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JDUR

04/05/20 5:34 AM

#262304 RE: mc1988 #262303

I see your point but in terms of the current ruling you would have to have overwhelming evidence during an appeal, during the trial I would agree with you.

On another note, do you think Hikma is working with Teva? I mean they can do a fake launch of the limited application using Teva as the supplier and Teva can produce the generic with no limitation of the expanded usage per the settlement.

This would be some next level strategy or Teva could have just boxed in Amarin and forced them to go to court with other generics knowing that it was a possibility for the patents to ruled as obvious in a limited sense. Thus, settling would give them the upper hand. Does anyone have the full settlement agreement?

HDGabor

04/05/20 10:50 AM

#262361 RE: mc1988 #262303

m-

The Patents-In-Suit (Asserted Claims)

6 patents … 10 Claims are the topic.

U.S. Patent No. 8,293,728 (“the ‘728 Patent”), Claim 1 & Claim 16
U.S. Patent No. 8,318,715 (“the ‘715 Patent”), Claim 14
U.S. Patent No. 8,357,677 (“the ‘677 Patent”), Claim 1 & Claim 8
U.S. Patent No. 8,367,652 (“the ‘652 Patent”), Claim 1
U.S. Patent No. 8,431,560 (“the ‘560 Patent”), Claim 4 & Claim 17
U.S. Patent No. 8,518,929 (“the ‘929 Patent”), Claim 1 & Claim 5

Yes, the '728 contains a reference to Kurabayashi … but is not about ApoB reduction.
ApoB is part of the U.S. Patent No. 8,318,715 (“the ‘715 Patent”) Claim 14, U.S. Patent No. 8,357,677 (“the ‘677 Patent”) Claim 8 and U.S. Patent No. 8,518,929 (“the ‘929 Patent”) Claim 5.

'728 is a is a continuation of co-pending U.S. application Ser. No. 12/702,889 ('727 patent). The co-pending U.S. application Ser. No. 12/702,889 ('727 patent) was approved as (see Doc 262)

Applicant was able to overcome the above 103 obviousness rejection by showing: … The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or a mixture of ethyl-EPA and DHA

Kurabayashi teaches differently:_ ss changes in Apo-B exist.

Best,
G