In a decisive and damaging blow for the Irish pharmaceutical giant, a US Federal Court decision has ruled that six patents owned by Amarin Corporation, and used in its successful drug VASCEPA, are invalid.
VASCEPA, a treatment for cardiovascular disease originally synthesized from fish oils, received FDA approval in 2012, with the FDA stating that “VASCEPA is the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels”. Its entry into the pharmaceutical market saw the beginning of exponential revenue growth for Amarin – from $26 million in 2014 to almost $430 million in 2019 – with nearly all the corporation’s revenue being generated by the drug.
Amarin’s profit expectations for 2020 were, understandably, bullish. However, this new decision has seen the value of Amarin’s shares drop by over 60%. The ruling came after two of Amarin’s competitors, Dr Reddy’s Laboratories and Hikma Pharmaceuticals, sought to manufacture and market their own versions of VASCEPA. The federal judge ruled in their favor, stating that while any generic version of VASCEPA would indeed infringe upon the patents concerned, those patents were in fact “obvious” and thus invalid. Amarin’s rivals had argued that since fish oil has been used to treat cardiovascular conditions for more than thirty years, Amarin’s hitherto protected methodology was not sufficiently novel.
In a statement, CEO and President of Amarin, John F. Thero, said:
“Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies … we plan to fight to protect our VASCEPA franchise for the benefit of our patients, physicians, the broader healthcare community and our investors. We believe we are favorably situated to obtain an injunction against generic launch pending appeal.”
A Hikma spokesman stated: “We are very pleased with the court’s decision and are working diligently to gain the FDA’s approval of our application so we can provide patients with a generic version of this important medicine”.