Late last week, a complaint filed in the District of New Jersey against Amarin Pharma, as well as several generic drug manufacturers, alleged that the defendants conspired to restrain trade in the manufacture of Vascepa, a cholesterol medication.
Heart disease compounded with high cholesterol is a leading cause of death in the United States, the complaint began. Vascepa is a brand name prescription drug approved to treat hyperglyceridemia in adults by the Food and Drug Administration. The drug is an isolated ethyl created from omega-3 fatty acids found in fish oil, but does not have some of the dietary effects of fish oil.
In July 2016, three generic drug companies filed applications to launch generic versions of this product and included in those applications allegations that the patents owned by Amarin Pharma were invalid or not infringed upon. Amarin Pharma sued these three companies, as well as a later filer, to defend the patents. Amarin settled with two companies, Teva and Apotex, to not begin selling until 2029. However the other two parties went to trial and the patents were invalidated due to obviousness. However, after winning the case, the two manufacturers discovered that during the pendency of the case, Amarin had entered into exclusive contracts for one of the required compounds with all 4 suppliers, making it difficult to obtain the amounts necessary to compound the generic for the commercial marketplace.
The plaintiff, a worker’s union providing ERISA=style medical insurance for its members, alleged that the original patent litigation was fraudulent as Amarin was aware of the obviousness of the science used to create the drugs. The union also argued that the settlement actions with Teva and Apotx were collusive behaviors amongst those parties to deliberately delay entry of the generic and to deliberately maintain higher prices for the brand name drug. In regards to the supply issue, the Union notes that the exclusive contracts that Amarin maintains has resulted in two to three times the amount of API compound that Amarin uses to create the Vascepa product and that Amarin has been disposing of the excess instead of permitting a competitor to use the product.
The Union lists claims of monopolization due to Amarin’s contracts with the producers of API, conspiracy to restrict trade, unfair or deceptive trade practices, unjust enrichment, and Sherman act violations. The suit seeks certification as a class action, treble damages, equitable relief including an injunction and a constructive trust for disgorged profits.
The plaintiffs are represented by the firms of Kessler Topaz Meltzer & Check and Carella Byrne Cecchi Olstein Brody & Agnello.
