throbber
Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 1 of 15 PageID #: 43
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Defendants.
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`LANNETT HOLDINGS, INC. AND LANNETT COMPANY, INC.’S
`ANSWER, DEFENSES AND COUNTERCLAIMS
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`Defendants Lannett Holdings, Inc. and Lannett Company, Inc. (collectively “Lannett”),
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`answers the Complaint filed by Impax Laboratories, Inc., AstraZeneca AB and AstraZeneca UK
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`Limited (collectively “Plaintiffs”), and sets forth its defenses and counterclaims, as follows:
`
`THE PARTIES
`
`1.
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`Lannett lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 1, and therefore denies these allegations.
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`2.
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`Lannett lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 2, and therefore denies these allegations.
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`3.
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`Lannett lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 3, and therefore denies these allegations.
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`4.
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`Lannett lacks knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 4, and therefore denies these allegations.
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`
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`ACTIVE 27527082v2 09/24/2014
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`
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`IMPAX LABORATORIES, INC.,
`ASTRAZENECA AB, and
`ASTRAZENECA UK LIMITED,
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`Plaintiffs,
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`v.
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`LANNETT HOLDINGS, INC., and
`LANNETT COMPANY, INC.,
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`
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`
`
`C.A. No. 1:14-cv-999 (RGA)
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`Page 1 of 15
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`AstraZeneca Exhibit 2006
`Lannett v. AstraZeneca
`IPR2015-01629
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 2 of 15 PageID #: 44
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`
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`5.
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`Lannett admits that Lannett Holdings, Inc. is a corporation organized and existing
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`under the laws of the State of Delaware. Any remaining allegations in paragraph 5 are
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`conclusions of law for which no response is required. To the extent a response is required,
`
`Lannett denies any and all other allegations in paragraph 5.
`
`6.
`
`Lannett admits that Lannett Company, Inc. is a corporation organized and existing
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`under the laws of the State of Delaware. Any remaining allegations in paragraph 6 are
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`conclusions of law for which no response is required. To the extent a response is required,
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`Lannett denies any and all other allegations in paragraph 6.
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`7.
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`Lannett admits that Lannett Holdings, Inc. is wholly owned subsidiary of Lannett
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`Company, Inc. Any remaining allegations in paragraph 7 are conclusions of law for which no
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`response is required. To the extent a response is required, Lannett denies any and all other
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`allegations in paragraph 7.
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`8.
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`Lannett admits that Lannett Company, Inc. is involved in the manufacture and/or
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`sale of various pharmaceutical products, with business activities in several states, including in
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`the State of Delaware. Any and all remaining allegations in paragraph 8 are denied.
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`NATURE OF THE ACTION
`
`9.
`
`Lannett admits that this purports to be an action alleging infringement of U.S.
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`Patent Nos. 6,750,237 (“the ’237 patent”) and 7,220,767 (“the ’767 patent”). Lannett further
`
`admits that Lannett Holdings, Inc. submitted Abbreviated New Drug Application No. 206350
`
`seeking approval to market Lannett’s Zolmitriptan Nasal Spray, 5mg/spray (“the Lannett
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`product”) prior to the expiration of the ’237 and ’767 patents. Lannett denies the remaining
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`allegations of paragraph 9.
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`2
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`Page 2 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 3 of 15 PageID #: 45
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`JURISDICTION AND VENUE
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`10.
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`Lannett admits that paragraph 10 of the complaint invokes the subject matter
`
`jurisdiction of this Court based on 28 U.S.C. §§ 1331 - 1338(a), 2201 and 2202. Lannett lacks
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`knowledge or information sufficient to form a belief as to whether the Court has subject matter
`
`jurisdiction and therefore denies the allegations in paragraph 10.
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`11.
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`Lannett admits that this Court has personal jurisdiction for purposes of this action
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`only.
`
`12.
`
`13.
`
`14.
`
`Admitted.
`
`Admitted.
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`The allegations in paragraph 14 are conclusions of law for which no response is
`
`required. To the extent a response is required, Lannett denies any and all other allegations in
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`paragraph 14.
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`15.
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`Lannett admits that Lannett Holdings, Inc. and Lannett Company, Inc. have
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`certain individuals who are officers in both Lannett Holdings, Inc. and Lannett Company, Inc.
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`To the extent the remaining allegations in paragraph 15 are understood, they are denied and/or
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`are conclusions of law for which no response is required.
`
`16.
`
`17.
`
`18.
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`Denied.
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`Denied.
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`Lannett admits that Lannett Holdings, Inc. is a wholly owned subsidiary of
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`Lannett Company, Inc. Lannett admits that Lannett Company, Inc. markets, sells, and/or
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`distributes pharmaceutical products in Delaware. Any and all remaining allegations in
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`paragraph 18 are denied.
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`19.
`
`Admitted.
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`3
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`Page 3 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 4 of 15 PageID #: 46
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`20.
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`The allegations in paragraph 20 are conclusions of law for which no response is
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`required. To the extent a response is required, Lannett denies any and all other allegations in
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`paragraph 20.
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`21.
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`Lannett admits that if and when products are manufactured and sold as a result of
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`FDA approval of Lannett’s ANDA, it is possible that Delaware might be a destination for such
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`products. Any and all remaining allegations in paragraph 21 are denied.
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`22.
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`The allegations in paragraph 22 are conclusions of law for which no response is
`
`required. To the extent a response is required, Lannett denies any and all other allegations in
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`paragraph 22.
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`23.
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`Lannett admits that venue is proper in this District for purposes of this action
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`only.
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`
`
` A.
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`24.
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`FACTUAL BACKGROUND
`
`Zomig
`
`Lannett admits that New Drug Application (“NDA”) No. 021450 is for the
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`manufacture and sale of zolmitriptan nasal spray, 5 mg/spray and that such spray has been used
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`for the acute treatment of migraine with or without aura in adults. Lannett lacks knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations in paragraph
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`24, and therefore denies these allegations.
`
`B.
`
`The ’237 Patent
`
`25.
`
`Lannett admits that the ‘237 patent contains claims directed to a pharmaceutical
`
`formulation containing zolmitriptan. Lannett admits that a copy purporting to be the ’237 patent
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`was attached to the Complaint as Exhibit A. Lannett admits that the “Orange Book: Approved
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`4
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`Page 4 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 5 of 15 PageID #: 47
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`Drug Products With Therapeutic Equivalence Evaluations” published by the FDA (the “Orange
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`Book”) stated that NDA No. 021450 applicant was “AstraZeneca AB.” Lannett denies that the
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`‘237 patent was duly and legally issued. Lannett lacks knowledge or information sufficient to
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`form a belief as to the truth of the remaining allegations in paragraph 25, and therefore denies
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`these allegations.
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`26.
`
`Lannett lacks knowledge or information sufficient to form a belief as to the truth
`
`of the allegations in paragraph 26, and therefore denies these allegations.
`
`C.
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`The ’767 Patent
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`27.
`
`Lannett admits that the ‘767 patent contains claims directed to a pharmaceutical
`
`formulation containing zolmitriptan. Lannett admits that a copy purporting to be the ’767 patent
`
`was attached to the Complaint as Exhibit B. Lannett admits that the “Orange Book: Approved
`
`Drug Products With Therapeutic Equivalence Evaluations” published by the FDA (the “Orange
`
`Book”) stated that NDA No. 021450 applicant was “AstraZeneca AB.” Lannett denies that the
`
`‘767 patent was duly and legally issued. Lannett lacks knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations in paragraph 27, and therefore denies
`
`these allegations.
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`28.
`
`Lannett lacks knowledge or information sufficient to form a belief as to the truth
`
`of the allegations in paragraph 28, and therefore denies these allegations.
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`
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`
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`D.
`
`Lannett’s ANDA No. 206350
`
`29.
`
`Lannett admits that Lannett Holdings, Inc. submitted Abbreviated New Drug
`
`Application No. 206350 seeking approval to market Lannett’s Zolmitriptan Nasal Spray,
`
`5mg/spray (“the Lannett product”). Any and all remaining allegations in paragraph 29 are
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`denied.
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`
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`5
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`Page 5 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 6 of 15 PageID #: 48
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`
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`30.
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`31.
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`32.
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`Admitted.
`
`Admitted.
`
`Lannett admits that Plaintiffs filed a complaint within 45 days of Lannett’s Notice
`
`Letter, but lacks knowledge or information sufficient to form a belief as to whether the suit was
`
`properly commenced within 45 days of receiving Lannett’s Notice and therefore deny same.
`
`COUNT I
`(INFRINGEMENT OF U.S. PATENT NO. 6,750,237 B1)
`
`33.
`
`Lannett restates its answers to the allegations in paragraphs 1-32 and incorporates
`
`by reference its responses as if fully set forth herein.
`
`34.
`
`Lannett admits that Lannett Holdings, Inc. submitted Abbreviated New Drug
`
`Application No. 206350 seeking approval to market the Lannett product prior to the expiration of
`
`the ’237 patent. Lannett admits that Lannett Holdings, Inc. filed with the FDA, pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4), a certification alleging
`
`that the claims of the ’237 patent are invalid. Any and all remaining allegations in paragraph 34
`
`are denied.
`
`35.
`
`Lannett admits that in ANDA No. 206350, Lannett Holdings, Inc. has stated that
`
`the Lannett Product is pharmaceutically and therapeutically equivalent to the product which is
`
`the subject of NDA No. 021450. Any and all remaining allegations in paragraph 34 are denied.
`
`36.
`
`Paragraph 36 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 36.
`
`37.
`
`Paragraph 37 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 37.
`
`38.
`
`Paragraph 38 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 38.
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`6
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`Page 6 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 7 of 15 PageID #: 49
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`
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`39.
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`Paragraph 39 contains conclusions of law for which no response is required. To
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`the extent a response is required, Lannett denies any and all allegations in paragraph 39.
`
`40.
`
`Paragraph 40 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 40.
`
`COUNT II
`(INFRINGEMENT OF U.S. PATENT NO. 7,220,767 B2)
`
`41.
`
`Lannett restates its answers to the allegations in paragraphs 1-40 and incorporates
`
`by reference its responses as if fully set forth herein.
`
`42.
`
`Lannett admits that Lannett Holdings, Inc. submitted Abbreviated New Drug
`
`Application No. 206350 seeking approval to market the Lannett product prior to the expiration of
`
`the ’767 patent. Lannett admits that Lannett Holdings, Inc. filed with the FDA, pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4), a certification alleging
`
`that the claims of the ’767 patent are invalid. Any and all remaining allegations in paragraph 42
`
`are denied.
`
`43.
`
`Lannett admits that in ANDA No. 206350, Lannett Holdings, Inc. has stated that
`
`the Lannett Product is pharmaceutically and therapeutically equivalent to the product which is
`
`the subject of NDA No. 021450. Any and all remaining allegations in paragraph 43 are denied.
`
`44.
`
`Paragraph 44 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 44.
`
`45.
`
`Paragraph 45 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 45.
`
`46.
`
`Paragraph 46 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 46.
`
`
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`7
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`Page 7 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 8 of 15 PageID #: 50
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`47.
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`Paragraph 47 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 47.
`
`
`
` 48.
`
`Paragraph 48 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 48.
`
`COUNT III
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF U.S. PATENT NO. 6,750,237 B1)
`
`49.
`
`Lannett restates its answers to the allegations in paragraphs 1-48 and incorporates
`
`by reference its responses as if fully set forth herein.
`
`50.
`
`Paragraph 50 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 50.
`
`51.
`
`52.
`
`53.
`
`Denied.
`
`Denied.
`
`Paragraph 53 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 53.
`
`COUNT IV
`(DECLARATORY JUDGMENT OF INFRINGEMENT OF U.S. PATENT NO. 7,200,767 B2)
`
`54.
`
`Lannett restates its answers to the allegations in paragraphs 1-53 and incorporates
`
`by reference its responses as if fully set forth herein.
`
`55.
`
`Paragraph 55 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 55.
`
`56.
`
`57.
`
`58.
`
`Denied.
`
`Denied.
`
`Paragraph 58 contains conclusions of law for which no response is required. To
`
`the extent a response is required, Lannett denies any and all allegations in paragraph 58.
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`
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`8
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`Page 8 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 9 of 15 PageID #: 51
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`
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`LANNETT’S AFFIRMATIVE DEFENSES
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`Lannett, without prejudice to the denials set forth in its Answer, alleges the
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`following defenses to Plaintiffs’ Complaint. Lannett reserves its right to assert additional
`
`defenses as it learns more information through discovery.
`
`First Affirmative Defense
`
`1.
`
`Lannett has not and will not infringe, directly or indirectly, whether literally or
`
`under the doctrine of equivalents, any valid claim of the ’237 and ‘767 patents by making,
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`using, selling, offering for sale, or importing into the United States the Lannett Product, nor do
`
`Lannett’s activities relating to the filing of the Lannett ANDA result in infringement of any
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`valid claim of the ’237 and ’767 patents.
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`Second Affirmative Defense
`
`
`
`2.
`
`Each claim of the ’237 and ‘767 patent is invalid for failure to comply with one
`
`or more of the statutory provisions of 35 U.S.C. §§ 101, et seq., including, but not limited to,
`
`§§ 101, 102, 103, and/or 112.
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`Third Affirmative Defense
`
`
`
`
`
`3.
`
`Plaintiffs’ Complaint fails to state a claim upon which relief may be granted.
`
`Fourth Affirmative Defense
`
`4.
`
`This Court lacks subject matter jurisdiction over Plaintiffs’ patent infringement
`
`claims.
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`Fifth Affirmative Defense
`
`5.
`
`Lannett Company, Inc. is not a proper party to this action.
`
`9
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`Page 9 of 15
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`

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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 10 of 15 PageID #: 52
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`
`COUNTERCLAIMS
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`As separate and independent Counterclaims against Plaintiffs, Lannett alleges as
`
`
`follows:
`
`
`
`1.
`
`The Parties
`
`Lannett Holdings, Inc. is a corporation organized and existing under the laws of
`
`the State of Delaware having a place of business at 103 Foulk Road, Suite 202, Wilmington,
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`DE 19803.
`
`
`
`2.
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`Lannett Company, Inc. is a corporation organized and existing under the laws
`
`of the State of Delaware having a place of business at 13200 Townsend Road, Philadelphia,
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`PA 19154.
`
`
`
`3.
`
`Upon
`
`information
`
`and belief, Plaintiff/Counterclaim-Defendant
`
`Impax
`
`Laboratories, Inc. is a Delaware corporation with its headquarters at 30831 Huntwood Avenue,
`
`Hayward, CA 94544. (Complaint, paragraph 1).
`
`
`
`4.
`
`Upon
`
`information and belief, Plaintiff/Counterclaim-Defendant
`
`Impax
`
`Pharmaceuticals, is the branded products division of Impax Laboratories, Inc. (Complaint,
`
`paragraph 2).
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`
`
`5.
`
`Upon information and belief, Plaintiff/Counterclaim-Defendant AstraZeneca AB
`
`is a Swedish corporation having its principal place of business at Karlebyhus, Astraallén,
`
`Södertälje, SE-151 85, Sweden. (Complaint, paragraph 3).
`
`
`
`6.
`
`Upon information and belief, Plaintiff/Counterclaim-Defendant AstraZeneca
`
`UK Limited is an English corporation having its headquarters at 2 Kingdom Street, Paddington,
`
`London, W2 6BD, England. (Complaint, paragraph 4).
`
`Jurisdiction and Venue
`
`
`
`10
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`Page 10 of 15
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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 11 of 15 PageID #: 53
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`7.
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`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, based on an
`
`actual controversy between Lannett and Plaintiffs/Counterclaim-Defendants.
`
`
`
`8.
`
`This Court has original jurisdiction over the subject matter of these
`
`Counterclaims at least under 28 U.S.C. §§ 1331, 1338(a), and 1367, 35 U.S.C. § 271(e)(5), and
`
`21 U.S.C. § 355(j)(5)(C).
`
`9.
`
`This Court has personal jurisdiction over Plaintiffs/Counterclaim-Defendants at
`
`least because Plaintiffs/Counterclaim-Defendants have subjected themselves to the jurisdiction
`
`of this Court.
`
`
`
`10.
`
`Upon information and belief, Plaintiff/Counterclaim-defendant AstraZeneca
`
`AB has at least a partial ownership interest in each of the ‘237 and 767 patents.
`
`
`
`11.
`
`The current “Orange Book: Approved Drug Products With Therapeutic
`
`Equivalence Evaluations” published by the FDA (the “Orange Book”) states that the New Drug
`
`Application (“NDA”) applicant for zolmitriptan nasal spray is “AstraZeneca AB” and that the
`
`NDA Number is 021450. The Patent and Exclusivity Information provided by the Orange Book
`
`lists the ‘237 and the ‘767 patents.
`
`
`
`12.
`
`Lannett filed Abbreviated New Drug Application No. 206350 (“the Lannett
`
`ANDA”) to the FDA seeking approval to market zolmitriptan nasal spray prior to the expiration
`
`of the Orange Book listed ’237 and ’767 patents. The Lannett ANDA includes a certification
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) for the ’237 and ’767 patents.
`
`
`
`13.
`
`On or about June 13, 2014, Lannett sent a
`
`letter,
`
`inter alia,
`
`to
`
`Plaintiffs/Counterclaim-Defendant AstraZeneca AB pursuant to 21 U.S.C. § 255(j)(2)(B)(i)
`
`and/or (ii), informing Plaintiffs/Counterclaim-Defendants of Lannett’s ANDA certification that
`
`
`
`11
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`Page 11 of 15
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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 12 of 15 PageID #: 54
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`if it were to manufacture, use, sell, offer to sell, and/or import into the United States the Lannett
`
`Product, such acts would not infringe any valid or enforceable claim of the Orange Book-listed
`
`’237 and ’767 patents. Lannett attached to its letter a detailed statement of factual and legal
`
`bases which support Lannett’s certifications for the ’237 and ’767 patents.
`
`
`
`14. Within forty-five days of receiving Lanett’s letter, Plaintiffs/Counterclaim-
`
`defendants filed the Complaint against Lannett. Plaintiffs/Counterclaim-Defendants allege that
`
`a sale, offer for sale, use, or commercial manufacture of Lannett’s Product during the terms of
`
`the ’237 and ’767 patents would infringe those patents.
`
`
`
`15. Plaintiffs/Counterclaim-Defendants further allege that the submission of the
`
`Lannett ANDA constitutes infringement.
`
`FIRST COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of the ’237 Patent)
`
`
`
`
`
`16. Lannett restates paragraphs 1-15 of these Counterclaims as if set forth fully herein.
`
`17. Plaintiffs/Counterclaim-Defendants have alleged that Lannett has infringed
`
`and/or will infringe the ’237 patent, and Lannett has denied these allegations.
`
`
`
`18. As evidenced by Plaintiffs/Counterclaim-Defendants’ Complaint and Lannett’s
`
`Answer and Affirmative Defenses thereto, there is an actual, substantial, and continuing
`
`justiciable case or controversy between the parties regarding infringement of the ’237 patent.
`
`
`
`19. The filing of the Lannett ANDA, the proposed activities of Lannett under the
`
`ANDA, and the Lannett products have not, and would not, directly or indirectly infringe any
`
`valid and enforceable claim of the ’237 patent, either literally or under the doctrine of
`
`equivalents.
`
`
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`20. Lannett is entitled to a judicial determination that the filing of the Lannett
`
`ANDA, the proposed activities under the Lannett ANDA, and the Lannett products do not and
`
`
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`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 13 of 15 PageID #: 55
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`will not result in infringement of any valid claim of the ’237 patent, directly or indirectly, either
`
`literally or under the doctrine of equivalents.
`
`SECOND COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of the ’767 Patent)
`
`
`
`
`
`21. Lannett restates paragraphs 1-20 of these Counterclaims as if set forth fully herein.
`
`22. Plaintiffs/Counterclaim-Defendants have alleged that Lannett has infringed
`
`and/or will infringe the ’767 patent, and Lannett has denied these allegations.
`
`
`
`23. As evidenced by Plaintiffs/Counterclaim-Defendants’ Complaint and Lannett’s
`
`Answer and Affirmative Defenses thereto, there is an actual, substantial, and continuing
`
`justiciable case or controversy between the parties regarding infringement of the ’767 patent.
`
`
`
`24. The filing of the Lannett ANDA, the proposed activities of Lannett under the
`
`ANDA, and the Lannett products have not, and would not, directly or indirectly infringe any
`
`valid and enforceable claim of the ’767 patent, either literally or under the doctrine of
`
`equivalents.
`
`
`
`25. Lannett is entitled to a judicial determination that the filing of the Lannett
`
`ANDA, the proposed activities under the Lannett ANDA, and the Lannett products do not and
`
`will not result in infringement of any valid claim of the ’767 patent, directly or indirectly,
`
`either literally or under the doctrine of equivalents.
`
`THIRD COUNTERCLAIM
`(Declaratory Judgment of Invalidity of the ’237 Patent)
`
`
`
`26. Lannett restates paragraphs 1-25 of these Counterclaims as if set forth fully
`
`herein.
`
`
`
`27. As evidenced by Plaintiffs/Counterclaim-Defendants’ Complaint and Lannett’s
`
`Answer and Affirmative Defenses thereto, there is an actual, substantial, and continuing
`
`
`
`13
`
`Page 13 of 15
`
`

`
`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 14 of 15 PageID #: 56
`
`
`justiciable case or controversy between the parties regarding the validity of the claims of the
`
`’237 patent.
`
`
`
`28. One or more of the claims of the ’237 patent are invalid for failure to comply
`
`with one or more of the statutory provisions of 35 U.S.C. §§ 101 et seq., including §§ 102, 103,
`
`and 112.
`
`
`
`29. Lannett is entitled to a judicial determination that one or more of the claims of
`
`the ’237 patent are invalid for failure to comply with one or more of the statutory provisions of
`
`35 U.S.C. §§ 101 et seq., including §§ 102, 103, and 112.
`
`FOURTH COUNTERCLAIM
`(Declaratory Judgment of Invalidity of the ’767 Patent)
`
`
`
`30. Lannett restates paragraphs 1-29 of these Counterclaims as if set forth fully
`
`herein.
`
`
`
`31. As evidenced by Plaintiffs/Counterclaim-Defendants’ Complaint and Lannett’s
`
`Answer and Affirmative Defenses thereto, there is an actual, substantial, and continuing
`
`justiciable case or controversy between the parties regarding the validity of the claims of the
`
`’767 patent.
`
`
`
`32. One or more of the claims of the ’767 patent are invalid for failure to comply
`
`with one or more of the statutory provisions of 35 U.S.C. §§ 101 et seq., including §§ 102, 103,
`
`and 112.
`
`
`
`33. Lannett is entitled to a judicial determination that one or more of the claims of
`
`the ’767 patent are invalid for failure to comply with one or more of the statutory provisions of
`
`35 U.S.C. §§ 101 et seq., including §§ 102, 103, and 112.
`
`14
`
`
`
`
`
`Page 14 of 15
`
`

`
`Case 1:14-cv-00999-RGA Document 11 Filed 09/24/14 Page 15 of 15 PageID #: 57
`
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Lannett respectfully requests that this Court enter judgment:
`
`Dismissing Plaintiffs’ Complaint with prejudice;
`
`Denying Plaintiffs’ requested relief;
`
`Finding, declaring, and adjudging that Lannett has not and would not infringe any
`
`A.
`
`B.
`
`C.
`
`valid and enforceable claim of the ’237 and ’767 patents;
`
`D.
`
`Finding, declaring, and adjudging that one or more claims of the ’237 and ’767 patents
`
`are invalid;
`
`E.
`
`F.
`
`Awarding Lannett its reasonable costs;
`
`Finding this to be an exceptional case under 35 U.S.C. § 285 and awarding Lannett its
`
`reasonable attorneys’ fees and expenses incurred in this action; and
`
`G.
`
`Granting such other and further relief as this Court may deem just and proper.
`
`Respectfully submitted,
`
`
`
`FOX ROTHSCHILD LLP
`
`
`
`
`
`
` /s/ Austen C. Endersby
`Seth A. Niederman, Esquire (#4588)
`Austen C. Endersby, Esquire (#5161)
`Citizens Bank Center
`919 North Market Street, Suite 300
`Wilmington, DE 19801
`(302) 654-7444
`sniederman@foxrothschild.com
`aendersby@foxrothschild.com
`
`Attorneys for Defendants Lannett Holdings,
`Inc. and Lannett Company, Inc.
`
`
`
`
`
`Of Counsel:
`Joseph F. Posillico, Esq.
`FOX ROTHSCHILD LLP
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103-3222
`(215) 299-2000
`
`
`
`Dated: September 24, 2014
`
`
`
`
`
`15
`
`Page 15 of 15

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