Updated with analyst comments.
BEDMINSTER, NJ (
) -- The intellectual property worries that have hung over
prescription fish-oil pill AMR101 are vanishing Wednesday because U.S. patent examiners appear poised to approve a family of key patents that could protect the drug from generic competition through 2030.
Amarin shares are up 11% to $14.65 in Wednesday trading.
The U.S. Patent and Trademark Office issued a "Reasons for Allowance" notice for the so-called '889 patent application. This is an important method-of-use patent that Amarin has long sought to provide extra years of market exclusivity for AMR101 as a treatment for patients with very high levels of triglycerides. However, the U.S. patent office has rejected Amarin's '889 patent application multiple times, forcing the company to
appeal and causing consternation for Amarin investors
Finally, it seems as if Amarin's efforts have paid off. A "Reasons for Allowance" notice is typically filed when patent examiners are satisfied with a patent application's novel claims. An approval of the patent typically follows.
The '889 patent is "the single most-watched patent on Wall Street, in our view, so the stock should be up significantly today," said Leerink Swann, in an email to investor clients Wednesday morning.
In addition to the positive signal on the '889 patent, the U.S. patent office also issued "Reasons for Allowance" notices on three other related AMR101 patents.
Importantly, these patents should provide Amarin with market exclusivity for AMR101 through 2030. The strengthened intellectual property protection for AMR101 boosts the value of the drug and may also make it more attractive to potential Big Pharma acquirers.
With patent worries subsiding, the Amarin's next big step is the FDA approval decision for AMR101 expected in July 26. At that same time, FDA will decide whether or not to grant AMR101 status as a new chemical entity -- another important designation for market exclusivity.
--Written by Adam Feuerstein in Boston.
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