Winston & Strawn Secures Appellate Victory for Hikma, Invalidates 6 Patents for Purified Fish Oil Drug

On September 3, 2020, Winston obtained an appellate victory in the Federal Circuit for our client, Hikma. In a one-line order issued the day after oral argument, a three-judge panel shot down Amarin Pharma Inc.’s appeal of a lower court order invalidating six patents for Amarin’s drug Vascepa® (icosapent ethyl), a purified form of fish oil that is used to treat severe hypertriglyceridemia.

With annual sales of approximately $1 billion, Vascepa® is the only product sold by Amarin. Winston’s victory will allow Hikma to help patients by launching a less-expensive, generic version of the drug before the final patent would have expired in 2030.

The Federal Circuit’s decision affirmed Winston’s March 2020 trial court victory before Chief Judge Miranda Du of the District of Nevada, who agreed that versions of the fish oil used as the active ingredient in Vascepa® have been used for decades to lower triglycerides in the blood without raising cholesterol. In her 70-page trial opinion, Judge Du quoted multiple concessions that Winston obtained on cross-examination over a seven-day trial, supporting “key premises” that “lead directly” to the invalidity finding. Overall, Judge Du found that the Winston team “presented clear and convincing evidence” of its “persuasive obviousness argument.”