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Re: ggwpq post# 261446

Friday, 04/03/2020 4:16:25 PM

Friday, April 03, 2020 4:16:25 PM

Post# of 425847
The paragraph below is taken from the Markman advisor blog. What t I don't understand what is the convincing evidence is that was found that was so convincing to alter the patent office examiner. The finding that 4g reduces Apo B and not 2g is novel and surprising. So obviously EPA is not the same than previous treatment, nor it was obvious that that would happen and particularly at that dose (and not to lower doses)



"Instead, the Examiner allowed the claims after concluding that it was “unexpected” that administering 4 g/day of EPA to patients with high TGs would decrease Apo-B levels. In particular, the Examiner concluded that the prior art showed no change in Apo-B levels from administering EPA to patients with TG levels below 500 mg/dl. In addition, Amarin’s MARINE study showed that this result was shown for 4 g/day, but not for 2 g/day, which evidenced certain criticality of the 4 g dose. The Examiner also concluded that there was a long-felt need for a drug for patients with high TG levels that did not also increase LDL-C levels, which is associated with cardiovascular disease, especially given that the two prior drugs approved for treatment of high TGs (Lovasa® and Triplix®) appeared to raise LDL-C levels"
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