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`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, NJ 07102
`(973) 622-4444
`
`Attorneys for Plaintiff Horizon
`Therapeutics, Inc.
`
`
`
`Dennis A. Bennett
`Tim Burgdorf
`GLOBAL PATENT GROUP, LLC
`1005 North Warson Road, Suite 404
`St. Louis, Missouri 63132
`(314) 812-8020
`
`Robert F. Green
`Emer L. Simic
`Ann K. Kotze
`GREEN GRIFFITH & BORG-BREEN LLP
`NBC Tower, Suite 3100
`455 North Cityfront Plaza Drive
`Chicago, Illinois 60611
`(312) 883-8000
`
`Of Counsel for Plaintiff Horizon
`Therapeutics, Inc.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`Civil Action No. 1:15-CV-07624-
`RBK-JS
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`AMENDED COMPLAINT
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`
`HORIZON THERAPEUTICS, INC.,
`
`
`
` Plaintiff,
` v.
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`LUPIN LTD. and LUPIN
`PHARMACEUTICALS, INC.,
`
`
`
`
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` Defendants.
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`Plaintiff Horizon Therapeutics, Inc., by its undersigned attorneys, brings this action
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`against Defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, “Defendants”
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`or “Lupin”), and hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35 of the United States Code, arising from Defendants’ filing of an Abbreviated
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`New Drug Application (“ANDA”) with the United States Food and Drug Administration
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`(“FDA”) seeking approval to market a generic version of Plaintiff’s pharmaceutical product
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`RAVICTI® (glycerol phenylbutyrate) (“RAVICTI®”) prior to the expiration of United States
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`Patent No. 9,095,559 (“the ’559 patent”).
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`THE PARTIES
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`2.
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`Plaintiff Horizon Therapeutics, Inc. is a corporation organized and existing under
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`the laws of the State of Delaware, with a principal place of business at 150 S. Saunders Road,
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`Lake Forest, IL 60045.
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`3.
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`On information and belief, Defendant Lupin Limited (“Lupin Ltd.”) is a
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`corporation operating and existing under the laws of India, having a principal place of business at
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`B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400 051, India, and its
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`registered office at 159 CST Road, Kalina, Santacrux (E), Mumbai 400 098, India.
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`4.
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`On information and belief, Lupin Ltd. is in the business of, inter alia, developing,
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`manufacturing, obtaining regulatory approval, marketing, selling, and distributing generic copies
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`of branded pharmaceutical products throughout the United States, including within this judicial
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`district, through its own actions.
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`5.
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`On information and belief, Defendant Lupin Pharmaceuticals Inc. (“LPI”) is a
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`corporation operating and exiting under the laws of the Commonwealth of Virginia, with its
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`principal place of business at 111 South Calvert Street, 21st Floor, Baltimore, MD 21202.
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`6.
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`On information and belief, LPI is in the business of, inter alia, manufacturing,
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`obtaining regulatory approval, marketing, selling, and distributing generic copies of branded
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`pharmaceutical products throughout the United States, including within this judicial district,
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`through its own actions and through the actions of its agents and subsidiaries.
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`2
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`7.
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`8.
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`On information and belief, LPI is a wholly-owned subsidiary of Lupin Ltd.
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`On information and belief, LPI is registered with the State of New Jersey as a
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`wholesale distributor under Registration Number 5004060.
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`9.
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`On information and belief, LPI is registered with the State of New Jersey,
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`Division of Revenue and Enterprise Services, as Entity No. 0100953673.
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`10.
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`On information and belief, LPI acts at the direction of, under the control of, and
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`for the benefit of Lupin Ltd. and is controlled and/or dominated by Lupin Ltd.
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`11.
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`On information and belief, Lupin Ltd. and LPI have at least one officer and/or
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`director in common.
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`12.
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`On information and belief, Defendants participated and collaborated in the
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`research and development, and the preparation and filing, of ANDA No. 207694 (“the Lupin
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`ANDA”) for glycerol phenylbutyrate oral liquid (“the Lupin Product”), continue to participate
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`and collaborate in seeking FDA approval of that application, and intend to participate and
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`collaborate in the commercial manufacture, marketing, offer for sale and sale of the Lupin
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`Product throughout the United States, including in the State of New Jersey, in the event the FDA
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`approves Lupin’s ANDA.
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`13.
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`On information and belief, LPI is the US agent for Lupin Ltd. in connection with
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`the filing of the Lupin ANDA with the FDA and subsequent FDA communications relating
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`thereto.
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`14.
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`On information and belief, should the Lupin ANDA be finally approved by FDA,
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`LPI will sell, offer for sale and distribute the Lupin Product throughout the United States,
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`including within this judicial district.
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`15.
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`On information and belief, Lupin Ltd. and LPI have availed themselves of the
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`3
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`rights, benefits and privileges of this Court by filing at least one complaint for patent
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`infringement in the District of New Jersey: Lupin Ltd., et al. v. Merck, Sharp & Dohme Corp.,
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`Civil Action No. 3:10-cv-00683.
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`16.
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`On information and belief, Lupin Ltd. and LPI have admitted to, consented to or
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`have not contested, the jurisdiction of this Court in at least five prior District of New Jersey
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`actions: Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al., Civil Action No. 1:15-cv-
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`00335, Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al., Civil Action No. 1:14-cv-
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`05144, Janssen Products, L.P., et al. v. Lupin Ltd., et al., Civil Action No. 2:14-cv-01370,
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`Takeda Pharmaceutical Co. Ltd., et al. v. Lupin Ltd., et al., Civil Action No. 3:12-cv-07333, and
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`AstraZeneca Pharmaceuticals LP, et al. v. Lupin Ltd., et al., Civil Action No. 3:12-cv-06888.
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`17.
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`On information and belief, Lupin Ltd. and LPI have availed themselves of the
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`rights, benefits and privileges of this Court by asserting counterclaims in at least five prior
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`District of New Jersey actions: Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al., Civil
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`Action No. 1:15-cv-00335, Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al., Civil
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`Action No. 1:14-cv-05144, Janssen Products, L.P., et al. v. Lupin Ltd., et al., Civil Action No.
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`2:14-cv-01370, Takeda Pharmaceutical Co. Ltd., et al. v. Lupin Ltd., et al., Civil Action No.
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`3:12-cv-07333, and AstraZeneca Pharmaceuticals LP, et al. v. Lupin Ltd., et al., Civil Action
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`No. 3:12-cv-06888.
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`JURISDICTION AND VENUE
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`18.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331 and 1338(a).
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`19.
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`This Court has personal jurisdiction over Defendants by virtue of, inter alia, their
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`presence in New Jersey, having conducted business in New Jersey, having availed themselves of
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`the rights and benefits of New Jersey law such that they should reasonably anticipate being haled
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`into court in this judicial district, previously submitting to personal jurisdiction in this Court,
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`availing themselves of the jurisdiction of this Court (e.g., by the assertion of claims and
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`counterclaims), and having engaged in systematic and continuous contacts with the State of New
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`Jersey through the marketing and sales of generic drugs throughout the United States, and in
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`particular within this judicial district, through the receipt of revenue from the sales and
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`marketing of generic drug products, including Lupin products, within this judicial district, and
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`through their intent to market and sell the Lupin Product, if approved, to residents of this judicial
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`district.
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`20.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c) and §
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`1400(b).
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`THE PATENT-IN-SUIT
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`21.
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`On August 4, 2015, the USPTO duly and legally issued the ’559 patent entitled
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`“Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs.” At the time of its issue,
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`the ’559 patent was assigned to Horizon Therapeutics, Inc. Horizon Therapeutics, Inc. currently
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`is the sole assignee and owner of all right, title and interest in and to the ’559 patent, which
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`claims methods related to the treatment of urea cycle disorder patients with glyceryl tri-[4-
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`phenylbutyrate] based on measurement of fasting blood ammonia blood levels. A true and
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`correct copy of the ’559 patent is attached hereto as Exhibit A.
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`RAVICTI®
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`22.
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`Horizon Therapeutics, Inc. is the owner of FDA-approved New Drug Application
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`No. 203284 (“the RAVICTI® NDA”) for glycerol phenylbutyrate oral liquid 1.1gm/ml, which is
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`sold by Horizon Pharma USA, Inc. in the US under the tradename RAVICTI®.
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`23.
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`RAVICTI® is currently approved by the FDA for use as a nitrogen- binding agent
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`for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders
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`that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
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`24.
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`Pursuant to 21 U.S.C. § 355, and attendant FDA regulations, the ’559 patent is
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`listed in the FDA publication entitled Approved Drug Products and Therapeutic Equivalence
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`Evaluations (“the Orange Book”) for the RAVICTI® NDA.
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`25.
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`The ’559 patent qualifies for listing in the Orange Book in connection with NDA
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`No. 203284 because the ’559 patent claims an approved use of RAVICTI®.
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`LUPIN’S ANDA
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`26.
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`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
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`pursuant to 21 U.S.C. § 355(j), seeking approval to market glycerol phenylbutyrate oral liquid.
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`On information and belief, the Lupin ANDA seeks approval to market the Lupin Product for use
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`as a nitrogen-binding agent for chronic management of adult and pediatric patients ≥ 2 years of
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`age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino
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`acid supplementation alone.
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`27.
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`On information and belief, the conditions of use for which Lupin seeks approval
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`of the Lupin Product in the Lupin ANDA are the same as those set forth in the FDA-approved
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`labeling for RAVICTI®.
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`28.
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`On information and belief, the Lupin ANDA refers to and relies upon the
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`RAVICTI® NDA and contains data that, according to Lupin, demonstrate the bioequivalence of
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`the Lupin Product and RAVICTI®.
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`29.
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`Horizon Therapeutics, Inc. received from Lupin Ltd. a letter, dated November 6,
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`2015 (“the November 6th Letter”), stating that Lupin Ltd. included a certification in the Lupin
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`ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that the ’559 patent is invalid,
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`unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the
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`Lupin Product (the “Paragraph IV Certification”).
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`30.
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`The Lupin ANDA seeks approval to engage in the commercial manufacture, use
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`or sale of glycerol phenylbutyrate oral liquid before the expiration of the ’559 patent.
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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 9,095,559
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`31.
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`Plaintiff realleges and incorporates by reference the allegations of paragraphs 1-
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`30 of this Complaint.
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`32.
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`Defendants have infringed the ’559 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
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`by submitting the Lupin ANDA which seeks approval from the FDA to engage in the
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`commercial manufacture, use, offer to sell, sale or importation of the Lupin Product prior to the
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`expiration of the ’559 patent.
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`33.
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`Defendants’ use, offer to sell, or sale of the Lupin Product within the United
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`States, during the term of the ’559 patent also would infringe the ’559 patent under 35 U.S.C. §
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`271(a), (b) and/or (c).
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`34.
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`On information and belief, the conditions of use for the Lupin Product for which
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`Lupin seeks approval in the Lupin ANDA fall within one or more of the claims of the ’559
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`patent. If approved, use of the Lupin Product in accordance with the proposed labeling submitted
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`in the Lupin ANDA would infringe one or more of the claims of the ’559 patent.
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`35.
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`Upon approval of the Lupin ANDA, and the commercial marketing thereof,
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`Defendants will actively induce and/or contribute to infringement of the ’559 patent.
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`36.
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`Upon information and belief, Defendants had actual and constructive notice of the
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`’559 patent prior to filing Lupin’s ANDA, and Defendants’ infringement of the ’559 patent has
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`been, and continues to be, willful.
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`37.
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`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an
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`order of this Court that the effective date of the approval of Lupin’s ANDA be a date that is not
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`earlier than the expiration of the ’559 patent, or any later expiration of any exclusivity or
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`extension of the ’559 patent to which Plaintiff or the patent may become entitled.
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`38.
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`Plaintiff will be substantially and irreparably harmed if Defendants are not
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`enjoined from infringing or actively inducing or contributing to the infringement of the ’559
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`patent.
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`39.
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`Plaintiff has no adequate remedy at law.
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`40.
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`This case is exceptional, and Plaintiff is entitled to an award of attorneys’ fees
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`under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff prays for a judgment in their favor and against Defendants, and
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`respectfully requests the following relief:
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`A.
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`A judgment declaring that Defendants have infringed one or more claims of U.S.
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`Patent No. 9,095,559;
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`B.
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`A judgment pursuant to 35 U.S.C. § 271(e)(4) preliminarily and permanently
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`enjoining Defendants, their officers, directors, employees, representatives, agents, parents,
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`subsidiaries, affiliates, customers, distributors, suppliers, and those persons in active concert or
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`participation with any of them, and their successors and assigns, from using, offering to sell, or
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`selling the Lupin Product within the United States, prior to the expiration date of the ’559 patent;
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`C.
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`If Defendants use, offer to sell, or sell the Lupin Product within the United States,
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`prior to the expiration of the ’559 patent, including any extensions, a judgment awarding Plaintiff
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`monetary relief together with interest;
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`D.
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`That an order be issued under 35 U.S.C. § 271(e)(4)(A) that the effective date of
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`any FDA approval of the Lupin ANDA shall be a date not earlier than the expiration date of the
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`’559 patent, inclusive of any extensions;
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`E.
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`F.
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`G.
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`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
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`Costs and expenses in this action;
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`Such other and further relief as the Court deems just and proper.
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`
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`Respectfully submitted,
`
`s/ John E. Flaherty
`
`John E. Flaherty
`
` Matthew A. Sklar
` Ravin R. Patel
` McCARTER & ENGLISH LLP
`
`Four Gateway Center
`
`100 Mulberry St.
` Newark, NJ 07102
`(973) 622-4444
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`
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`
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`
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`Date: April 6, 2016
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`
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`Attorneys for Plaintiff Horizon Therapeutics, Inc.
`
` Dennis A. Bennett
` GLOBAL PATENT GROUP, LLC
`
`1005 North Warson Road, Suite 404
`
`St. Louis, Missouri 63132
`(314) 812-8020
`
`
` Robert F. Green
`Emer L. Simic
`Ann K. Kotze
`GREEN GRIFFITH & BORG-BREEN LLP
`NBC Tower, Suite 3100
`455 North Cityfront Plaza Drive
`
`Chicago, Illinois 60611
`(312) 883-8000
`
`
`
`
`
`Of Counsel for Plaintiff Horizon Therapeutics, Inc.
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`9
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`CERTIFICATE OF SERVICE
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`I hereby certify that on April 6, 2016, I caused the foregoing AMENDED
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`COMPLAINT to be served by ECF and electronic mail upon counsel of record.
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`
`
`s/ John E. Flaherty
` John E. Flaherty
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`
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`EXHIBIT A
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