Amarin Wins Bid to Revive Vascepa Patent Lawsuit After Stock Crash and Staff Cuts

Amarin has experienced significant challenges since the beginning of 2020, with its shares seeing a drastic decline of over 95% in value. The troubles primarily stem from the loss of patent protection for its main product, Vascepa, in 2020. This patent loss opened the door for generic competition, leading to a tumultuous period for the Dublin-based company.

However, Amarin has recently gained a new opportunity to contest the generic version of its heart medication produced by Hikma Pharmaceuticals. The U.S. Court of Appeals for the Federal Circuit has revived Amarin’s lawsuit against Hikma, marking a significant development in the ongoing legal battle. The court's decision was based on the allegation that Hikma's actions might have led to induced patent infringement.

The legal dispute centers on "skinny labels," which permit generic drug manufacturers to obtain approval for specific uses of a drug without encompassing all the approved indications of the original branded medication. Hikma's version of Vascepa, which is derived from fish oil, was initially approved by the FDA with a narrow label targeting severe hypertriglyceridemia but omitted indications related to cardiovascular risk reduction. This practice has been contentious, not only in Amarin and Hikma's case but also in other lawsuits involving companies like Teva and GSK.

Vascepa, known chemically as icosapent ethyl, was first approved by the FDA in 2012 to lower triglyceride levels in adults with severe hypertriglyceridemia. In 2019, it received a second approval for reducing cardiovascular risks in adults with certain risk factors. Amarin filed a lawsuit against Hikma in 2020 after Hikma sought approval for a generic version of Vascepa that only included the indication for severe hypertriglyceridemia.

The appeals court found that Hikma's marketing and public communications may have encouraged doctors to prescribe the generic for all of Vascepa's approved uses, which would infringe upon Amarin’s patents. The court specifically pointed out that Hikma referred to its product as “generic Vascepa” without clarifying its label limitations, potentially misleading healthcare providers.

Hikma and Amarin have yet to comment on this recent court decision. Chad Landmon, an expert in intellectual property and FDA practices, remarked that this case is unique because it involves a generic that was already on the market, whereas most patent litigation occurs before a generic is approved and released. He noted that while the decision is likely a disappointment for Hikma, it also represents a setback for the broader generic and biosimilar industries.

Since losing the U.S. patent for Vascepa, Amarin has focused on maximizing its presence in the European market. The company’s shift in strategy has been accompanied by significant changes in its executive team and workforce. Last summer, Amarin announced it would lay off its entire U.S. sales force and reduce its non-sales staff by 30%, which accounted for approximately 120 out of 385 employees. Additionally, the company appointed Patrick Holt as its new CEO. However, Holt announced his departure earlier this month, and Aaron Berg, who previously served as an interim CEO, will now take on the role permanently.

Despite the recent legal developments, Amarin's shares have remained largely unaffected, continuing to reflect the significant loss in value experienced since 2020.