Case 3:21-cv-10309-BRM-ZNQ Document 1 Filed 04/27/21 Page 1 of 55 PageID: 1
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`UNITED STATES DISTRICT COURT
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`DISTRICT OF NEW JERSEY
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`DR. REDDY’S LABORATORIES INC.,
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`Plaintiff,
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`v.
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`AMARIN PHARMA, INC., AMARIN
`PHARMACEUTICALS IRELAND
`LIMITED, AMARIN CORPORATION PLC
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`Defendants.
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`COMPLAINT
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`Plaintiff Dr. Reddy’s Laboratories Inc. (“DRL”) brings this antitrust lawsuit against
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`Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Amarin Corporation plc
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`(collectively “Amarin” or “Defendants”), by and through its counsel, and alleges as follows:
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`INTRODUCTION
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`1.
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`This is an action under the Sherman Act and New Jersey law arising out of
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`Amarin’s anticompetitive conduct to delay and prevent generic competition to its branded Vascepa
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`(icosapent ethyl) product. Since it first began marketing Vascepa in 2012, Amarin has embarked
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`on an anticompetitive strategy to insulate Vascepa from generic competition. This is
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`understandable: Vascepa is Amarin’s only product, and one for which Amarin has been steadily
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`increasing prices since its launch. However, Amarin’s anticompetitive conduct has delayed generic
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`entry while Amarin overcharges payers and patients.
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`2.
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`Specifically, DRL has developed its generic icosapent ethyl drug product, prevailed
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`twice in patent litigation with Amarin, and obtained the necessary regulatory approval to market
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`its generic drug. Consequently, there was nothing preventing DRL from launching a generic
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`icosapent ethyl drug product except for Amarin’s illegal conduct to foreclose the supply of a
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`critical input to manufacturing—the icosapent ethyl active pharmaceutical ingredient (“API”).
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`Absent Amarin’s anticompetitive conduct, DRL would have launched its generic drug product to
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`compete with Amarin’s branded Vascepa in August 2020.
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`3.
`
`In particular, after prevailing in patent litigation in district court in March 2020,
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`DRL promptly began preparations for launch, only to discover that Amarin had foreclosed all the
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`suppliers of the icosapent ethyl API who have sufficient capacity to support a commercial launch
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`in a
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`timely manner. First, XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. Indeed, as DRL
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`later discovered, Amarin had entered into a de facto exclusive agreement XXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXX. As a point of comparison, the entire U.S. market for Vascepa
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`is estimated to require only 450 metric tons / year of icosapent ethyl API.
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`4.
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. But for
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`Amarin’s de facto exclusive agreement XXXXXXXXXXX, DRL would have been able to obtain
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`the necessary icosapent ethyl API XXXXXXXXXXX and launch its generic icosapent ethyl
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`product as soon as August 2020, when it received the necessary regulatory approval.
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`5.
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`Second, when XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXX, DRL contacted all potentially viable suppliers of icosapent ethyl API in an attempt to obtain
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`enough supplies to launch as soon as possible. However, DRL’s efforts were again thwarted. Since
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`as early as 2012, Amarin had entered into exclusive or de facto exclusive agreements with the only
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`icosapent ethyl API suppliers with sufficient capacity to support a commercial launch of generic
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`icosapent ethyl drug product without having to first expand their capacity. These suppliers are
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`Novasep Holding SAS (“Novasep,” including its subsidiary Finorga SAS), Nisshin Pharma Inc.
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`(“Nisshin”), BASF Group (“BASF”), and Chemport Inc. (“Chemport”). Amarin’s agreements with
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`these suppliers have a minimum purchase requirement in exchange for exclusivity, and at least
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`some of these agreements also require Amarin to pay the suppliers in cash if it cannot satisfy the
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`minimum purchase requirement in order for the suppliers to maintain exclusivity with Amarin.
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. DRL also
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`reached out to other suppliers who have not entered into exclusive or de facto exclusive contracts
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`with Amarin, but these suppliers all have limited capacity or have not made the requisite regulatory
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`filings, and, thus, they could not supply DRL for the next 1-2 years at the earliest.
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`6.
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`Amarin’s hoarding of icosapent ethyl API supplies is contrary to industry practice,
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`cannot be justified by any legitimate business reason, and can only be explained as part of an
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`anticompetitive strategy to prevent and delay generic competition to its branded Vascepa. It is
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`industry practice for a branded drug manufacturer to have only one to two API suppliers, even
`
`though more may be available, because it is costly to qualify and ensure quality control at the
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`suppliers. Thus, Amarin retaining five API suppliers when there is no indication of supply issues
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`makes no economic sense, and the fact that these contracts are exclusive or de facto in nature is
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`even more suspect. In fact, the evidence suggests that Amarin had sufficient or an excess of API
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`supply. Amarin reportedly stated in December 2018, XXXXXXXXXXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXXXXXXXX, that it had enough API supply for at least two years,
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`totaling $1 billion worth in Vascepa sales. Given Amarin’s existing API supplies, it has no
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`legitimate business reason XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
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`Accordingly, the only explanation for Amarin’s various supply agreements is that it has been
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`paying API suppliers to not supply to generic competitors, including DRL, either through literal
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`exclusive agreements or through agreements that allow Amarin to effectively acquire all available
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`supplies of the respective API suppliers.
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`7.
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`Amarin’s exclusive or de facto exclusive agreements, XXXXXXXXXXXXXX
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`XXXXXXXXXXXXXXXX, foreclosed a substantial part of the market for the supply of icosapent
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`ethyl API. Because of Amarin’s conduct, DRL’s launch is delayed despite DRL’s best efforts to
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`find an alternative API supplier, as the other API suppliers all have limited capacity or have not
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`made the requisite regulatory filings and, thus, could not support a timely launch by DRL.
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`Accordingly, Amarin’s various exclusive or de facto exclusive agreements with icosapent ethyl
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`API suppliers have delayed generic competition from DRL. This delay is particularly egregious
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`because there was no legal or regulatory hurdle preventing DRL from launching as of August 2020,
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`and DRL has been prepared to launch as soon as the requisite icosapent ethyl API became available.
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`8.
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`But for Amarin’s locking up of the icosapent ethyl API supply, DRL would have
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`been ready, willing, and able to launch in August 2020, upon receiving regulatory approval.
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`Instead, Amarin’s XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX and the other
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`icosapent ethyl API suppliers have delayed DRL’s launch by a minimum of 10 months, and
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`delayed a launch that will cover the demand for which DRL had set forth resources and planned
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`to meet absent Amarin’s anticompetitive conduct by more than a year. In particular, had Amarin
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`not entered into a de facto exclusive agreement XXXXXXXXXXX, DRL would have been able
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`to obtain the necessary icosapent ethyl API XXXXXXXXXX to launch in August 2020. However,
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`Amarin’s conduct XXXXXXXXXXXXXX from supplying any meaningful quantity of icosapent
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`ethyl API for DRL to launch in a timely manner.1
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`9.
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`In addition, because Amarin has foreclosed a substantial share of the supply for
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`icosapent ethyl API, DRL was forced to incur additional significant costs to qualify an additional
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`alternative API supplier that had not, amongst other things, made the requisite regulatory filings.
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`DRL cannot commercially market its generic icosapent ethyl drug product using this alternative
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`API supplier until more than a year after when DRL would have launched but for Amarin’s
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`anticompetitive conduct.
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`10.
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`DRL seeks in this action to obtain an order requiring Amarin to cease its unlawful
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`exclusive or de facto exclusive agreements, including XXXXXXXXXXXXXXXX, to recover
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`DRL’s lost profits from the delayed launch, treble damages, and an award of DRL’s costs and
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`attorneys’ fees.
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`                                                            
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`  1
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` XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
`XXXXXXXXXXXXXXXXXXXXXXXXXXX has delayed DRL’s launch by more than a year.
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`PARTIES
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`11.
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`Plaintiff Dr. Reddy’s Laboratories Inc. is a company organized and existing under
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`the laws of New Jersey with its principal place of business in Princeton, New Jersey.
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`12.
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`On information and belief, Defendant Amarin Pharma, Inc. is a company organized
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`and existing under the laws of Delaware with its principal place of business at 1430 Route 206,
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`Bedminster, NJ 07921.
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`13.
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`On information and belief, Defendant Amarin Pharmaceuticals Ireland Limited is
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`a company incorporated under the laws of Ireland with registered offices at 88 Harcourt Street,
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`Dublin 2, Dublin, Ireland.
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`14.
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`On information and belief, Defendant Amarin Corporation plc is a company
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`incorporated under the laws of England and Wales with principal executive offices at 77 Sir John
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`Rogerson’s Quay, Block C, Grand Canal Docklands, Dublin 2, Ireland.
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`JURISDICTION AND VENUE
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`15.
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`This action arises under the antitrust laws of the United States, including Sections
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`1 and 2 of the Sherman Act, 15 U.S.C. §§ 1 and 2, Sections 4 and 16 of the Clayton Act, 15 U.S.C.
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`§§ 15(a) and 26, the New Jersey Antitrust Act, N.J. Stat. § 56:9, and New Jersey common law.
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`16.
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`The actions complained of have occurred in and substantially affected interstate
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`commerce. Specifically, Amarin is engaged in interstate commerce and in activities substantially
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`affecting interstate commerce. Amarin’s conduct alleged herein has a substantial effect on
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`interstate commerce. Amarin purchases icosapent ethyl API in interstate commerce and Amarin’s
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`products are marketed and sold in all states and territories of the United States. Drug wholesalers
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`and, ultimately, patients across the country purchase Amarin’s drugs, including Vascepa.
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`17.
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`Defendant may be found in, transacts business in, is headquartered in, and is subject
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`to personal jurisdiction in the District of New Jersey.
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`18.
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`This Court has subject matter jurisdiction based on 28 U.S.C. §§ 1331 and 1337(a),
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`and 15 U.S.C. §§ 15 and 26. This Court has supplemental subject matter jurisdiction over the New
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`Jersey state law claims pursuant to 28 U.S.C. § 1367(a).
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`19.
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`The violations of law alleged in this Complaint took place, in part, and have injured
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`DRL in this judicial district. Venue is therefore proper in the District of New Jersey pursuant to
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`15 U.S.C. §§ 15 and 22, and 28 U.S.C. § 1391.
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`STATEMENT OF FACTS
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`I.
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`STATUTORY AND REGULATORY BACKGROUND
`A. Hatch-Waxman Framework
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`20.
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`The Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., as
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`amended by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No.
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`98-417, 98 Stat. 1585 (1984), commonly known as the “Hatch-Waxman Act,” requires approval
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`by the Food and Drug Administration (“FDA”) before a company may market or sell a branded or
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`generic pharmaceutical product in the United States. The overarching purpose of the Hatch-
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`Waxman Act is to balance the preservation of brand pharmaceutical companies’ incentives to
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`innovate with the public interest in access to lower-cost, high-quality generic drugs through the
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`creation of a carefully calibrated regulatory framework.
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`21.
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`To achieve the first goal, the Hatch-Waxman Act provides for multiple types of
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`exclusivity for brand drugs. For example, the Hatch-Waxman Act provides for a five-year
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`exclusivity period for “new chemical entities” (“NCE”), i.e. where the active pharmaceutical
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`ingredient has not been previously approved for any other drug. 21 U.S.C. § 355(c)(3)(E)(ii).
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`Generic manufacturers are permitted to file their Abbreviated New Drug Applications (“ANDAs”)
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`one year before the expiration of the NCE exclusivity.
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`22.
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`To achieve the second goal of “get[ting] generic drugs into the hands of patients at
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`reasonable prices – fast,” Andrx. Pharms., Inc. v. Biovail Corp. Int’l, 256 F.3d 799, 809 (D.C. Cir.
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`2001) (internal quotation marks omitted) (quoting In re Barr Labs., Inc., 930 F.2d 72, 76 (D.C.
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`Cir. 1991)), the Hatch-Waxman Act creates a procedure for generic manufacturers to file ANDAs
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`with the FDA. An ANDA filer need not conduct full clinical trials, as is required for a New Drug
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`Application (“NDA”). Instead, an ANDA filer only has to show that its drug is bioequivalent to
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`the “reference listed drug,” typically the brand drug, to demonstrate that the generic product has
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`the same or comparable safety and efficacy as the reference listed drug.
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`23.
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`Under the Hatch-Waxman Act, NDA holders are required to identify all patents
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`covering the brand drug and such patents’ expiration dates in an FDA publication referred to as
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`the “Orange Book.” 21 U.S.C. § 355(b)(1) and (c)(2). If an ANDA applicant seeks FDA approval
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`to sell a generic drug before the expiration of the patents listed in the Orange Book as covering the
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`drug, the ANDA must contain a certification that each of the relevant patents “is invalid or will
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`not be infringed.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Such a certification is known as a “Paragraph
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`IV Certification.” The first filer of an ANDA for a product with a Paragraph IV Certification is
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`entitled to 180 days of exclusivity from the first commercial marketing of the drug. 21 U.S.C. §
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`355(j)(5)(B)(iv)(I). If there are several first filers with the Paragraph IV Certification, the first
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`filers all share the 180-day exclusivity.
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`24.
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`The filing of a Paragraph IV Certification permits the NDA-holders as well as the
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`holder of any patent identified as purportedly covering the reference listed drug in the Orange
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`Book to bring an action against the ANDA applicant for patent infringement. If such an action is
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`brought within 45 days from the NDA holder’s receipt of the Paragraph IV Certification
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`notification, the FDA is precluded from granting final approval of the ANDA until the earlier of
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`(i) 30 months from the NDA holder’s receipt of the Paragraph IV Certification notification; or (ii)
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`the date on which a final judgment is entered in the patent infringement case holding that such
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`patent is invalid, not infringed, or unenforceable.
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`25.
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`If an ANDA has satisfied all FDA regulatory requirements and the 30-month stay
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`period has not expired or the ANDA applicant is otherwise prevented from launching because of
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`patents, the FDA will grant tentative approval of the ANDA. The ANDA applicant may sell the
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`generic product in the United States only upon receipt of final approval from the FDA, not upon
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`receipt of tentative approval. Conversely, if the ANDA receives final approval, e.g. because the
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`30-month stay has expired, the ANDA applicant may immediately launch its generic drug
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`regardless of the progress of the patent litigation. If the generic launches while the patent litigation,
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`which may include the appellate process, is on-going, that launch is known as an “at risk” launch.
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`26.
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`As an alternative to filing a Paragraph IV Certification, if the relevant patents cover
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`only a specific use that the drug is approved for, the ANDA applicant may submit a “Section viii
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`statement” that it is not seeking approval for the use claimed by the patents. 21 U.S.C. §
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`355(j)(2)(A)(viii). Such a statement is known as a “Section viii carve-out,” and a generic drug
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`label approved with a Section viii statement is known as a “carved out” or “skinny” label.
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`Submitting an ANDA with a carved out label does not automatically trigger the patent litigation
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`process described above, and the FDA may approve the carved out ANDA without having to wait.
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`The legality of the FDA approving generic drugs with carved out labels has been upheld by the
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`courts. See, e.g., Sigma-Tau Pharms., Inc. v. Schwetz, 288 F. 3d 141, 147-48 (4th Cir. 2002);
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`Bristol-Myers Squibb Co. v. Shalala, 91 F. 3d 1493, 1500 (D.C. Cir. 1996).
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`B. Benefits of Generic Competition
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`27.
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`Generic drugs typically are sold at substantial discounts from the price of the brand
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`drug. The first generic drug that enters the market generally is priced at a significant discount to
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`the brand drug and, as additional generic drugs enter the market, generic drug prices may fall to as
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`low as 5% of the brand drug’s price. A 2017 study commissioned by the Association for Accessible
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`Medicines (“AAM”) found that while brand drug prices generally increased by over 200% between
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`2008 and 2016, generic drug prices generally decreased by approximately 75% during this period.
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`28.
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`Because generic drugs are typically priced substantially lower than the brand drug
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`price, in a competitive market, they typically take substantial market share from the corresponding
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`brand drugs upon launch, with the proportion of patients and payers switching to the generic drug
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`increasing over time. The increase in the volume that generic drugs take from their corresponding
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`brand drugs means that the savings that generic drugs provide increase over time.
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`29.
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`Generic drug competition generates large savings for consumers and federal, state,
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`and private payers. “Payers” include health plans and pharmacy benefits managers. A 2004 FDA
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`study found that consumers whose needs can be fully satisfied with generic drugs could enjoy
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`reductions of 52% in their daily medication costs. More recently, the 2017 AAM study found that
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`generic drugs generated savings of $1.67 trillion for the U.S. health care system between 2007 and
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`2016.
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`30.
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`Generic savings have steadily increased from $8-10 billion in 1994, as found by a
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`1998 Congressional Budget Office Report, to $253 billion in 2016, as found by the 2017 AAM
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`study. Within the $253 billion in savings from generic drugs in 2016, Medicaid savings constituted
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`$37.9 billion, and Medicare savings constituted $77 billion. The 2017 AAM study also cites to
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`industry data showing that generic drugs account for 89% of prescriptions, but only 26% of the
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`costs. Similarly, the 2016 Report to Congress on “Prescription Drugs: Innovation, Spending, and
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`Patient Access” from the U.S. Department of Health and Human Services unequivocally states:
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`“Generic drugs account for the majority of dispensed prescriptions, but a relatively small
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`percentage of spending.” 2
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`C. Supply and Use of API in Drug Products
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`31.
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`Brand and generic manufacturers ordinarily purchase the API for their drugs from
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`API suppliers. The manufacturers combine the API with inactive ingredients and process the drugs
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`into their final dosage form. The API for a brand drug and its generic equivalent is typically the
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`same.
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`32.
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`To sell an API in the United States, the API supplier typically needs to file a Drug
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`Master File (“DMF”) with the FDA. The DMF provides confidential and detailed information
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`about, among other things, the facilities and processes used to manufacture, process, package, and
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`store the API. To use an API for a specific drug, a manufacturer must reference the API supplier’s
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`DMF in its application for approval filed with the FDA. More than one manufacturer can reference
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`the DMF of the same API supplier. As part of its review of an NDA or ANDA, the FDA would
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`need to perform a complete review of the technical information contained in the DMF referenced
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`therein, including, among other things, inspecting the facilities described in the DMF.
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`33.
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`The entire process, from API development to FDA approval for use of that API
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`supplier’s DMF in support of an NDA or ANDA, ordinarily takes more than a year to complete,
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`and can extend to as long as three years. External factors, such as travel restrictions in response to
`
`                                                            
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`  2
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` U.S. Dep’t of Health and Hum. Servs., Prescription Drugs: Innovation, Spending, and Patient Access, at 8 (2016).
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`the current COVID-19 pandemic, can further delay the FDA’s ability to inspect the API supplier’s
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`facilities and otherwise delay its review and approval of the use of the DMF.
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`34.
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`If a manufacturer wants or needs to change its API supplier for a drug, it must file
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`a supplement with the FDA referencing the new API supplier’s DMF and submit data for drug
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`batches using the new supplier’s API. The manufacturer may only market its drug using the new
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`supplier’s API if the FDA approves of the change. FDA review and approval of the change in API
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`supplier can take 6 months or more from the time the new DMF is referenced in the NDA or
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`ANDA.
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`35.
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`Generic drug manufacturers typically use API from API suppliers that already have
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`a DMF on file and reference that DMF in their ANDAs, as opposed to partnering with API
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`suppliers that have not filed a DMF yet. However, in some situations, such as where all API
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`suppliers with a DMF on file are unable or unwilling to supply to a generic manufacturer, the
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`generic manufacturer may need to work with a new API supplier (who does not yet have a DMF
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`on file) to develop the API for a specific drug. This collaboration process may include the generic
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`manufacturer providing specifications, information and data to the API supplier; co-developing
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`the API; and overseeing the quality control for the process throughout the development of the API.
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`Such collaborative relationships, when they happen, are typically entered into as part of an
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`agreement that the API would be used in that generic manufacturer’s drug.
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`36.
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`Generally, because of the significant costs involved in qualifying an API supplier
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`as well as the need to continue to ensure quality control by the API supplier, it is industry practice
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`for both brand and generic drug manufacturers to use only one or two API suppliers to support a
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`drug application. Where there are concerns about ensuring the adequate supply of API for a drug,
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`a manufacturer may enter into an exclusive supply contract with an API supplier. Conversely, an
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`exclusive supply contract is unnecessary if there is no concern about API supplies. It is unusual
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`and contrary to industry practice for brand and generic manufacturers to have multiple exclusive
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`API supply contracts. Moreover, it is contrary to industry practice for brand and generic
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`manufacturers to acquire significant excess API supplies due to, among other things, the costs of
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`acquisition and storage as well as quality control issues.
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`II.
`
`37.
`
`VASCEPA
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`Vascepa is the brand name for the icosapent ethyl drug product marketed by Amarin.
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`The API for the drug is eicosapentaenoic acid (“EPA” or “icosapent ethyl”), a type of omega-3
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`fatty acid derived from fish oil.
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`38.
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`Amarin submitted the NDA for Vascepa on September 25, 2011. The FDA
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`approved the NDA on July 26, 2012. This original approval included only one indication for
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`Vascepa: “as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe
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`(≥500 mg/dL) hypertriglyceridemia.” Subsequently, the FDA determined that Vascepa was
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`entitled to NCE exclusivity, see supra at I.A., which ran from the NDA approval date to July 26,
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`2017.
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`39.
`
`Amarin submitted a supplemental NDA for Vascepa on March 28, 2019, seeking
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`approval for an additional indication. The FDA approved the following new indication on
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`December 13, 2019: “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 [(a)]
`
`established cardiovascular disease or [(b)] 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.
`{80265674:1} 
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` 
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`12
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`

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`Case 3:21-cv-10309-BRM-ZNQ Document 1 Filed 04/27/21 Page 14 of 55 PageID: 14
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` 
`
`40.
`
`Amarin currently markets Vascepa in the 1g and 500mg strengths. The list price for
`
`the drug as of September 2020 was $330.98 / 120 count for the 1g strength and $387.24 / 240
`
`count for the 500mg strength. As the daily dose for Vascepa is 4g/day, this translates to
`
`$330.98/month for the 1g strength and $387.24/month for the 500mg strength.
`
`41.
`
`Since it first received approval to market Vascepa, and in the absence of generic
`
`competition, Amarin has been steadily hiking the price of Vascepa. In particular, Amarin increased
`
`the price of Vascepa by approximately 51% from 2013 (when Vascepa price listing was first
`
`available) to 2017, with the list price in December 2017 at approximately $280/month. Between
`
`December 2017 and November 2019, the price increased by approximately 8% to $303.65/month
`
`for the 1g strength. Finally, in less than a year since the approval of the new indication, the list
`
`price for the 1g strength jumped by 9% to $330.98/month as of September 2020.
`
`42.
`
`Vascepa is Amarin’s only product, earning it over $427 million in net product
`
`revenue in 2019. Amarin’s revenues have been growing dramatically over the years, as shown
`
`below. In July 2020, Amarin reported “Q1 2020 net total revenue of $155.0 million[, representing
`
`an] increase of 112% over Q1 2019.”3 Amarin reported net revenue for the sale of Vascepa in the
`
`United States in 2020 to be over $607 million,4 and further believes that Vascepa total net revenue
`
`“will grow to reach multiple billions of dollars” beyond 2020.5
`
`                                                            
`
`  3
`
` Investor Presentation, Amarin Corp. plc, “Leading a New Paradigm in Cardiovascular Disease Management,” at 17
`(July 1, 2020).
`4 Amarin Corp. plc, Annual Report (Form 10-K), at F-5 (Feb. 25, 2021).
`5 Press Release, Amarin Corp. plc, “Amarin Receives FDA Approval of VASCEPA® (icosapent ethyl) to Reduce
`Cardiovascular Risk” (Dec. 13, 2019), https://www.prnewswire.com/news-releases/amarin-receives-fda-approval-
`of-vascepa-icosapent-ethyl-to-reduce-cardiovascular-risk-
`300974860.html#:~:text=Beyond%202020%2C%20Amarin%20believes%20that,annual%20revenue%20levels%20
`beyond%202020..
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` 
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`Case 3:21-cv-10309-BRM-ZNQ Document 1 Filed 04/27/21 Page 15 of 55 PageID: 15
`
` 
`
`700
`
`600
`
`500
`
`400
`
`300
`
`200
`
`100
`
`0
`
`Vascepa Net Product Revenue (in $ million)
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`Vascepa Net Product Revenue (in $ million)
`
`
`
`43.
`
`Clearly, the importance of Vascepa to Amarin cannot be overstated. As its president
`
`and chief executive officer stated in a company press release, “Amarin’s goal is to protect the
`
`commercial potential of Vascepa to 2030.” 6 And it endeavored to do just that through an
`
`anticompetitive strategy to lock up the supply for icosapent ethyl API to prevent generic
`
`competition, as described in more detail below.
`
`III. VASCEPA PATENT LITIGATIONS AND APPROVAL OF GENERIC
`ICOSAPENT ETHYL DRUG PRODUCTS
`
`44.
`
`On July 26, 2016, DRL, Teva Pharmaceuticals USA, Inc. (“Teva”), and Hikma
`
`Pharmaceuticals USA Inc. (“Hikma”) submitted their respective ANDAs for generic icosapent
`
`ethyl drug product, all of which contain Paragraph IV Certifications. These companies are the first
`
`ANDA filers with Paragraph IV Certifications for generic icosapent ethyl drug product.
`
`                                                            
`
`  6
`
` Press Release, Amarin Corp. plc, “Amarin Announces FDA New Chemical Entity Market Exclusivity
`Determination for Vascepa(R) (icosapent ethyl) Capsules” (May 31, 2016), https://investor.amarincorp.com/news-
`releases/news-release-details/amarin-announces-fda-new-chemical-entity-market-exclusivity.
`14
`{80265674:1} 
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` 
`
`

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`Case 3:21-cv-10309-BRM-ZNQ Document 1 Filed 04/27/21 Page 16 of 55 PageID: 16
`
` 
`
`45.
`
`On October 31, 2016, Amarin filed suit alleging patent infringement against Hikma
`
`and its affiliates. On November 4, 2016, Amarin filed suit against DRL. The DRL case was
`
`subsequently consolidated into the Hikma case. When Vascepa’s new indication was approved in
`
`2019, both Hikma and DRL carved out the 2019-approved indication from their labels, as
`
`permitted by the FDCA. See supra at I.A. After a bench trial in January 2020, the court issued an
`
`order invalidating the asserted patents for obviousness on March 30, 2020. Amarin Pharma v.
`
`Hikma Pharms. USA Inc., 449 F. Supp. 3d 967, 971 (D. Nev. 2020), aff’d, Nos. 2020-1723, 2020-
`
`1901, 2020 U.S. App. LEXIS 28140 (Fed. Cir. Sep. 3, 2020). Amarin appealed the decision, but
`
`the Court of Appeals for the Federal Circuit summarily affirmed the district court decision on
`
`September 3, 2020, the day after oral argument. The entire order reads: “THIS CAUSE having been
`
`heard and considered, it is ORDERED AND ADJUDGED: PER CURIAM AFFIRMED. See Fed. Cir.
`
`R. 36.” Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., Nos. 2020-1723, 2020-1901, 2020 U.S.
`
`App. LEXIS 28140 (Fed. Cir. Sep. 3, 2020) (emphasis in original).
`
`46.
`
`In the meantime, the FDA had approved Hikma’s ANDA for the 1g strength on
`
`May 21, 2020. On August 7, 2020, the FDA also granted final approval to DRL’s ANDA for the
`
`1g strength and tentative approval for the 500mg strength. These final approvals removed any
`
`remaining legal impediment to launch, which meant that DRL and Hikma were permitted to launch
`
`their generics at least for the 1g strength as soon as they were ready. In fact, in November 2020,
`
`Hikma announced a launch of its generic icosapent ethyl drug product in limited quantities. As
`
`Hikma’s chief executive officer explained at a recent J.P. Morgan Healthcare Conference, Hikma’s
`
`November 2020 launch was in limited quantities because Hikma was “restrained” in building
`
`inventory, “and that is linked to the access to the active ingredients.” On the other hand, as
`
`{80265674:1} 
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`Case 3:21-cv-10309-BRM-ZNQ Document 1 Filed 04/27/21 Page 17 of 55 PageID: 17
`
` 
`
`explained below, Amarin’s anticompetitive locking up of API supplies prevented DRL from
`
`launching despite the clearing of all legal and regulatory hurdles.
`
`47.
`
`On November 18, 2016, Amarin filed suit against Teva. The case was consolidated
`
`into the Hikma case, but Amarin and Teva settled the lawsuit on or about May 24, 2018. Amarin’s
`
`press release stated that Teva is licensed to launch its generic icosapent ethyl drug product on
`
`“August 9, 2029, or earlier under certain customary circumstances.” 7 A later press release
`
`suggested that Amarin did not commit to supplying Teva with icosapent ethyl. On September 11,
`
`2020, the FDA granted final approval for Teva’s ANDA.
`
`48.
`
`Finally, on information