Recent article at The street
The web site of the U.S. Patent and Trademark Office indicates that Amarin's patent application for AMR101 was issued a "final rejection" notice on Aug. 12, although the notice had not yet been mailed to the company.
A "final rejection" from patent examiners is not as definitive as it sounds. Amarin can and likely will appeal the decision.
An Amarin spokesperon wouldn't confirm or comment on the patent office's decision, but as the news spread (publicly available on the patent office's web site), Amarin shares closed down 61 cents, or 5%, to $12.29 Wednesday. Intraday, the stock was down as much as 10%.
Amarin is seeking a method of use patent that would grant additional years of exclusivity to AMR101 as a treatment for patients with very high levels of triglycerides, or soluble fats in the blood. Amarin is expected to file an approval application with FDA for AMR101 in this patient population before the end of September and launch the drug next year, if approved.
Under FDA law, Amarin would get five years of exclusivity -- likely extended by another 18 months -- to sell AMR101 without further patent protection once the drug is approved. But getting additional patent protection to keep generic competitors on the sideline is important for peak sales of AMR101 and Amarin's valuation.
"Amarin is not getting bought for $100 a share with eight years of exclusivity," said Monness Crespi Hardt analyst Avik Roy. Concerns about AMR101's patent situation -- and the hurdle that may put n front of a lucrative marketing partnership or acquisition -- is a big reason for why Roy has a neutral rating on the stock. He models generic competition in 2019, assuming a 2013 drug launch.
Amarin shares have been a big winner this year in part because investors believe the company is a likely takeover target due to the billion-dollar sales potential of AMR101
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