The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years.
But, now, the drugmaker is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish-oil-derived heart med in the lower courts.
Tuesday, the U.S. Court of Appeals for the Federal Circuit revived (PDF) Amarin’s Vascepa patent lawsuit against generics giant Hikma.
“Because Amarin’s allegations against Hikma plausibly state a claim for induced infringement, we reverse,” the court wrote in a legal filing this week.
The case comes down to so-called “skinny labels,” which allow generic drug makers to get their copycat medicines approved for one or several—but not necessarily all—approved indications of their brand-name counterparts. The practice has proven controversial in Amarin and Hikma’s case, plus at least one other lawsuit involving Teva and GSK.
Vascepa, also known as icosapent ethyl, won its first approval to reduce triglyceride levels in adults with severe hypertriglyceridemia in 2012. In 2019, the drug snagged a second FDA nod to reduce cardiovascular risks in adults with certain risk factors.
Amarin originally sued Hikma in Delaware in 2020 after the generics maker in 2016 filed for approval of a copycat version of Vascepa that only included the severe hypertriglyceridemia nod and not the label language around cardio risks.
The FDA approved Hikma’s Vascepa generic with a “skinny label” in May of 2020, court documents show.
The appeals court this week ruled that Hikma’s generic label, press releases and marketing work may have prompted doctors to prescribe the copycat in violation of Amarin’s patents. The court specifically noted that Hikma publicly referred to its product as “generic Vascepa” without acknowledging the med’s label limitations.
In turn, doctors were likely encouraged to prescribe the cheaper generic med for Vascepa’s full range of approved uses, the appeals court ruled.
Amarin and Hikma did not immediately respond to Fierce Pharma’s request for comment.
Chad Landmon, chair of the IP and FDA practice groups at law firm Axinn, Veltrop & Harkrider, noted that the Amarin-Hikma case is unusual because it concerns a launched generic, whereas most IP litigation occurs before approval and rollout.
“I’m sure the decision is obviously a disappointment to Hikma, but I think also the generic and biosimilar industries probably are a little disappointed,” he told Fierce in an interview.
Ever since Amarin’s U.S. patent loss on Vascepa, the company has been striving to make the most of the European market.
Meanwhile, the market shift has resulted in much executive turnover and layoffs at the Irish company.
Last summer, Amarin revealed that it would lay off its entire U.S. sales force and reduce its non-sales staff by 30%—amounting to roughly 120 out of 385 employees. The company also announced the appointment of Patrick Holt as its new CEO.
Earlier this month, Holt said he was headed for the exit. Amarin’s new CEO will be Aaron Berg, who briefly served as Amarin’s interim chief executive last year following the abrupt departure of helmsman Karim Mikhail.
Amarin's shares have lost more than 95% of their value since the start of 2020. Its shares haven't much budged in response to the latest legal development.