The US Court of Appeals for the Federal Circuit has upheld a district court ruling that had invalidated six patents on Amarin's Vascepa (icosapent ethyl), opening the door to generic competition for the fish-oil-derived drug. The decision follows hints that an unfavourable ruling was on the way when at a very brief hearing earlier this week, the three-judge panel had no questions for the defendants in the patent case, Hikma Pharmaceuticals and Dr. Reddy's Laboratories.
The verdict deals a blow to Amarin as Vascepa's potential market was broadened late last year when the FDA expanded the drug's label to include lowering persistent cardiovascular risk in certain patients, a decision the company said at the time meant that "millions of people" would qualify for the treatment. Vascepa was first cleared in the US in 2012 for the narrower population of patients with severe hypertriglyceridaemia.
Amarin had been counting on the patents to block generic competition until 2030, claiming Vascepa was a "major advance" against high triglycerides and that it also eliminated some of the risks associated with other medicines. However, Hikma and Dr. Reddy's argued that a version of Vascepa's active ingredient has been known since the 1990s, so the treatment method was not that unique. Hikma won FDA approval for its generic version of Vascepa in May, with the company saying Thursday that it "is working towards a launch."
Meanwhile, in response to the appeals court ruling, Amarin stated it "is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current panel decision," while CEO John Thero vowed that the company would "vigorously pursue available remedies." Amarin suggested that generic companies that launch their own Vascepa versions are "likely to have limited supply capacity" in any case, so it intends to keep up its current promotion levels for the drug, at least for now. "After assessing the scope, timing and pricing of potential generic competition, [we] will decide whether to further expand, contract or maintain such levels of Vascepa promotion," the company noted.
Meanwhile, Thero said Amarin remains "confident" in the global market potential for Vascepa, adding that the company will pursue additional regulatory approvals in China, Europe and countries in the Middle East. "We are particularly excited about the anticipated commercialisation opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021," he added.
The drug generated US sales of around $1.1 billion for 12 months ending July.
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