Apologize if this has already been posted. Markman replies to questions following filing of the generic response
In response to some of the comments below:
Amarin has challenged Judge Du's "weighing" of the secondary considerations. Amarin has separately challenged the secondary considerations that Judge Du found did not weigh in favor of nonobviousness (eg., praise, skepticism, unexpected benefits.) Thus, the Court could take up either one of these challenges, or both. One is not dependent upon the other. Technically, as discussed above in the post, there is a pathway to reversal where the Court determines that "weighing" the secondary considerations was legal error, and reverses without considering any challenges to the secondary considerations. But there is also another pathway where, if the Court determines that "weighing" the secondary considerations was, in fact, legal error, that will invite the Court to weigh all the evidence for and against obviousness de novo. At that point, the Court might reasonably reconsider the weight of the prima facie case, the weight of the secondary considerations found in favor of obviousness (commercial success and long-felt need), but also the weight of those secondary considerations found by Judge Du not to be in favor of non-obviousness (praise, skepticism, etc.) Thus, does the “weighing” of the secondary considerations argument potentially act as a mechanism for the Court to reconsider praise, skepticism and praise? Yes, potentially. The oral arguments may provide insight into how far the Court is inclined to go down this path.
If the Court reaches the point where it is weighing, de novo, the prima facie case against the secondary considerations, I would not say that it is purely subjective, but it is nonetheless an exercise in which reasonable judges, reasonable experts, and reasonable people (eg., jurors) can disagree. That is inherent in the process.
If Amarin loses the appeal, the likelihood of refiling these patents to more adequately claim a second patient population would be extremely remote. The priority date would be 2020, rather than 2008, and Amarin would have to overcome a host of prior art published since 2008, which would make this very difficult. The patents that Amarin has covering this drug, which could warrant an injunction, are listed in the Orange Book. A fair presumption is that Amarin has already asserted the best patents that it has to block Hikma and Dr. Reddy’s, at least with respect to the Marine indication.
