Replies to post #266683 on Amarin Corp Plc (AMRN)

[HDGabor]

e-

Du used Mori finding prima facie of obviousness

Agree … and the USPTO used it also as finding prima facie of obviousness

NOT Kurabayashi!

???

As explained above as to Defendants’ prima facie obviousness case, Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels.

Other prior art (e.g., Kurabayashi and Hayashi) similarly taught that EPA did not increase LDL-C in patients with triglyceride levels up to 400 mg/dL.

the findings of fact above, the prior art showed that purified EPA produced each of the claimed effects in clinical studies. In particular, Mori and Hayashi disclosed that EPA reduced triglycerides by at least about 20%; Mori, Hayashi, and Kurabayashi disclosed that EPA did not increase LDL-C; and Kurabayashi disclosed that EPA reduced Apo B.

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Kurabayashi goes to sec. cons. factor (#3) and not to prima facie of obviousness --hence its secondary and Mori is the kicker here.

If I understood you correctly, you agree ("Kubayashi … its secondary") Apo-B is a valid secondary consideration ("unexpected benefite". (?)

Mori is the kicker here

Mori support obviousness … acc. to the USPTO & Judge Du (and I did not see a valid rebuttal) … if it is the key - but not - end of story …

EVEN IF sec. cons. was strong enough (which she claimed was not--b/c she negated one against other) it DOESN'T MATTER b/c under ZUP, strong showing of obviousness allows you to work around sec. cons. even if they are considerable.

Why Kurabayashi is the key / relevant?

(score 1 - 10 … numbers just for the example)

"strong showing of obviousness":
- with obvious Apo-B reduction: 7
- without: 5

secondary consideration:
- "Unexpected benefit" & "Unfelt need": 6
- "Commercial success" & "Unfelt need": 5
- "Commercial success" & "Unfelt need" & "Unexpected benefit": 8

USPTO: 5 vs 6 … granted
Judge Du: 7 vs 6 … obvious
reality: 5 vs 8 … non-obvious

Best,
G

[amarininvestor]

Eight,

My understanding is that the district court claims are all prima facie obvios but she does not claim that she find in this case that there is a strong showing of obviousness . She gives this reference saying that even in cases of strong obvioness (although I don't see her claiming that this is one of those), secondary may not be enough and give the reference of ZUP. I am not a lawyer, so would love to hear your thoughts on whether I am interpreting this correctly.

The Court thus finds that the satisfaction of long-felt need and commercial success secondary considerations weigh in Plaintiffs’ favor, and the remaining secondary considerations weigh in Defendants’ favor. More specifically, the Court finds that Vascepa is a commercial success even though it has not yet turned a profit, and that there was long felt need for a single pill that reduced TG levels without increasing LDL-C levels. However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious. See, e.g., ZUP, 896 F.3d at 1373 (holding that “a strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations”).
For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. § 103