UNIFORMED FIRE OFFICERS ASSOCIATION
`FAMILY PROTECTION PLAN LOCAL 854 and
`UNIFORMED FIRE OFFICERS ASSOCIATION
`FOR RETIRED FIRE OFFICERS FAMILY
`PROTECTION PLAN, on behalf of themselves and
`all others similarly situated,
`
`
`
`
`
`
`
`
` v.
`
`AMARIN PHARMA, INC., AMARIN
`PHARMACEUTICALS IRELAND LIMITED,
`AMARIN CORPORATION PLC, BASF
`AMERICAS CORPORATION, BASF
`CORPORATION, BASF PHARMA (CALLANISH)
`LTD, BASF USA HOLDING LLC, CHEMPORT,
`INC., NISSHIN PHARMA, INC., NOVASEP LLC,
`NOVASEP, INC., GROUPE NOVASEP SAS, AND
`FINORGA SAS,
`
`
`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 1 of 80 PageID: 1
`
`
`
`
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Civil Action No.
`
`
`
`
`
`
`
`
`
`
`
`COMPLAINT and
`DEMAND FOR JURY TRIAL
`
`Plaintiffs,
`
` Defendants.
`
`
`
`Plaintiffs Uniformed Fire Officers Association Family Protection Plan Local 854 and the
`
`Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan (collectively
`
`“Plaintiffs” or “UFOA”) bring this action on behalf of themselves and all others similarly situated
`
`against Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, Amarin Corporation PLC
`
`(collectively “Amarin”); BASF Americas Corporation, BASF Corporation, BASF Pharma
`
`(Callanish) Limited, BASF USA Holding LLC (collectively “BASF”); Chemport, Inc.
`
`(“Chemport”); Nisshin Pharma, Inc. (“Nisshin”); Novasep, LLC, Novasep, Inc., Groupe Novasep
`
`SAS, Finorga SAS (collectively “Novasep,” together with Amarin, BASF, Chemport, and Nisshin,
`
`
`
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 2 of 80 PageID: 2
`
`
`
`“Defendants”). These allegations are based on investigations of counsel, publicly available
`
`materials and knowledge, information, and belief.
`
`INTRODUCTION
`
`1.
`
`This case arises from Defendants’ illegal scheme to delay competition in the United
`
`States and its territories for Vascepa, a prescription medication approved by the U.S. Food and
`
`Drug Administration (“FDA”) to treat hyperglyceridemia in adults. Plaintiffs seek overcharge
`
`damages arising from Defendants’ unlawful scheme to prevent generic competition for Vascepa
`
`by hoarding the world’s supply of the active pharmaceutical ingredient needed to make the drug.
`
`2.
`
`The active ingredient in Vascepa is icosapent ethyl (“IPE”), made from
`
`eicosapentaeonic acid (“EPA”), an omega-3 fatty acid found in fish oil. Vascepa has been shown
`
`both to lower triglycerides and to reduce the risk of cardiovascular events in patients who have
`
`high triglycerides (150 mg/dL or higher). In 2020, annual sales of Vascepa in the United States
`
`were over $600 million.
`
`3.
`
`In September and October of 2016, four drug companies filed applications with the
`
`FDA to launch generic versions of Vascepa: Roxane Laboratories, Inc. and related entities, later
`
`acquired by Hikma Pharmaceuticals Plc (“Hikma”), Dr. Reddy’s Laboratories Inc. (“DRL”), Teva
`
`Pharmaceuticals USA, Inc. and related entities (“Teva”), and Apotex, Inc. (“Apotex”).1 Hikma,
`
`DRL, and Teva each contended that all of the asserted patent claims were either invalid or not
`
`infringed by their respective generic version of Vascepa. Amarin sued each of these generics in
`
`turn. Apotex contended that some of the asserted patent claims were either invalid or not infringed
`
`by Apotex’s generic version of Vascepa, but did not challenge all of the asserted patent claims.
`
`
`1 Applications were previously filed with the FDA, but they were rejected after Amarin
`successfully extended its New Chemical Entity exclusivity period, rendering those earlier-filed
`applications premature.
`
`
`
`
`2
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 3 of 80 PageID: 3
`
`
`
`
`4.
`
`Amarin settled with Teva in May 2018 and Apotex in June 2020. Pursuant to those
`
`agreements, Teva and Apotex have agreed to forego selling their respective generic versions of
`
`Vascepa in the United States until August 9, 2029, or earlier under certain circumstances.
`
`5.
`
`Hikma and DRL, however, continued their patent fight and won at trial – on March
`
`30, 2020, Judge M. Du Miranda, Federal District Court Judge for the District of Nevada, held that
`
`Amarin’s patents were invalid due to obviousness.
`
`6.
`
`After its patent victory, DRL promptly began preparations to launch generic
`
`Vascepa, “only to discover that Amarin had foreclosed all the suppliers of the icosapent ethyl API
`
`who have sufficient capacity to support a commercial launch in a timely manner.”2
`
`7.
`
`Hikma received FDA approval to launch its generic version of 1mg Vascepa on
`
`May 22, 2020.3
`
`8.
`
`DRL received FDA approval to launch its generic version of 1mg Vascepa on
`
`August 7, 2020.4 As of that date, DRL had removed all legal and regulatory barriers to its entry
`
`into the market for 1mg Vascepa, but it has been entirely foreclosed from entering that market due
`
`to Amarin’s use of a series of exclusive contracts and other anticompetitive conduct to lock up the
`
`world’s supply of IPE, the active pharmaceutical ingredient in Vascepa. Amarin had secured a
`
`supply of several times Amarin’s own needs based on its anticipated sales.
`
`
`2 Complaint, Doc. No. 1, Dr. Reddy’s Laboratories Inc. v. Amarin Pharma, Inc., Amarin
`Pharmaceuticals Ireland Limited, and Amarin Corporation PLC, No. 3:21-cv-10309-BRM-ZNQ
`(D.N.J. Apr. 27, 2021) (“DRL Complaint”), ¶ 3.
`3 “Hikma receives FDA approval for its generic Vascepa,” PR Newswire (May 22, 2020),
`https://www.prnewswire.com/news-releases/hikma-receives-fda-approval-for-its-generic-
`vascepa-301064061.html (last accessed May 6, 2021).
`209499,
`ANDA
`4
`Product
`Details
`for
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=2
`09499#312 (last accessed May 6, 2021).
`
`
`
`
`3
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 4 of 80 PageID: 4
`
`
`
`
`9.
`
`Amarin lost its appeal of Judge Miranda’s March 30, 2020, invalidity order on
`
`September 3, 2020.
`
`10.
`
`Hikma launched limited amounts of its 1mg generic Vascepa on November 5, 2020,
`
`hampered by Amarin’s anticompetitive capture of the world’s supply of IPE.
`
`11.
`
`Amarin was able to prevent DRL’s generic Vascepa launch and limit Hikma’s
`
`launch by purposely contracting with at least four different API manufacturers5 – one or two is
`
`standard in the pharmaceutical industry – using agreements that prevent these suppliers from
`
`selling IPE API to any other manufacturer,6 and has otherwise foreclosed access to at least one
`
`other major supplier.
`
`12.
`
`Amarin has no legitimate procompetive reason for entering into exclusive supply
`
`agreements with these four manufacturers. The total annual capacity of these suppliers has been
`
`more than triple Amarin’s requirements at relevant times in the past, and is at least double
`
`Amarin’s current requirements.
`
`13.
`
`Notably, Amarin has repeatedly touted its anticompetitive scheme to investors,
`
`often coyly referring to “taking advantage of manufacturing barriers to entry,”7 but sometimes
`
`bluntly stating that the addition of a new supplier “fortifies Amarin’s efforts to shield its Vascepa
`
`patent beyond its scheduled 2030 expiration.”8
`
`
`5 Nisshin Pharma Inc., Equatez Ltd., Chemport Inc., and Novasep.
`6 See, e.g., Amarin Corp. plc, Quarterly Report (Form 10-Q), at 16 (Nov. 8, 2011) (“Following
`FDA approval of [Vascepa] both agreements [with Equateq and Chemport] include annual
`purchase levels enabling Amarin to maintain supply exclusivity with each respective supplier”)
`(emphasis added).
`7 Amarin Corp. plc, Annual Report (Form 10-K), at 3 (Feb. 29, 2012).
`8 Press Release, Amarin Corp. plc, “Amarin Announces Approval of Supplemental New Drug
`Application for Chemport as Additional Vascepa® Active Pharmaceutical Ingredient Supplier”
`(Apr. 18, 2013), https://investor.amarincorp.com/news-releases/news-release-details/amarin-
`announces-approval-supplemental-new-drug-application (last accessed May 6, 2021).
`
`
`
`
`4
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 5 of 80 PageID: 5
`
`
`
`
`14.
`
`As a result of Amarin’s scheme, DRL’s launch of generic Vascepa has been delayed
`
`since August 2020, Hikma’s launch of generic Vascepa has been constrained by limited supply,
`
`and Plaintiffs and members of the class have been forced to pay anticompetitive prices for Vascepa
`
`and its generic equivalent.
`
`JURISDICTION AND VENUE
`
`15.
`
`This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332(d) because
`
`this is a class action involving common questions of law or fact in which the aggregate amount in
`
`controversy exceeds $5,000,000, exclusive of interest and costs; there are more than one hundred
`
`members of each class; and at least one member of each of the putative classes is a citizen of a
`
`state different from that of one of the Defendants.
`
`16.
`
`This Court also has supplemental jurisdiction over state law claims pursuant to 28
`
`U.S.C. § 1367(a).
`
`17.
`
`Venue is appropriate within this District under 28 U.S.C. § 1391. Defendants
`
`transact business within this District and/or have agents in and/or that can be found in this District,
`
`and a portion of the affected interstate trade and commerce discussed below was carried out in this
`
`District. At all relevant times, Amarin’s U.S. operations were headquartered in this District.
`
`18.
`
`The Court has personal jurisdiction over each of the Defendants. Defendants have
`
`transacted business, maintained substantial contacts, and/or committed overt acts in furtherance of
`
`the illegal scheme throughout the United States, including in this District. The scheme has been
`
`directed at and has had the intended effect of causing injury to individuals and companies residing
`
`in or doing business throughout the United States, including in this District. Personal jurisdiction
`
`lies under Fed. R. Civ. P. 4(k)(2) over the foreign domiciliary defendants.
`
`
`
`
`5
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 6 of 80 PageID: 6
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`
`
`
`A. Plaintiffs
`
`THE PARTIES
`
`19.
`
`Plaintiff Uniformed Fire Officers Association Family Protection Plan Local 854
`
`(“UFOAFPP”) is a health and welfare benefits plan headquartered and with a principal place of
`
`business in New New York, New York. UFOAFPP administers the assets of defined contribution
`
`plans formed to provide certain benefits including prescription drug benefits. UFOAFPP provides
`
`health and welfare benefits to members and participants who reside in numerous locations in the
`
`United States. UFOAFPP purchased and/or provided reimbursement for some or all of the
`
`purchase price for Vascepa other than for re-sale, in at least Connecticut, New York, and New
`
`Jersey at supracompetitive prices during the Class Period and has thereby been injured. In addition,
`
`there is a substantial probability that UFOAFPP will in the future purchase Vascepa manufactured
`
`by Amarin, and it has purchased and/or intends to purchase generic versions of Vascepa, other
`
`than for re-sale, once they become available. UFOAFPP paid and reimbursed more for these
`
`products than they would have absent Defendants’ anticompetitive conduct to fix, raise, maintain,
`
`and stabilize the prices and allocate markets for Vascepa.
`
`20.
`
`Plaintiff Uniformed Fire Officers Association For Retired Fire Officers Family
`
`Protection Plan (“RFOFPP”) is a health and welfare benefits plan headquartered and with a
`
`principal place of business in New New York, New York. RFOFPP administers the assets of
`
`defined contribution plans formed to provide certain benefits including prescription drug benefits.
`
`RFOFPP provides health and welfare benefits to members and participants who reside in numerous
`
`locations in the United States. RFOFPP purchased and/or provided reimbursement for some or all
`
`of the purchase price for Vascepa other than for re-sale, in at least Connecticut, Delaware, Florida,
`
`New York, New Jersey, Pennsylvania, South Carolina, and Virginia at supracompetitive prices
`
`during the Class Period and has thereby been injured. In addition, there is a substantial probability
`
`
`
`
`6
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 7 of 80 PageID: 7
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`
`
`that RFOFPP will in the future purchase Vascepa manufactured by Amarin, and it has purchased
`
`and/or intends to purchase generic versions of Vascepa, other than for re-sale, once they become
`
`available. RFOFPP paid and reimbursed more for these products than they would have absent
`
`Defendants’ anticompetitive conduct to fix, raise, maintain, and stabilize the prices and allocate
`
`markets for Vascepa.
`
`B. Defendants
`
`21.
`
`Defendant Amarin Pharma, Inc. is a company organized and existing under the laws
`
`of Delaware with its principle place of business at 1430 Route 206, Bedminster, NJ 07921.
`
`22.
`
`Defendant Amarin Pharmaceuticals Ireland Limited is a company incorporated
`
`under the laws of Ireland with registered offices at 88 Harcourt Street, Dublin 2, Dublin, Ireland.
`
`23.
`
`Defendant Amarin Corporation plc is a company incorporated under the laws of
`
`England and Wales with principal executive offices at 77 Sir John Rogerson’s Quay, Block C,
`
`Gran Canal Docklands, Dublin 2, Ireland. Defendants Amarin Pharma, Inc., Amarin
`
`Pharmaceuticals Ireland Limited, and Amarin Corporation plc are collectively referred to herein
`
`as “Amarin.”
`
`24.
`
`Defendant BASF Americas Corporation is a company organized and existing under
`
`the laws of Delaware with its principle place of business at 1105 North Market Street, Suite 1306,
`
`P.O. Box 8985, Wilmington, DE 19899.
`
`25.
`
`Defendant BASF Corporation is a company organized and existing under the laws
`
`of Delaware with its principle place of business at 100 Park Avenue, Florham Park, NJ 07932.
`
`26.
`
`Defendant BASF Pharma (Callanish) Limited is a company incorporated under the
`
`laws of England with registered offices at 2 Stockport Exchange, Railway Road, Stockport, SK1
`
`3GG, United Kingdom.
`
`
`
`
`7
`
`

`

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`
`
`
`27.
`
`Defendant BASF USA Holding LLC is a company organized and existing under
`
`the laws of Delaware with its principle place of business at 100 Park Avenue, Florham Park,
`
`NJ 07932. Defendants BASF Americas Corporation, BASF Corporation, BASF Pharma
`
`(Callanish) Limited, and BASF USA Holding LLC are collectively referred to herein as “BASF.”
`
`28.
`
`Defendant Chemport Inc. is a company incorporated under the laws of the Republic
`
`of Korea with its principal place of business at 15-1, Dongsu-dong, Naju-si, Jeollanam-do 520-
`
`330 Korea.
`
`29.
`
`Defendant Nisshin Pharma, Inc. is a company incorporated under the laws of Japan
`
`with its principal place of business at 25, Kanda-Nishiki-cho 1-chome, Chiyoda-ku, Tokyo 101-
`
`8441, Japan.
`
`30.
`
`Defendant Novasep, LLC is a company organized and existing under the laws of
`
`New Jersey with its principal place of business at 23 Creek Circle, Boothwyn, PA 19061.
`
`31.
`
`Defendant Novasep, Inc. is a company organized and existing under the laws of
`
`New Jersey with its principal place of business at 23 Creek Circle, Boothwyn, PA 19061.
`
`32.
`
`Defendant Groupe Novasep SAS is a company incorporated under the laws of
`
`France with its principal place of business at 39, Rue Saint Jean De Dieu Lyon, 69007 France.
`
`33.
`
`Defendant Finorga SAS is a company organized and existing under the laws of
`
`France with its principal place of business at Route De Givors Chasse Sur Rhone, 38670 France.
`
`Defendants Novasep, LLC, Novasep, Inc., Group Novasep SAS, and Finorga SAS are collectively
`
`referred to herein as “Novasep.”
`
`REGULATORY BACKGROUND
`
`A. Approval of a first entrant
`
`34.
`
`Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et
`
`seq., manufacturers that create a new drug must obtain approval from the FDA to sell the product
`
`
`
`
`8
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 9 of 80 PageID: 9
`
`
`
`by filing a New Drug Application (“NDA”).9 An NDA must include specific data concerning the
`
`safety and effectiveness of the drug, as well as any information on applicable patents.10
`
`35. When the FDA approves a brand pharmaceutical manufacturer’s NDA, the
`
`manufacturer may list in Approved Drug Products with Therapeutic Equivalence Evaluations (the
`
`“Orange Book”) certain patents that the manufacturer asserts could reasonably be enforced against
`
`a manufacturer that makes, uses, or sells a generic version of the brand drug before the expiration
`
`of the listed patents. After the FDA approves the NDA, the brand manufacturer may list such
`
`patents in the Orange Book.11
`
`36. When they do not face generic competition, brand manufacturers can usually sell
`
`the branded drug far above the marginal cost of production, generating profit margins well in
`
`excess of 70% while making hundreds of millions of dollars in sales.
`
`B. Approval of a generic drug
`
`37.
`
`Once lawful periods of patent exclusivity expire on branded drug products, generic
`
`drug manufacturers can seek FDA approval to market and sell generic versions of the branded
`
`drug. Under the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98
`
`Stat. 1585 (1984)—commonly known as “Hatch-Waxman”—competitors wishing to sell a generic
`
`equivalent of a branded drug may file an abbreviated new drug application (“ANDA”), which
`
`relies in substantial part on the scientific findings of safety and efficacy contained in the branded
`
`drug manufacturer’s NDA. The brand drug is called the reference listed drug (“RLD”).
`
`
`9 21 U.S.C. §§ 301-392.
`10 21 U.S.C. §§ 355(a), (b).
`11 21 U.S.C. §§ 355(b)(1), (c)(2).
`
`
`
`
`9
`
`

`

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`
`
`38.
`
`To gain FDA approval, generic drugs must be bioequivalent to their branded
`
`counterparts. Bioequivalence means that the active ingredient of the proposed generic would be
`
`present in the blood of a patient to the same extent and for the same amount of time as the active
`
`ingredient of the brand.12 Bioequivalent drug products containing identical amounts of the same
`
`active ingredients, having the same route of administration and dosage form, and meeting
`
`applicable standards of strength, quality, purity, and identity are therapeutically equivalent and
`
`may be substituted for one another. The FDA assigns an “AB” rating to generics that meet the
`
`necessary criteria in relation to their branded counterparts.
`
`39.
`
`Because generic drugs are therapeutically equivalent to brand-name drugs, generic
`
`manufacturers compete by offering their drugs at low prices. Entry of a single generic can result
`
`in steep price reductions for purchasers. Entry of several generics tends to result in even steeper
`
`price reductions, driving price down close to marginal manufacturing costs.
`
`40.
`
`To benefit from these low prices, every state has adopted substitution laws requiring
`
`or permitting pharmacies to substitute AB-rated generic equivalents when filling branded drug
`
`prescriptions, unless the prescribing physician specifically directs otherwise. Due in part to these
`
`substitution laws, the launch of AB-rated generics causes a rapid price decline and shift from
`
`branded to generic drug sales. A generic that is unconstrained by supply issues often captures 80%
`
`or more of the market within the first six months of entry, regardless of the number of generic
`
`entrants. The effects of generic entry are still more dramatic after a year. In a review of industry
`
`
`12 21 U.S.C. § 355(j)(8)(B).
`
`
`
`
`10
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 11 of 80 PageID: 11
`
`
`
`data, the FTC found that on average, within a year of generic entry, generics had captured 90% of
`
`corresponding brand sales and prices had dropped 85% with multiple generics on the market.13
`
`C. Regulatory exclusivities
`
`41.
`
`A “new chemical entity” is a drug that contains an active moiety—the part of the
`
`drug responsible for the physiological or pharmacological action of the drug—that the FDA has
`
`not previously approved in another NDA.14 Approval of an NDA with a new chemical entity
`
`provides a five-year exclusivity (“NCE exclusivity”) during which the FDA cannot approve an
`
`ANDA for a drug containing the same active moiety as the new chemical entity.15
`
`D. Supply and Use of API in Drug Products
`
`42.
`
`Final drug products consumed by patients and the active pharmaceutical ingredients
`
`contained in those final drug products are frequently manufactured by different companies. In such
`
`cases the manufacturer of the final drug product, whether brand or generic, combines the API
`
`purchased from other sources with inactive ingredients to manufacture the final dosage form.
`
`Although a generic manufacturer’s process for manufacturing the final dosage form may be
`
`different from the manufacturer of the RLD, it is typical for the different manufacturers to use
`
`identical API.
`
`43.
`
`As part of the process for obtaining regulatory approval to sell an active
`
`pharmaceutical ingredient in the United States, the API manufacturer ordinarily must file a Drug
`
`
`13 See Federal Trade Commission, Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers
`Billions 8 (2010), https://www.ftc.gov/sites/default/files/documents/reports/pay-delay-how-drug-
`company-payoffs-cost-consumers-billions-federal-trade-commission-staff-
`study/100112payfordelayrpt.pdf.
`14 21 C.F.R. § 314.108(a).
`15 21 C.F.R. § 314.108(b)(2).
`
`
`
`
`11
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 12 of 80 PageID: 12
`
`
`
`Master File (“DMF”) with the FDA. The DMF provides “confidential detailed information about
`
`facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of”
`
`the API.16 The manufacturer of a final dosage form, in turn, references the DMF of each of its API
`
`suppliers in its New Drug Application (whether Abbreviated or full).17 The FDA then reviews the
`
`technical information contained in, and inspects the relevant facilities described in, each DMF
`
`referenced in the ANDA or NDA. A single DMF may be referenced by multiple manufacturers.
`
`44.
`
`It takes significant time to develop a process for manufacturing an API and then
`
`prepare and file the necessary DMF.
`
`45.
`
`If a manufacturer wants or needs to change its API supplier for a drug, it must file
`
`a supplement with the FDA referencing the new API supplier’s DMF and submit data for drug
`
`batches using the new supplier’s API. The manufacturer may only market its drug using the new
`
`supplier’s API if the FDA approves of the change. It is time consuming to prepare and file the
`
`necessary supplement and then obtain FDA approval of the change in API supplier.
`
`46.
`
`If a current DMF holder is willing, a generic drug manufacturer may use API from
`
`an API supplier that already has a DMF on file and reference that DMF in their ANDAs. If,
`
`however, no current DMF holder is willing to supply the generic manufacturer with API, it must
`
`identify a new API supplier (who does not yet have a DMF on file) and work with that supplier to
`
`develop the API and submit a DMF.
`
`47.
`
`Generally, because of the significant costs involved in qualifying an API supplier
`
`as well as the need to continue to ensure quality control by the API supplier, it is industry practice
`
`
`16 Guidelines For Master Drug Files, § I, https://www.fda.gov/drugs/guidances-drugs/drug-master-
`files-guidelines (last accessed May 13, 2021).
`17 21 CFR 314.420(b).
`
`
`
`
`12
`
`

`

`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 13 of 80 PageID: 13
`
`
`
`for both brand and generic drug manufacturers to use only one or two API suppliers to support a
`
`drug application.18
`
`A. Vascepa
`
`FACTS
`
`48.
`
`Vascepa is the brand name for the icosapent ethyl drug product marketed by
`
`Amarin, manufactured using the active pharmaceutical ingredient IPE, which is derived from
`
`eicosapentaenoic acid (“EPA”), a type of omega-3 fatty acid derived from fish oil.
`
`49.
`
`On July 26, 2012, Amarin received FDA approval to market Vascepa: “as an
`
`adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL)
`
`hypertriglyceridemia.” Subsequently, the FDA determined that Vascepa was entitled to NCE
`
`exclusivity, see supra at paragraph 41, which ran from the NDA approval date to July 26, 2017.
`
`50.
`
`On December 13, 2019, the FDA approved a new indication for Vascepa: “as an
`
`adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke,
`
`coronary revascularization, and unstable angina requiring hospitalization in adult patients with
`
`elevated triglyceride (TG) levels (≥ 150 mg/dL) and . . . established cardiovascular disease or . . .
`
`diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.” The new
`
`indication is entitled to data exclusivity, which is scheduled to expire on December 13, 2022.
`
`51.
`
`Amarin currently markets Vascepa in the 1g and 500mg strengths. Amarin has raised
`
`the price of 1g Vascepa dramatically since its launch: the list price for the 1mg strength of Vascepa was
`
`
`18 See, e.g., Mallu UR, Nair AK, Bapatu HR, Pavan Kumar M, Narla S, et al., “API Supplier
`Change or Addition of Alternate API Supplier in Generic Drug Products: Cost, Quality and
`Regulatory Factors” (Pharmaceutical Analytica Acta 2015) at 2 (“[T]wo suppliers shall be selected
`one as main and another one as alternative supplier for generic DP development.”).
`
`
`
`
`13
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`

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`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 14 of 80 PageID: 14
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`
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`estimated to be $308.25 per month in 2019,19 $355 per month in 2020,20 and is currently estimated
`
`to be around $368.86.21
`
`52.
`
`Vascepa is Amarin’s only product, with revenues of $607 million in 2020.22
`
`B. Amarin set out to lock up the world’s supply of Vascepa API for the explicit purpose
`of preventing generic competition
`
`53.
`
`54.
`
`As discussed above, the API for Vascepa is IPE, which is derived from fish oil.
`
`For more than a decade, Amarin has set out to lock up the world’s supply of IPE
`
`for the explicit purpose of “protecting the potential commercial exclusivity” of Vascepa.23
`
`55.
`
`From the beginning Amarin stated its intention to take advantage of manufacturing
`
`barriers to entry to prevent competition: “We will seek to protect the potential commercial
`
`exclusivity of [Vascepa] through a combination of obtaining and maintaining intellectual property
`
`rights and regulatory exclusivity, taking advantage of manufacturing barriers to entry and
`
`maintaining trade secrets.”24
`
`
`19 “J&J’s Xarelto, Amarin’s Vascepa are cost-effective, not budget friendly,” EndpointsNews (Oct.
`18,
`2019),
`https://endpts.com/jjs-xarelto-amarins-vascepa-are-cost-effective-but-not-budget-
`friendly-icer/ (last accessed May 6, 2021).
`20 “A cardiologist asks: How much is too much to pay for a promising drug?,” The Philadelphia
`Inquirer
`(Jan. 20, 2020), https://www.inquirer.com/health/expert-opinions/vascepa-price-
`cardiology-triglycerides-fish-oil-20200122.html (last accessed May 6, 2021).
`21 “Vascepa Prices, Coupons, and Patient Assistant Programs,” https://www.drugs.com/price-
`guide/vascepa (last accessed May 6, 2021).
`22 Amarin Corp. plc, Annual Report (Form 10-K), at F-5 (Feb. 25, 2021).
`23 Amarin Corp. plc Annual Report (Form 10-K), at 3 (Feb. 20, 2012).
`24 Id. (emphasis added); see also Amarin Corp. plc Annual Report (Form 10-K), at 21 (Feb. 27,
`2014) (“FDA marketing exclusivity is separate from, and in addition to, patent protection, trade
`secrets and manufacturing barriers to entry which also help protect Vascepa against generic
`competition.”).
`
`
`
`
`14
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`Case 3:21-cv-12061 Document 1 Filed 06/02/21 Page 15 of 80 PageID: 15
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`
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`56.
`
`On April 18, 2013, Amarin announced that it had filed a supplemental New Drug
`
`Application (“sNDA”) to add Chemport Inc. (“Chemport”) as an API supplier.25 In that
`
`announcement Amarin confirmed that the “manufacturing barriers to entry” that it intended to take
`
`advantage of are the various exclusive contracts that it used to foreclose the supply of Vascepa
`
`API: “The addition of Chemport contributes to the planned expansion of the Vascepa
`
`manufacturing supply chain and is additional progress toward Amarin’s goal to protect the
`
`commercial potential of Vascepa to beyond 2030 through a combination of patent protection,
`
`regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to
`
`entry.”26
`
`57.
`
`Joseph Zakrewski, Amarin’s CEO, further confirmed that the key barrier to entry
`
`was the supply of API, stating that: “The move [to add Chemport as an API supplier] also fortifies
`
`Amarin’s efforts to shield its Vascepa patent beyond its scheduled 2030 expiration.”27
`
`58.
`
`Amarin further explained its anticompetitive strategy in its 2014 Annual Report:
`
`“Certain of our agreements with our suppliers include minimum purchase obligations and limited
`
`exclusivity provisions based on such minimum purchase obligations. If we do not meet the
`
`respective minimum purchase obligations in our supply agreements, our suppliers, in certain cases,
`
`will be free to sell the active pharmaceutical ingredient of Vascepa to potential competitors . . .
`
`
`25 Press Release, Amarin Corp. plc, “Amarin Announces Approval of Supplemental New Drug
`Application for Chemport as Additional Vascepa® Active Pharmaceutical Ingredient Supplier”
`(Apr. 18, 2013), https://investor.amarincorp.com/news-releases/news-release-details/amarin-
`announces-approval-supplemental-new-drug-application (last accessed May 6, 2021).
`26 Id. (emphasis added).
`27 “Amarin wins U.S. nod to add S. Korea supplier,” Hartford Business Journal (Apr. 19, 2013)
`(emphasis added), https://www.hartfordbusiness.com/article/amarin-wins-us-nod-to-add-s-korea-
`supplier (last accessed May 6, 2021).
`
`
`
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`
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`While we anticipate that intellectual property barriers and FDA regulatory exclusivity will be the
`
`primary means to protect the commercial potential of Vascepa, the availability of Vascepa active
`
`pharmaceutical ingredient from our suppliers to our potential competitors would make our
`
`competitors’ entry into the market easier and more attractive.”28
`
`59.
`
`Amarin expected its scheme to work, and wanted the market to know that fact: “In
`
`April 2012, the FDA published draft guidance for companies that may seek to develop generic
`
`versions of Vascepa. If an application for a generic version of Vascepa were filed and if new
`
`chemical entity, or NCE exclusivity is not granted to Vascepa, the FDA may accept the filing for
`
`review and we would likely engage in costly litigation with the applicant to protect our patent
`
`rights. If the generic filer is ultimately successful in patent litigation against us, meets the
`
`requirements for a generic version of Vascepa to the satisfaction of the FDA (after any applicable
`
`regulatory exclusivity period and, typically, the litigation-related 30-month stay period expires),
`
`and is able to supply the product in significant commercial quantities, the generic company
`
`could, with the market introduction of a generic version of Vascepa, limit our U.S. sales, which
`
`would have an adverse impact on our business and results of operations.”29
`
`60.
`
`Amarin further warned the market that failure of its anticompetitive scheme was a
`
`material investment risk: “Risks Related to our Reliance on Third Parties – We may not be able to
`
`maintain our exclusivity with our third-party Vascepa suppliers if we do not meet minimum
`
`purchase obligations due to lower than anticipated sales of Vascepa.”30
`
`
`28 Amarin Corp. plc, Annual Report (Form 10-K), at 40 (March 3, 2015).
`29 Amarin Corp. plc, Quarterly Report (Form 10-Q), at 31 (Aug. 8, 2013) (emphasis added).
`30 Amarin Corp. plc, Quarterly Report (Form 10-Q), at 46 (Nov. 7, 2013); see also Amarin Corp.
`plc, Quarterly Report