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@marjac
what are your thoughts on on going case around patent tribunal constitutionality in the supreme court?
Tribunal said that it will have an impact on over 100 cases if SC wants oversight of this. Will this have any impact on the Amarin's original patents which have all been fizzled out?
https://www.reuters.com/business/us-supreme-court-questions-patent-tribunals-constitutionality-2021-03-01/
Thanks Marjac !!
Deal is unlikely. The patent as of now is invalid. New ANDAs will keep popping. Without patent resolution, there is no easy way out.
Coming prepared was one of them. He clearly was not prepared.
What about the second line. Why assume it is because of treatment?
Concur!
As we await imp decisions, does anyone know what is happening with Teva v.GSK? When is the decision due?
Not really. If you look at the context, the message is more on the line that there is shortage but we have worked to fix it.
The second question, Erez, is on the US two products. One is Kuvan 500 mg powder. I think you launched the other two forms, but this one is pending FDA approval. So what’s holding it back and when do you see this getting approved? And second is on Icospaent/Vascepa. What’s the outlook for the launch? And when do you think you can have sort of a smooth supply of API?
Amit, if you can take the first one, because I don’t recall the status of it. Bear with me. We will give you the details of it in a second. As for the second, we indeed faced a shortage of supply. I believe that we overcome it and we are going to launch within the next give or take two months.
Erez, you said, you launch it in the next couple of months, but you said something about the API supply. Would it be with a smooth supply or would it be with a limited supply?
Smooth supply.
Smooth supply.
Please share it here and send it to Amarin IR and the legal team. Let them file the statement and ask the judge to dismiss requesting payment for legal fees as welll
Where was he quoted? I could not find anything in the earnings call
Here is a review. I have not vetted it. Just posting.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760937/pdf/nutrients-12-03718.pdf
In the En Banc, I am surprise that Reyna did not raise his eye brows after reading this conclusion
WEAK evidence of the existence of secondary considerations, which do not overcome the Court's finding that all Asserted Claims are prima facie obvious."
I can not imagine a more clear statement that first concludes that patent is obvious and then tries to look for reason to reason why not.
Can you remind me the defenders secondary considerations?
Role of objective indica in favor of patents
Long felt need and commercial success.
Judge Du explicit statements that these favored Amarin will.go against her
https://www.bassberry.com/news/ptab-guidance-objective-indicia-of-nonobviousness/
It will be a interesting question for her to tackle.
Independent of the legal language, what argument are there to make this a non-obvious invention?
Everything has unmet need. Nothing new , since the increase was easy to tackle. One pill argument was already made by Mori.
Commercial success was an after thought .
Again , these are meaningful question that will have to be answered.
BIG QUESTION
Assuming the case gets remanded with instructions , how will the totality of evidence play out in Du's court?
What is the judge just rewrites the opinion as follows:
Giving equal consideration to the unmet need and commercial success and other prima facie evidence , the court considers te patent claim as obvious.
1. Two pill vs one pill is not convincing, especially in context of what Mori taught.
2. Commercial success at time of patent filing was irrelevant.
The patent claims in totality are obvious !
I am playing the devil's advocate . How can these be refuted based on what was know in 2008?
GS is the father and mother of all Satans. The best part each one of the scumbag is out of wedlock. GS can not even honor the evil code.
Are secondary considerations strong enough on their own merit to reverse the case or remand it?
Finally, when confronting an adverse obviousness ruling, consider whether the original forum gave sufficient consideration to secondary considerations and did so before reaching the obviousness conclusion. If not, the case may be remanded or, if the considerations are strong enough, reversed.
Another nice read on "secondary" considerations
https://www.finnegan.com/en/insights/articles/time-to-stop-thinking-about-secondary-considerations-as.html
I was not aware of that.
Agree. This is not a political case. SC hates cases that involve making decision that affect people directly .
They rather spend time on Graham
APPROX 10k petitions every year. SC accepts 100-150.
130-200 per week.
Odds are still scary
what % of cases that go to the conference get a hearing ?
I am guessing there are more layers.
1. SC may send it back to the court and ask them to apply proper standards, which meets the Graham criteria
2. They take up the case to revisit and settle Graham standards.
3. The affirm the circuit Court's decision stating all standards were applied fairly and equitably with out the weighting
If they affirm, the patent issue is settled as obvious. Any other decision and Hikma walks away quickly and pulls out it generics from market and nobody interferes with Amarin
I completely agree! Very well written.
I don't know the legal wording but I am guessing that the superme court will " vacate" the ruling and remand it back to the circuit court or review / rehearing.
where is it? May 18 is the last filing that I see.
I love the dissenting opinion in this case :
https://www.casemine.com/judgement/us/5b5aaee98f67d60f0a10099c#p1373
The requirement that the secondary considerations "overcome" the conclusion based on the first three factors is incorrect, for the obviousness determination must be based on the invention as a whole including the evidence of all four Graham factors. It is incorrect to convert the fourth Graham factor into "rebuttal," requiring it to outweigh the other three factors. Consideration of the objective indicia "is not just a cumulative or confirmatory part of the obviousness calculus, but constitutes independent evidence of nonobviousness." Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008). This evidence must be considered together with the other evidence, and not separated out and required to outweigh or rebut the other factors. All of the factors must be considered in connection with proving invalidity by clear and convincing evidence. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en banc).
The fourth Graham factor is of particular analytic value in guarding against judicial hindsight. The majority's decision is a textbook example of hindsight, where the inventor's teaching is used as a template to render the invention obvious. Precedent warns against this fallacy, see, e.g., KSR, 550 U.S. at 421 ("A factfinder should be aware, of course, of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning."); Polaris Industries, Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1068 (Fed. Cir. 2018) ("We have observed that the prejudice of hindsight bias often overlooks that the genius of invention is often a combination of known elements which in hindsight seems preordained.") (internal quotation marks omitted); In re Ethicon, 844 F.3d 1344, 1355-56 (Fed. Cir. 2017) (the "'insidious' exercise of decisional hindsight, whereby that which the inventor taught is used by the decision-maker to reconstruct the invention."); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1320 (Fed. Cir. 2004) ("[W]e are mindful of the repeated warnings of the Supreme Court and this court as to the danger of hindsight bias."). The district court and the panel majority do not identify any suggestion in the prior art to make the specific wakeboard modifications made by Duff—the only source of these modifications is judicial hindsight.
My colleagues also err in their analysis of the objective indicia. For example, the panel majority concedes that Nash obtained the patented wakeboard and used it to develop a wakeboard that "resembled the claimed invention." Maj. Op. at 15. Yet the panel majority holds that because ZUP did not give Nash a "blueprint" of the ZUP Board, the evidence of copying is somehow diminished. Id. at 15. No precedent, no logic, requires a "blueprint" in order to copy a simple structure in plain view and possessed by the accused infringer.
The district court also misapplied the factor of long-felt need. The court reasoned that since improvement in wakeboards was known to be desirable, this sufficed to provide the motivation to make the improvement achieved by Duff. Dist. Ct. Op. at 447. Motivation to solve a known problem is not motivation to make a specific solution, as the district court erroneously equated:
Additionally, the Court finds that one of ordinary skill in the art would have been motivated in 2008 to combine these elements in order to aid in rider stability, to allow a wide variety of users to enjoy the device, and to aid users in maneuvering between positions on a water board. These motivations are a driving force throughout the prior art and have been shared by many inventors in the water recreational device industry. And the specific desire to aid users in maneuvering between positions on a water board has been a consistent motivation in the prior art for decades.
Dist. Ct. Op. at 447 (internal citations omitted). The panel majority adopts this reasoning, although neither my colleagues nor the district court find that Duff's novel combination was suggested in the prior art as the path to long-sought improvement. To the contrary, Duff's realignment of known elements in a crowded field, achieving benefits not previously achieved, weighs against obviousness.
The sport of wakeboarding has long challenged inexperienced and weak riders. The prior art has long sought improvement, yet no one presented the specific structure created by Duff. And I repeat the words of Nash's CEO, himself an inventor of water sports products, that "you have a great product by the way!"
On the proper analysis, summary judgment of obviousness was improperly granted. See Surowitz v. Hilton Hotels Corp., 383 U.S. 363, 373 (1966) ("The basic purpose of the Federal Rules is to administer justice through fair trials, not through summary dismissals as necessary as they may be on occasion."). On consideration of all of the Graham factors, applied to the invention as a whole, clear and convincing evidence of obviousness was not present- ed. From my colleagues' contrary ruling, I respectfully dissent.
The concept of prima facie obviousness based solely on prior art is a procedural tool of ex parte examination. See In re Piasecki, 745 F.2d 1468, 1471-72 (Fed. Cir. 1984) ("The concept of prima facie obviousness in ex parte patent examination is but a procedural mechanism to allocate in an orderly way the burdens of going forward and of persuasion as between the examiner and the applicant.").
Does anyone have a link to Judge Du ruling from March 2020? Can you share it?
Where does Amarin's litigation for Reduce-It fit here?
https://www.hbsr.com/files/article__how_the_new_multipatent_infringement_rulings_will_affect_pharmacuitcal_treatment_claims.pdf
Gone with the wind?
Hello,
The email address elisabeth.schwartz@amarincorp.com is no longer active. Your email has been forwarded to investor.relations@amarincorp.com. Please use investor.relations@amarincorp.com for further inquiries.
Thank you
Impressed how good everyone is in explaining the Amarin case.
The only idiots are Amarin lawyers. Where does JT find these idiots?
https://www.jdsupra.com/legalnews/objective-indicia-of-nonobviousness-3965545/
I am not disputing that either. All I am saying is oxidation is different from free radicals formation .
The argument that gV is bad product is somehow inferior and contains oxidized products that are bad is unsubstantiated.
It has the same amount of EPA (within limits) that is considered acceptable by FDA to be bioequivalent.
The API has to show the same level of purity.
The chem, mfg and controls (CMC) have protocols that are validated and approved by FDA to ensure that the impurities are well characterized and not toxic.
We are knocking on the wrong door when it comes to the gV.
The only issue with gV is around patent violation both the original patent and the CVD patent infringement.
There is no other issue worth debate than patents.
Yes that is how the thread started. However, the statement made was BHATT said that Eponova may be more oxidized in Strength trial and hence it may not be effective .hence we switched to strength.
1. Even if GV was more susceptible to oxidation, no more than 10% will be oxidized before it expires.
2. Peroxide and free radicals can be harmful to the body. Oxidized products are not necessarily harmful. Infact , body eliminates drugs that we take by oxidising them in the liver and them combining then with glucuronide or glutathione and removing them in the urine.
3. So oxidation or oxidative products are not necessarily bad. Sometimes free radicals are produced during the process of oxidation which can be harmful. This is a well known issue but is more common with even food products , especially the charbroiled meats, pollutants that we inhale and our body tries to break them down , "sometimes" resulting in harmful products .
4. When drugs get oxidized in the bottle , they are unlikely to exist as free radicals
5. Eg aspirin gets hydrolyzed to salicylic acid and acetic acid. Nothing wrong with it. In the body , the same thing happens.
6. Oxidation is NOT bad. Infact , all drugs are removed by liver via oxidation .
https://pubmed.ncbi.nlm.nih.gov/9443166/
7. All I am trying to do is eliminate the wrong understanding that gV is bad because it is not EPA. It is EPA , the same one present in Vascepa.
2. How are expiration dates established?
FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug. This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.
For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA’s regulations (see 21 CFR 211.166 as well as related sections 211.137 and 211.160) .
FDA recommends that applicants and manufacturers follow the recommendations in internationally harmonized guidance documents on stability testing such as the International Council on Harmonization guidance documents (ICH) Q1(A-F) and Q5C.
FDA inspections of manufacturing facilities may include an evaluation of the firm’s stability testing program to verify that labeled expiration dates are supported by a scientifically sound study and appropriate data.
FDA requires that the drug be shown to be STABLE Throughout the SHELF LIFE . The drug needs to meet the standards all through product expiration !
So TG market should not be greater than 10% of Vascepa market BEFORE the drug was approved for Reduce-It indication. Is that the correct interpretation?
https://www.loncarblog.com/vascepa-sales
This means the TG market is less than $50 mil for TG?
I think we should compare 2017-18 sales and attribute all of them TG for Vascepa. the drug had no data to support CVD indication in 2018.
The market should be around 100-200 mil for TG , MAX
Hikma already has 13% all scripts. This translates to 60-80 mil of Vascepa sales.
This is too high . Implies HIKMA captured all TG market. It can not be true.
Why is everyone stuck on oxidized stuff being bad?
Sarcasm - I have not heard anyone saying Oxygen is bad for you
The argument here is EPANOVA used in Strength trial is not EPA but "Oxidized" EPA.
This statement is WRONG. When patients take Epanova, they take what the label claims. What is certain is that they take at least 90% or greater of the label claim. Is there some oxidized product. Probably yes. But it is in small quantities and the patients have been taking this product since it was approved . The product was not shown to be dangerous or unsafe
In the strength trial, suddenly claiming that people were not getting EPA but " oxidized " EPA Is dumb.
What we know is Epanova contains a mixture of EPA AND DHA in some proportion that is less than 1 g EPA claimed in VASCEPA.
So is the 4g of Epanova comparable to 4G Vascepa? NO!!!
The amount is EPA is far less in Epanova . It also has DHA which Vascepa does not contain.
What my issue is people suddenly claiming that in Stength trial people were getting " oxidized" EPA and not EPA.
This is silly!
they do accelerated stability studies. They extrapolste how.long will it take for the drug to degrade to 90% of label. Based on that they project shelf life. Let's say the studies show 3 years shelf life . Just to be conservative they can request a shelf life of 2 years. It is acceptable. They can not claim or will be approved for. 4 year shelf life .
Rara,
Everything your expert said is on the mark. FDA will not measure or ask to measure oxidation ( unless there is a API issue). I agree.
Again EPA has ONE MW - 302.45
Same with the ester derivative (Vascepa) + 29
Both, on a mass spec will light up and show only ONE molecular weight. The ester hydrolyses easily to EPA and though it has a different MW ( Add C2H5 = 29) , it will also show up as EPA on mass spec due to parent fragmentation.
Any of your oxidized EPA will have. A HIGHER MW.
You make a standard curve and based on the signal quantify the EPA (302.45) . You do not measure the oxidized product.
If it is less than 90% of the threshold, you and FDA will want to know why it does not match the label.
Since Epanova has not been flagged at not meeting the label requirements, it has the required amount of EPA as agreed upon by the FDA!!!
Again, happy to back down but don't making the oxidation argument .
FDA required API (Active pharmaceutical ingredient) to be over 90% of label claim at end of shelf life. Epanova has to show that to get the shelf life label.
Omega -3-acids come in various types and EPA is one of them.
Vascepa claims 96% or higher purity of EPA .
Epanova claims purity of over 85% or Epa DHA combined.
How much is EPA? I do not know. How much is DHA? I don't know.
Did Strength use EPA? Yes. At what dose? Probably around 2-3 g . Definitely not 4 g.
Did they have DHA? Yes. Whatever was notEPA in the 86% was DHA.
Did they have "oxidized" EPA ? Likely but in amounts that is considered acceptable by FDA?????
Oxidized IRON is no more iron . You can call it oxidized iron but it is ferrous or ferric oxide.
You can call oxidized EPA by adding EPA to its name. But it is no more EPAjust like oxidized iron is no more iron.
I can not make it any simpler.
There is only ONE EPA
Molecular formula: C20H30O2
Molar mass: 302.451
5Z,8Z,11Z,14Z,17Z)-eicosa- 5,8,11,14,17-pentenoic acid
YOU CONVERT THE ACID TO ESTER BY ESTERIFICATION USING ACETIC ANHYDRIDE TO GET
ICOSAPENT ETHYL Or Vascepa.
Ester undergo spontaneous hydrolysis in blood aided by plasma esterases to give the original acid.
If there is something else other than EPA, Then there is NO EPA. It is something else !
Again EPA has one formula, one MW , known orientation of the sunrise l double bonds.
There is not such thing as different EPA.