Mike-"Expect" here is why: Dear Honorable Miranda Du C.J.,
I am a New York attorney, who once worked for Kenyon & Kenyon in patent litigation. I am a current shareholder in Amarin and appreciate your hard work adjudicating our litigation with the generics, Dr. REDDY et al. , especially your thorough and thought out detailed opinion.
As you know, Amarin and the generics are locked in an appeal and shortly will have oral argument. My understanding is that a settlement can be possible between the parties, yet since Your Honor invalidated Amarin's patents', any settlement is contingent on the Court vacating the initial decision.
I would like to make a suggestion. For the sake of settlement, can the Court signal in public or private disclosure that it is willing in principle to vacate the Order for the benefit of settlement? The longer the court litigation takes, the more lives will be put in jeopardy. Amarin will not spend the needed capital to educate and market the wonder drug they produced, which has been proven to reduce strokes and cardiovascular disease by about 20% to 30%. Moreover, in the bigger picture it is in the interest of all Americans for Amarin and the generics to settle the litigation, as Amarin successfully settled with Teva and Apotex, to ensure the maximum number of Americans have access to Vascepa.
I recognize that Your Honor is confident that your opinion is just. However, history has taught us to expect the unexpected and it would be in Your Honor's interest to remove the possibility that Your Honor's decision would be overturned. Your Honor would be hailed as a champion of the health of the American people and a selfless patriot who put aside her personal legal aspirations for the benefit of the health of Millions of Americans.
In regard to Your Honor's opinion, specifically on the issue of prima facie of obviousness, I would respectfully point out that your Honor wrote on p. 60 that:
"Moreover, Plaintiffs’ arguments also depend on another factual premise that lacks evidentiary support that patients with TG levels above 500 mg/dL respond differently to TG-lowering therapy than patients with TG levels below 500 mg/dL."
This seems to be incorrect since Amarin wrote extensively in their pre trial brief and post trial brief, how all pre-vascepa drugs worked differently on over 500 trigs population-as they increased the LDL significantly, while on populations below 500 they didn't increase LDL significantly. Further, Amarin explained the mechanism of lowering trigs resulted in an increase of LDL.
I would further respectfully point out that your Honor wrote on p. 60 that:"Indeed, Dr. Toth conceded that POSAs could rely on data in patients with triglycerides below 500 mg/dL to make reasonable predictions about how patients above that threshold would respond. As headmitted, “a skilled artisan would know that a drug that reduces triglycerides in a patient at 400, is very likely to also reduce triglycerides in a patient at 600.” Thus, the Court finds that a POSA “would have reasonably expected purified EPA to reduce triglyceride levels above 500,” even without data confirming that result."
This seems to be incorrect since Dr. Toth was discussing predicting whether a drug that lowers trigs at 400 would do so also at 600--he wasn't discussing the subject matter of raising LDL. He didn't say that a drug that doesn't raise LDL in 400 range or lower will also not raise LDL in a 600 trig population.
I hope you would consider my suggestion and allow the pharmaceutical companies come to a just settlement, which will benefit all Americans.
