Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 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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`B. BRAUN MEDICAL INC.
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`Defendant.
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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 Defendant B. Braun Medical Inc. (B. Braun”).
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`1.
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`This is an action by Fresenius against B. Braun for infringement of United States
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`Patent No. 8,476,010 (“the ʼ010 patent”). This action arises out of B. Braun’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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`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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`3.
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`Upon information and belief, Defendant B. Braun is a Pennsylvania corporation
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`with its principal place of business at 824 Twelfth Avenue, Bethlehem, PA 18018-3524.
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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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`B. BRAUN MEDICAL INC.
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`Defendant.
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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 Defendant B. Braun Medical Inc. (B. Braun”).
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`1.
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`This is an action by Fresenius against B. Braun for infringement of United States
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`Patent No. 8,476,010 (“the ʼ010 patent”). This action arises out of B. Braun’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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`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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`3.
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`Upon information and belief, Defendant B. Braun is a Pennsylvania corporation
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`with its principal place of business at 824 Twelfth Avenue, Bethlehem, PA 18018-3524.
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 2 of 9 PageID #: 2
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`JURISDICTION AND VENUE
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`Subject Matter Jurisdiction
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`4.
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`5.
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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 B. Braun
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`6.
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`Upon information and belief, this Court has personal jurisdiction over B. Braun
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`because B. Braun through its affiliates and/or agents (1) has sought approval from the FDA to
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`market and sell its proposed generic Diprivan® product throughout the United States, including
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`in Delaware; (2) conducts business in this Judicial District; and (3) has engaged in continuous
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`and systematic contacts with Delaware and/or purposefully availed itself of this forum by, among
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`other things, marketing, making, shipping, using, offering to sell or selling, or causing others to
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`use, offer to sell, or sell, B. Braun products in this Judicial District, and deriving substantial
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`revenue from such activities. Upon information and belief, B. Braun utilizes the services of its
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`registered agent, Corporation Service Company located at 2711 Centerville Rd., Suite 400,
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`Wilmington, DE 19808, for its sales and marketing in Delaware. Upon information and belief,
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`Corporation Service Company is a corporation organized and existing under the laws of
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`Delaware.
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`7.
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`Additionally, B. Braun has been sued for patent infringement in this district and
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`did not contest personal jurisdiction. See Hospira, Inc. v. B. Braun Medical, Inc., C.A. No. 13-
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`819; see also Rydex Techs. LLC v. B. Braun Medical Inc. et al., C.A. No. 13-663. B. Braun has
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`also purposefully availed itself of the rights and benefits of this Court by asserting counterclaims
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`2
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 3 of 9 PageID #: 3
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`in lawsuits filed in this Court, and proactively filing suit for patent infringement in this district.
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`See B. Braun Medical Inc. et al. v. Termuro Medical Corp. et al., CA No. 09-347.
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`8.
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`Upon information and belief, B. Braun has agreements with retailers, wholesalers
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`or distributors providing for the distribution of its products in the State of Delaware.
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`9.
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`Upon information and belief, B. Braun 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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`10.
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`Upon information and belief, B. Braun 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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`11.
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`On February 24, 2016, B. Braun sent a letter to Fresenius, a Delaware Limited
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`Liability Company, stating that it had filed ANDA No. 207929 seeking FDA approval to market
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`a generic Diprivan® product prior to the expiration of the ’010 patent.
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`12.
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`Upon information and belief, B. Braun 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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`13.
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`Upon information and belief, as a result of B. Braun’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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`14.
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`Upon information and belief, B. Braun’s systematic and continuous business
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`contacts within Delaware render it at home in Delaware.
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`15.
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`Upon information and belief, this Court has personal jurisdiction over B. Braun
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`for the reasons stated herein, including, inter alia, B. Braun’s activities in the forum, activities
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`3
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 4 of 9 PageID #: 4
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`directed at the forum, significant contacts with the forum, and consent, all of which render B.
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`Braun at home in the forum. Personal jurisdiction is proper at least under Acorda Therapeutics
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`Inc. v. Mylan Pharms Inc., No. 2015-1456, 2016 WL 1077048 (Fed. Cir. 2016).
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`Venue
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`16.
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`Venue is proper in this 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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`17.
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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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`18.
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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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`19.
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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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`20.
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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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`4
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 5 of 9 PageID #: 5
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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 B. Braun ANDA
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`21.
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`B. Braun filed with the FDA an ANDA under 21 U.S.C. § 355(j) seeking approval
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`to 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, in 20 mL, 50 mL and 100
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`mL vials, that B. Braun asserts is a generic copy of Diprivan® (“B. Braun’s generic Diprivan®
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`products”) prior to the expiration of the ʼ010 patent.
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`22.
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`23.
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`The FDA assigned the B. Braun ANDA the number 207929.
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`B. Braun filed with the FDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(II), a
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`certification that U.S. Patent Nos. 5,714,520; 5,731,355; 5,731,356 and 5,908,869 (“the ’520,
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`’355, ’356, and ’869 patents”) have expired.
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`24.
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`B. Braun 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 B. Braun’s generic
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`Diprivan® products (“B. Braun’s Paragraph IV Certification”). B. Braun notified Fresenius of
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`this certification, in a letter dated February 24, 2016 sent by U.S. Mail (“B. Braun Notice
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`Letter”).
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`25.
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`In the B. Braun Notice Letter, B. Braun offered Fresenius confidential access to
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`ANDA No. 207929 on terms and conditions set forth in an attached “Offer of Confidential
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`Access” (“OCA”). The initial OCA provided by B. Braun contained various terms and
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`conditions, several of which went above and beyond protections typically afforded in a
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`protective order. Fresenius and B. Braun proceeded to negotiate the provisions of the OCA, and
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 6 of 9 PageID #: 6
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`a final version of the OCA was executed by both parties on March 25, 2015.
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`26.
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`On April 4, 2016, Fresenius received certain abbreviated portions of ANDA No.
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`207929 from B. Braun, pursuant to the OCA.
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`27.
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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 due to the limited information Fresenius has received from B. Braun to
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`date, Fresenius turns to the judicial process and the aid of discovery to obtain, under appropriate
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`judicial safeguards, such information as is required to further confirm its allegations of
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`infringement and to present to the Court evidence that B. Braun’s generic Diprivan® products fall
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`within the scope of one or more claims of the ’010 patent.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,476,010 BY B. BRAUN
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`28.
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`The allegations of paragraphs 1-27 are realleged and incorporated herein by
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`reference.
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`29.
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`The use of B. Braun’s generic Diprivan® products is covered by one or more
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`claims of the ʼ010 patent.
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`30.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution,
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`and/or importation of B. Braun’s generic Diprivan® products would infringe one or more claims
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`of the ʼ010 patent.
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`31.
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`B. Braun has infringed the ʼ010 patent by submitting and maintaining the B.
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`Braun ANDA before the FDA seeking approval to market B. Braun’s generic Diprivan® products
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`containing propofol before the expiration of the ʼ010 patent.
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`32.
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`B. Braun was aware of the ʼ010 patent when engaging in these knowing and
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`purposeful activities and was aware that filing B. Braun’s 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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`6
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 7 of 9 PageID #: 7
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`33.
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`Upon information and belief, B. Braun intends to engage in the manufacture, use,
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`offer for sale, sale, marketing, distribution, and/or importation of B. Braun’s generic Diprivan®
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`products immediately and imminently upon approval of the B. Braun ANDA.
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`34.
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`The foregoing actions by B. Braun constitute and/or would constitute
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`infringement of the ʼ010 patent.
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`35.
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`Upon information and belief, B. Braun acted without a reasonable basis for
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`believing that it would not be liable for infringing the ʼ010 patent, actively inducing infringement
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`of the ʼ010 patent, and/or contributing to the infringement by others of the ʼ010 patent.
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`36.
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`Fresenius will be substantially and irreparably harmed by B. Braun’s 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 B. Braun is not enjoined from the commercial manufacture, use, offer to sell, sale in, and
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`importation into the United States of B. Braun’s generic Diprivan® products.
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`37.
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`B. Braun’s activities render this case an exceptional one, and Fresenius is entitled
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`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:
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`a.
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`A judgment that B. Braun’s submission of the B. Braun’s ANDA No. 207929
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`infringes one or more claims of the ʼ010 patent and that the making, using, offering to sell, or
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`selling in the United States, or importing into the United States of B. Braun’s generic Diprivan®
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`products prior to the expiration of the ʼ010 patent will infringe of one or more claims of the
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`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 B. Braun’s ANDA No. 207929 seeking approval to manufacture, use, offer
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`7
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`Case 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 8 of 9 PageID #: 8
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`for sale, sell in and import into the United States a propofol injectable emulsion containing 10mg
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`propofol per 1 ml of emulsion formulation, in 20 mL, 50 mL and 100 mL vials, or any product or
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`compound the use of which infringes the ʼ010 patent, shall be a date that is not earlier than the
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`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 B. Braun’s generic Diprivan® products, or any other product or
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`compound the use of which infringes the ʼ010 patent, or inducing or contributing to the
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`infringement of the ʼ010 patent 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 B. Braun’s ANDA No. 207929 before
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`the expiration of the ʼ010 patent;
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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® products,
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`or any product or compound the use of which infringes the ʼ010 patent, prior to the expiration of
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`the patent in accordance with 35 U.S.C. § 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 1:16-cv-00250-RGA Document 1 Filed 04/11/16 Page 9 of 9 PageID #: 9
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`Dated: April 11, 2016
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`Of Counsel:
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`Daryl L. Wiesen
`John T. Bennett
`Sam Sherry
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`(617) 523-1231 (fax)
`DWiesen@goodwinprocter.com
`JBennett@goodwinprocter.com
`SSherry@goodwinprocter.com
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`Krupa Parikh
`GOODWIN PROCTER LLP
`901 New York Ave. NW
`Washington, D.C. 20009
`(202) 346-4000
`(202) 346-4444 (fax)
`KParikh@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)
`Michael J. Farnan (Bar No. 5165)
`919 North Market Street
`12th Floor
`Wilmington, DE 19801
`Phone: 302-777-0300
`Fax: 302-777-0301
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
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`Attorneys for Plaintiff
`Fresenius Kabi USA, LLC
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`9
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