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HinduKush

02/04/21 8:11 PM

#323649 RE: Bouf #323646

Two summary excerpts from the District Court’s bench order:

(1)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. (ECF No. 373 at 76-80, 246-47.)
(2)Further, while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.) Where “the PTO did not have all material facts before it, considered judgment may lose significant force” See i4i, 564 U.S. at “Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious.”


Kurabayshi is critical to the determination of Vascepa patent justification (lowering ApoB without raising LDL in TG>500)

Whalatane

02/04/21 8:14 PM

#323651 RE: Bouf #323646

Bouf. Agree. Gr8 to have your experience and insights on this board
Kiwi

marjac

02/04/21 8:23 PM

#323654 RE: Bouf #323646

Bouf,

I saw that HK responded, which I incorporate. By knocking out Kurbayashi and Mori, we the generics cannot meet their 'clear and convincing' burden of proof.

I think we both acknowledge that this is a tough case. But just because it is not easy or guaranteed, does not mean that we cannot and should not make the best arguments possible, and hopefully reach a point of critical mass where we prevail.

sts66

02/06/21 4:27 PM

#323946 RE: Bouf #323646

K was critical in that Du claimed the USPTO did not review it as part of one of the patents related to Apo-b - that was a big mistake.