I will leave Amrn's legal arguments vis-a-vis Cyclobenzaprine and the errors in weighing secondary considerations aside, as the board has already digested these problems and pronounced. It seems the Cyclobenzaprine issue is strong if pitched to the right panel by Singer in the right way. It seems the weighing of secondary objective indicia against each other is pretty clearly without precedent or basis in prior practice or legal guidelines from teh Supreme court. The third argument regarding the correct TG populations for analysis and the factual errors stemming from generic and Du analyses are a mixed bag of legal appeal opportunity because facts (such as the Mori statistical analysis errors pointed out by many including the Curfman/Bhatt/Pencina article) which could have been entered in the record at time of District court discovery were not and thus may have become legally inadmissible.
Z.Silbersher Esq: It is not until page 24 that Amarin finally addresses the generics’ principle contention—namely, that all that matters here is whether the evidence supported an expectation that pure EPA would not increase LDL-C in a patient with TG levels at exactly 500 mg/dL. Amarin’s principle retort is that the Lovasa® label warned that patients above 500, but also including patients at exactly 500, could experience significant LDL-C increases. Amarin’s point is that evidence in the art suggested a material patient-population departure at 500 mg/dL. At that level, according to Amarin, persons of skill believed that LDL-C increases could be markedly higher. And that is precisely why, according to Amarin, prior art references such Mori and Hayahshi are irrelevant.
This response is unfortunately not as crisp as someone sympathetic to Amarin’s plight may have hoped for. Notably, Amarin does not point to any admissions by Dr. Heinecke that were solicited at trial. Again, Amarin’s principle task here is to dissemble Dr. Heineck’s opinion. His opinion was the lynchpin of Judge Du’s decision to invalidate the patents. The reason the generics have placed so much focus on a patient with exactly 500 mg/dL is because that is what exactly Judge Du did in the Bench Order. (Bench Order at 58). Judge Du cited to caselaw holding that if a patent covers a range of patients (eg., TG levels from 500 to 1500 mg/dL), all that is required to invalidate the patent is to show prior art anticipating any patient within that range, including a patient at exactly 500 mg/dL.
Amarin cannot challenge this caselaw because it is firmly established. And thus, it is forced to try to take apart Dr. Heinecke’s opinion. That is a more difficult task. Its main point is that Dr. Heinecke’s opinion is an outlier when viewed within the context of all of the available prior art—including, other TG-lowering drugs and the understood mechanism-of-action.
But, at the end of the day, Amarin cannot hang its hat on any clear admission by Dr. Heinecke undercutting his own opinion. That is the best type of evidence usually required to show that a finding of fact based upon an expert’s opinion was clear error. Instead, what Amarin can and does point to is a wealth of evidence to support its “two patient populations” argument. Indeed, this is what made this case a close call in the first instance.
Yet, the problem that Amarin now faces is that it is no longer trying the case to a fact-finder. Rather, the case is on appeal. Amarin’s contention that scientists did not expect pure EPA to be LDL-C neutral in severe patients is not the issue. The issue, rather, is whether Judge Du’s finding that it was expected was clear error.
Thus, the appeal remains a dispute between the prior art adequately taught enough about the “two patient populations,” on the one hand, or whether what it taught was sufficient for a patient at exactly 500 mg/dL. While it may be intuitive from a medical perspective to discuss two patient populations, the generics’ argument, which has a basis in law, is that all that matters is what the patents require. And to anticipate the patents, all that is required is a showing relevant to a patient at exactly 500. Whether Amarin has, or even can, do enough to undermine that line of argument simply highlights the fact that, for better or worse, the Judge credited the testimony of the generics’ expert over that of Amarin’s.
