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I agree with JL...
Read Amarin's Press Release closely...
It doesn't say or imply "removes".
The first sentence summarizes what it does.
"Slowed Coronary Plaque PROGRESSION..." which was the 'Primary Endpoint'...
Aug 29, 2020
Primary endpoint of slowed coronary plaque progression reported to have been met with VASCEPA
Significant coronary plaque regression of low attenuation plaque (LAP) reported with VASCEPA provides further insight to potential mechanisms of action
VASCEPA is the first and only agent studied on top of statins reported to exhibit coronary plaque regression in hypertriglyceridemic patients
9/2 Appeal Call-in Info is available...
Scroll down and hit the PDF info...
See 9/2 Panel "E" and "F"...
Public Access for Arguments | US Court of Appeals for the Federal Circuit
http://www.cafc.uscourts.gov/public-access-arguments
JL - Are you saying your interpretation is that Vascepa allows "less Plaque to form" vs someone on a Placebo and NOT that it "goes in the Arteries and carves out existing Plaque"?
Short Interest at a (12) month low as of mid-August:
Amarin Corporation plc (AMRN) Short Interest | Nasdaq
https://www.nasdaq.com/market-activity/stocks/amrn/short-interest
Love this Article! I wish all of our PR was so clear and in "2nd Grade English" as I like to say!
I believe 2 of 3...
ESC: Amarin's Vascepa cuts patients' arterial plaque after 18 months of treatment | FiercePharma
https://www.fiercepharma.com/pharma/esc-amarin-s-vascepa-cuts-patients-arterial-plaque-after-18-months-treatment
Amarin PR:
VASCEPA® (Icosapent Ethyl) Reported to Significantly Reduce Coronary Plaque in EVAPORATE Study Final Results Presented at ESC Congress 2020 | Amarin Corporation plc
https://investor.amarincorp.com/news-releases/news-release-details/vascepar-icosapent-ethyl-reported-significantly-reduce-coronary
That's what I do to catch up. Click the posters name a few times and you'll get to all of their posts! Easy to catch up! Happy to Help!
STS66: True yet did Amarin refute any of this in their Post Trial Briefs?
Trial Outcome: I think the anxiety of the Appeal (and this Board) is this:
Judge Du based her verdict on the evidence as provided and not refuted or proven false or incorrect by Amarin's Attorneys - Pre-Trial, Trial, or Post Trial Briefs.
Our Appeal technically MUST prove she did something wrong. We technically cannot bring new evidence, opinions, and/or refute evidence that Amarin's Attorneys did not argue was inadmissible, fake, bogus, or whatever we on this board want to call it.
Now: If we get the "by the book" Appeals Judges, they will find she did not make any mistakes finding in favor of the Generics (whether their evidence was bogus or not because our Attorneys failed to prove it wrong!)
Now: If we get 2 out of 3 more open-minded Judges, they will listen to everything and Remand or Over-turn it.
Important to Note: In 2015, Appeals Judges were told to stop being so Liberal and to ONLY over-turn verdicts IF the District Judge made a mistake.
WE ALL KNOW: The biggest mistake was Amarin's Attorneys NOT refuting the BS evidence that she used as the basis for her verdict.
NOW on to the SC's: We are concerned that the strength of the SC's will NOT overcome the strenght of Obviousness (remember now matter how Du "weighed" them, she still found the case for Obviousness was stronger) SO we can only hope that the Judges we get are willing to look at how Du got to the verdict with incorrect evidence.
If we do, we'll have 2 Judges who don't care what they were told in 2015!
We have a strong case only if the Judges are willing to look at how the case was determined on the bogus evidence.
We have a weak case (in my opinion) if we think they will accept the SC's as the determining factor to overturn it. If the Judges ignore the bad evidence, I believe they will Affirm it saying they agree with Judge Du that Obviousness was stronger than the SC's!
KEEP IN MIND - This trial is ONLY about a Drug treating Pancreatitis - NOT HEART DISEASE! Are the SC's regarding the need for a new drug for Pancreatitis strong enough to find in favor against Obviousness for a Drug Treating "ONLY" Pancreatitis? I don't think so! (Even Amarin didn't care about Pancreatitis back then - I've been an Investor since 2012 and have followed this product every step of the way and even Pancreatitis was not important to Amarin. SC's decide things like importance, value, unexpected benefits...)
Disclosure: I HAVE A HUGE INVESTMENT IN AMARIN and AM HOPEFUL THE JUDGES OVERTURN or REMAND THIS BACK TO THE DISTRICT COURT.
If Remanded back, I see a Win there yet another lost year waiting for Du's new decision!
I also see the European market large enough to keep me invested. And if we lose, I love the idea of creating our own Generic version to burn the Generics (as Amarin said they will!)
I am long and not leaving!
BINGO!
Montana: Read this post I put up a week or so ago. The Judges will (should) go back and review HOW and WHY Du utilized the SC's to be sure she used them correctly. The HOPE is they will see the 'errors and reliance' on flawed 'evidence':
START:
One thing in the Novo case I find in favor of Amarin is where the Novo Judges say they didn't believe one side "intentionally left out evidence to bolster their case" as though that would be grounds for the case being overturned - see below. That IS a point Singer will make in that the material used by the Generics was intentionally cropped to mislead Judge Du.
"Dr. Sturis was accused of failing to notify the PTO that the original test plan did not include his data calculations at 120 minutes. The Federal Circuit found it to be a nonmaterial omission because it did not qualify as “but-for” material. The Court explained that this was not a case in which adverse results were hidden in favor of more positive data, nor did the omission undermine the opinion stated in the declaration."
Patent Appeal Reversal Statistics. Not great yet certainly doesn't represent our case. Someone asked for Reversal Stastics - (hope the link works):
https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.perkinscoie.com/images/content/1/8/v4/184121/Fed.-Circ.-s-2017-Patent-Decisions-A-Statistical-Analysis.pdf&ved=2ahUKEwiw6uaChq_rAhWalXIEHQwQDiwQFjACegQIBBAB&usg=AOvVaw0e-xW5QZ2NwkkuFKrYy1Cl
YES - Yet like Novo, the Judges will review how the sides got to the SC's meaning what was used by the Judge to determine the Patent was Obvious first and foremost.
One of the arguments in Amarins case is the flawed info Due was provided to find the Patent Obvious. The examples she used were flawed science whereas the info in the Novo case was determined to not be flawed. The Patent Office also rejected the Novo Patent 4 times before approving it - a much different case than ours and a much higher hurdle for Novo...
Even in the Novo case one of the Judges questioned the evidence used to determine that the Patent was obvious to be sure it was not flawed asking if the evidence was intentionally altered to help the Generics:
"Dr. Sturis was accused of failing to notify the PTO that the original test plan did not include his data calculations at 120 minutes. The Federal Circuit found it to be a nonmaterial omission because it did not qualify as “but-for” material. The Court explained that this was not a case in which adverse results were hidden in favor of more positive data, nor did the omission undermine the opinion stated in the declaration."
In short - the Judges should go back to first make sure the determination that the Patent was deemed Obvious was not a flawed decision (as they did with the Novo decision) then they review the SC's to see if they were properly applied...
Singer will fight the decision that found the Patent obvious because the Generic's Cropped the data to bolster their position on a document they used to help their case... ADVERSE RESULTS WERE HIDDEN and IT UNDERMINED THE DECISION BY THE JUDGE AND WAS (most likely) INTENTIONAL!
One thing in the Novo case I find in favor of Amarin is where the Novo Judges say they didn't believe one side "intentionally left out evidence to bolster their case" as though that would be grounds for the case being overturned - see below. That IS a point Singer will make in that the material used by the Generics was intentionally cropped to mislead Judge Du.
"Dr. Sturis was accused of failing to notify the PTO that the original test plan did not include his data calculations at 120 minutes. The Federal Circuit found it to be a nonmaterial omission because it did not qualify as “but-for” material. The Court explained that this was not a case in which adverse results were hidden in favor of more positive data, nor did the omission undermine the opinion stated in the declaration."
To get a better feel, read this BMS Appeal case...
https://caselaw.findlaw.com/us-federal-circuit/1669399.html
You will get sick and think we are Toast yet then go back and re-read my post.
The very important part I got from the Appeal Judges' opinion was they went back (DURING THE APPEAL) to see if the Trial Judge flawed in his/her Judgement of invalidating the NEW patent - WHY - Because it holds weight when you have to consider it WITH the SC's. They work hand-in-hand. They won't just look at the flawed SC review by Du. They found the Judge did not err in invalidating the Patent.
In our case Judge Du did!
That's where our strength is...
Singer is fighting 2 issues: Du used flawed Science to ultimately invalidate the patent then used a flawed approach to the SC's...
As the Attorney noted at the end of my Post: "We only have to Win one of these two arguments to Win the appeal!"
I am not fond of the BMS Trial Conclusion nor should anyone on this Board YET I read this perspective (see below from Investor Village) and if you look closely at the BMS trial, the Judges looked back at the evidence and to determine how the "NEW" Patent info was or was not obvious (forget the SC's for a minute.) They used that info to then "compare" the SC's to see if the SC's deemed the Patent Obvious.
The BMS case Appeals Judges noted that there was already Proof that the Drug would help a certain class yet while this "enhanced" NEW version by BMS did better, it did not create a new drug. And then (not surprisingly): The SC's did not help prove differently EVEN THOUGHT THEY WERE WEIGHED AGAINST EACH OTHER AS IN OUR CASE (that was the only valid argument the BMS case held which is why the Judges felt the SC's did not help...)
In our case: We hold strong proof that the material used to determine by the Judge that Vascepa was "obvious" was very flawed information. Take the "flawed information" (which is enough to overturn the case by itself) and add in the known positive SC's and you have a product that is Patentable. WHY: because there is no clear evidence that people above 500 Triglycerides would or would not not see a negative increase. Even Judge Du said there was no evidence yet she relied on the "incorrect interpretation of the evidence they supplied"!
Why is there no evidence: Because no one except Amarin was forced to go thru a "required" (8) year study to prove so! There was no evidence or proof that it would work yet in the BMS case there was!
If you read into the BMS appeal, the Judges clearly reviewed the past evidence and found the basis for the NEW patent to be unsupported (meaning un-patentable) thus the SC's were not going to help... That is why the Judgement was "Affirmed"... Our case is different!
In our case: The basis (evidence) for the Patent deemed un-patentable was flawed. Once our Judges see this, it really makes the need to review the SC's mute in our case...
Here is what supports this (this is an article on line from Investor Village) - https://www.investorvillage.com/smbd.asp?mb=2294&mn=7201&pt=msg&mid=20694973:
HCW - AMRN: Patent Attorney Perspectives on Vascepa Appeal Opening Brief
Amarin files opening appeal brief, our consulted patent attorney weighs in. With Amarin having now filed its opening appeal brief with the U.S. Court of Appeals for the Federal Circuit, we took the opportunity to consult with a patent attorney on initial perspectives. At a high level, our patent attorney concluded the company has done a thorough job presenting their case, which we note is being lead by Jonathan Singer, the head of the life sciences litigation practice at IP litigation leader Fish & Richardson, and serving as lead council in the Vascepa patent litigation appeals case. We point out that the appeals court reviews issues of law de novo and issues of fact for clear error. The clearly erroneous standard is highly deferential to the district court, while the de novo standard permits the appellate court to substitute its own judgment for that of the district court. Therefore, appellants are potentially in a better position if they can argue that the district court erred in its legal conclusions. Our attorney concluded that Amarin has done so here, while effectively presenting its opening shot in the best light possible. She further believed the brief explained the technology and the basis of the invention thoroughly, why it was needed and the approach the inventor took to solve the problem of lowering triglycerides (TGs) in patients with severe hyperlipidemia without raising LDLs. We note on the substance, Amarin essentially has two main lines of argument: (1) that the court erred in finding a prima facie case of obviousness because it did not apply the correct analytical framework; and (2) that the court erred in its approach to secondary considerations (also called objective indicia of non-obviousness). Our consulted attorney particularly found Amarin's second line of argument compelling, both on the merits and on the clarity and force of argument. That said, the company only needs to be right on one.
Interesting Singer (Attorney) Record: "AMRN’s counsel has won 7 of 9 Hatch-Waxman appeals..."
(BUMP): Positive Refresher: HAMOA Post (Read in Full)...
The reply brief from the generics was as expected. They went to great lengths to promote a narrative that relies on the impression that Amarin's case is weak on multiple points. However, for the generics there is no getting around the fact that central to the district court's finding of obviousness is a major procedural error that the appeals court will have no choice but to address. Setting aside the reply brief for a moment, it's illuminating to revisit the actual language of Judge Du's opinion as it relates to the law.
Here it is, in all its glory:
vii. Weighing These Secondary Considerations
The Court thus finds that the satisfaction of long-felt need and commercial success secondary considerations weigh in Plaintiffs’ favor, and the remaining secondary considerations weigh in Defendants’ favor. More specifically, the Court finds that Vascepa is a commercial success even though it has not yet turned a profit, and that there was long felt need for a single pill that reduced TG levels without increasing LDL-C levels. However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious. See, e.g., ZUP, 896 F.3d at 1373 (holding that “a strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations”).
For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. § 103.
The generics can say what they will, but the appellate panel will look long and hard at the above conclusory paragraph from the decision, as it represents not just major judicial error (as there is no basis in law for the "weighing" methodology), but error that very likely yielded a different finding (obviousness) than would have been reached had the error not been committed. The district court, notwithstanding the generic's desperate attempt to deny as much, clearly and erroneously assigned negative values to the "unproven" objective indicia in its calculation that yielded a finding of "weak evidence of the existence of secondary considerations". In effect, the evidence of secondary considerations was only rendered weak by the courts erroneous discounting of their value based on the flawed "weighing" methodology. If the erroneous "weighing" made them weak, what were they before? When the district court writes, ". . . these secondary considerations are outweighed by the fact that the Court found Plaintiff's other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious", the court is explaining exactly, in no uncertain terms, how it got to its obviousness conclusion, and that explanation provides the appeals court with a blueprint for the district court's error. This is not the inconsequential error that the generic's are attempting to pass it off as. It's a monumental error that was at the heart of the district court's obviousness finding.
Another interesting point from the district court's decision, related to Mori:
In the district court's language below, you can see that the finding of prima facie obviousness was based largely on the court's dismissal of Dr. Toth's testimony in support of non-obviousness. The court based that dismissal on three grounds that , we now know, can all be pretty easily refuted. First, the court claims that, based on Mori, Toth was wrong when he stated about the prior art that "all these treatments increased LDL-C in patients with very high triglycerides". Mori, as we now know per Bhatt's recent paper, showed exactly what Toth stated, that there was no statistically significant differential effect on LDL between the DHA and EPA groups. And the court's second dismissal of Toth's testimony, related to Von Schacky's interpretation of Mori, was also factually incorrect, as it turns out that Von Schacky was right in concluding that Mori showed no difference in LDL-C effects between EPA and DHA. And the third dismissal of Toth testimony is based on the very weak argument that anything from 1977 would, by definition, not be considered relevant to a POSA in 2008. Now, the issue of admissibility of the new Mori information to the appeals case takes on even more significance, as the statistically correct interpretation of Mori largely undercuts the district court's critical finding of prima facie obviousness. Add to that the fact that the district court, had it followed proper procedure for applying the four Graham factors, would likely have not reached a conclusion of prima facie obviousness, even given the dismissal of Toth's testimony, and you have the makings of a real dismantling of the district court's decision. But obviously, the big question here is if/how the correct Mori analysis gets into the appeal.
The Court therefore finds that Defendants established by clear and convincing evidence at Trial that all Asserted Claims are prima facie obvious. Plaintiffs arguments to the contrary are unavailing. Many of Plaintiffs’ arguments depend on the premise that POSAs as of March 2008 would not have expected that using a composition of purified EPA would not increase LCL-C levels. (ECF No. 379 at 22-23.) But this premise is not supported by the evidence. To explain, Plaintiffs primarily point to testimony from Dr. Toth to support this premise. But there are at least three issues with Dr. Toth’s testimony. First, he agreed under questioning that, as of “March 2008 [. . .] the prior art reflect[ed] that all these treatments increased LDL-C in patients with very high triglycerides.” (ECF No. 370 at 1574:1-1575:1.) But that cannot be correct, because Mori taught that EPA did not increase LDL-C levels like DHA did. (Ex. 1538 at 3.) Second, Dr. Toth testified that von Schacky contributed to his view that all TG-lowering therapies increase LDL-C levels. (ECF No. 370 at 1697:9-1703:7.) But as Defendants point out (ECF No. 378 at 26), von Schacky did not correctly summarize Mori. Specifically, von Schacky, citing Mori, wrote, “In more recent comparative studies, no effects of either EPA or DHA were seen on total cholesterol, HDL, or LDL levels.” (Ex. 1605 at 5.) But even Dr. Toth agreed on cross- examination that is not what Mori said. (ECF No. 371 at 1847:8-17.) Mori actually found that LDL-C increased with DHA, but not EPA. (Ex. 1538 at 3.) Third, part of Dr. Toth’s opinion, and Plaintiffs’ argument, is based on the Carlson reference from 1977. (ECF No. 377 at 43-44 (citing ECF No. 370 at 1577:22-25 and Ex. 1026.).) The Court is unpersuaded that an article from 1977 reflects the knowledge of a POSA in 2008. Thus, Plaintiffs’ argument, in part based on Dr. Toth’s testimony—that a POSA would have thought that both DHA and EPA would cause an increase in LDL-C in March 2008—lacks evidentiary support. The Court accordingly rejects this argument.
Lastly, as others have noted, the attempt by generics to claim that the district court, in its decision, was not stating that the court believed that the PTO was unaware of Kurabayashi when issuing the patents in suit, is ridiculous in light of the actual language below from the decision:
As explained above as to Defendants’ prima facie obviousness case, Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels. (ECF No. 373 at 76-80, 246-47.) Further, while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.) Where “the PTO did not have all material facts before it, its considered judgment may lose significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious.
So it's possible "unexpected benefit" could make its way into the appeals court's consideration of the district court's obviousness finding.
As for the issues of prima facie/rebuttal methodology and the related burden shifting, it will be interesting to see how Singer takes on the Novo v. Cyclobenzaprine citation showdown. The generics obviously are leaning heavily on convincing the court to look at this case through a Novo lens, and Amarin is banking on a Cyclobenzaprine perspective. I think it's fair to say that the generics mischaracterized Cyclobenzaprine in several key ways in their brief in order to encourage a Novo view, so I think Singer, who was winning counsel on Cyclobenzaprine, and who obviously knows this stuff better than anyone in the world, will have a strong response
I agree! The board has strayed from the 'positives' in the case... When I read more confusion than clarity, I start to believe it until I head back to Hamoa's posts as a refresher course! Read his last 4 or 5 posts. Uplifting + clear and probably spot on to Singer's agenda!
Positive Refresher: HAMOA Post (Read in Full)...
The reply brief from the generics was as expected. They went to great lengths to promote a narrative that relies on the impression that Amarin's case is weak on multiple points. However, for the generics there is no getting around the fact that central to the district court's finding of obviousness is a major procedural error that the appeals court will have no choice but to address. Setting aside the reply brief for a moment, it's illuminating to revisit the actual language of Judge Du's opinion as it relates to the law.
Here it is, in all its glory:
vii. Weighing These Secondary Considerations
The Court thus finds that the satisfaction of long-felt need and commercial success secondary considerations weigh in Plaintiffs’ favor, and the remaining secondary considerations weigh in Defendants’ favor. More specifically, the Court finds that Vascepa is a commercial success even though it has not yet turned a profit, and that there was long felt need for a single pill that reduced TG levels without increasing LDL-C levels. However, these secondary considerations are outweighed by the fact that the Court found Plaintiffs’ other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious. See, e.g., ZUP, 896 F.3d at 1373 (holding that “a strong showing of obviousness may stand even in the face of considerable evidence of secondary considerations”).
For the reasons discussed above, in view of all four Graham factors (including alleged secondary considerations), Defendants have proven by clear and convincing evidence that all Asserted Claims are invalid as obvious under 35 U.S.C. § 103.
The generics can say what they will, but the appellate panel will look long and hard at the above conclusory paragraph from the decision, as it represents not just major judicial error (as there is no basis in law for the "weighing" methodology), but error that very likely yielded a different finding (obviousness) than would have been reached had the error not been committed. The district court, notwithstanding the generic's desperate attempt to deny as much, clearly and erroneously assigned negative values to the "unproven" objective indicia in its calculation that yielded a finding of "weak evidence of the existence of secondary considerations". In effect, the evidence of secondary considerations was only rendered weak by the courts erroneous discounting of their value based on the flawed "weighing" methodology. If the erroneous "weighing" made them weak, what were they before? When the district court writes, ". . . these secondary considerations are outweighed by the fact that the Court found Plaintiff's other proffered secondary considerations favor Defendants. Thus, at best, Plaintiffs have presented weak evidence of the existence of secondary considerations, which do not overcome the Court’s finding that all Asserted Claims are prima facie obvious", the court is explaining exactly, in no uncertain terms, how it got to its obviousness conclusion, and that explanation provides the appeals court with a blueprint for the district court's error. This is not the inconsequential error that the generic's are attempting to pass it off as. It's a monumental error that was at the heart of the district court's obviousness finding.
Another interesting point from the district court's decision, related to Mori:
In the district court's language below, you can see that the finding of prima facie obviousness was based largely on the court's dismissal of Dr. Toth's testimony in support of non-obviousness. The court based that dismissal on three grounds that , we now know, can all be pretty easily refuted. First, the court claims that, based on Mori, Toth was wrong when he stated about the prior art that "all these treatments increased LDL-C in patients with very high triglycerides". Mori, as we now know per Bhatt's recent paper, showed exactly what Toth stated, that there was no statistically significant differential effect on LDL between the DHA and EPA groups. And the court's second dismissal of Toth's testimony, related to Von Schacky's interpretation of Mori, was also factually incorrect, as it turns out that Von Schacky was right in concluding that Mori showed no difference in LDL-C effects between EPA and DHA. And the third dismissal of Toth testimony is based on the very weak argument that anything from 1977 would, by definition, not be considered relevant to a POSA in 2008. Now, the issue of admissibility of the new Mori information to the appeals case takes on even more significance, as the statistically correct interpretation of Mori largely undercuts the district court's critical finding of prima facie obviousness. Add to that the fact that the district court, had it followed proper procedure for applying the four Graham factors, would likely have not reached a conclusion of prima facie obviousness, even given the dismissal of Toth's testimony, and you have the makings of a real dismantling of the district court's decision. But obviously, the big question here is if/how the correct Mori analysis gets into the appeal.
The Court therefore finds that Defendants established by clear and convincing evidence at Trial that all Asserted Claims are prima facie obvious. Plaintiffs arguments to the contrary are unavailing. Many of Plaintiffs’ arguments depend on the premise that POSAs as of March 2008 would not have expected that using a composition of purified EPA would not increase LCL-C levels. (ECF No. 379 at 22-23.) But this premise is not supported by the evidence. To explain, Plaintiffs primarily point to testimony from Dr. Toth to support this premise. But there are at least three issues with Dr. Toth’s testimony. First, he agreed under questioning that, as of “March 2008 [. . .] the prior art reflect[ed] that all these treatments increased LDL-C in patients with very high triglycerides.” (ECF No. 370 at 1574:1-1575:1.) But that cannot be correct, because Mori taught that EPA did not increase LDL-C levels like DHA did. (Ex. 1538 at 3.) Second, Dr. Toth testified that von Schacky contributed to his view that all TG-lowering therapies increase LDL-C levels. (ECF No. 370 at 1697:9-1703:7.) But as Defendants point out (ECF No. 378 at 26), von Schacky did not correctly summarize Mori. Specifically, von Schacky, citing Mori, wrote, “In more recent comparative studies, no effects of either EPA or DHA were seen on total cholesterol, HDL, or LDL levels.” (Ex. 1605 at 5.) But even Dr. Toth agreed on cross- examination that is not what Mori said. (ECF No. 371 at 1847:8-17.) Mori actually found that LDL-C increased with DHA, but not EPA. (Ex. 1538 at 3.) Third, part of Dr. Toth’s opinion, and Plaintiffs’ argument, is based on the Carlson reference from 1977. (ECF No. 377 at 43-44 (citing ECF No. 370 at 1577:22-25 and Ex. 1026.).) The Court is unpersuaded that an article from 1977 reflects the knowledge of a POSA in 2008. Thus, Plaintiffs’ argument, in part based on Dr. Toth’s testimony—that a POSA would have thought that both DHA and EPA would cause an increase in LDL-C in March 2008—lacks evidentiary support. The Court accordingly rejects this argument.
Lastly, as others have noted, the attempt by generics to claim that the district court, in its decision, was not stating that the court believed that the PTO was unaware of Kurabayashi when issuing the patents in suit, is ridiculous in light of the actual language below from the decision:
As explained above as to Defendants’ prima facie obviousness case, Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels. (ECF No. 373 at 76-80, 246-47.) Further, while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.) Where “the PTO did not have all material facts before it, its considered judgment may lose significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious.
So it's possible "unexpected benefit" could make its way into the appeals court's consideration of the district court's obviousness finding.
As for the issues of prima facie/rebuttal methodology and the related burden shifting, it will be interesting to see how Singer takes on the Novo v. Cyclobenzaprine citation showdown. The generics obviously are leaning heavily on convincing the court to look at this case through a Novo lens, and Amarin is banking on a Cyclobenzaprine perspective. I think it's fair to say that the generics mischaracterized Cyclobenzaprine in several key ways in their brief in order to encourage a Novo view, so I think Singer, who was winning counsel on Cyclobenzaprine, and who obviously knows this stuff better than anyone in the world, will have a strong response.
Meet Jonathan Singer...
Let's hope the shot was Vascepa!
A ‘Cure for Heart Disease’? A Single Shot Succeeds in Monkeys
https://www.nytimes.com/2020/06/27/health/heart-disease-gene-editing.html
A novel gene-editing experiment seems to have permanently reduced LDL and triglyceride levels in monkeys.
What if a single injection could lower blood levels of cholesterol and triglycerides — for a lifetime?
In the first gene-editing experiment of its kind, scientists have disabled two genes in monkeys that raise the risk for heart disease. Humans carry the genes as well, and the experiment has raised hopes that a leading killer may one day be tamed.
“This could be the cure for heart disease,” said Dr. Michael Davidson, director of the Lipid Clinic at the University of Chicago Pritzker School of Medicine, who was not involved in the research.
But it will be years before human trials can begin, and gene-editing technology so far has a mixed tracked record. It is much too early to know whether the strategy will be safe and effective in humans; even the monkeys must be monitored for side effects or other treatment failures for some time to come.
The results were presented on Saturday at the annual meeting of the International Society for Stem Cell Research, this year held virtually with about 3,700 attendees around the world. The scientists are writing up their findings, which have not yet been peer-reviewed or published.
The researchers set out to block two genes: PCSK9, which helps regulate levels of LDL cholesterol; and ANGPTL3, part of the system regulating triglyceride, a type of blood fat. Both genes are active in the liver, which is where cholesterol and triglycerides are produced. People who inherit mutations that destroyed the genes’ function do not get heart disease.
People with increased blood levels of triglycerides and LDL cholesterol have dramatically greater risks of heart disease, heart attacks and strokes, the leading causes of death in most of the developed world. Drug companies already have developed and are marketing two so-called PCSK9 inhibitors that markedly lower LDL cholesterol, but they are expensive and must be injected every few weeks.
Researchers at Verve Therapeutics, led by Dr. Sekar Kathiresan, the chief executive, decided to edit the genes instead. The medicine they developed consists of two pieces of RNA — a gene editor and a tiny guide that directs the editor to a single sequence of 23 letters of human DNA among the genome’s 32.5 billion letters.
The RNA is shrouded in tiny lipid spheres to protect the medicine from being instantly degraded in the blood. The lipid spheres travel directly to the liver where they are ingested by liver cells. The contents of the spheres are released, and once the editor lands on its target, it changes a single letter of the sequence to another — like a pencil erasing one letter and writing in another.
Not only did the system work in 13 monkeys, the researchers reported, but it appeared that every liver cell was edited. After gene editing, the monkeys’ LDL levels dropped by 59 percent within two weeks. The ANGPTL3 gene editing led to a 64 percent decline in triglyceride levels.
One danger of gene editing is the process may result in modification of DNA that scientists are not expecting. “You will never be able to have no off-target effects,” warned Dr. Deepak Srivastava, president of the Gladstone Institutes in San Francisco.
In treating a condition as common as heart disease, he added, even an uncommon side effect can mean many patients are affected. So far, however, the researchers say that they have not seen any inadvertent editing of other genes.
Another question is how long the effect on cholesterol and triglyceride levels will last, Dr. Davidson said. “We hope it will be one-and-done, but we have to validate that with clinical trials,” he said.
Jennifer Doudna, a biochemist of the University of California, Berkeley, and a discoverer of Crispr, the revolutionary gene editing system, said: “In principle, Verve’s approach could be better because it’s a one-time treatment.”
But it is much too soon to say if it will be safe and long-lasting, she added.
If the strategy does work in humans, its greatest impact may be in poorer countries that cannot afford expensive injections for people at high risk of heart disease, said Dr. Daniel Rader, chairman of the department of genetics at the University of Pennsylvania and a member of Verve’s scientific advisory board.
Dr. Kathiresan, of Verve, noted that half of all first heart attacks end in sudden death, making it imperative to protect those at high risk.
Dr. Kathiresan began the research at the Massachusetts General Hospital and the Broad Institute, where he and his colleagues found a collection of genes that increase risk of heart attack at a relatively young age, as well as eight genes that, when mutated, decrease risk.
Those protective genes, he reasoned, could be targets for gene editing if there were a way to alter them in people. Gene editing is only now succeeding, and so far its successes have been in rare diseases.
Other investigators and companies have tried editing genes in mice to prevent heart disease, with some success, but primates are a much more difficult challenge.
Dr. Kathiresan said that to his knowledge, his study is the first to use the pencil-and-eraser type gene editing in primates for a very common disease. Verve licensed the technology, called base editing, from Beam Therapeutics.
If all goes well, Dr. Kathiresan hopes in a few years to begin treating people who have had heart attacks and still have perilously high cholesterol. For them, the risk of another heart attack is so high that the possible benefit may far outweigh the risks of the treatment.
Heart disease generally occurs only after decades of high cholesterol levels, Dr. Davidson noted. By age 50, people most likely to have a heart attack already have a significant accumulation of plaque in their arteries.
But if the PCSK9 gene could be knocked out in 20-year-olds, he said, “there would be no heart disease in their future.”
Thanks Brother!
YES or NO to this:
To hold an advisory (non-binding) vote to approve the compensation of the Company's "named executive officers" as described in full in the "Executive Compensation Discussion and Analysis" section, the tabular disclosure regarding such compensation, and the accompanying narrative disclosure in the accompanying Proxy Statement.
BIO or Anyone: What are the right answers?
Proposal(s)
1.
To re-elect Dr. Lars G. Ekman as a director.
BOARD RECOMMENDATION: FOR
FOR AGAINST ABSTAIN
2.
To re-elect Mr. Joseph S. Zakrzewski as a director.
BOARD RECOMMENDATION: FOR
FOR AGAINST ABSTAIN
3.
To hold an advisory (non-binding) vote to approve the compensation of the Company's "named executive officers" as described in full in the "Executive Compensation Discussion and Analysis" section, the tabular disclosure regarding such compensation, and the accompanying narrative disclosure in the accompanying Proxy Statement.
BOARD RECOMMENDATION: FOR
FOR AGAINST ABSTAIN
4.
To appoint Ernst & Young LLP as auditors of the Company to hold office until the conclusion of the next general meeting at which accounts are laid before the Company and to authorize the Audit Committee of the Board of Directors of the Company to fix the auditors' remuneration as described in full in the accompanying Proxy Statement.
BOARD RECOMMENDATION: FOR
FOR AGAINST ABSTAIN
5.
To approve the Amarin Corporation plc 2020 Stock Incentive Plan as described in full in the accompanying Proxy Statement in advance of the expiration of the 2011 Plan.
BOARD RECOMMENDATION: FOR
FOR AGAINST ABSTAIN
FROM ELIZABETH - Not sure if this was posted or noticed on the Amarin Site yesterday... It was posted on the Yahoo Board by "Steve" with this caption:
"As I mentioned in a previous reaction, I contacted investor relations at Amarin and asked for clarification on the generic issue and appeal. Elizabeth sent me this update to the corp. website just added today."
https://investor.amarincorp.com/static-files/af1b94a9-3453-4ceb-8a07-66f9fe452efa
See this Post - it is also at the top of all of the Posts...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155589177
ZIP: Didn't I read early on that this was her FIRST patent case she ever took on? You noted that she was not favorable to patents...
ANYONE: This site has been crashing now for a week due to the sick number of Ad's that are allowed... Anyone else seeing the same crap???
Then the question is will they List Generic Vascepa as an acceptable use for Cardiovasular Conditions?
JL already replied with his position...
JL: Could you see a Cardiologist actually prescribing an unapproved Generic for a Heart Condition? I would think they would want to stay so far away from something like that...
I sent Hamoas finding to Elisabeth...
Circuit-City: Read my Post #262127. Interested in your feedback...
Understood yet most of the frustration here is Du based her decision on Marine only. Her weight of the Secondary Considerations are 100% based on whether letting Generics selling pure EPA for Pancreatitis ONLY should be allowed.
Amarin didn't care about it so why give Secondary Considerations any weight?
Now, if R-It is effected, should she have given the Secondary Considerations more weight?
YES!
YET she said she wouldn't do that.
I hope Secondary Considerations can include R-It AND hope the Appellant Judges 100% agree!
Otherwise I am concerned that they will back Du because she weighed them against the Marine Patent!
If you could ask Du, she will say the Secondary Considerations to not allow Generics sell pure EPA for Pancreatitis were not enough.
Yet they are if a Judge can allow the negative effect it will have on R-It!
I am not an Attorney yet can only say that the Judges are being asked to litigate the Generics wanting to use Marine to sell pure EPA.
She already said she 150% knows they plan to steal sales of Reduce-It. She then said that since she WHOLLY felt Marine was Obvious that the Secondary Considerations did not change her mind in letting the Generics sell pure EPA for Pancreatitis - we didn't like our ability to sell for Pancreatitis yet the Generics "want to"!
NOW: Are Judges in her position or in our case now - The Appellant Judges - allowed to NOT Approve pure EPA to Generics because it will destroy another Companies ability to sell pure EPA for Cardiovascular issues?
Take Amarin out of the picture and pretend Amarin ONLY owned the lousy Marine patent. Pretend Bristol Myers owned Reduce-It.
Can a Judge stop a Generic from selling Pure EPA for Pancreatitis because it will effect Bristol Myers ability to sell it for Cardiovascular issues?
The MASSIVE CONFUSION here is Amarin owns both.
How can that be litigated separately yet as one in the same? It was litigated separately. We wish it was litigated as one in the same!
Need other case examples to see if we own BOTH patents that giving one away will seriously kill the bigger one - where it was backed by a Judge!