Amarin Corp Plc (AMRN)

[Jasbg]

Toddrk@ Great Find - Thanks.

And your right - 'does not get more Obvious than this article' - that Nevada case ended in 'a wrong ruling' (the very nice version).

Coopied conclusions here:

Conclusions We conclude that the judge’s opinion on obviousness was based on a statistically incorrect interpretation of the results presented in Mori et al., which she relied on as prior art. The presence of a statistically significant difference within one arm combined with the absence of a difference within the other arm does not imply a statistically significant difference between the arms. In fact, if Mori et al. had conducted the appropriate statistical test for difference between arms, most likely the opposite conclusion would have been reached, and it would not have been possible to claim that it was obvious that there were differential effects of DHA and EPA on LDL levels. The proper statistical analysis that we conducted is not a highly technical analysis that would be known not only by expert biostatisticians; it would also have been known by persons having ordinary statistical knowledge. A person with a general familiarity with statistical analysis would have questioned the use of Mori et al. as valid prior art, on the basis of both the invalid statistical analysis and the hypothesis-generating nature of the study. An appeal of Judge Du’s opinion in the bench trial in the US District Court was recently accepted by the US Court of Appeals for the Federal Circuit, which will review the case on an expedited basis. To provide a sound legal interpretation of the validity of the icosapent ethyl patents, we believe that Judge Du’s determination of obviousness should be reviewed by the appeals court in the light of the flawed statistical analysis in the small study by Mori et al. We believe that the appropriate standard of review is “clear error,” and given the arguments we have made, we can come to no other conclusion than crucial facts in Judge Du’s opinion are clearly erroneous. The error in the prior art does not constitute new evidence; rather, our observation constitutes a re-interpretation of evidence that was already cited multiple times in the judge’s opinion. What are the broader implications of Judge Du’s opinion? We cannot know with certainty how frequently a decision on patent obviousness may be based on flawed science, but there is little reason to assume that the case is unusual. While we agree with Justice Ruth Bader Ginsburg’s recent Supreme Court opinion in Thryv Inc. v. Click-to-Call Technologies LP that bad patents need to be weeded out6, it is equally important that judges take care not to stifle needed innovation by invalidating legitimate patents. If this opinion is allowed to stand on the basis of inaccurate science, it will be less likely that Amarin will invest further in the development and marketing of icosapent ethyl, which would be to the detriment of patients. Current research suggests novel mechanisms by which purified EPA may provide cardiovascular benefit7. Finally, if the opinion is not overturned on appeal, there may be a chilling effect on drug development more generally, given the prospect that patents may be invalidated by judges retrospectively on the basis of flawed science

Jasbg