/ David N. Wynn
`David N. Wynn
`ARENT FOX LLP
`1675 Broadway
`New York, NY 10019
`(212) 484-3900
`
`Attorneys for Par Pharmaceutical, Inc. and Par
`Pharmaceutical Companies, Inc.
`
`19
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`Page 19 of 19
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`