Amarin Corp Plc (AMRN)

[studythosestocks]

More light on importance of Marine Patent approved today and possible extended delay of generics coming to market if they prevail. Apologize if repeating but off today and found this VERY interesting:

First here is the patent approved. Worth a quick review to see the extent of the patent

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=6&f=G&l=50&co1=AND&d=PTXT&s1=hypertriglyceridemia&OS=hypertriglyceridemia&RS=hypertriglyceridemia

Notice the following from the patent:

In another embodiment, the invention provides a method of treating moderate to severe hypertriglyceridemia comprising administering a composition as described herein to a subject in need thereof one to about four times per day. In another embodiment, the invention provides a method of treating moderate to severe hypertriglyceridemia comprising administering to a subject about 2 g to about 4 g per day of EPA (e.g., ethyl eicosapentaenoate), for example about 3.8 g to about 4 g per day.

In one embodiment, the present invention provides a method of blood lipid therapy comprising administering to a subject or subject group in need thereof a pharmaceutical composition as described herein. In another embodiment, the subject or subject group has hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia and/or very high triglycerides.

Now to the interesting stuff which others probably understand better than I. Credit to someone on twitter giving a very shortened version of this. Not my find but his/hers:

Here is the link taken from:

https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf
page iii
Has the Study Identified Any Circumstances That Can Prevent FDA Approval of Generic ANDAs Beyond 30 Months?
Yes. If a brand-name company lists an additional patent in the Orange Book after the generic applicant has filed its ANDA, more than one 30-month stay may be generated. The generic applicant is required to re-certify to this later-listed patent, and if, upon notice of the generic’s re-certification, the brand-name company sues within 45 days, then FDA approval of the generic’s previously filed ANDA is stayed for an additional 30-months from the notice date or until a court decision in the newly instituted patent litigation.
From 1992 through 2000, brandname companies have listed patents in the Orange Book after an ANDA has been filed for the drug product in 8 instances; 6 of these 8 instances occurred since 1998. For the 8 drug products, the additional delay of FDA approval caused by the additional 30month stay (beyond the first 30-month stay) ranged from 4 to 40 months. In all 4 of the cases so far with a court decision on the validity or infringement of a later-issued patent, the patent has been found either invalid or not infringed by the ANDA.
Arguments exist that the later-issued patents, which have provided the basis for additional 30-month stays, do not meet FDA’s requirements for listing patents in the Orange Book. (These arguments are discussed in detail in Appendix H to the Report.) Under current court rulings and FDA procedures, however, it is very difficult for generic applicants to test these arguments. Recent court opinions have held that Hatch-Waxman does not provide a private right of action through which generic applicants may challenge a patent listing in the Orange Book. The FDA has stated that it lacks the resources and the expertise to review patents to determine whether they are properly listed.

Just something to chew on. Looks like in a perfect AMRN world they could possibly get this delayed another 30 months?? Smarter minds chime in. Well, time to change the oil in my cars.
Best,
Study