Amarin Pharma Led ‘Scheme’ to Suppress Competition for Hyperglyceridemia Treatment Vascepa, Class Action Alleges

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A proposed class action alleges Amarin Pharma, BASF and a number of affiliates have engaged in a scheme to squash generic competition in the United States for Vascepa, an FDA-approved prescription medication used to treat hyperglyceridemia in adults, in part by hoarding the worldwide supply of a critical ingredient. 

The 80-page complaint, filed in New Jersey federal court on June 2, alleges Amarin has used patent litigation and supply exclusivity agreements with four ingredient manufacturers, among other methods, as a means to erect barriers of entry into the $600 million-per-year American market for Vascepa. As a result of the alleged scheme supposedly spearheaded by Amarin, the launch by at least four different companies of generic versions of the medication have been delayed or blocked, and consumers have been forced to pay “anticompetitive prices” for Vascepa, the lawsuit alleges. 

The case alleges the defendants have in effect “hoard[ed]” the world’s supply of Vascepa’s active pharmaceutical ingredient, icosapent ethyl (IPE). IPE is made from eicosapentaenoic acid (EPA), an omega-3 fatty acid found in fish oil. According to the suit, IPE is indispensable to Vascepa given its ability to both lower a patient’s triglycerides and reduce the risk of cardiovascular events in those who have high triglyceride levels. 

In September and October 2016, four drug companies filed applications with the FDA to launch generic versions of Vascepa: Roxane Laboratories, which was later acquired by Hikma Pharmaceuticals; Dr. Reddy’s Laboratories; Teva Pharmaceuticals; and Apotex, the suit begins. Per the complaint, Hikma, Dr. Reddy’s and Teva each contended that all of the asserted patent claims were either invalid or not infringed upon by their respective generic versions of Vascepa.

Amarin, the lawsuit says, sued each of the companies in turn. Per the suit, Amarin settled with Teva in May 2018 and Apotex in June 2020, with each having agreed to forego selling their respective generics of Vascepa in the United States until August 2029, or earlier under certain circumstances. 

Hikma and Dr. Reddy’s, however, pursued their patent fight and won at trial, with a federal judge finding that Amarin’s patents were “invalid due to obviousness.” 

Although Hikma and Dr. Reddy’s made the necessary arrangements to launch their respective generic versions of Vascepa in 2020, their entry into the market was blocked by Amarin by way of a series of “exclusive contracts and other anticompetitive conduct” to lock up the world’s supply of IPE, Vascepa’s active ingredient, the lawsuit alleges. Amarin, the suit claims, secured a supply of IPE “several times [its] own needs based on its anticipated sales.” 

The lawsuit alleges Amarin was able to prevent Dr. Reddy’s launch of its generic Vascepa and limit Hikma’s November 2020 launch of its own version by purposely contracting with at least four different API manufacturers—contracting with one or two is standard in the pharma industry, the suit points out—and using these agreements to prevent suppliers from selling IPE API to anyone else. The company has also “foreclosed access to at least one other major supplier,” the suit reads. 

“Amarin has no legitimate procompetitive reason for entering into exclusive supply agreements with these four manufacturers,” the complaint charges. “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.”

Named as defendants in the lawsuit are 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.

The case looks to represent the following: 

“All persons and entities who indirectly purchased, paid and/or provided reimbursement for some or all of the purchase price for Vascepa, other than for resale, in the States of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, the District of Columbia, and Puerto Rico, at any time during the period from August 7, 2020 through and until the anticompetitive effects of Defendants’ challenged conduct cease (the ‘Class Period’).” 

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