Amarin Corp Plc (AMRN)

[mc1988]

Regarding this part in the bench order https://www.courtlistener.com/recap/gov.uscourts.nvd.118340/gov.uscourts.nvd.118340.381.0_1.pdf

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.) 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, its considered judgment may lose significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious.

I'd like to highlight that this specific part made a reference to ECF No. 373 at 246-247:

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.)

It appears the judge made a glaring error because I checked ECF No. 373 pages 246-247 and nowhere does the defendant's (Hikma's) proposed findings of fact on pages 246-247 mention the Patent Office's examiner not considering Kurabayashi.

Looking through the ECF No. 373 document as a whole though (see https://www.courtlistener.com/recap/gov.uscourts.nvd.118340/gov.uscourts.nvd.118340.373.0.pdf), the correct reference is on page 85 where it says:

369. But without a finding that purified EPA was actually given to patients with triglycerides above 500 mg/dL in the prior art, the examiner no longer characterized his obviousness finding as “strong.” Instead, he found that Amarin “was able to overcome the ... obviousness rejection” with expert declarations alleging secondary considerations—namely, an “unexpected” reduction in Apo B, and a “long felt unmet medical need” to reduce triglycerides without raising LDL-C. DX 1521 at 1831-34. The examiner did not cite Kurabayashi, which showed that EPA reduced Apo B. Nor did the examiner acknowledge the teaching in Mori that DHA, but not EPA, increases LDL-C. Nor did the examiner address that Lovaza was frequently administered with statins to address LDL-C increases.

That is an assertion made by the defendant (Hikma), and to me, the judge relied on it without verifying the accuracy of the claim.