Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 1 of 9 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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`DR. REDDY’S LABORATORIES, LTD. and DR.
`REDDY’S LABORATORIES, INC.,
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`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 Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively and/or
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`individually “DRL”).
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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 DRL’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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`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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`DR. REDDY’S LABORATORIES, LTD. and DR.
`REDDY’S LABORATORIES, INC.,
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`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 Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively and/or
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`individually “DRL”).
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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 DRL’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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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 2 of 9 PageID #: 2
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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 (“APP”).
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`DRL
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`3.
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`Upon information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. (“DRL
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`Ltd.”) is a corporation operating and existing under the laws of India, with its principal place of
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`business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, 500034, India.
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`4.
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`Upon information and belief, Defendant Dr. Reddy’s Laboratories, Inc. (“DRL
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`Inc.”) is a New Jersey corporation with its principal place of business at 200 Somerset Corporate
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`Boulevard, Building II, 7th Floor, Bridgewater, NJ 08807.
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`5.
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`On information and belief, Defendant Dr. Reddy’s Inc. is a wholly-owned
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`subsidiary of Dr. Reddy’s Ltd., and is controlled by Dr. Reddy’s Ltd.
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`6.
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`On information and belief, both DRL Inc. and DRL Ltd. submitted, collaborated
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`and/or acted in concert in the preparation or submission of ANDA Number 205067 (“DRL
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`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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`2
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 3 of 9 PageID #: 3
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`Personal Jurisdiction Over DRL
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`9.
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`Upon information and belief, this Court has personal jurisdiction over DRL, at
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`least because DRL has engaged in continuous and systematic contacts with Delaware and/or
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`purposefully availed itself of this forum by, among other things, making, shipping, using,
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`offering to sell or selling, or causing others to use, offer to sell, or sell, DRL’s pharmaceutical
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`products in this Judicial District, and deriving substantial revenue from such activities.
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`10.
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`Further, DRL has previously admitted in Merck & Co., Inc. v. Dr. Reddy’s Labs,
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`Ltd., Mo. 04-1313 (GMS) that due to their many contacts with Delaware they were “subject to
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`personal jurisdiction in this judicial district.”
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`Venue
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`11.
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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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`12.
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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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`3
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 4 of 9 PageID #: 4
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`The Diprivan® Drug Product
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`13.
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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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`14.
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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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`15.
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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 DRL ANDA
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`16.
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`DRL 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 that DRL asserts is a generic copy of
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`Diprivan® (“DRL’s generic Diprivan® product”) prior to the expiration of the ʼ010 patent.
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`17.
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`18.
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`The FDA assigned the DRL ANDA number 205067.
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`By letter dated April 11, 2013, DRL notified Fresenius that it had filed an ANDA
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`seeking approval to market DRL’s generic Diprivan® product prior to the patents then listed in
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`the Orange Book (“DRL Notice Letter”).
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`19.
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`The ʼ010 patent had not issued at the time DRL submitted its certification under
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`§ 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act.
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`20.
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`DRL is required to amend the patent certification in its ANDA to address the ʼ010
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`patent prior to approval of its ANDA but, on information and belief, has yet to do so. Despite
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`4
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 5 of 9 PageID #: 5
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`repeated requests by Plaintiff's counsel, DRL has, to date, refused to disclose whether it will
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`submit a Paragraph IV certification as to the ʼ010 patent.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,476,010 BY DRL
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`21.
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`The allegations of paragraphs 1-20 are realleged and incorporated herein by
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`reference.
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`22.
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`The use of DRL’s generic Diprivan® product is covered by one or more claims of
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`the ʼ010 patent.
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`23.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution,
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`and/or importation of DRL’s generic Diprivan® product would infringe one or more claims of the
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`ʼ010 patent.
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`24.
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`DRL has infringed the ʼ010 patent by submitting the DRL ANDA to the FDA
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`seeking approval to market DRL’s generic Diprivan® product containing propofol before the
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`expiration of the ʼ010 patent.
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`25.
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`Upon information and belief, Defendants DRL Inc. and DRL Ltd. acted in concert
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`and actively and knowingly caused to be submitted, assisted with, participated in, encouraged,
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`contributed to, aided and abetted, and/or directed the submission of the DRL ANDA to the FDA.
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`26.
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`Defendants DRL Inc. and DRL Ltd. induced the infringement of the ʼ010 patent
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`by actively and knowingly aiding and abetting the preparation and submission of the DRL
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`ANDA and in the preparation to sell DRL’s generic Diprivan® product in the United States.
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`27.
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`Upon information and belief, DRL was aware of the ʼ010 patent when engaging
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`in these knowing and purposeful activities and was aware that filing the DRL ANDA constituted
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`an act of infringement of the ʼ010 patent.
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`5
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 6 of 9 PageID #: 6
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`28.
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`Use of DRL’s generic Diprivan® product in accordance with and as directed by
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`DRL’s proposed labeling for that product would infringe one or more claims of the ʼ010 patent.
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`29.
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`Upon information and belief, DRL intends to engage in the manufacture, use,
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`offer for sale, sale, marketing, distribution, and/or importation of DRL’s generic Diprivan®
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`product with its proposed labeling immediately and imminently upon approval of the DRL
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`ANDA.
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`30.
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`Upon information and belief, DRL plans and intends to, and will, actively induce
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`infringement of the ʼ010 patent when the DRL ANDA is approved, and plans and intends to, and
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`will, do so immediately and imminently upon approval.
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`31.
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`Upon information and belief, DRL knows that DRL’s generic Diprivan® product
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`and the proposed labeling for DRL’s generic Diprivan® product is especially made or adapted for
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`use in infringing the ʼ010 patent and that DRL’s generic Diprivan® product and the proposed
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`labeling are not suitable for substantial noninfringing use. Upon information and belief, DRL
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`plans and intends to, and will, contribute to the infringement of the ʼ010 patent immediately and
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`imminently upon approval of the DRL ANDA.
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`32.
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`The foregoing actions by DRL constitute and/or would constitute infringement of
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`the ʼ010 patent, active inducement of infringement of the ʼ010 patent, and/or contribution to the
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`infringement by others of the ʼ010 patent.
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`33.
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`Upon information and belief, DRL acted without a reasonable basis for believing
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`that it would not be liable for infringing the ʼ010 patent, actively inducing infringement of the
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`ʼ010 patent, and/or contributing to the infringement by others of the ʼ010 patent.
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`34.
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`Fresenius will be substantially and irreparably harmed by DRL’s infringing
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`activities unless the Court enjoins those activities. Fresenius will have no adequate remedy at
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`6
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 7 of 9 PageID #: 7
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`law if DRL is not enjoined from the commercial manufacture, use, offer to sell, sale in and
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`importation into the United States of DRL’s generic Diprivan® product.
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`35.
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`DRL’s activities render this case an exceptional one, and Fresenius is entitled to
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`an award of their 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:
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`a.
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`A judgment that DRL’s submission of the DRL ANDA No. 205067 infringes one
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`or more claims of the ʼ010 patent and that the making, using, offering to sell, or selling in the
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`United States, or importing into the United States of DRL’s generic Diprivan® product 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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`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 DRL ANDA No. 205067 or any product or compound the use of which
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`infringes the ʼ010 patent, shall be a date that is not earlier than the expiration of the patent;
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`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 DRL’s generic Diprivan® product, or any other product or compound
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`the use of which infringes the ʼ010 patent, or inducing or contributing to the infringement of the
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`ʼ010 patent patents until after the expiration of the patent;
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`d.
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`An Order enjoining Defendants and all persons acting in concert with Defendants
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`from seeking, obtaining, or maintaining approval of the DRL ANDA No. 205067 before the
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`expiration of the ʼ010 patent;
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`7
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 8 of 9 PageID #: 8
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`e.
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`An award of Plaintiff’s damages or other monetary relief to compensate Plaintiff
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`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® product,
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`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. §
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`271(e)(4)(C);
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`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;
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`An award of Plaintiff’s reasonable costs and expenses in this action; and
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`An award of any further and additional relief to Plaintiff as this Court deems just
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`g.
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`h.
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`and proper.
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`8
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`Case 1:14-cv-00160-RGA Document 1 Filed 02/06/14 Page 9 of 9 PageID #: 9
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`Dated: February 6, 2014
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`Of Counsel:
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`Daryl L. Wiesen
`John Bennett
`Sundar Subramanyam
`Sam Sherry
`Todd Marabella
`Jennifer L. Ford
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`(617) 523-1231 (fax)
`DWiesen@goodwinprocter.com
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`JBennett@goodwinprocter.com
`SSubramanyam@goodwinprocter.com
`SSherry@goodwinprocter.com
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`TMarabella@goodwinprocter.com
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`JFord@goodwinprocter.com
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`Respectfully submitted,
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`FARNAN LLP
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`/s/ Brian E. Farnan
`Brian Farnan (Bar No. 4089)
`919 North Market Street
`12th Floor
`Wilmington, DE 19801
`Phone: 302-777-0336
`Fax: 302-777-0301
`bfarnan@farnanlaw.com
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`Attorneys for Plaintiff
`Fresenius Kabi USA, LLC
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`9
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