Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 1 of 12 PageID #: 1
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`UNITED STATES DISTRICT COURT
`DISTRICT OF DELAWARE
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`FRESENIUS KABI USA, LLC,
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`v.
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`Plaintiff,
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`CLARIS LIFESCIENCES LTD.
`and CLARIS LIFESCIENCES INC.,
`Defendants.
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`Civil Action No. _________
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`COMPLAINT
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`Fresenius Kabi USA, LLC (“Fresenius”) brings this action for patent infringement
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`against Defendants Claris Lifesciences Ltd. (“Claris Ltd.”) and Claris Lifesciences Inc. (“Claris
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`Inc.”) (collectively, “Claris” or “Defendants”).
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`1.
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`This is an action by Fresenius against Defendants for infringement of United
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`States Patent No. 8,476,010 (“the ʼ010 patent”). This action arises out of Claris’s filing of an
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`Abbreviated New Drug Application (“ANDA”) seeking approval by the United States Food and
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`Drug Administration (“FDA”) to sell generic versions of Diprivan®, an innovative intravenously
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`administered sedative and anesthetic, prior to the expiration of the ʼ010 patent.
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`Fresenius
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`THE PARTIES
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`2.
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`Fresenius is a Delaware limited liability company with its principal place of
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`business at Three Corporate Drive, Lake Zurich, Illinois 60047. Fresenius Kabi USA, LLC was
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`formerly known as APP Pharmaceuticals, LLC.
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`UNITED STATES DISTRICT COURT
`DISTRICT OF DELAWARE
`
`
`FRESENIUS KABI USA, LLC,
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`
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`
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`v.
`
`Plaintiff,
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`CLARIS LIFESCIENCES LTD.
`and CLARIS LIFESCIENCES INC.,
`Defendants.
`
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`Civil Action No. _________
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`COMPLAINT
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`Fresenius Kabi USA, LLC (“Fresenius”) brings this action for patent infringement
`
`against Defendants Claris Lifesciences Ltd. (“Claris Ltd.”) and Claris Lifesciences Inc. (“Claris
`
`Inc.”) (collectively, “Claris” or “Defendants”).
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`1.
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`This is an action by Fresenius against Defendants for infringement of United
`
`States Patent No. 8,476,010 (“the ʼ010 patent”). This action arises out of Claris’s filing of an
`
`Abbreviated New Drug Application (“ANDA”) seeking approval by the United States Food and
`
`Drug Administration (“FDA”) to sell generic versions of Diprivan®, an innovative intravenously
`
`administered sedative and anesthetic, prior to the expiration of the ʼ010 patent.
`
`Fresenius
`
`THE PARTIES
`
`2.
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`Fresenius is a Delaware limited liability company with its principal place of
`
`business at Three Corporate Drive, Lake Zurich, Illinois 60047. Fresenius Kabi USA, LLC was
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`formerly known as APP Pharmaceuticals, LLC.
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`
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 2 of 12 PageID #: 2
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`Defendants
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`3.
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`Upon information and belief, Claris Ltd. is a corporation organized and existing
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`under the laws of India, with its principal place of business at Nr. Parimal Crossing, Ellisbridge,
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`Ahmedabad, 380006, India.
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`4.
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`Upon information and belief, Claris Inc. is a corporation organized and existing
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`under the laws of New Jersey with its principal place of business at 1445 US Highway 130,
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`North Brunswick, NJ 08902.
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`5.
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`Upon information and belief, Claris Inc. is a wholly-owned subsidiary of and is
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`controlled by Claris Ltd.
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`6.
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`Upon information and belief, both Claris Ltd. and Claris Inc. submitted,
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`collaborated and/or acted in concert in the preparation or submission of ANDA No. 203421 (the
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`“Claris ANDA”).
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`Subject Matter Jurisdiction
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`JURISDICTION AND VENUE
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`7.
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`8.
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`This action for patent infringement arises under 35 U.S.C. § 271.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`Personal Jurisdiction Over Defendants
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`9.
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`10.
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`Upon information and belief, this Court has personal jurisdiction over Claris Ltd.
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`Upon information and belief, Claris Ltd., through its wholly-owned subsidiary
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`and agent Claris Inc., markets, distributes and/or sells generic drugs throughout the United States
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`and within the State of Delaware.
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`2
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 3 of 12 PageID #: 3
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`11.
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`Upon information and belief, Claris Ltd. has engaged in and maintained
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`systematic and continuous business contacts within the State of Delaware, and has purposefully
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`availed itself of the benefits and protections of the laws of Delaware, rendering it at home in
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`Delaware.
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`12.
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`Upon information and belief, Claris Ltd. routinely files ANDAs in the United
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`States and markets a numerous generic injectable pharmaceutical products, including, inter alia,
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`ciprofloxacin, fluconazole, furosemide, levofloxacin, metoprolol tartrate, metronidazole,
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`norepinephrine bitartrate, and ondansetron hydrochloride.
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`13.
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`Upon information and belief, Claris Ltd. has agreements with pharmaceutical
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`retailers, wholesalers or distributors providing for the distribution of its products in the State of
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`Delaware, including, inter alia, ciprofloxacin, fluconazole, furosemide, levofloxacin, metoprolol
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`tartrate, metronidazole, norepinephrine bitartrate, and ondansetron hydrochloride.
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`14.
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`Upon information and belief, Claris Ltd. has committed, or aided, abetted,
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`contributed to and/or participated in the commission of the tortious action of patent infringement
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`that has led to foreseeable harm and injury to Fresenius, which manufactures Diprivan®, for sale
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`and use throughout the United States, including the State of Delaware.
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`15.
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`Upon information and belief, Claris Ltd. has applied for FDA approval to market
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`and sell a generic version of Diprivan® throughout the United States, including in Delaware.
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`16.
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`On November 4, 2014, Claris Ltd. sent a letter to Fresenius, a Delaware Limited
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`Liability Company, stating that it had filed ANDA No. 203421 seeking FDA approval to market
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`a generic Diprivan® product prior to the expiration of the ’010 patent (the “Claris Notice
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`Letter”).
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`3
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 4 of 12 PageID #: 4
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`17.
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`Upon information and belief, Claris Ltd. will market, sell, and offer for sale its
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`proposed generic version of Diprivan® in the State of Delaware following FDA approval of that
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`product.
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`18.
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`Upon information and belief, as a result of Claris Ltd.’s marketing, selling, or
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`offering for sale of its generic version of Diprivan® in the State of Delaware, Fresenius will lose
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`sales of Diprivan® and be injured in the State of Delaware.
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`19.
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`Upon information and belief, Claris Ltd.’s systematic and continuous business
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`contacts within Delaware render it at home in Delaware.
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`20.
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`Upon information and belief, this Court has personal jurisdiction over Claris Ltd.
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`for the reasons stated herein, including, inter alia, Claris Ltd.’s activities in the forum, activities
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`directed at the forum, significant contacts with the forum, and consent, all of which render Claris
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`Ltd. at home in the forum.
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`21.
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`This Court also has personal jurisdiction over Claris Ltd. under Federal Rule of
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`Civil Procedure 4(k)(2).
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`22.
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`23.
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`Upon information and belief, this Court has personal jurisdiction over Claris Inc.
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`Upon information and belief, Claris Inc., as an agent of Claris Ltd., markets,
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`distributes and/or sells generic drugs throughout the United States and within the State of
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`Delaware.
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`24.
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`Upon information and belief, Claris Inc. has engaged in and maintained
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`systematic and continuous business contacts within the State of Delaware, and has purposefully
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`availed itself of the benefits and protections of the laws of Delaware.
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`4
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 5 of 12 PageID #: 5
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`25.
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`Upon information and belief, Claris Inc. collaborated and/or acted in concert with
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`Claris Ltd. to apply for FDA approval to market and sell a generic version of Diprivan®
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`throughout the United States, including in Delaware.
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`26.
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`Upon information and belief, Claris Inc. collaborated in the decision to send the
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`Claris Notice Letter to Fresenius, a Delaware Limited Liability Company.
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`27.
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`Upon information and belief, Claris Inc. will act as the agent of Claris Ltd. by
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`marketing, selling, and/or offering for sale a generic version of Diprivan® in the State of
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`Delaware on Claris Ltd.’s behalf following FDA approval of that product.
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`28.
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`Upon information and belief, Claris Inc. has committed, or aided, abetted,
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`contributed to and/or participated in the commission of the tortious action of patent infringement
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`that has led to foreseeable harm and injury to Fresenius, which manufactures Diprivan®, for sale
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`and use throughout the United States, including the State of Delaware.
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`29.
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`Upon information and belief, Claris Inc.’s systematic and continuous business
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`contacts within Delaware render it at home in Delaware.
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`30.
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`Upon information and belief, this Court has personal jurisdiction over Claris Inc.
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`for the reasons stated herein, including by virtue of Claris Inc.’s activities in the forum, activities
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`directed at the forum, and significant contacts with the forum, all of which render Claris Inc. at
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`home in the forum.
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`Venue
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`31.
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`Venue is proper in this Judicial District under 28 U.S.C. § 1391 and 1400(b).
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`The Patent-in-Suit: United States Patent No. 8,476,010
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`BACKGROUND
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`5
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 6 of 12 PageID #: 6
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`32.
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`The ʼ010 patent, entitled “Propofol Formulations with Non-Reactive Container
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`Closures,” was duly and lawfully issued on July 2, 2013 to inventors Neil P. Desai, Andrew
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`Yang, and Sherry Xiaopei Ci. The named inventors assigned the ʼ010 patent to APP
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`Pharmaceuticals, LLC, which later changed its name to Fresenius Kabi USA, LLC.
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`Accordingly, Fresenius is the owner of all rights, title, and interest in the ʼ010 patent. The ʼ010
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`patent is listed in the FDA publication “Approved Drug Products with Therapeutic Equivalence
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`Evaluations,” commonly referred to as “The Orange Book” (“Orange Book”) with respect to
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`Diprivan®. The ʼ010 patent will expire on June 1, 2025. A true and accurate copy of the ʼ010
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`patent is attached hereto as Exhibit A.
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`The Diprivan® Drug Product
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`33.
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`Fresenius currently sells, promotes, distributes, and markets Diprivan® (propofol)
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`injectable emulsion in the United States.
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`34.
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`Diprivan® is indicated, generally speaking, for the induction and maintenance of
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`general anesthesia and sedation in certain patient populations.
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`35.
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`Fresenius holds an approved New Drug Application (“NDA”) No. 19627 under
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`Section 505(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 355(a) in connection
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`with the Diprivan® 1% (propofol) injectable emulsion product containing 10 mg propofol per 1
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`ml of emulsion.
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`The Claris ANDA
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`6
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 7 of 12 PageID #: 7
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`36.
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`Claris filed with the FDA an ANDA under 21 U.S.C. § 355(j) seeking approval to
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`manufacture, use, offer for sale, sell in and import into the United States a propofol injectable
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`emulsion containing 10mg propofol per 1 ml of emulsion formulation that Claris asserts is a
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`generic copy of Diprivan® (“Claris’s generic Diprivan® products”) prior to the expiration of the
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`ʼ010 patent.
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`37.
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`38.
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`The FDA assigned the Claris ANDA the number 203421.
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`Claris filed with the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), a
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`certification alleging that the claims of the ʼ010 patent are invalid, unenforceable and/or would
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`not be infringed by the manufacture, use, importation, sale or offer for sale of Claris’s generic
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`Diprivan® products (“Claris’s Paragraph IV Certification”). Claris notified Fresenius of this
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`certification, in a letter dated November 4, 2014 sent by U.S. Mail.
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`39.
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`In the Claris Notice Letter, Claris offered Fresenius confidential access to ANDA
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`No. 203421 on terms and conditions set forth in an attached “Offer of Confidential Access”
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`(“OCA”). The OCA provided by Claris contained various terms and conditions, several of
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`which went above and beyond protections typically afforded in a protective order. For instance,
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`the initial Claris OCA limited the number of Fresenius in-house counsel who could access the
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`Claris ANDA and did not provide for access by in-house counsel’s staff.
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`40.
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`On November 10, 2014, Fresenius provided Claris with a revised draft of the
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`OCA.
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`41.
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`On November 21, 2014, Claris’s counsel communicated to Teva that Claris would
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`not consider Fresenius’s proposed changes to the OCA.
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`7
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 8 of 12 PageID #: 8
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`42.
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`Given the 45-day statutory deadline to file suit set forth in 21 U.S.C.
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`§ 355(j)(5)(B)(iii) and Claris’s refusal to negotiate regarding an OCA, Fresenius turns to the
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`judicial process and the aid of discovery to obtain, under appropriate judicial safeguards, such
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`information as is required to further confirm their allegations of infringement and to present to
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`the Court evidence that Claris’s generic Diprivan® products fall within the scope of one or more
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`claims of the ’010 patent.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,476,010 BY
`DEFENDANTS
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`43.
`
`The allegations of paragraphs 1-42 are realleged and incorporated herein by
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`reference.
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`44.
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`The use of Claris’s generic Diprivan® products is covered by one or more claims
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`of the ʼ010 patent.
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`45.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution,
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`and/or importation of Claris’s generic Diprivan® products would infringe one or more claims of
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`the ʼ010 patent.
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`46.
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`Defendants have infringed the ʼ010 patent by submitting and maintaining the
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`Claris ANDA before the FDA seeking approval to market Claris’s generic Diprivan® products
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`containing propofol before the expiration of the ʼ010 patent.
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`47.
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`Upon information and belief, Defendants acted in concert and actively and
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`knowingly caused to be submitted, assisted with, participated in, encouraged, contributed to,
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`aided and abetted, and/or directed the submission and maintenance of the Claris ANDA to the
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`FDA.
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`8
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 9 of 12 PageID #: 9
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`48.
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`Defendants induced the infringement of the ʼ010 patent by actively and
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`knowingly aiding and abetting the preparation, submission, and maintenance of the Claris
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`ANDA with the Paragraph IV Certification and in the preparation to sell Claris’s generic
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`Diprivan® product in the United States.
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`49.
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`Defendants were aware of the ʼ010 patent when engaging in these knowing and
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`purposeful activities and were aware that filing the Claris ANDA with the Paragraph IV
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`Certification with respect to the ʼ010 patent constituted an act of infringement of the ’010 patent.
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`50.
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`Use of Claris’s generic Diprivan® products in accordance with and as directed by
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`Claris’s proposed labeling for that product would infringe one or more claims of the ʼ010 patent.
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`51.
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`Upon information and belief, Defendants intend to engage in the manufacture,
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`use, offer for sale, sale, marketing, distribution, and/or importation of Claris’s generic Diprivan®
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`products with its proposed labeling immediately and imminently upon approval of the Claris
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`ANDA.
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`52.
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`Upon information and belief, Defendants plan and intend to, and will, actively
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`induce infringement of the ʼ010 patent when the Claris ANDA is approved, and plan and intend
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`to, and will, do so immediately and imminently upon approval.
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`53.
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`Upon information and belief, Defendants know that Claris’s generic Diprivan®
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`product and the proposed labeling for Claris’s generic Diprivan® product is especially made or
`
`adapted for use in infringing the ʼ010 patent and that Claris’s generic Diprivan® product and the
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`proposed labeling are not suitable for substantial noninfringing use. Upon information and
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`belief, Defendants plan and intend to, and will, contribute to the infringement of the ʼ010 patent
`
`immediately and imminently upon approval of the Claris ANDA.
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`9
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 10 of 12 PageID #: 10
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`54.
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`The foregoing actions by Defendants constitute and/or would constitute
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`infringement of the ʼ010 patent, active inducement of infringement of the ʼ010 patent and/or
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`contribution to the infringement by others of the ʼ010 patent.
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`55.
`
`Upon information and belief, Defendants acted without a reasonable basis for
`
`believing that they would not be liable for infringing the ʼ010 patent, actively inducing
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`infringement of the ʼ010 patent, and/or contributing to the infringement by others of the ʼ010
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`patent.
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`56.
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`Fresenius will be substantially and irreparably harmed by Defendants’ infringing
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`activities unless the Court enjoins those activities. Fresenius will have no adequate remedy at
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`law if Defendants are not enjoined from the commercial manufacture, use, offer to sell, sale in,
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`and importation into the United States of Claris’s generic Diprivan® products.
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`57.
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`Defendants’ activities render this case an exceptional one, and Fresenius is
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`entitled to an award of its reasonable attorney fees under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
`
`
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`WHEREFORE, Fresenius respectfully requests the following relief:
`
`a.
`
`A judgment that Defendants’ submission of Claris ANDA No. 203421 infringes
`
`one or more claims of the ʼ010 patent and that the making, using, offering to sell, or selling in the
`
`United States, or importing into the United States of Claris’s generic Diprivan® products prior to
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`the expiration of the ʼ010 patent will infringe, actively induce infringement, and/or contribute to
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`the infringement of one or more claims of the patent;
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`
`
`10
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 11 of 12 PageID #: 11
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`b.
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of Claris ANDA No. 203421 seeking approval to manufacture, use, offer for
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`sale, sell in and import into the United States a propofol injectable emulsion containing 10mg
`
`propofol per 1 ml of emulsion formulation, or any product or compound the use of which
`
`infringes the ʼ010 patent, shall be a date that is not earlier than the expiration of the patent;
`
`c.
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`An Order permanently enjoining Defendants and all persons acting in concert
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`with Defendants from commercially manufacturing, using, offering for sale, selling, marketing,
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`distributing, or importing Claris’s generic Diprivan® products, or any other product or compound
`
`the use of which infringes the ʼ010 patent, or inducing or contributing to the infringement of the
`
`ʼ010 patent until after the expiration of the patent;
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`d.
`
`An Order enjoining Defendants and all persons acting in concert with Defendants
`
`from seeking, obtaining, or maintaining approval of the Claris ANDA No. 203421 before the
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`expiration of the ʼ010 patent;
`
`e.
`
`An award of Plaintiff’s damages or other monetary relief to compensate Plaintiff
`
`if Defendants engage in the commercial manufacture, use, offer to sell, sale or marketing or
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`distribution in, or importation into the United States of Defendants’ generic Diprivan® products,
`
`or any product or compound the use of which infringes the ʼ010 patent, or the inducement or
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`contribution of the foregoing, prior to the expiration of the patent in accordance with 35 U.S.C. §
`
`271(e)(4)(C);
`
`f.
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`A judgment that this is an exceptional case and awarding Plaintiff its attorneys’
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`fees under 35 U.S.C. § 285;
`
`g.
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`An award of Plaintiff’s reasonable costs and expenses in this action; and
`
`
`
`11
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`
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`Case 1:14-cv-01498-RGA Document 1 Filed 12/19/14 Page 12 of 12 PageID #: 12
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`h.
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`An award of any further and additional relief to Plaintiff as this Court deems just
`
`and proper.
`
`Respectfully submitted,
`
`FARNAN LLP
`
`
`/s/ Brian E. Farnan
`Brian Farnan(Bar No. 4089)
`919 North Market Street
`12th Floor
`Wilmington, DE 19801
`Phone: 302-777-0300
`Fax: 302-777-0301
`bfarnan@farnanlaw.com
`
`
`
`
`
`
`
`Attorneys for Plaintiff
`Fresenius Kabi USA, LLC
`
`
`
`Dated: December 19, 2014
`
`
`
`Of Counsel:
`
`Daryl L. Wiesen
`John T. Bennett
`Sundar Subramanyam
`Srikanth Reddy
`Jennifer L. Ford
`Todd Marabella
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`(617) 523-1231 (fax)
`DWiesen@goodwinprocter.com
`
`JBennett@goodwinprocter.com
`SSubramanyam@goodwinprocter.com
`SReddy@goodwinprocter.com
`JFord@goodwinprocter.com
`TMarabella@goodwinprocter.com
`
`
`
`
`
`12
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