Case 1:14-cv-02758-PAC Document 170 Filed 10/10/17 Page 1 of 4
`Case 1:14-cv-02758—PAC Document 170 Filed 10/10/17 Page 1 of 4
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
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`
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`Kowa Company, Ltd, et 211.,
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`Plaintiffs,
`
`V'
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`Amneat Pharmaceuticals, LLC,
`
`
`
`
`
`
`Defendant.
`
`
`Kowa Company, Ltd., et a1.,
`
`
`Plaintiffs,
`
`V'
`
`Civil Action No. 14-CV—2758 (PAC)
`
`Civil Action No. 14—CV-7934 (PAC)
`
`Apotex, fine, et 31.,
`
`
`
`
`Defendants.
`
`{PROPOSED} FINAL JUDGMENT
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`
`
`
`Case 1:14-cv-02758—PAC Document 170 Filed 10/10/17 Page 1 of 4
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`
`
`Kowa Company, Ltd, et 211.,
`
`Plaintiffs,
`
`V'
`
`Amneat Pharmaceuticals, LLC,
`
`
`
`
`
`
`Defendant.
`
`
`Kowa Company, Ltd., et a1.,
`
`
`Plaintiffs,
`
`V'
`
`Civil Action No. 14-CV—2758 (PAC)
`
`Civil Action No. 14—CV-7934 (PAC)
`
`Apotex, fine, et 31.,
`
`
`
`
`Defendants.
`
`{PROPOSED} FINAL JUDGMENT
`
`
`
`
`
`Case 1:14-cv-02758-PAC Document 170 Filed 10/10/17 Page 2 of 4
`Case 1:14-cv-02758-PAC Document 170 Filed 10/10/17 Page 2 of 4
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`This matter having come on for triai on the merits before the undersigned Hon. Paul A.
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`Crotty (without a jury), and having been tried to conclusion between January 17, 2017 and
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`January 30, 2017, with closing arguments held on February 3, 2017, and upon alt of the prior
`
`pleadings and proceedings herein, and upon and in accordance with the Court’s Findings of Fact
`
`and Conclusions of Law dated April It, 2017 and September 19, 2017, it is hereby ORDERED,
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`ADJUDGED and DECRBED as foliows:
`
`1.
`
`Defendant Amneai Pharmaceuticals, LLC (“Amneai”) has failed to meet its
`
`burden of proving that U.S. Patent No. 5,856,336 (“the ‘336 patent”) is invalid. The ‘336 patent
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`is valid. All affirmative defenses and counterclaims asserted by Amneal with respect to the ‘336
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`patent are hereby dismissed on the merits and with prejudice.
`
`2.
`
`Amneal admitted infringement of claims 1 and 2 of the ‘336 patent in this action.
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`Amneal infringed claims 1 and 2 of the ‘336 patent by filing Abbreviated New Drug Application
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`(“ANDA”) No. 206961 with the Food and Drug Administration (“FDA”) including a
`
`certification under § 5050)(2)(A)(vii)(iV) of the Federal Food, Drug and Cosmetic Act (21
`
`U.S.C. § 355). Amneal would further infringe claims 1 and 2 of the ‘336 patent by making,
`
`using, offering to sell, or selling within the United States or by importing into the United States
`
`pitavastatin calcium tablets as described in ANDA No. 20—5961.
`
`3.
`
`Amneai has failed to meet its burden of proving that US. Patent No. 8,557,993
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`(“the ‘993 patent”) is invaiid, The ‘993 patent is valid. All affirmative defenses and
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`counterciaims asserted by Amneal with respect to the ‘993 patent are hereby dismissed 0n the
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`merits and with prejudice.
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`4.
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`Amneai admitted infringement of claims 1, 22, 23, 24, and 25 of the ‘993 patent
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`in this action. Amneal infringed claims 1, 22, 23, 24, and 25 ofthe ‘993 patent by filing ANDA
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`
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`Case 1:14-cv-02758-PAC Document 170 Filed 10/10/17 Page 3 of 4
`Case 1:14-cv-02758—PAC Document 170 Filed 10/10/17 Page 3 of 4
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`No. 20—5961 with the FDA including a certification under § 505(j)(2)(A)(vii)(IV) of the Federal
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`Food, Drug and Cosmetic Act (21 U.S.C. § 355). Amneai would further infringe claims 1, 22,
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`23, 24, and 25 of the ‘993 patent by making, using, offering to sell, or selling within the United
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`States or by importing into the United States pitavastatin calcium tablets as desoribed in ANDA
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`No. 20—5961.
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`5.
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`Amneal, its officers, agents and employees, and all persons acting (directly or
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`indirectly) in privity or concert with them, are permanently enjoined pursuant to 35 [18.0 §
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`27t(e)(4)(B) frorn making, using, offering to selt or seliing within the United States and from
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`importing into the United States the pitavastatin calcium product as described in ANDA No. 20-
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`5961 until after February 2, 2024, the expiration of the ‘993 patent, as that date may be extended
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`pursuant to law.
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`6.
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`Pursuant to 35 U.S.C. § 27t(e)(4)(A), the effective date of any approval of
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`Amneal’s ANDA No. 20—5961, or amendments thereof, shall be a date which is not earlier than
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`February 2, 2024, after the expiration date of the ‘993 patent, as that date may be extended
`
`pursuant to iaw.
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`7.
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`Defendants Apotex, Inc. and Apotex Corp. (collectively, “Apotex”) have failed to
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`meet their burden of proving that US. Patent No. 8,557,993 is invalid. The ‘993 patent is valid.
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`All affirmative defenses and counterclaims asserted by Apotex with respect to the ‘993 patent are
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`hereby dismissed on the merits and with prejudice.
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`8.
`
`Apotex infringed the ‘993 patent by filing Abbreviated New Drug Application
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`(“ANDA”) No. 20—6068 with the Food and Drug Administration (“FDA”) including a
`
`certification under § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act (21
`
`U.S.C. § 355). Apotex would further infringe claims 1, 22, 23, 24, and 25 of the ‘993 patent by
`
`
`
`Case 1:14-cv-02758-PAC Document 170 Filed 10/10/17 Page 4 of 4
`Case 1:14-cv-02758—PAC Document 170 Filed 10/10/17 Page 4 of 4
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`making, using, offering to sell, or selling within the United States or by importing into the United
`
`States pitavastatin calcium tablets as described in ANDA No. 20—6068.
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`9.
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`Apotex, its officers, agents and employees, and all persons acting (directly or
`
`indirectly) in privity or concert with them, are permanently enjoined pursuant to 35 U.S.C. §
`
`27l(e)(4)(B) from making, using, offering to sell or selling within the United States and from
`
`importing into the United States the pitavastatin calcium product as described in ANDA No. 20»
`
`6068 until after February 2, 2024, the expiration of the ‘993 patent, as that date may be extended
`
`pursuant to law.
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`10.
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`Pursuant to 35 USC. § 27l(e)(4)(A), the effective date of any approval of
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`Apotex’s ANDA No. 20-6068, or amendments thereof, shall he a date which is not earlier than
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`February 2, 2024, after the expiration date of the ‘993 patent, as that date may be extended
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`pursuant to law.
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`11.
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`Plaintiffs Kowa Company, Ltd, Kowa Pharmaceuticals America, inc, and Nissan
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`Chemical Industries, Ltd. (collectively “Plaintiffs”) have requested that the Court award their
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`reasonable attorney fees pursuant to 35 USC. § 285. Plaintiffs may file a motion requesting
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`such additional relief within 21 days of the date hereof, with a briefing schedule to be set by the
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`Court.
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`Dated: New York, New York
`October£1» 2017
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`SQ ORDERED
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`
`' PAUL A. CROT’i Y
`United States District Judge
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`
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