Amarin Corp Plc (AMRN)

[HDGabor]

g-

I did not read all patents' doc. But according to one of them (NOTICE OF ALLOWANCE AND FEES DUE, Application No: 13=349,153; 2-16-cv-02525-MMD-NJK - Doc 89 - Exhibit 27)

The prior art teaches

The prior art does not teach the administration of ethyl-EPA to patients having TG levels between 500 and 1500 mg/dl (very high) as such there is no anticipation.

However the prior art teaches that:

96% pure ethyl-EPA has been administered to patients with TG levels between 50- 499 mg/dl (borderline high/high) in order to lower TG levels in amounts that range from 1.8 per day up to 4.0 per day and for periods of time ranging from few weeks up to two years (see non-final rejection dated 04/04/2012 pages 3 through page 6). In every case substantial reduction of TG levels was observed.

The prior art also teaches that the administration of mixture of ethyl EPA and DHA (also known as Lovaza or Omacor) to patients with TG levels above 500 mg/dl (very high). The results show dramatic reduction in TG levels (about 50%).

Based on these references it was concluded that it will be obvious to treat patients having TG above 500 mg/dl with 96% pure ethyl-EPA (see pages 6-9 of the non-final rejection dated 04/04/20).

However Applicant was able to overcome the above 103 obviousness rejection by showing

1- Unexpected results and
2- Long felt unmet medical need

1. is Apo-B reduction
2. is no-increase of LDL-C

Both treatments lower TG significantly (50-60%) however both treatments also raised LDL-C (the bad cholesterol) significantly (about 50%). (See Lovaza package and Triplix Package see also Table on page 13 of Applicants arguments dated 09/21/2011 appl# 12/702,889)

According to Dr Weintraub there is need for treatment for patients with TG above 500 mg/dl (very high) that not only reduces the level of TG but also does not increase LDL-C which is associated

We "know" that Unexpected benefit exists, Kura did not teach / suggest anything, did not motivate anybody (except Judge Du).

Her LDL-C is more crazy (top of science):

The Court is persuaded that there was a long-felt need for a drug like Vascepa ... Thus, the Asserted Claims represent an improvement — albeit a prima facie obvious one — over the prior art. And this secondary consideration therefore weighs slightly in favor of finding the Asserted Claims nonobvious.

Secondary considerations are to avoid hindsight. An existing Long-felt need (confirmed by commercial success despite existing, cheaper alternative; generic Lovaza) has to nil the prima facie obviousness determination ... does not vica versa - as Judge did - PFO weaken the LFN. The Judge did not consider the fact that nobody made this type of drug, everybody tried to develop an EPA / DHA mix (e.g. Epanova) ... despite Mori "teaching / suggestion" ...

No question: Judge Du is clever than the whole pharma industry. Something was obvious for her but not for anybody else ...

Best,
G