For a drug company with one commercial product, losing a patent challenge right on the heels of a major new FDA approval is a serious setback. That’s why Amarin took its Vascepa patent defense all the way to the Supreme Court, but it has fallen short.
On Monday, the United States’ top court declined to take up Amarin’s challenge on a patent loss handed down last September, leaving the prior decision in place. Amarin’s stock was trading down about 10% on Monday morning.
In September, the United States Court of Appeals for the Federal Circuit ruled in favor of Hikma and other generic challengers, finding that patents on Amarin’s fish oil-derived heart drug Vascepa were invalid based on obviousness.
Now, Hikma’s generic has an FDA approval and has launched in the U.S. So far, Hikma has faced supply hurdles, limiting the overall damage to Amarin’s brand. In its first-quarter results, Amarin said generics represented 9% of overall prescriptions.
Still, with key Vascepa patents invalidated, the med faces an uncertain future in the U.S.
After Amarin lost its patents, the drugmaker looked to Europe to bolster its prospects. In April, the company launched Vascepa there, and some analysts now think the company can eke out more than $1 billion in Vascepa sales by the end of the decade.
Before the appeals loss, Amarin in late 2019 scored an important FDA label expansion for the drug to reduce the risk of cardiovascular events in adults with high triglyceride levels. With that approval, the company set its sights high. At the time, CEO John Thero said the company expected peak sales to reach the “multiple billions.”