Case 2:22-cv-01754 Document 1 Filed 03/29/22 Page 1 of 59 PageID: 1
`
`Charles H. Chevalier
`Rachel S. Johnston
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102-5310
`Telephone: (973) 596-4500
`cchevalier@gibbonslaw.com
`rjohnston@gibbonslaw.com
`
`Christine A. Gaddis
`GIBBONS P.C.
`141 West Front Street Suite 240
`Red Bank, New Jersey 07701
`Telephone: (732) 704-5901
`cgaddis@gibbonslaw.com
`
`Of Counsel:
`
`Edgar H. Haug
`Sandra Kuzmich, PhD
`Nicholas F. Giove
`Andrew S. Wasson
`HAUG PARTNERS LLP
`745 Fifth Avenue
`New York, NY 10151
`Telephone: (212) 588-0800
`ehaug@haugpartners.com
`skuzmich@haugpartners.com
`ngiove@haugpartners.com
`awasson@haugpartners.com
`
`Attorneys for Plaintiffs La Jolla Pharmaceutical Company,
`La Jolla Pharma, LLC, and The George Washington University
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`LA JOLLA PHARMACEUTICAL
`COMPANY; LA JOLLA PHARMA, LLC
`and THE GEORGE WASHINGTON
`UNIVERSITY,
`
`Civil Action No. ____________________
`
`(Filed Electronically)
`
`Plaintiffs,
`
`v.
`
`GLAND PHARMA LIMITED, SHANGHAI
`FOSUN PHARMACEUTICAL (GROUP)
`CO., LTD. and FOSUN PHARMA USA INC.
`
`Defendants.
`
`

`

`Case 2:22-cv-01754 Document 1 Filed 03/29/22 Page 2 of 59 PageID: 2
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`COMPLAINT
`
`Plaintiffs La Jolla Pharmaceutical Company (“LJPC”), La Jolla Pharma, LLC (“LJP
`
`LLC,” together with LJPC, “La Jolla”) and The George Washington University (“GW”)
`
`(collectively, “Plaintiffs”), by their undersigned attorneys, for their Complaint against Gland
`
`Pharma Limited (“Gland”), Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun
`
`Shanghai”), and Fosun Pharma USA Inc. (“Fosun USA”) (collectively, “Defendants”), allege:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement arising under the patent laws of the
`
`United States, Title 35 of the United States Code, involving U.S. Patent Nos. 11,219,662 (“the
`
`’662 patent”) (attached as Exhibit A), 9,220,745 (“the ’745 patent”) (attached as Exhibit B),
`
`10,028,995 (“the ’995 patent”) (attached as Exhibit C), 10,493,124 (“the ’124 patent”) (attached
`
`as Exhibit D), 11,096,983 (“the ’983 patent”) (attached as Exhibit E), 9,572,856 (“the ’856
`
`patent”) (attached as Exhibit F), 9,867,863 (“the ’863 patent”) (attached as Exhibit G),
`
`10,335,451 (“the ’451 patent”) (attached as Exhibit H), 10,500,247 (“the ’247 patent”) (attached
`
`as Exhibit I), and 10,548,943 (“the ’943 patent”) (attached as Exhibit J) (collectively, “the
`
`patents-in-suit”).
`
`THE PARTIES
`
`2.
`
`LJPC is a corporation organized and existing under the laws of the State of
`
`Delaware, having a principal place of business at 201 Jones Road, Suite 400, Waltham,
`
`Massachusetts 02451.
`
`3.
`
`LJP LLC is a limited liability company organized and existing under the laws of
`
`the State of Delaware, having a principal place of business at 201 Jones Road, Suite 400,
`
`Waltham, Massachusetts 02451.
`
`2
`
`

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`4.
`
`LJP LLC is the owner of New Drug Application (“NDA”) No. 209360, which
`
`was approved by the U.S. Food and Drug Administration (“FDA”) for the manufacture and sale
`
`of Giapreza® (angiotensin II acetate), EQ 2.5 mg base/mL, solution for intravenous
`
`administration (hereinafter, “Giapreza®”).
`
`5.
`
`LJP LLC is the current owner and assignee of the ’662 patent, which is listed in
`
`FDA’s publication titled “Approved Drug Products with Therapeutics Equivalence Evaluations”
`
`(commonly known as the “Orange Book”) as covering Giapreza®.
`
`6.
`
`GW is a Congressionally-chartered institution of higher education, having a
`
`principal place of business at 1918 F St., N.W., Washington, D.C. 20052.
`
`7.
`
`GW is the current owner and assignee of the ’745 patent, the ’995 patent, the ’124
`
`patent, the ’983 patent, the ’856 patent, the ’863 patent, the ’451 patent, the ’247 patent, and the
`
`’943 patent, which are listed in FDA’s Orange Book as covering Giapreza®.
`
`8.
`
`GW granted La Jolla an exclusive, worldwide license under the ’745 patent, the
`
`’995 patent, the ’124 patent, the ’983 patent, the ’856 patent, the ’863 patent, the ’451 patent, the
`
`’247 patent, and the ’943 patent to make, have made, use, import, offer for sale and sell
`
`Giapreza®.
`
`9.
`
`Upon information and belief, Gland is a corporation organized and existing under
`
`the laws of India, having a principal place of business at Survey No. 143-148, 150 & 151 Near
`
`Gandimaisamma ‘X’ Roads, D.P. Pally, Dundigal- Gandimaisamma Mandal, Medchal-
`
`Malkajgiri District, Hyderabad, Telangana- 500 043, India.
`
`10.
`
`Upon information and belief, Gland is in the business of, among other things:
`
`(i) alone or in concert with and/or through related entities (including Fosun Shanghai and Fosun
`
`USA), the development and manufacture of generic pharmaceutical products for sale throughout
`
`3
`
`

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`the United States, including throughout the State of New Jersey; (ii) alone or in concert with
`
`and/or through related entities (including Fosun Shanghai and Fosun USA), the preparation,
`
`submission, and filing of Abbreviated New Drug Applications seeking FDA approval to market
`
`generic drugs throughout the United States, including throughout the State of New Jersey; and
`
`(iii) alone or in concert with and/or through related entities (including Fosun Shanghai and Fosun
`
`USA), the distribution of generic pharmaceutical products for sale throughout the United States,
`
`including throughout the State of New Jersey.
`
`11.
`
`Upon information and belief, Gland is the current owner of Abbreviated New
`
`Drug Application No. 216966 (“Gland’s ANDA”) and is seeking final approval of Gland’s
`
`ANDA to engage in the commercial use, sale, and/or distribution of angiotensin II, 2.5 mg/mL
`
`vial (“Gland’s ANDA Product”) throughout the United States, including in New Jersey, before
`
`the expiration of the patents-in-suit. Upon information and belief, Gland’s ANDA includes a
`
`paragraph IV certification under 21 U.S.C. § 355(j)(2) (“paragraph IV certification”) to the
`
`patents-in-suit.
`
`12.
`
`Upon information and belief, Fosun Shanghai is a Chinese corporation having a
`
`principal place of business at No. 1289 Yishan Road, 9th Floor, Building A, Shanghai, F4
`
`200233, China.
`
`13.
`
`Upon information and belief, Fosun Shanghai is in the business of, among other
`
`things: (i) alone or in concert with and/or through related entities (including Fosun USA and
`
`Gland), the development and manufacture of generic pharmaceutical products for sale
`
`throughout the United States, including throughout the State of New Jersey; (ii) alone or in
`
`concert with and/or through related entities (including Fosun USA and Gland), the preparation,
`
`submission, and filing of Abbreviated New Drug Applications seeking FDA approval to market
`
`4
`
`

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`generic drugs throughout the United States, including throughout the State of New Jersey; and
`
`(iii) alone or in concert with and/or through related entities (including Fosun USA and Gland),
`
`the distribution of generic pharmaceutical products for sale throughout the United States,
`
`including throughout the State of New Jersey.
`
`14.
`
`Upon information and belief, Gland is a subsidiary of Fosun Shanghai. Upon
`
`information and belief, Gland acts at the direction of, under the control of, and for the benefit of
`
`Fosun Shanghai, and is controlled and/or dominated by Fosun Shanghai. Upon information and
`
`belief, Gland and Fosun Shanghai have at least one officer and/or director in common.
`
`15.
`
`Upon information and belief, on September 18, 2017, Fosun Shanghai and Gland
`
`“reached agreement that [Fosun Shanghai] will acquire an approximate 74% stake in Gland
`
`Pharma for no more than US$ 1,091.30 million.” Fosun Shanghai publicly stated that “the
`
`agreement will establish a closer cooperation between the management teams of Fosun Pharma
`
`and Gland Pharma to jointly promote the sustainable and stable development of Gland Pharma”
`
`and noted that “[c]urrently, Gland Pharma’s main business model is joint development of
`
`products and introduction of licenses to provide all global major pharmaceutical companies with
`
`the manufacturing services [sic] in relation to injectable generic drugs.”1
`
`16.
`
`Upon information and belief, Fosun USA is a Delaware corporation having a
`
`principal place of business at 104 Carnegie Center Drive, Suite 204, Princeton, New Jersey
`
`08540.
`
`17.
`
`Upon information and belief, Fosun USA is in the business of, among other
`
`things: (i) alone or in concert with and/or through related entities (including Fosun Shanghai and
`
`Gland), the development and manufacture of generic pharmaceutical products for sale
`
`1 https://www.fosunpharma.com/en/news/news-details-3700.html (last visited on Mar. 21, 2022).
`
`5
`
`

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`throughout the United States, including throughout the State of New Jersey; (ii) alone or in
`
`concert with and/or through related entities (including Fosun Shanghai and Gland), the
`
`preparation, submission, and filing of Abbreviated New Drug Applications seeking FDA
`
`approval to market generic drugs throughout the United States, including throughout the State of
`
`New Jersey; and (iii) alone or in concert with and/or through related entities (including Fosun
`
`Shanghai and Gland), the distribution of generic pharmaceutical products for sale throughout the
`
`United States, including throughout the State of New Jersey.
`
`18.
`
`Upon information and belief, Fosun USA is registered with the State of New
`
`Jersey’s Division of Revenue and Enterprise Services as a business operating in New Jersey with
`
`Business Identification Number 0101045291. Upon information and belief, Fosun USA is
`
`registered with the State of New Jersey’s Department of Health as a drug & medical device
`
`“manufacturer and wholesaler” under Registration Number 5005532.
`
`19.
`
`Upon information and belief, Fosun USA is a subsidiary of Fosun Shanghai.
`
`Upon information and belief, Fosun USA acts at the direction of, under the control of, and for the
`
`benefit of Fosun Shanghai, and is controlled and/or dominated by Fosun Shanghai. Upon
`
`information and belief, Fosun USA and Fosun Shanghai have at least one officer and/or director
`
`in common.
`
`JURISDICTION AND VENUE
`
`20.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`21.
`
`This Court has personal jurisdiction over Defendants under: (i) Fed. R. Civ. P.
`
`4(k)(1); (ii) Fed. R. Civ. P. 4(k)(2); and/or (iii) N.J. Ct. R. 4:4-4.
`
`22.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, Gland manufactures generic pharmaceutical products that are imported, distributed,
`
`6
`
`

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`Case 2:22-cv-01754 Document 1 Filed 03/29/22 Page 7 of 59 PageID: 7
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`and sold throughout the United States—including in New Jersey—and thus avails itself of the
`
`privileges and benefits of the laws and commerce of the United States, including New Jersey.2
`
`23.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, Gland regularly does or solicits business in New Jersey, engages in other persistent
`
`courses of conduct in New Jersey, and/or derives substantial revenue from services or things
`
`used or consumed in New Jersey, thereby demonstrating that Gland has continuous and
`
`systematic contacts with New Jersey.
`
`24.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, Gland has purposefully directed its activities at residents and corporate entities within
`
`the State of New Jersey and the claims set forth herein as to Gland arise out of or relate to those
`
`activities.
`
`25.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, Gland, together with Fosun Shanghai and Fosun USA, has committed, induced,
`
`and/or contributed to acts of patent infringement in New Jersey.
`
`26.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, Gland has previously submitted to the jurisdiction of this Court and has availed itself
`
`of New Jersey’s legal protections in prior litigations.3
`
`2 See, e.g., Novartis Pharm. Corp. v. Actavis LLC, No. 13-1028 (D.N.J. filed Feb. 20, 2013),
`ECF No. 241, Gland’s Answer at ¶ 13 (admitting that Gland “manufactures products that are
`sold throughout the United States, including in New Jersey”); Medicure Int’l., Inc. v. Gland
`Pharma Ltd., No. 18-16246 (D.N.J. filed November 16, 2018), ECF No. 13, Gland’s Answer at
`¶ 4 (admitting that Gland “develops, manufactures and/or distributes generic pharmaceutical
`products, and that certain generic pharmaceutical products developed, manufactured and/or
`distributed by Gland are ultimately sold in the United States, including in New Jersey.”).
`3 See, e.g., Novartis Pharm. Corp. v. Gland Pharma Ltd., No. 14-1841 (D.N.J. filed Mar. 21,
`2014); Novartis Pharm. Corp. v. Actavis LLC, No. 13-1028 (D.N.J. filed Feb. 20, 2013);
`Novartis Pharm. Corp. v. Wockhardt USA LLC, No. 12-3967 (D.N.J. filed June 27, 2012);
`Medicure Int’l., Inc. v. Gland Pharma Ltd., No. 18-16246 (D.N.J. filed Nov. 16, 2018).
`
`7
`
`

`

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`27.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, Gland has previously invoked this Court’s jurisdiction by asserting counterclaims in
`
`prior litigations.4
`
`28.
`
`This Court has personal jurisdiction over Gland at least because, upon information
`
`and belief, it is reasonable and fair for this Court to exercise personal jurisdiction over Gland.
`
`29.
`
`Upon information and belief, Gland “sells its products primarily under a business
`
`to business (‘B2B’) model in over 60 countries with its core markets being United States,
`
`Europe, Canada, Australia and India.”5
`
`30.
`
`Upon information and belief, “[g]eographically, USA continues to be [Gland’s]
`
`primary market.”6
`
`31.
`
`Upon information and belief, Gland’s regulatory “team is constantly engaged
`
`with regulators including the USFDA.”7
`
`32.
`
`Upon information and belief, Gland, “along with its partners has 284 ANDA
`
`filings in the United States, of which 234 were approved and 50 were pending approval.”8
`
`4 See Novartis Pharms. Corp. v. Actavis LLC, No. 13-1028 (D.N.J. filed Feb. 20, 2013); Novartis
`Pharma Corp. v. Wockhardt USA LLC, No. 12-3967 (D.N.J. filed June 27, 2012); Medicure
`Int’l., Inc. v. Gland Pharma Ltd., No. 18-16246 (D.N.J. filed Nov. 16, 2018).
`5 https://glandpharma.com/images/Annual%20Report%202020-21%20(Double%20Page).pdf
`(last visited Mar. 21, 2022) (emphasis added).
`6 https://glandpharma.com/images/Annual%20Report%202020-21%20(Double%20Page).pdf
`(last visited Mar. 21, 2022).
`7 https://glandpharma.com/images/Annual%20Report%202020-21%20(Double%20Page).pdf
`(last visited Mar. 21, 2022) (emphasis added).
`8 https://glandpharma.com/images/Annual%20Report%202020-21%20(Double%20Page).pdf
`(last visited Mar. 21, 2022).
`
`8
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`

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`33.
`
`Upon information and belief, “[a]s on March 31, 2021, [Gland] has filed 45
`
`DMFs in the United States.”9
`
`34.
`
`Upon information and belief, Gland derives substantial revenue from the sale of
`
`generic pharmaceutical products throughout the United States, including in New Jersey.
`
`35.
`
`This Court has personal jurisdiction over Fosun Shanghai at least because:
`
`(i) Fosun Shanghai is doing business in New Jersey and maintains continuous and systematic
`
`contacts with this Judicial District; (ii) Fosun Shanghai has purposefully directed its activities
`
`and the activities of Fosun USA and Gland, its subsidiaries, at residents and corporate entities
`
`within the State of New Jersey; (iii) the claims set forth herein as to Fosun Shanghai arise out of
`
`or relate to those activities; (iv) Fosun Shanghai, together with Gland and Fosun USA, its
`
`subsidiaries, is in the business of developing and manufacturing generic pharmaceutical products
`
`for importation, sale, and/or distribution in the State of New Jersey; (v) Fosun Shanghai, together
`
`with Gland and Fosun USA, its subsidiaries, has committed, induced, and/or contributed to acts
`
`of patent infringement in New Jersey; (vi) Fosun Shanghai’s contacts with the State of New
`
`Jersey (direct and/or indirect) are continuous and systematic; and (vii) it is reasonable and fair
`
`for this Court to exercise personal jurisdiction over Fosun Shanghai.
`
`36.
`
`This Court has personal jurisdiction over Fosun USA at least because, upon
`
`information and belief: (i) Fosun USA maintains a principal place of business in New Jersey
`
`located at 104 Carnegie Center, Suite 204, Princeton, New Jersey 08540; (ii) Fosun USA is
`
`doing business in New Jersey and maintains continuous and systematic contacts with this
`
`Judicial District; (iii) Fosun USA, together with Gland and its parent Fosun Shanghai, is in the
`
`9 https://glandpharma.com/images/Annual%20Report%202020-21%20(Double%20Page).pdf
`(last visited Mar. 21, 2022).
`
`9
`
`

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`business of developing and manufacturing generic pharmaceutical products for importation, sale,
`
`and/or distribution in the State of New Jersey; (iv) Fosun USA, together with Gland and its
`
`parent Fosun Shanghai, has committed, induced, and/or contributed to acts of patent
`
`infringement in New Jersey; (v) Fosun USA is registered with the State of New Jersey’s Division
`
`of Revenue and Enterprise Services as a business operating in New Jersey with Business
`
`Identification Number 0101045291; and (vi) Fosun USA is registered with the State of New
`
`Jersey’s Department of Health as a drug & medical device “manufacturer and wholesaler” under
`
`Registration Number 5005532.
`
`37.
`
`Upon information and belief, Fosun USA or its affiliates, sell, offer for sale, and
`
`distribute generic pharmaceutical products for which Gland is the named ANDA applicant.
`
`Upon information and belief, Defendants each, directly or indirectly, derive substantial revenue
`
`from the sales of such generic pharmaceutical products in the United States, including in the
`
`State of New Jersey.
`
`38.
`
`In its Notice Letter (see Paragraph 54, infra), Gland represents that it prepared,
`
`submitted, and filed Gland’s ANDA with FDA seeking approval to engage in the commercial
`
`manufacture, use, and/or sale of Gland’s ANDA Product before the expiration of the patents-in-
`
`suit throughout the United States, including in this Judicial District.
`
`39.
`
`This Court has personal jurisdiction over Defendants at least because, upon
`
`information and belief, if Gland’s ANDA receives final FDA approval, Gland’s ANDA Product
`
`will be manufactured by Defendants and offered for sale, sold, distributed, and/or used by
`
`Defendants in the United States, including in the State of New Jersey.
`
`40.
`
`This Court has personal jurisdiction over Defendants at least because, upon
`
`information and belief, if Gland’s ANDA receives final approval, Gland’s ANDA Product will
`
`10
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`

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`be prescribed by physicians practicing in New Jersey and/or administered to patients in New
`
`Jersey.
`
`41.
`
`Upon information and belief, Defendants’ acts of preparing and filing Gland’s
`
`ANDA and directing notice of the submission to Plaintiffs were performed at the direction of,
`
`with the authorization of, and with the cooperation, participation, assistance, and, at least in part,
`
`for the benefit of Gland, Fosun Shanghai, and Fosun USA. The acts giving rise to this
`
`infringement action, including the present and/or anticipated commercial manufacture, use,
`
`and/or sale of Gland’s ANDA Product before the expiration of the patents-in-suit throughout the
`
`United States, including in this Judicial District, will have real and injurious consequences for
`
`the State of New Jersey. Because defending against an infringement lawsuit such as this one is
`
`an essential and expected part of a generic pharmaceutical company’s business, Defendants
`
`reasonably anticipated being sued in New Jersey.
`
`42.
`
`43.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and/or 1400(b).
`
`Venue is further proper as to Gland, a foreign corporation, in any Judicial District
`
`that has personal jurisdiction, including this Judicial District.
`
`44.
`
`Venue is further proper as to Fosun Shanghai, a foreign corporation, in any
`
`judicial district that has personal jurisdiction, including this Judicial District.
`
`FACTS COMMON TO ALL COUNTS
`
`45.
`
`Giapreza® is sold and marketed under NDA No. 209360, which was approved by
`
`FDA on December 21, 2017.
`
`46.
`
`Giapreza® is a sterile, aqueous solution of synthetic human angiotensin II acetate
`
`for intravenous administration by infusion.
`
`47.
`
`Giapreza® is supplied in a vial as a concentrated solution of 2.5 mg/mL
`
`angiotensin II that is diluted in 0.9% sodium chloride prior to use.
`
`11
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`48.
`
`Each 1 mL of Giapreza® contains 2.5 mg angiotensin II equivalent to an average
`
`of 2.9 mg angiotensin II acetate, 25 mg mannitol, and water for injection adjusted with sodium
`
`hydroxide and/or hydrochloric acid to pH of 5.5.
`
`49.
`
`The recommended starting dosage of Giapreza® is 20 ng/kg/min via continuous
`
`intravenous infusion.
`
`50.
`
`Giapreza® is a vasoconstrictor that increases blood pressure in adults with septic
`
`or other distributive shock. Concomitant use of angiotensin converting enzyme (ACE) inhibitors
`
`may increase a patient’s response to Giapreza®.
`
`51.
`
`The safety of Giapreza® was evaluated in 321 adults with septic or other
`
`distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3. Patients
`
`in the ATHOS-3 clinical study were receiving other vasopressors in addition to Giapreza® or
`
`placebo, which were titrated to effect on mean arterial pressure (MAP). The Giapreza®
`
`prescribing information provides the following additional information regarding the ATHOS-3
`
`Clinical Study:
`
`12
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`52.
`
`53.
`
`FDA’s Orange Book lists the patents-in-suit as covering Giapreza®.
`
`Under 21 U.S.C. § 355(j)(2)(B), the filer of an Abbreviated New Drug
`
`Application containing a paragraph IV certification must provide notice of the filing to each
`
`patent owner and each New Drug Application holder. Under 21 U.S.C. § 355(j)(2)(B)(iv)(II),
`
`such notice must “include a detailed statement of the factual and legal basis of the opinion of the
`
`applicant that the patent is invalid or will not be infringed.” Likewise, 21 C.F.R. § 314.95(c)(7)
`
`requires that such notice include a “detailed statement of the factual and legal basis of the
`
`applicant’s opinion that the patent is not valid, unenforceable, or will not be infringed.” The
`
`detailed statement must include: “For each claim of a patent alleged not to be infringed, a full
`
`and detailed explanation of why the claim is not infringed” and “[f]or each claim of a patent
`
`alleged to be invalid or unenforceable, a full and detailed explanation of the ground supporting
`
`the allegation.” 21 C.F.R. § 314.95(c)(7)(i)–(ii).
`
`54.
`
`Gland sent a letter regarding ANDA No. 216966 to “La Jolla Pharmaceutical
`
`Company [sic] LLC”10 and GW dated February 14, 2022, purportedly pursuant to
`
`§ 505(j)(2)(B)(ii) of the Federal Food Drug & Cosmetic Act (“FDCA”), 21 U.S.C. §
`
`355(j)(2)(B)(ii) and § 314.95 of Title 21 of the Code of Federal Regulations (the “Notice
`
`Letter”).
`
`55.
`
`56.
`
`Plaintiffs received a copy of the Notice Letter on February 15, 2022.
`
`The Notice Letter states that Gland’s “ANDA was submitted under 21 U.S.C. §
`
`355(j)(l) and 2(A) with a paragraph IV certification to obtain approval to engage in the
`
`commercial manufacture, use, or sale of Angiotensin II injection for intravenous infusion 2.5
`
`10 The entity that owns New Drug Application NDA No. 209360 is “La Jolla Pharma, LLC,” not
`“La Jolla Pharmaceutical Company LLC.”
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`mg/mL in a vial, before the expiration of the [patents-in-suit], which are listed in Approved Drug
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`Products with Therapeutic Equivalence Evaluation (‘Orange Book’) against Giapreza®
`
`(angiotensin II), Injection for Intravenous Infusion 2.5 mg/mL in a vial.”
`
`57.
`
`Upon information and belief, the reference listed drug for Gland’s ANDA is
`
`Giapreza® (angiotensin II) 2.5 mg/mL Injection for Intravenous Infusion.
`
`58.
`
`The Notice Letter further states that “[p]ursuant to 21 C.F.R. § 314.95(c)(6), we
`
`advise you that the [patents-in-suit] are alleged to be not infringed, invalid, and/or unenforceable
`
`in a paragraph IV certification submitted by Gland in connection with ANDA No. 216966.”
`
`59.
`
`The Notice Letter does not include any unenforceability contentions with respect
`
`to any of the patents-in-suit.
`
`60.
`
`The FDA’s Orange Book lists the “Patent Expiration” for the ’745, ’995, ’124,
`
`and ’983 patents as December 18, 2034; the “Patent Expiration” for the ’856 patent as July 18,
`
`2031; the “Patent Expiration” for the ’863, ’451, ’247, and ’943 patents as December 16, 2029;
`
`and the “Patent Expiration” for the ’662 patent as January 6, 2037.
`
`61.
`
`Gland’s Notice Letter included an Offer of Confidential Access to “certain
`
`[unspecified] information” from Gland’s ANDA, purportedly pursuant to 21 U.S.C. §
`
`355(j)(5)(C). Gland demanded that Plaintiffs accept the Offer of Confidential Access before it
`
`would produce “certain [unspecified] information” from Gland’s ANDA. Gland’s Offer of
`
`Confidential Access contained numerous unreasonable and overly restrictive provisions.
`
`Plaintiffs proposed revisions comport with provisions that “would apply had a protective order
`
`been entered for the purpose of protecting trade secrets and other confidential business
`
`information.” See 21 U.S.C. § 355. Plaintiffs and Defendants did not reach agreement on the
`
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`Case 2:22-cv-01754 Document 1 Filed 03/29/22 Page 15 of 59 PageID: 15
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`terms of an Offer of Confidential Access and, to date, Defendants have not produced a copy of
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`Gland’s ANDA to Plaintiffs.
`
`62.
`
`In its Notice Letter, Gland stated that its proposed label states that Gland’s ANDA
`
`Product “is indicated to increase blood pressure in adults with septic or other distributive shock.”
`
`63.
`
`In its Notice Letter, Gland stated that its proposed label “recommends starting
`
`angiotensin II injection intravenously at 20 nanograms (ng)/kg/min, and titrating by increments
`
`of up to 15 ng/kg/min as needed.”
`
`64.
`
`The ’745 patent, titled, “Angiotensin II Alone or in Combination for the
`
`Treatment of Hypotension,” was duly and legally issued by the U.S. Patent and Trademark
`
`Office on December 29, 2015. Inventor Lakhmir Chawla assigned all rights, title, and interest in
`
`the ’745 patent to GW.
`
`65.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’745 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’745 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`66.
`
`The ’995 patent, titled, “Angiotensin II Alone or in Combination for the
`
`Treatment of Hypotension,” was duly and legally issued by the U.S. Patent and Trademark
`
`Office on July 24, 2018. Inventor Lakhmir Chawla assigned all rights, title, and interest in the
`
`’995 patent to GW.
`
`67.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’995 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’995 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`68.
`
`The ’124 patent, titled, “Angiotensin II Alone or in Combination for the
`
`Treatment of Hypotension,” was duly and legally issued by the U.S. Patent and Trademark
`
`15
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`Office on December 3, 2019. Inventor Lakhmir Chawla assigned all rights, title, and interest in
`
`the ’124 patent to GW.
`
`69.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’124 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’124 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`70.
`
`The ’983 patent, titled, “Angiotensin II Alone or in Combination for the
`
`Treatment of Hypotension,” was duly and legally issued by the U.S. Patent and Trademark
`
`Office on August 24, 2021. Inventor Lakhmir Chawla assigned all rights, title, and interest in the
`
`’983 patent to GW.
`
`71.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’983 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’983 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`72.
`
`The ’856 patent, titled, “Method of Treating Low Blood Pressure,” was duly and
`
`legally issued by the U.S. Patent and Trademark Office on February 21, 2017. Inventor Lakhmir
`
`Chawla assigned all rights, title, and interest in the ’856 patent to GW.
`
`73.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’856 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’856 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`74.
`
`The ’863 patent, titled, “Method of Treating Low Blood Pressure,” was duly and
`
`legally issued by the U.S. Patent and Trademark Office on January 16, 2018. Inventor Lakhmir
`
`Chawla assigned all rights, title, and interest in the ’863 patent to GW.
`
`16
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`
`75.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’863 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’863 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`76.
`
`The ’451 patent, titled, “Method of Treating Low Blood Pressure,” was duly and
`
`legally issued by the U.S. Patent and Trademark Office on July 2, 2019. Inventor Lakhmir
`
`Chawla assigned all rights, title, and interest in the ’451 patent to GW.
`
`77.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’451 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’451 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`78.
`
`The ’247 patent, titled, “Method of Treating Low Blood Pressure,” was duly and
`
`legally issued by the U.S. Patent and Trademark Office on December 10, 2019. Inventor
`
`Lakhmir Chawla assigned all rights, title, and interest in the ’247 patent to GW.
`
`79.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’247 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’247 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`80.
`
`The ’943 patent, titled, “Method of Treating Low Blood Pressure,” was duly and
`
`legally issued by the U.S. Patent and Trademark Office on February 4, 2020. Inventor Lakhmir
`
`Chawla assigned all rights, title, and interest in the ’943 patent to GW.
`
`81.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’943 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’943 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`82.
`
`GW granted La Jolla an exclusive, worldwide license under the ’745 patent, the
`
`’995 patent, the ’124 patent, the ’983 patent, the ’856 patent, the ’863 patent, the ’451 patent, the
`
`17
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`Case 2:22-cv-01754 Document 1 Filed 03/29/22 Page 18 of 59 PageID: 18
`
`’247 patent, and the ’943 patent to make, have made, use, import, offer for sale and sell
`
`Giapreza®.
`
`83.
`
`The ’662 patent, titled, “Method for Treating Hypotension in a Patient that Has
`
`Received an ACE Inhibitor by Administering Angiotensin II,” was duly and legally issued by the
`
`U.S. Patent and Trademark Office on January 11, 2022. Inventors Lakhmir Chawla and George
`
`Tidmarsh assigned all rights, title, and interest in the ’662 patent to LJPC. LJPC subsequently
`
`assigned all rights, title, and interest in the ’662 patent to LJP LLC.
`
`84.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the ’662 patent was submitted to FDA in
`
`connection with NDA No. 209360. The ’662 patent was subsequently listed in the Orange Book
`
`as covering Giapreza®.
`
`85.
`
`Upon information and belief, Defendants intend to manufacture, import, use, sell,
`
`or offer to sell Gland’s ANDA Product for uses that would infringe one or more of the claims of
`
`the