throbber
Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 1 of 23 PageID #: 1
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 1 of 23 Page|D #: 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`) ) ) ) )
`
`INO THERAPEUTICS LLC and IKARIA,
`
`INC.,
`
`Plaintiffs,
`
`V.
`
`) C.A. No.
`
`) ) ) )
`
`)
`
`PRAXAIR DISTRIBUTION, INC. and
`
`PRAXAIR, INC.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs INO Therapeutics LLC (hereinafter “INOT”), and Ikaria,
`
`Inc.
`
`(hereinafter
`
`“Ikaria”) (collectively, “Plaintiffs”) for their Complaint against defendants Praxair Distribution,
`
`Inc. and Praxair, Inc. (collectively “Praxair” or “Defendants”), hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff INOT is a wholly-owned subsidiary of Ikaria and is a limited
`
`liability company organized and existing under the laws of the State of Delaware, having its
`
`principal place of business at Perryville III Corporate Park, P. O. Box 9001, 53 Frontage Road,
`
`Third Floor, Hampton, New Jersey 08827-9001.
`
`2.
`
`Plaintiff Ikaria is a corporation organized and existing under the laws of
`
`the State of Delaware, having its principal place of business at Perryville III Corporate Park, P.O.
`
`Box 9001, 53 Frontage Road, Third Floor, Hampton, New Jersey 08827-9001.
`
`3.
`
`Plaintiff Ikaria is a research-driven healthcare company that discovers,
`
`develops, manufactures and markets innovative products to address the needs of critically ill
`
`patients.
`
`

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`4.
`
`On information and belief, Praxair Distribution,
`
`Inc.
`
`is a corporation
`
`organized and existing under the laws of the State of Delaware, with its head office at 28
`
`McCandless Ave, Pittsburgh, Pennsylvania 15201.
`
`5.
`
`On information and belief, Praxair, Inc.
`
`is a corporation organized and
`
`existing under the laws of the State of Delaware, having its principal place of business at 39 Old
`
`Ridgebury Road, Danbury, Connecticut 06810.
`
`6.
`
`On information and belief, Praxair Distribution, Inc.
`
`is a wholly-owned
`
`subsidiary of Praxair, Inc.
`
`7.
`
`On information and belief, Praxair Distribution, Inc. assembled and caused
`
`to be filed with the United States Food and Drug Administration (“FDA”), pursuant to 21 U.S.C.
`
`§ 355(j) (Section 505(j) of the Federal Food, Drug and Cosmetic Act), Abbreviated New Drug
`
`Application (“ANDA”) No. 207141 (hereinafter “the Praxair ANDA”) concerning a proposed
`
`drug product, Noxivent, 100 ppm and 800 ppm nitric oxide for inhalation (“Praxair’s Proposed
`
`ANDA Product”).
`
`JURISDICTION AND VENUE
`
`8.
`
`This action arises under the patent laws of the United States of America.
`
`This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and
`
`1338(a).
`
`9.
`
`This Court has personal jurisdiction over Praxair Distribution, Inc. On
`
`information and belief, Praxair Distribution, Inc. is a corporation organized and existing under
`
`the laws of the State of Delaware. On information and belief, Praxair Distribution,
`
`Inc.
`
`maintains a corporate agent for service of process at 2711 Centerville Road, Suite 400,
`
`Wilmington, Delaware 19808.
`
`

`
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`10.
`
`This Court also has personal
`
`jurisdiction over Praxair,
`
`Inc.
`
`On
`
`information and belief, Praxair, Inc. is a corporation organized and existing under the laws of the
`
`State of Delaware. On information and belief, Praxair, Inc. maintains a corporate agent for
`
`service of process at 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808.
`
`11.
`
`Venue is proper in this Court at least pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`INOmax® (NITRIC OXIDE) FOR INHALATION
`
`12.
`
`INOT holds approved New Drug Application (“NDA”) No. N020845 for
`
`nitric oxide 100 and 800 ppm for inhalation to among other things treat neonates with pulmonary
`
`hypertension, and is prescribed and sold in the United States under the trademark lNOmax®.
`
`The U.S. Food and Drug Administration (“FDA”) approved NDA No. N020845 on December
`
`23, 1999.
`
`THE PATENTS-IN-SUIT
`
`13.
`
`United States Patent No. 8,282,966 (the “’966 patent,” copy attached as
`
`Exhibit A) is entitled “Methods of Reducing the Risk of Occurrence of Pulmonary Edema in
`
`Children in Need of Treatment with Inhaled Nitric Oxide” and was duly and legally issued by the
`
`United States Patent and Trademark Office (“USPTO”) on October 9, 2012. The ’966 patent is
`
`listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the
`
`“Orange Book”) for INOmax® (NDA No. N020845).
`
`14.
`
`15.
`
`The ’966 patent is owned by INOT.
`
`United States Patent No. 8,293,284 (the “’284 patent,” copy attached as
`
`Exhibit B) is entitled “Methods of Reducing the Risk of Occurrence of Pulmonary Edema in
`
`Term or Near-Term Neonates in Need of Treatment with Inhaled Nitric Oxide” and was duly and
`
`

`
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`legally issued by the USPTO on October 23, 2012. The ’284 patent is listed in the FDA’s
`
`Orange Book for INOmax ® (NDA No. NO20845).
`
`16.
`
`17.
`
`The ’284 patent is owned by INOT.
`
`United States Patent No. 8,431,163 (the “’163 patent,” copy attached as
`
`Exhibit C) is entitled “Methods of Reducing the Risk of Occurrence of Pulmonary Edema
`
`Associated with the Inhalation of Nitric Oxide Gas” and was duly and legally issued by the
`
`USPTO on April 30, 2013. The ’163 patent is listed in the FDA’s Orange Book for INOmax ®
`
`(NDA No. NO20845).
`
`18.
`
`19.
`
`The ’163 patent is owned by INOT.
`
`United States Patent No. 8,795,741 (the “’741 patent,” copy attached as
`
`Exhibit D) is entitled “Methods For Treating Patients Who Are Candidates For Inhaled Nitric
`
`Oxide Treatment” and was duly and legally issued by the USPTO on August 4, 2014. The ’741
`
`patent is listed in the FDA’s Orange Book for INOmax ® (NDA No. NO20845).
`
`20.
`
`21.
`
`The ’741 patent is owned by INOT.
`
`United States Patent No. 8,846,112 (the “’112 patent,” copy attached as
`
`Exhibit E) is entitled “Methods Of Distributing A Pharmaceutical Product Comprising Nitric
`
`Oxide Gas For Inhalation” and was duly and legally issued by the USPTO on September 30,
`
`2014. The ’112 patent is listed in the FDA’s Orange Book for INOmax ® (NDA No. NO20845).
`
`22.
`
`23.
`
`The ’112 patent is owned by INOT.
`
`United States Patent No. 8,291,904 (the “’904 patent,” copy attached as
`
`Exhibit F) is entitled “Gas Delivery Device And System” and was duly and legally issued by the
`
`USPTO on October 23, 2012. The ’904 patent is listed in the FDA’s Orange Book for INOmax ®
`
`(NDA No. NO20845).
`
`

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`24.
`
`25.
`
`The ’904 patent is owned by INOT.
`
`United States Patent No. 8,573,210 (the “’210 patent,” copy attached as
`
`Exhibit G) is entitled “Nitric Oxide Delivery Device” and was duly and legally issued by the
`
`USPTO on November 5, 2013. The ’210 patent is listed in the FDA’s Orange Book for INOmax
`
`® (NDA No. N020845).
`
`26.
`
`The ’2l0 patent is owned by INOT.
`
`27.
`
`United States Patent No. 8,573,209 (the “’209 patent,” copy attached as
`
`Exhibit H) is entitled “Gas Delivery Device And System” and was duly and legally issued by the
`
`USPTO on November 5, 2013. The ’209 patent is listed in the FDA’s Orange Book for INOmax
`
`® (NDA No. N020845).
`
`28.
`
`29.
`
`The ’209 patent is owned by INOT.
`
`United States Patent No. 8,776,794 (the “’794 patent,” copy attached as
`
`Exhibit 1) is entitled “Nitric Oxide Delivery Device” and was duly and legally issued by the
`
`USPTO on July 15, 2014. The ’794 patent is listed in the FDA’s Orange Book for INO1nax ®
`
`(NDA No. N020845).
`
`30.
`
`31.
`
`The ’794 patent is owned by INOT.
`
`United States Patent No. 8,776,795 (the “’795 patent,” copy attached as
`
`Exhibit J) is entitled “Gas Delivery Device and System” and was duly and legally issued by the
`
`USPTO on July 15, 2014. The ’795 patent is listed in the FDA’s Orange Book for INOmax ®
`
`(NDA No. N020845).
`
`32.
`
`The ’795 patent is owned by INOT.
`
`

`
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`33.
`
`On information and belief, Praxair Distribution, Inc. submitted the Praxair
`
`ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer for
`
`sale, sale, and/or importation of Praxair’s Proposed ANDA Product.
`
`34.
`
`On information and belief, the Praxair ANDA seeks FDA approval of
`
`Praxair’s Proposed ANDA Product having the same use as INOmax®, which use is covered by
`
`the patents in suit. The Praxair ANDA refers to and relies upon INOT’s NDA No. N020845 for
`
`INOmax®.
`
`35.
`
`On information and belief, Praxair Distribution, Inc. actively collaborated
`
`with Praxair, Inc. and/or participated in and/or directed activities related to the submission of the
`
`Praxair ANDA and the development of Praxair’s Proposed ANDA Product, was actively
`
`involved in preparing the ANDA, and/or intends to directly benefit from and has a financial stake
`
`in the approval of the ANDA. On information and belief, upon approval of the Praxair ANDA,
`
`Praxair Distribution, Inc. will be involved in the manufacture, distribution, and/or marketing of
`
`Praxair’s Proposed ANDA Product.
`
`36.
`
`On information and belief, Praxair, Inc. actively collaborated with Praxair
`
`Distribution, Inc. and/or participated in and/or directed activities related to the submission of the
`
`Praxair ANDA and the development of Praxair’s Proposed ANDA Product, was actively
`
`involved in preparing the ANDA, and/or intends to directly benefit from and has a financial stake
`
`in the approval of the ANDA. On information and belief, upon approval of the Praxair ANDA,
`
`Praxair, Inc. will be involved in the manufacture, distribution, and/or marketing of Praxair’s
`
`Proposed ANDA Product.
`
`37.
`
`By letter dated January 6, 2015 (the “January 6 Letter”), and pursuant to
`
`21 U.S.C. § 355(j)(2)(B)(ii), Praxair Distribution, Inc. notified Plaintiffs that it had submitted to
`
`

`
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`the FDA the Praxair ANDA, seeking approval to engage in the commercial manufacture, use, or
`
`sale of Praxair’s Proposed ANDA Product before the expiration of the ’966 patent, the ’284
`
`patent, the ’l63 patent, the ’741 patent, the ’ll2 patent, the ’904 patent, the ’2l0 patent, the ’209
`
`patent, the ’794 patent, and the ’795 patent. The January 6 Letter was received by Plaintiffs on
`
`January 8, 2015.
`
`38.
`
`In its January 6 Letter, Praxair Distribution, Inc. notified Plaintiffs, as part
`
`of the Praxair ANDA,
`
`it had filed a certification of the type described in 21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) with respect to the ’966 patent, the ’284
`
`patent, the ’l63 patent, the ’74l patent, the ’ll2 patent, the ’904 patent, the ’2l0 patent, the ’209
`
`patent, the ’794 patent, and the ’795 patent. On information and belief, Praxair Distribution, Inc.
`
`certified that, the ’966 patent, the ’284 patent, the ’l63 patent, the ’74l patent, the ’ll2 patent,
`
`the ’904 patent, the ’2l0 patent, the ’209 patent, the ’794 patent, and the ’795 patent are invalid,
`
`unenforceable and/or will not be infringed by the manufacture, use or sale of Praxair’s Proposed
`
`ANDA Product.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,282,966
`
`COUNT I
`
`39.
`
`Plaintiffs repeat and reallege paragraphs 1 through 38 above as if fully set
`
`forth herein.
`
`40.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 355(j) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’966 patent,
`
`Defendants committed an act of infringement of the ’966 patent under 35 U.S.C. § 27l(e)(2). On
`
`information and belief, Defendants were aware of the ’966 patent at the time the Praxair ANDA
`
`was submitted.
`
`

`
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`41.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’966
`
`patent, they would further infringe the ’966 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`42.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’966 patent. Plaintiffs do not have an adequate remedy at law.
`
`43.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(Vii)(IV) against the ’966 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,293,284
`
`COUNT II
`
`44.
`
`Plaintiffs repeat and reallege paragraphs 1 through 43 above as if fully set
`
`forth herein.
`
`45.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’284 patent,
`
`Defendants committed an act of infringement of the ’284 patent under 35 U.S.C. § 27l(e)(2). On
`
`information and belief, Defendants were aware of the ’284 patent at the time the Praxair ANDA
`
`was submitted.
`
`46.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’284
`
`patent, they would further infringe the ’284 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`

`
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`47.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’284 patent. Plaintiffs do not have an adequate remedy at law.
`
`48.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against the ’284 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,431,163
`
`COUNT III
`
`49.
`
`Plaintiffs repeat and reallege paragraphs 1 through 48 above as if fully set
`
`forth herein.
`
`50.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’163 patent,
`
`Defendants committed an act of infringement of the ’163 patent under 35 U.S.C. § 271(e)(2). On
`
`information and belief, Defendants were aware of the ’163 patent at the time the Praxair ANDA
`
`was submitted.
`
`51.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’l63
`
`patent, they would further infringe the ’163 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`52.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’163 patent. Plaintiffs do not have an adequate remedy at law.
`
`53.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against the ’ 163 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`

`
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`INFRINGEMENT OF U.S. PATENT NO. 8,795,741
`
`COUNT IV
`
`54.
`
`Plaintiffs repeat and reallege paragraphs 1 through 53 above as if fully set
`
`forth herein.
`
`55.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’741 patent,
`
`Defendants committed an act of infringement of the ’741 patent under 35 U.S.C. § 271(e)(2).
`
`56.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’741
`
`patent, they would further infringe the ’741 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`57.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’741 patent. Plaintiffs do not have an adequate remedy at law.
`
`58.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`35 5(j)(2)(A)(vii)(IV) against the ’741 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,846,112
`
`COUNT V
`
`59.
`
`Plaintiffs repeat and reallege paragraphs 1 through 58 above as if fully set
`
`forth herein.
`
`60.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`10
`
`

`
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`Proposed ANDA Product throughout the United States prior to the expiration of the ’ 1 l2 patent,
`
`Defendants committed an act of infringement of the ’1l2 patent under 35 U.S.C. § 271(c)(2).
`
`61.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’ll2
`
`patent, they would further infringe the ’ll2 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`62.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’l 12 patent. Plaintiffs do not have an adequate remedy at law.
`
`63.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(Vii)(IV) against the ’ll2 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF US. PATENT NO. 8,291,904
`
`COUNT VI
`
`64.
`
`Plaintiffs repeat and reallege paragraphs 1 through 63 above as if fully set
`
`forth herein.
`
`65.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 35 50) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’904 patent,
`
`Defendants committed an act of infringement of the ’904 patent under 35 U.S.C. § 27l(e)(2). On
`
`information and belief, Defendants were aware of the ’904 patent at the time the Praxair ANDA
`
`was submitted.
`
`66.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`11
`
`

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`into the United States, or induce or contribute to any such conduct during the term of the ’904
`
`patent, they would further infringe the ’904 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`67.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’904 patent. Plaintiffs do not have an adequate remedy at law.
`
`68.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against
`
`the ’904 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,573,210
`
`COUNT VII
`
`69.
`
`Plaintiffs repeat and reallege paragraphs 1 through 68 above as if fully set
`
`forth herein.
`
`70.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’2l0 patent,
`
`Defendants committed an act of infringement of the ’2l0 patent under 35 U.S.C. § 27l(e)(2). On
`
`information and belief, Defendants were aware of the ’2l0 patent at the time the Praxair ANDA
`
`was submitted.
`
`71.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’2l0
`
`patent, they would further infringe the ’2l0 patent under 35 U.S.C. §§ 27l(a), (b), and/or (c).
`
`72.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’210 patent. Plaintiffs do not have an adequate remedy at law.
`
`12
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 13 of 23 PageID #: 13
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 13 of 23 Page|D #: 13
`
`73.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against
`
`the ’210 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,573,209
`
`COUNT VIII
`
`74.
`
`Plaintiffs repeat and reallege paragraphs 1 through 73 above as if fully set
`
`forth herein.
`
`75.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’209 patent,
`
`Defendants committed an act of infringement of the ’209 patent under 35 U.S.C. § 271(e)(2). On
`
`information and belief, Defendants were aware of the ’209 patent at the time the Praxair ANDA
`
`was submitted.
`
`76.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’209
`
`patent, they would further infringe the ’209 patent under 35 U.S.C. §§ 271(a), (b), and/or (C).
`
`77.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’209 patent. Plaintiffs do not have an adequate remedy at law.
`
`78.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against the ’209 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`13
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 14 of 23 PageID #: 14
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 14 of 23 Page|D #: 14
`
`INFRINGEMENT OF U.S. PATENT NO. 8,776,794
`
`COUNT IX
`
`79.
`
`Plaintiffs repeat and reallege paragraphs 1 through 78 above as if fully set
`
`forth herein.
`
`80.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 355 (j) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’794 patent,
`
`Defendants committed an act of infringement of the ’794 patent under 35 U.S.C. § 271(e)(2).
`
`81.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’794
`
`patent, they would further infringe the ’794 patent under 35 U.S.C. §§ 27l(a), (b), and/or (0).
`
`82.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’794 patent. Plaintiffs do not have an adequate remedy at law.
`
`83.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against
`
`the ’794 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,776,795
`
`COUNT X
`
`84.
`
`Plaintiffs repeat and reallege paragraphs 1 through 83 above as if fully set
`
`forth herein.
`
`85.
`
`By submitting the Praxair ANDA under 21 U.S.C. § 3550) for the purpose
`
`of obtaining approval
`
`to engage in the commercial manufacture, use or sale of Praxair’s
`
`l4
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 15 of 23 PageID #: 15
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 15 of 23 Page|D #: 15
`
`Proposed ANDA Product throughout the United States prior to the expiration of the ’795 patent,
`
`Defendants committed an act of infringement of the ’795 patent under 35 U.S.C. § 271(e)(2).
`
`86.
`
`If Defendants commercially make, use, offer to sell, or sell Praxair’s
`
`Proposed ANDA Product within the United States, or import Praxair’s Proposed ANDA Product
`
`into the United States, or induce or contribute to any such conduct during the term of the ’795
`
`patent, they would further infringe the ’795 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
`
`87.
`
`Plaintiffs will be irreparably harmed if Defendants are not enjoined from
`
`infringing the ’795 patent. Plaintiffs do not have an adequate remedy at law.
`
`88.
`
`Praxair Distribution,
`
`Inc.’s
`
`certification
`
`under
`
`21 U.S.C.
`
`§
`
`355(j)(2)(A)(vii)(IV) against the ’795 patent was wholly unjustified, and thus this case is
`
`exceptional under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`A judgment that Defendants have infringed one or more claims of the ’966
`
`patent by filing ANDA No. 207141 relating to Praxair’s Proposed ANDA Product before the
`
`expiration of the ’966 patent;
`
`B.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for
`
`sale,
`
`sale and/or
`
`importation of Praxair’s Proposed ANDA Product will infringe the ’966 patent;
`
`C.
`
`A permanent injunction restraining and enjoining Defendants, and their
`
`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
`
`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
`
`importation into the United States, of Praxair’s Proposed ANDA Product until the expiration of
`
`15
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 16 of 23 PageID #: 16
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 16 of 23 Page|D #: 16
`
`the ’966 patent or any later date of exclusivity to which Plaintiffs and/or the ’966 patent are or
`
`become entitled to;
`
`D.
`
`An order that the effective date of any approval of Praxair’s ANDA No.
`
`207141 relating to Praxair’s Proposed ANDA Product under Section 505(j) of the Federal Food,
`
`Drug and Cosmetic Act (21 U.S.C. § 3550)) shall be a date that is not earlier than the expiration
`
`date of the ’966 patent or any later date of exclusivity to which Plaintiffs and/or the ’966 patent
`
`are or become entitled;
`
`E.
`
`A judgment that Defendants have infringed one or more claims of the ’284
`
`patent by filing ANDA No. 207141 relating to Praxair’s Proposed ANDA Product before the
`
`expiration of the ’284 patent;
`
`F.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for
`
`sale,
`
`sale and/or
`
`importation of Praxair’s Proposed ANDA Product will infringe the ’284 patent;
`
`G.
`
`A permanent injunction restraining and enjoining Defendants, and their
`
`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
`
`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
`
`importation into the United States, of Praxair’s Proposed ANDA Product until the expiration of
`
`the ’284 patent or any later date of exclusivity to which Plaintiffs and/or the ’284 patent are or
`
`become entitled to;
`
`H.
`
`An order that the effective date of any approval of Praxair’s ANDA No.
`
`207141 relating to Praxair’s Proposed ANDA Product under Section 505(j) of the Federal Food,
`
`Drug and Cosmetic Act (21 U.S.C. § 3556)) shall be a date that is not earlier than the expiration
`
`date of the ’284 patent or any later date of exclusivity to which Plaintiffs and/or the ’284 patent
`
`are or become entitled;
`
`16
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 17 of 23 PageID #: 17
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 17 of 23 Page|D #: 17
`
`I.
`
`A judgment that Defendants have infringed one or more claims of the ’163
`
`patent by filing ANDA No. 207141 relating to Praxair’s Proposed ANDA Product before the
`
`expiration of the ’163 patent;
`
`J.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for sale,
`
`sale and/or
`
`importation of Praxair’s Proposed ANDA Product will infringe the ’163 patent;
`
`K.
`
`A permanent injunction restraining and enjoining Defendants, and their
`
`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
`
`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
`
`importation into the United States, of Praxair’s Proposed ANDA Product until the expiration of
`
`the ’163 patent or any later date of exclusivity to which Plaintiffs and/or the ’l63 patent are or
`
`become entitled to;
`
`L.
`
`An order that the effective date of any approval of Praxair’s ANDA No.
`
`207141 relating to Praxair’s Proposed ANDA Product under Section 5050) of the Federal Food,
`
`Drug and Cosmetic Act (21 U.S.C. § 3550)) shall be a date that is not earlier than the expiration
`
`date of the ’l63 patent or any later date of exclusivity to which Plaintiffs and/or the ’163 patent
`
`are or become entitled;
`
`M.
`
`A judgment that Defendants have infringed one or more claims of the ’741
`
`patent by filing ANDA No. 207141 relating to Praxair’s Proposed ANDA Product before the
`
`expiration of the ’741 patent;
`
`N.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for sale,
`
`sale and/or
`
`importation of Praxair’s Proposed ANDA Product will infringe the ’74l patent;
`
`O.
`
`A permanent injunction restraining and enjoining Defendants, and their
`
`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
`
`17
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 18 of 23 PageID #: 18
`Case 1:15—cv—OO170—GMS Document 1 Filed 02/19/15 Page 18 of 23 Page|D #: 18
`
`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
`
`importation into the United States, of Praxair’s Proposed ANDA Product until the expiration of
`
`the ’741 patent or any later date of exclusivity to which Plaintiffs and/or the ’74l patent are or
`
`become entitled to;
`
`P.
`
`An order that the effective date of any approval of Praxair’s ANDA No.
`
`207141 relating to Praxair’s Proposed ANDA Product under Section 5050) of the Federal Food,
`
`Drug and Cosmetic Act (21 U.S.C. § 3550)) shall be a date that is not earlier than the expiration
`
`date of the ’74l patent or any later date of exclusivity to which Plaintiffs and/or the ’741 patent
`
`are or become entitled;
`
`Q.
`
`A judgment that Defendants have infringed one or more claims of the ’ll2
`
`patent by filing ANDA No. 207141 relating to Praxair’s Proposed ANDA Product before the
`
`expiration of the ’ 1 12 patent;
`
`R.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for
`
`sale,
`
`sale and/or
`
`importation of Praxair’s Proposed ANDA Product will infringe the ’ 1 12 patent;
`
`S.
`
`A permanent injunction restraining and enjoining Defendants, and their
`
`officers, agents, attorneys and employees, and those acting in privity or concert with them, from
`
`engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or
`
`importation into the United States, of Praxair’s Proposed ANDA Product until the expiration of
`
`the ’ll2 patent or any later date of exclusivity to which Plaintiffs and/or the ’ll2 patent are or
`
`become entitled to;
`
`T.
`
`An order that the effective date of any approval of Praxair’s ANDA No.
`
`207141 relating to Praxair’s Proposed ANDA Product under Section 5050) of the Federal Food,
`
`Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a date that is not earlier than the expiration
`
`18
`
`

`
`Case 1:15-cv-00170-GMS Document 1 Filed 02/19/15 Page 19 of 23 PageID #: 19
`Case 1:15—cv—OO170—GMS Document 1 File

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