Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 1 of 16 PageID: 230019Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 1 of 16 PageID: 1
`
`
`
`
`
`
`
`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
`GLOBAL PATENT GROUP, LLC
`1005 North Warson Road, Suite 404
`St. Louis, Missouri 63132
`(314) 812-8020
`
`Of Counsel for Plaintiff Horizon
`Therapeutics, Inc.
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`HORIZON THERAPEUTICS, INC.
`
`
`
`CIVIL ACTION No.
`
`Document Filed Electronically
`
`
`
`COMPLAINT FOR
`
`
`
`
`
` Plaintiff,
`
` v.
`
`
`LUPIN LTD. and LUPIN
`PHARMACEUTICALS INC.,
`
`
`
`
`
` Defendants.
`
`PATENT INFRINGEMENT
`
`COMPLAINT
`
`Plaintiff Horizon Therapeutics, Inc., by its undersigned attorneys, brings this
`
`action against Defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively,
`
`“Defendants” or “Lupin”), and hereby allege as follows:
`
`
`
`
`ME1 21337947v.1
`
`Page 1 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 2 of 16 PageID: 230020Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 2 of 16 PageID: 2
`
`
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the
`
`United States, Title 35 of the United States Code, arising from Defendants’ filing of an
`
`Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug
`
`Administration (“FDA”) seeking approval to market a generic version of Plaintiff’s
`
`pharmaceutical product RAVICTI® (glycerol phenylbutyrate) (“RAVICTI®”) prior to
`
`the expiration of United States Patent Nos. 8,404,215 (“the ’215 patent”), 8,642,012 (“the
`
`’012 patent”), and 9,095,559 (“the ’559 patent”).
`
`THE PARTIES
`
`2.
`
`Plaintiff Horizon Therapeutics, Inc. is a corporation organized and
`
`existing under the laws of the State of Delaware, with a principal place of business at 520
`
`Lake Cook Road, Suite 520, Deerfield, Illinois.
`
`3.
`
`On information and belief, Defendant Lupin Limited (“Lupin Ltd.”) is a
`
`corporation operating and existing under the laws of India, having a principal place of
`
`business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400 051,
`
`India, and its registered office at 159 CST Road, Kalina, Santacrux (E), Mumbai 400 098,
`
`India.
`
`4.
`
`On information and belief, Lupin Ltd. is in the business of, inter alia,
`
`developing, manufacturing, obtaining regulatory approval, marketing, selling, and
`
`distributing generic copies of branded pharmaceutical products throughout the United
`
`States, including within this judicial district, through its own actions.
`
`5.
`
`On information and belief, Defendant Lupin Pharmaceuticals Inc. (“LPI”)
`
`is a corporation operating and existing under the laws of the Commonwealth of Virginia,
`
`with its principal place of business at 111 South Calvert Street 21st Floor, Baltimore, MD
`
`21202.
`
`6.
`
`On information and belief, LPI is in the business of, inter alia,
`
`manufacturing, obtaining regulatory approval, marketing, selling, and distributing generic
`
`
`ME1 21337947v.1
`
`2
`
`Page 2 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 3 of 16 PageID: 230021Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 3 of 16 PageID: 3
`
`
`
`copies of branded pharmaceutical products throughout the United States, including within
`
`this judicial district, through its own actions and through the actions of its agents and
`
`subsidiaries.
`
`Ltd.
`
`7.
`
`8.
`
`On information and belief, LPI is a wholly-owned subsidiary of Lupin
`
`On information and belief, LPI is registered with the State of New Jersey
`
`as a wholesale distributor under Registration Number 5004060.
`
`9.
`
`On information and belief, LPI is registered with the State of New Jersey,
`
`Division of Revenue and Enterprise Services, as Entity No. 0100953673.
`
`10.
`
`On information and belief, LPI acts at the direction of, under the control
`
`of, and for the benefit of Lupin Ltd. and is controlled and/or dominated by Lupin Ltd.
`
`11.
`
`On information and belief, Lupin Ltd. and LPI have at least one officer
`
`and/or director in common.
`
`12.
`
`On information and belief, Defendants participated and collaborated in the
`
`research and development, and the preparation and filing, of ANDA No. 207694 (“the
`
`Lupin ANDA”) for glycerol phenylbutyrate oral liquid (“the Lupin Product”), continue to
`
`participate and collaborate in seeking FDA approval of that application, and intend to
`
`participate and collaborate in the commercial manufacture, marketing, offer for sale and
`
`sale of the Lupin Product throughout the United States, including in the State of New
`
`Jersey, in the event the FDA approves Lupin’s ANDA.
`
`13.
`
`On information and belief, LPI is the US agent for Lupin Ltd. in
`
`connection with the filing of the Lupin ANDA with the FDA and subsequent FDA
`
`communications relating thereto.
`
`14.
`
`On information and belief, should the Lupin ANDA be finally approved
`
`by FDA, LPI will sell, offer for sale and distribute the Lupin Product throughout the
`
`United States, including within this judicial district.
`
`
`ME1 21337947v.1
`
`3
`
`Page 3 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 4 of 16 PageID: 230022Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 4 of 16 PageID: 4
`
`
`
`15.
`
`On information and belief, Lupin Ltd. and LPI have availed themselves of
`
`the rights, benefits and privileges of this Court by filing at least one complaint for patent
`
`infringement in the District of New Jersey: Lupin Ltd., et al. v. Merck, Sharp & Dohme
`
`Corp., Civil Action No. 3:10-cv-00683.
`
`16.
`
`On information and belief, Lupin Ltd. and LPI have admitted to,
`
`consented to or have not contested, the jurisdiction of this Court in at least five prior
`
`District of New Jersey actions: Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et al.,
`
`Civil Action No. 1:15-cv-00335, Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd., et
`
`al., Civil Action No. 1:14-cv-05144, Janssen Products, L.P., et al. v. Lupin Ltd., et al.,
`
`Civil Action No. 2:14-cv-01370, Takeda Pharmaceutical Co. Ltd., et al. v. Lupin Ltd., et
`
`al., Civil Action No. 3:12-cv-07333, and AstraZeneca Pharmaceuticals LP, et al. v.
`
`Lupin Ltd., et al., Civil Action No. 3:12-cv-06888.
`
`17.
`
`On information and belief, Lupin Ltd. and LPI have availed themselves of
`
`the rights, benefits and privileges of this Court by asserting counterclaims in at least five
`
`prior District of New Jersey actions: Senju Pharmaceutical Co., Ltd., et al. v. Lupin Ltd.,
`
`et al., Civil Action No. 1:15-cv-00335, Senju Pharmaceutical Co., Ltd., et al. v. Lupin
`
`Ltd., et al., Civil Action No. 1:14-cv-05144, Janssen Products, L.P., et al. v. Lupin Ltd.,
`
`et al., Civil Action No. 2:14-cv-01370, Takeda Pharmaceutical Co. Ltd., et al. v. Lupin
`
`Ltd., et al., Civil Action No. 3:12-cv-07333, and AstraZeneca Pharmaceuticals LP, et al.
`
`v. Lupin Ltd., et al., Civil Action No. 3:12-cv-06888.
`
`JURISDICTION AND VENUE
`
`18.
`
`This Court has jurisdiction over the subject matter of this action under 28
`
`U.S.C. §§ 1331, 1338(a), 2201 and 2202.
`
`19.
`
`This Court has personal jurisdiction over Defendants by virtue of, inter
`
`alia, their presence in New Jersey, having conducted business in New Jersey, having
`
`availed themselves of the rights and benefits of New Jersey law such that they should
`
`reasonably anticipate being haled into court in this judicial district, previously submitting
`
`to personal jurisdiction in this Court, availing themselves of the jurisdiction of this Court
`
`
`ME1 21337947v.1
`
`4
`
`Page 4 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 5 of 16 PageID: 230023Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 5 of 16 PageID: 5
`
`
`
`(e.g., by the assertion of claims and counterclaims), and having engaged in systematic
`
`and continuous contacts with the State of New Jersey through the marketing and sales of
`
`generic drugs throughout the United States, and in particular within this judicial district,
`
`through the receipt of revenue from the sales and marketing of generic drug products,
`
`including Lupin products, within this judicial district, and through their intent to market
`
`and sell the Lupin Product, if approved, to residents of this judicial district.
`
`
`20.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c)
`
`and § 1400(b).
`
`THE PATENTS-IN-SUIT
`
`21.
`
`On March 26, 2013, the U.S. Patent and Trademark Office (“USPTO”)
`
`duly and legally issued the ’215 patent entitled “Methods of Therapeutic Monitoring of
`
`Nitrogen Scavenging Drugs.” At the time of its issue, the ’215 patent was assigned to
`
`Hyperion Therapeutics Inc., which later changed its name to Horizon Therapeutics, Inc.
`
`Horizon Therapeutics, Inc. currently is the sole assignee and owner of all right, title and
`
`interest in and to the ’215 patent, which discloses and claims, inter alia, a method for
`
`adjusting the dosage of a nitrogen scavenging drug in a subject who has previously been
`
`administered an initial dosage of the nitrogen scavenging drug. A true and correct copy
`
`of the ’215 patent is attached hereto as Exhibit A.
`
`22.
`
`On February 4, 2014, the USPTO duly and legally issued the ’012 patent
`
`entitled “Methods of Treatment Using Ammonia-Scavenging Drugs.” At the time of its
`
`issue, the ’012 patent was assigned to Hyperion Therapeutics Inc., which later changed its
`
`name to Horizon Therapeutics, Inc. Horizon Therapeutics, Inc. currently is the sole
`
`assignee and owner of all right, title and interest in and to the ’012 patent, which
`
`discloses and claims, inter alia, a method of treating a patient having urea cycle disorder.
`
`A true and correct copy of the ’012 patent is attached hereto as Exhibit B.
`
`23.
`
`On August 4, 2015, the USPTO duly and legally issued the ’559 patent
`
`entitled “Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs.” At the
`
`time of its issue, the ’559 patent was assigned to Horizon Therapeutics, Inc. Horizon
`
`
`ME1 21337947v.1
`
`5
`
`Page 5 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 6 of 16 PageID: 230024Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 6 of 16 PageID: 6
`
`
`
`Therapeutics, Inc. currently is the sole assignee and owner of all right, title and interest in
`
`and to the ’559 patent, which discloses and claims, inter alia, methods for evaluating
`
`daily ammonia exposure based on a single fasting ammonia blood level measurement. A
`
`true and correct copy of the ’559 patent is attached hereto as Exhibit C.
`
`RAVICTI®
`
`24.
`
`Horizon Therapeutics, Inc. is the owner of FDA-approved New Drug
`
`Application No. 203284 (“the RAVICTI® NDA”) for glycerol phenylbutyrate oral liquid
`
`1.1gm/ml, which is sold by Horizon Pharma USA, Inc. in the US under the tradename
`
`RAVICTI®.
`
`25.
`
`RAVICTI® is currently approved by the FDA for use as a nitrogen-
`
`binding agent for chronic management of adult and pediatric patients ≥ 2 years of age
`
`with urea cycle disorders that cannot be managed by dietary protein restriction and/or
`
`amino acid supplementation alone.
`
`26.
`
`Pursuant to 21 U.S.C. § 355, and attendant FDA regulations, the ’215,
`
`’012, and ’559 patents are listed in the FDA publication entitled Approved Drug Products
`
`and Therapeutic Equivalence Evaluations (“the Orange Book”) for the RAVICTI® NDA.
`
`27.
`
`The ’215, ’012, and ’559 patents qualify for listing in the Orange Book in
`
`connection with NDA No. 203284 because each patent claims an approved use of
`
`RAVICTI®.
`
`LUPIN’S ANDA
`
`28.
`
`On information and belief, Lupin submitted the Lupin ANDA to the FDA,
`
`pursuant to 21 U.S.C. § 355(j), seeking approval to market glycerol phenylbutyrate oral
`
`liquid. On information and belief, the Lupin ANDA seeks approval to market the Lupin
`
`Product for use as a nitrogen-binding agent for chronic management of adult and
`
`pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by
`
`dietary protein restriction and/or amino acid supplementation alone.
`
`
`ME1 21337947v.1
`
`6
`
`Page 6 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 7 of 16 PageID: 230025Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 7 of 16 PageID: 7
`
`
`
`29.
`
`On information and belief, the conditions of use for which Lupin seeks
`
`approval of the Lupin Product in the Lupin ANDA are the same as those set forth in the
`
`FDA-approved labeling for RAVICTI®.
`30.
`
`On information and belief, the Lupin ANDA refers to and relies upon the
`
`RAVICTI® NDA and contains data that, according to Lupin, demonstrate the
`
`bioequivalence of the Lupin Product and RAVICTI®.
`
`
`31.
`September 4, 2015 (“the September 4th Letter”), stating that Lupin Ltd. included a
`
`Horizon Therapeutics, Inc. received from Lupin Ltd. a letter, dated
`
`certification in the Lupin ANDA, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), that the
`
`’215 and ’012 patents are invalid, unenforceable and/or will not be infringed by the
`
`commercial manufacture, use or sale of the Lupin Product (the “Paragraph IV
`
`Certification”).
`
`
`32.
`
`The Lupin ANDA seeks approval to engage in the commercial
`
`manufacture, use or sale of glycerol phenylbutyrate oral liquid before the expiration of
`
`the ’215 and ’012 patents.
`
`
`
`33.
`
`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,404,215
`
`Plaintiff realleges and incorporates by reference the allegations of
`
`paragraphs 1-32 of this Complaint.
`
`
`34.
`
`Defendants have infringed the ’215 patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting the Lupin ANDA which seeks approval from the FDA to
`
`engage in the commercial manufacture, use, offer to sell, sale or importation of the Lupin
`
`Product prior to the expiration of the ’215 patent.
`
`
`35.
`
`Defendants’ use, offer to sell, or sale of the Lupin Product within the
`
`United States, during the term of the ’215 patent also would infringe the ’215 patent
`
`under 35 U.S.C. § 271(a), (b) and/or (c).
`
`
`
`
`ME1 21337947v.1
`
`7
`
`Page 7 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 8 of 16 PageID: 230026Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 8 of 16 PageID: 8
`
`
`
`36.
`
`On information and belief, the conditions of use for the Lupin Product for
`
`which Lupin seeks approval in the Lupin ANDA fall within one or more of the claims of
`
`the ’215 patent. If approved, use of the Lupin Product in accordance with the proposed
`
`labeling submitted in the Lupin ANDA would infringe one or more of the claims of the
`
`’215 patent.
`
`
`
`37.
`
`Upon approval of the Lupin ANDA, and the commercial marketing
`
`thereof, Defendants will actively induce and/or contribute to infringement of the ’215
`
`patent.
`
`
`38.
`September 4th Letter which purportedly advised Plaintiff of Lupin’s Paragraph IV
`
`This action is being filed within 45 days of receipt by Plaintiff of the
`
`Certification filed relative to the ’215 patent.
`
`
`39.
`
`Upon information and belief, Defendants had actual and constructive
`
`notice of the ’215 patent prior to filing Lupin’s ANDA, and Defendants’ infringement of
`
`the ’215 patent has been, and continues to be, willful.
`
`
`40.
`
`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including an order of this Court that the effective date of the approval of Lupin’s ANDA
`
`be a date that is not earlier than the expiration of the ’215 patent, or any later expiration
`
`of any exclusivity or extension of the ’215 patent to which Plaintiff or the patent may
`
`become entitled.
`
`
`41.
`
`Plaintiff will be substantially and irreparably harmed if Defendants are not
`
`enjoined from infringing or actively inducing or contributing to the infringement of the
`
`’215 patent.
`
`
`42.
`
`
`43.
`
`Plaintiff has no adequate remedy at law.
`
`This case is exceptional, and Plaintiff is entitled to an award of attorneys’
`
`fees under 35 U.S.C. § 285.
`
`
`ME1 21337947v.1
`
`8
`
`Page 8 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 9 of 16 PageID: 230027Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 9 of 16 PageID: 9
`
`
`
`COUNT II FOR INFRINGEMENT OF U.S. PATENT NO. 8,642,012
`
`44.
`
`Plaintiff realleges and incorporates by reference the allegations of
`
`paragraphs 1-43 of this Complaint.
`
`
`45.
`
`Defendants have infringed the ’012 patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting the Lupin ANDA which seeks approval from the FDA to
`
`engage in the commercial manufacture, use, offer to sell, sale or importation of the Lupin
`
`Product prior to the expiration of the ’012 patent.
`
`
`46.
`
`Defendants’ use, offer to sell, or sale of the Lupin Product within the
`
`United States, during the term of the ’012 patent also would infringe the ’012 patent
`
`under 35 U.S.C. § 271(a), (b) and/or (c).
`
`
`47.
`
`Upon information and belief, the conditions of use for the Lupin Product
`
`for which Lupin seeks approval in the Lupin ANDA fall within one or more of the claims
`
`of the ’012 patent. If approved, use of the Lupin Product in accordance with the
`
`proposed labeling submitted in the Lupin ANDA would infringe one or more of the
`
`claims of the ’012 patent.
`
`
`48.
`
`Upon approval of the Lupin ANDA, and the commercial marketing of the
`
`Lupin Product, Defendants will actively induce and/or contribute to infringement of the
`
`’012 patent.
`
`
`49.
`September 4th Letter which purportedly advised Plaintiff of Lupin’s Paragraph IV
`
`This action is being filed within 45 days of receipt by Plaintiff of the
`
`Certification filed relative to the ’012 patent.
`
`
`50.
`
`Upon information and belief, Defendants had actual and constructive
`
`notice of the ’012 patent prior to filing Lupin’s ANDA, and Defendants’ infringement of
`
`the ’012 patent has been, and continues to be, willful.
`
`
`51.
`
`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including an order of this Court that the effective date of the approval of Lupin’s ANDA
`
`
`ME1 21337947v.1
`
`9
`
`Page 9 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 10 of 16 PageID: 230028Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 10 of 16 PageID: 10
`
`
`
`be a date that is not earlier than the expiration of the ’012 patent, or any later expiration
`
`of any exclusivity or extension of the ’012 patent to which Plaintiff or the patent may
`
`become entitled.
`
`
`52.
`
`Plaintiff will be substantially and irreparably harmed if Defendants are not
`
`enjoined from infringing or actively inducing or contributing to the infringement of the
`
`’012 patent.
`
`
`53.
`
`
`54.
`
`Plaintiff has no adequate remedy at law.
`
`This case is exceptional, and Plaintiff is entitled to an award of attorneys’
`
`fees under 35 U.S.C. § 285.
`
`
`
`55.
`
`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 9,095,559
`
`Plaintiff realleges and incorporates by reference the allegations of
`
`paragraphs 1-54 of this Complaint.
`56.
`
` The ’559 patent issued on August 4, 2015, and will expire on March 9,
`
`2032.
`
`
`57.
`
`Defendants have filed a Paragraph IV Certification in the Lupin ANDA
`
`seeking approval to market the Lupin Product prior to the expiration of, inter alia, the
`
`’215 patent, which expires on March 9, 2032. Because the ’559 patent also expires on
`
`March 9, 2032, Defendants seek approval of the Lupin ANDA, and to market the Lupin
`
`Product, prior to the expiration of the ’559 patent.
`
`
`58.
`
`By submitting and seeking approval of the Lupin ANDA, and also seeking
`
`approval to engage in the commercial manufacture, use, offer to sell, sale or importation
`
`of the Lupin Product, prior to the date on which the ’559 patent expires, Defendants have
`
`infringed the ’559 patent pursuant to 35 U.S.C. § 271(e)(2)(A).
`
`
`
`
`
`
`ME1 21337947v.1
`
`10
`
`Page 10 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 11 of 16 PageID: 230029Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 11 of 16 PageID: 11
`
`
`
`59.
`
`Defendants’ use, offer to sell, or sale of the Lupin Product within the
`
`United States, during the term of the ’559 patent also would infringe the ’559 patent
`
`under 35 U.S.C. § 271(a), (b) and/or (c).
`
`
`60.
`
`Upon information and belief, the conditions of use for the Lupin Product
`
`for which Lupin seeks approval in the Lupin ANDA fall within one or more of the claims
`
`of the ’559 patent. If approved, use of the Lupin Product in accordance with the
`
`proposed labeling submitted in the Lupin ANDA would infringe one or more of the
`
`claims of the ’559 patent.
`
`
`61.
`
`Upon approval of the Lupin ANDA, and the commercial marketing of the
`
`Lupin Product, Defendants will actively induce and/or contribute to infringement of the
`
`’559 patent.
`
`
`
`62.
`
`Upon information and belief, Defendants had actual and constructive
`
`notice of the ’559 patent as of its issue date, and Defendants’ infringement of the ’559
`
`patent is willful.
`
`
`63.
`
`Plaintiff is entitled to the relief provided by 35 U.S.C. § 271(e)(4),
`
`including an order of this Court that the effective date of the approval of Lupin’s ANDA
`
`be a date that is not earlier than the expiration of the ’559 patent, or any later expiration
`
`of any exclusivity or extension of the ’559 patent to which Plaintiff or the patent may
`
`become entitled.
`
`
`64.
`
`Plaintiff will be substantially and irreparably harmed if Defendants are not
`
`enjoined from infringing or actively inducing or contributing to the infringement of the
`
`’559 patent.
`
`
`65.
`
`
`66.
`
`Plaintiff has no adequate remedy at law.
`
`This case is exceptional, and Plaintiff is entitled to an award of attorneys’
`
`fees under 35 U.S.C. § 285.
`
`
`ME1 21337947v.1
`
`11
`
`Page 11 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 12 of 16 PageID: 230030Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 12 of 16 PageID: 12
`
`
`
`COUNT IV FOR DECLARATION OF INFRINGEMENT OF U.S. PATENT
`
`NO. 9,095,559
`
`67.
`
`Plaintiff realleges and incorporates by reference the allegations of
`
`paragraphs 1-66 of this Complaint.
`
`
`68.
`
`and 2202.
`
`
`69.
`
`This count arises under the Declaratory Judgment Act, 28 U.S.C. §§ 2201
`
`There currently exists an actual case or controversy such that the Court
`
`may entertain Plaintiff’s request for declaratory relief consistent with Article III of the
`
`United States Constitution, and this actual case or controversy requires a declaration of
`
`rights by this Court.
`
`
`70.
`
`Defendants’ use, offer to sell, or sale of the Lupin Product within the
`
`United States, during the term of the ’559 patent, would infringe the ’559 patent
`
`
`
`71.
`
`Defendants seek approval of the Lupin ANDA, and to market the Lupin
`
`Product, prior to the expiration of the ’559 patent.
`
`
`72.
`
`Defendants have made, and will continue to make, substantial preparation
`
`in the United States to manufacture, offer to sell, sell and/or import the Lupin Product
`
`prior to the expiration of the ’559 patent.
`
`
`73.
`
`Plaintiff is entitled to a declaratory judgment that the use, offer for sale,
`
`and/or sale of the Lupin Product prior to the expiration of the ’559 patent by Defendants
`
`would constitute direct infringement, contributory infringement, and/or active
`
`inducement of infringement of the ’559 patent.
`
`
`74.
`
`Plaintiff will be substantially and irreparably harmed if Defendants are not
`
`enjoined from infringing or actively inducing or contributing to the infringement of the
`
`’559 patent.
`
`
`75.
`
`
`ME1 21337947v.1
`
`Plaintiff has no adequate remedy at law.
`
`12
`
`Page 12 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 13 of 16 PageID: 230031Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 13 of 16 PageID: 13
`
`
`
`
`76.
`
`This case is exceptional, and Plaintiff is entitled to an award of attorneys’
`
`fees under 35 U.S.C. § 285.
`
`
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff prays for a judgment in their favor and against
`
`Defendants, and respectfully requests the following relief:
`
`A.
`
`A judgment declaring that Defendants have infringed one or more claims
`
`of U.S. Patent No. 8,404,215;
`
`B.
`
`A judgment declaring that Defendants have infringed one or more claims
`
`of U.S. Patent No. 8,642,012;
`
`C.
`
`A judgment declaring that Defendants have infringed and will infringe one
`
`or more claims of U.S. Patent No. 9,095,559;
`
`D.
`
`A judgment pursuant to 35 U.S.C. § 271(e)(4) preliminarily and
`
`permanently enjoining Defendants, their officers, directors, employees, representatives,
`
`agents, parents, subsidiaries, affiliates, customers, distributors, suppliers, and those
`
`persons in active concert or participation with any of them, and their successors and
`
`assigns, from using, offering to sell, or selling the Lupin Product within the United States,
`
`prior to the expiration date of the ’215 patent;
`
`E.
`
`A judgment pursuant to 35 U.S.C. § 271(e)(4) preliminarily and
`
`permanently enjoining Defendants, their officers, directors, employees, representatives,
`
`agents, parents, subsidiaries, affiliates, customers, distributors, suppliers, and those
`
`persons in active concert or participation with any of them, and their successors and
`
`assigns, from using, offering to sell, or selling the Lupin Product within the United States,
`
`prior to the expiration date of the ’012 patent;
`
`F.
`
`A judgment pursuant to 35 U.S.C. § 271(e)(4) preliminarily and
`
`permanently enjoining Defendants, their officers, directors, employees, representatives,
`
`agents, parents, subsidiaries, affiliates, customers, distributors, suppliers, and those
`
`persons in active concert or participation with any of them, and their successors and
`
`
`ME1 21337947v.1
`
`13
`
`Page 13 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 14 of 16 PageID: 230032Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 14 of 16 PageID: 14
`
`
`
`assigns, from using, offering to sell, or selling the Lupin Product within the United States,
`
`prior to the expiration date of the ’559 patent;
`
`G.
`
`A declaration pursuant to 28 U.S.C. § 2201 that if Defendants, their
`
`officers, directors, employees, representatives, agents, parents, subsidiaries, affiliates,
`
`customers, distributors, suppliers, and those persons in active concert or participation
`
`with any of them, and their successors and assigns, use, offer to sell, or sell the Lupin
`
`Product within the United States, prior to the expiration date of the ’559 patent, it will
`
`constitute an act of infringement of the ’559 patent;
`
`H.
`
`If Defendants use, offer to sell, or sell the Lupin Product within the United
`
`States, prior to the expiration of the ’215 patent, including any extensions, a judgment
`
`awarding Plaintiff monetary relief together with interest;
`
`I.
`
`If Defendants use, offer to sell, or sell the Lupin Product within the United
`
`States, prior to the expiration of the ’012 patent, including any extensions, a judgment
`
`awarding Plaintiff monetary relief together with interest;
`
`J.
`
`If Defendants use, offer to sell, or sell the Lupin Product within the United
`
`States, prior to the expiration of the ’559 patent, including any extensions, a judgment
`
`awarding Plaintiff monetary relief together with interest;
`
`K.
`
`That an order be issued under 35 U.S.C. § 271(e)(4)(A) that the effective
`
`date of any FDA approval of the Lupin ANDA shall be a date not earlier than the
`
`expiration date of the ’215, ’012, and/or ’559 patents, inclusive of any extensions;
`
`L.
`
`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C.
`
`§ 285;
`
`M.
`
`N.
`
`
`
`Costs and expenses in this action; and
`
`Such other and further relief as the Court deems just and proper.
`
`
`Date: October 19, 2015
`
`
`
`
`
`
`
`
`
`ME1 21337947v.1
`
`
`
`
`
` s/John E. Flaherty
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry St.
`Newark, NJ 07102
`(973) 622-4444
`
`14
`
`Page 14 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 15 of 16 PageID: 230033Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 15 of 16 PageID: 15
`
`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
`
`Of Counsel for Plaintiff Horizon
`Therapeutics, Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ME1 21337947v.1
`
`15
`
`Page 15 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`
`
`Case 1:33-av-00001 Document 7054 Filed 10/19/15 Page 16 of 16 PageID: 230034Case 1:15-cv-07624-RBK-JS Document 1 Filed 10/19/15 Page 16 of 16 PageID: 16
`
`
`
`
`
`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`Plaintiff Horizon Therapeutics, Inc., by its undersigned attorneys, hereby certify
`
`pursuant to Local Civil Rule 11.2 that the matter in controversy, to the extent that it is
`
`directed to allegations of infringement of the ’215 patent and the ’012 patent, is the
`
`subject of the following pending action, which involves a different defendant and a
`
`different ANDA and does not involve the ’559 patent:
`• Hyperion Therapeutics, Inc. v. Par Pharmaceutical, Inc.,
`
`Civil Action No. 14-cv-00384-JRG-RSP (E.D. Tex.);
`
`(Horizon Therapeutics, Inc. was formerly known as Hyperion Therapeutics, Inc.)
`
`
`
`s/ John E. Flaherty
`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
`GLOBAL PATENT GROUP, LLC
`1005 North Warson Road, Suite 404
`St. Louis, Missouri 63132
`(314) 812-8020
`
`Of Counsel for Plaintiff Horizon
`Therapeutics, Inc.
`
`
`
`
`Date: October 19, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ME1 21337947v.1
`
`16
`
`Page 16 of 102
`
`Owner Ex. 2001
`Lupin v. Horizon
`IPR2016-00829
`
`

`
`-6  5HY 

`
`
`Case 1:33-av-00001 Document 7054-4 Filed 10/19/15 Page 1 of 1 PageID: 230120Case 1:15-cv-07624-RBK-JS Document 1-1 Filed 10/19/15 Page 1 of 1 PageID: 17
` &,9,/ &29(5 6+((7
`7KH -6  FLYLO FRYHU VKHHW DQG WKH LQIRUPDWLRQ FRQWDLQHG KHUHLQ QHLWKHU UHSODFH QRU VXSSOHPHQW WKH ILOLQJ DQG VHUYLFH RI SOHDGLQJV RU RWKHU SDSHUV DV UHTXLUHG E\ ODZ H[FHSW DV SURYLGHG
`E\ ORFDO UXOHV RI FRXUW 7KLV IRUP DSSURYHG E\ WKH -XGLFLDO &RQIHUHQFH RI WKH 8QLWHG 6WDWHV LQ 6HSWHPEHU  LV UHTXLUHG IRU WKH XVH RI WKH &OHUN RI &RXUW IRU WKH SXUSRVH RI LQLWLDWLQJ
`WKH FLYLO GRFNHW VKHHW 6(( ,16758&7,216 21 1(;7 3$*( 2) 7+,6 )250

`
`, D

3/$,17,))6
`HORIZON THERAPEUTICS, INC.
`
`'()(1'$176
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`
`E

&RXQW\ RI 5HVLGHQFH RI )LUVW /LVWHG 3ODLQWLII
`Deerfield, Illinois
`(;&(37 ,1 86 3/$,17,)) &$6(6

`
`&RXQW\ RI 5HVLGHQFH RI )LUVW /LVWHG 'HIHQGDQW
`
`India
`,1 86 3/$,17,)) &$6(6 21/<

`
`127(
`
`
`
`,1 /$1' &21'(01$7,21 &$6(6 86( 7+( /2&$7,21 2)
`7+( 75$&7 2) /$1' ,192/9('
`
`F

$WWRUQH\V )LUP 1DPH $GGUHVV 7HOHSKRQH 1XPEHU DQG (PDLO $GGUHVV

`John E. Flaherty, Esq.
`McCarter & English, LLP, Four Gateway Center, 100 Mulberry Street,
`Newark, NJ, 07102. Tel: 973-622-4444 Email: jflaherty@mccarter.com
`,, %$6,6 2) -85,6',&7,21 3ODFH DQ ³;´ LQ 2QH %R[ 2QO\

`,,, &,7,=(16+,3 2) 35,1&,3$/ 3$57,(6 3ODFH DQ ³;´ LQ 2QH %R[ IRU 3ODLQWLII

`)RU 'LYHUVLW\ &DVHV 2QO\

` DQG 2QH %R[ IRU 'HIHQGDQW

` 37) '()
` 37)
` '()
`u 
`u 
`u  u 
`,QFRUSRUDWHG RU 3ULQFLSDO 3ODFH
`&LWL]HQ RI 7KLV 6WDWH
`RI %XVLQHVV ,Q 7KLV 6WDWH
`
`u  86 *RYHUQPHQW
`3ODLQW