But in the comments section below the article the iHub Amicus is being debated (posters from iHub doing also questioning - eg. BB) - Markman answers. Se quote below (or scroll down article and find it there)
sanjay S A week ago · 0 Likes
Thank you Mr.Zilbersher for your erudite posts which are very insightful. I would like to bring to your readers attention, that Judge Du in formulating her bench order repeatedly cites both Mori and Kurabayshi as the fundamental basis for establishing prima facie obviousness in the prior art at trial. Kurabayashi was THE reason for USPTO exmainer's decision for allowability of the MARINE patents as an "unexpected result" meeting a "long felt unmet need" for ApoB reduction in the face of substatntial TG lowering in teh TG>500mg/dl population without deleterious LDL increase. Where blatantly flase statistical misrepresentation underscore the prosecution of the obviousness case by Hikma and Heinecke, and a Judge's opinion is falsely influenced (and notwithstanding the deplorable inaction of the Amarin lawyers in pointing this out re Table 3 etc..): Is this not a case of tainted evidence -patently false and engineered to create an opposite scientific conclusion by the defense expert witness Heinecke? Please understand what this Amicus contends is a straight forward case of scientific misrepresentation and falsehood, not an attempt to readjudicate the subtelties of the evidence. What is at the heart of the Amicus brief, is fundamental: Do we no longer believe that judicial opinion should be based on sound science honestly presented. From a scientific viewpoint, Kurabayshi is hugely tainted evidence misrepresented on purpose, to persuade for obviousness. If such demonstrably false scientific errors were allowed to pass unchallenged, as they were by both parties and the court in this case, it would set a dangerous precedent for invalidation of USPTO patent adjudication decisions, based on clearly erroneous, scientifically false representations of data, thereby undermining the entire legal basis for establishment of what constitutes POSA understanding of prior art. Justice Stephen Breyer writing on behalf of the Federal judicial center states: “The Supreme Court recently made clear that the law imposes on trial judges the duty, with respect to scientific evidence, to become evidentiary gatekeepers…. this requirement extends beyond scientific testimony to all forms of expert testimony. The purpose of Daubert‘s gatekeeping requirement is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” This standard has not beenmet...not even close!
Jason Williams 2 weeks ago · 0 Likes
Mr. Silbersher
"With respect to the allegations themselves, putting aside the specific allegation of fraud"
Putting the allegation aside would be an absolute grievous violation to Amarin stakeholders whom have been defrauded of billions of dollars in a single day market cap loss and 10's of billions in lost US revenues. The cropped table highlights the literal false statement made by Heinecke and copied and pasted into Judge Du's Order. There is clear intent to defraud the court and this can be further elucidated by the fact both Heinecke and Hikma ignored the claim construction order throughout the trial and avoided comparisons to a non-treatment or placebo group. Had we had 10,000 words to submit our Amicus our expert could have crystallized these facts. We welcome any comments Hikma can make to the court to explain the cropped table and material literal lie of their expert witness Jay Heinecke at (Appx. 28-30) (Appx. 102826)
"With respect to the allegations themselves, putting aside the specific allegation of fraud"
If CAFC doesn't address our specific allegation and evidence of fraud, Amarin and Stakeholders will have had their Due Process rights trampled.
Thank you for your comments and be sure to read Heinecke's deposition asking for Kurabayashi Tables and legend...(EPA Appr9). Certainly Judge Du needed the full table and legend references.
JMO Jason
Further Heinecke motive is contain in USPTO applications with several lipid patents, Nevada prosecutors should carefully review this case.
J Mann 2 weeks ago · 0 Likes
My point is that an allegation of fraud and perjury has been leveled at Hikma's legal team. One would think that if they do nothing about this it is akin to admitting guilt and their (good ??) name destroyed. Surely if they feel they could defend it they will come out fighting or will they turn cowards and let the allegation hang over them
HDGABOR 3 weeks ago · 0 Likes
Thank you.
KR, G
Markman Advisors 3 weeks ago · 0 Likes
In response to some of the interesting comments below.
H. Novo -- Our earlier blog post, dated April 2, 2020, discussed the relative split within the Federal Circuit over the proper framework for assessing obviousness and whether the framework enunciated in Cyclobenzaprine has wide support among the Court. The majority’s opinion in the GSK case does not appear to have been motivated by a deference to jury verdicts, although that cannot be discounted. If anything, the majority’s opinion appears to be motivated by a quirk in the law of inducement that has disgruntled many brand pharmaceutical companies, namely, a generic can carve-out an indication, be aware of and profit from off-label sales, and nevertheless easily avoid patent liability. Judge Prost’s dissent essentially says, while reasonable minds can disagree on whether that is sound policy, altering that policy is a decision for Congress, not for the courts. If this case is taken up en banc, the majority of the Federal Circuit will more likely than not agree with Judge Prost on this point.
Astracastra – I did not expect a Rule 36 judgment primarily because neither party nor Judge Du identified any legal support for weighing secondary considerations against one another, and I believed the Court would want to address that. On the other hand, Rule 36 is something that has disgruntled anyone who has appeared before the Federal Circuit, and it has happened before in pharmaceutical cases. Thus, it was not a complete surprise, as I indicated in comments to our blog post on May 19, 2020. Regarding the precedent set by this case, the most concerning one is that there is now a district court opinion, affirmed on appeal, holding that patent holders can be penalized for presenting too much evidence of secondary considerations. That risk did not really exist before, and it may force patent holders to be more judicious when selecting their secondary considerations arguments. Given the number of obstacles to enforcing patents piled on over the past eight years, tacking on another one will not be welcomed by patent-holders.
Jomama – The facts and circumstances in the GSK case are very unique, and the FDA’s instruction for Teva to amend its label in 2011 does not appear to have been part of a tactical ploy by GSK. Also, the Orange Book presumably already lists Amarin’s patents covering its REDUCE-IT indication.
HDGABOR – These are good questions. In the district court case, Teva’s motions to dismiss shed more light on the circumstances of Teva’s amended label to cover the CHF indication. After the ‘000 patent issued, which narrowed the scope of the earlier ‘069 patent, Teva appears to have had good reason to believe that it would not infringe that patent even if its label included the CHF indication. More specifically, the ‘000 patent covered a method of treating CHF that included a specific time limitation for that treatment, and Teva’s amended label, even with the CHF indication, did not include or suggest that time limitation. Thus, Teva appears to have believed it could adopt a full label without risking liability for infringement. This is not an unreasonable strategy, and it appears to have initially been a sound one given that GSK refrained from suing Teva for infringement of the ‘000 patent for three years even after Teva adopted a full label. This underscores how much the GSK case may be a departure from existing law, and thus susceptible to reversal en banc. It also illustrates that, when it comes to proving patent infringement, the devil is in the details. Hikma, Dr. Reddy’s and any other generic for Vascepa are likely studying Amarin’s REDUCE-IT patents to determine how likely they are to be infringed even if they were to adopt a full label. And even if they are infringed, the JELIS study will present a veritable challenge to the validity of the REDUCE-IT patents.
Jason williams – An amicus brief in support of Amarin’s en banc petition was filed by what appears to be a group of Amarin shareholders. This is an unusual but nevertheless commendable effort that will presumably gain the attention of management, if not the Court.
J Mann – The generics do not have to respond to the Amicus brief, and they may not have the opportunity to do so. For the generics to be in a position where they even have the opportunity to respond, then leave to file the Amicus brief would have to be granted (the brief does not indicate it was filed with the consent of the parties,) and the Court would probably also have to invite a response to Amarin’s en banc petition, which may not happen. With respect to the allegations themselves, putting aside the specific allegation of fraud, the statistical interpretation of Table 3 is an interesting argument that relates to the Kurabayashi discussion that we blogged about extensively in two separate posts back in April 2020. As we discussed at the time, putting aside the merits of the argument, Amarin refrained, for whatever reason, from pressing this argument at trial or in its post-trial briefing. Accordingly, it never became a basis to distinguish the Marine patents over Kuarabayashi either before Judge Du or on appeal, and thus, it is unlikely to move the needle on an en banc petition. With respect to the more particular allegation that a fraud occurred, if the generics do respond to the Amicus brief, they are likely to point out that the entire Kurabayashi article, including the uncropped version of Table 3, was submitted as a separate exhibit into evidence during the trial. They will argue that that essentially negates any finding that the defendants defrauded the court with a cropped version of a table.
