- A federal court dealt an unexpected blow to New Jersey drugmaker Amarin on Monday, invalidating five patents held by the company on its heart pill Vascepa and potentially opening the door to generic competitors in the U.S.
- Shares in Amarin sank by 70% in Tuesday morning trading in response to the ruling, erasing roughly $3.5 billion in market value. No generic versions of Vascepa are currently approved by the Food and Drug Administration, so the court's decision does not mean an immediate launch of knockoff versions.
- Even so, the surprising setback spurred Wall Street analysts to rethink their forecasts for Vascepa, sales of which have grown steadily following results from a large cardiovascular study that showed a convincing heart benefit from treatment. The FDA approved the fish oil-derived pill for reducing heart risks in Dec. 2019.
Amarin's legal battle with generic challengers Hikma Pharmaceuticals and Dr. Reddy's Laboratories has lingered in the background of the dramatic upswing in the company's fortunes over the past year.
The Dec. 2019 approval for Vascepa, use of which had previously been limited to lowering triglyceride counts in certain high-risk people, greatly boosted the drug's — and Amarin's — prospects for growth. This year, the company forecast net revenue between $650 and $700 million, which is roughly triple what it earned in 2018, before the REDUCE-IT study proved Vascepa's heart benefit.
Now, with the U.S. District Court for the District of Nevada ruling against Amarin, that growth is at risk.
In the case, Amarin had sued Hikma and Dr. Reddy's for infringement on five patents it held concerning the use of Vascepa to reduce triglycerides. All five were set to expire in 2030.
District Court Judge Miranda Du did find, in fact, that generic versions of Vascepa from Hikma and Dr. Reddy's would infringe on Amarin's patents, but concluded those patents were invalid due to obviousness, a legal term indicating someone skilled in the field could logically have come up with the patented claims.
Amarin tried to argue the REDUCE-IT results, which were more compelling than doctors and analysts had expected, demonstrated the non-obviousness of its patents. Du, however, determined the study data weren't relevant because they went beyond the claims specified in the five patents.
"Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the court's decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of Vascepa in the United States," said Amarin CEO John Thero in a Mar. 30 statement.
Hikma and Dr. Reddy's aren't currently in a position to launch a generic drug, having yet to win FDA approval. But analysts think a launch could be possible by 2021 or 2022, much earlier than previously anticipated.
In a statement, Hikma said it's working to secure U.S. approval for its generic version of Vascepa, and would consider an at-risk launch in the event of an FDA OK and Amarin appealing the district court decision.
Amarin said it would continue with its marketing efforts for Vascepa, which the company had stepped up following the December approval. However, it suggested that promotional activities could be adjusted after a decision is made on how the company plans to proceed.
Some of Amarin's sales efforts have been put on hold due to the coronavirus pandemic, which led the company earlier this month to suspend all face-to-face meetings between its representatives and healthcare professionals.
Amarin also emphasized the court's ruling applies only in the U.S., outside of which no generic litigation is currently pending. Vascepa is approved in Canada and the company is seeking additional regulatory clearance in the EU and China.