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People have lost sight of the forest for the trees and are getting bogged down in minutiae.
Hikma's CEO and other CEOs of generics are not going to launch materially or launch at all until the GSK v. Teva case is fully resolved. Look at their market caps then look at potential damages. You don't risk your company on this.
You can analyze that case a thousand ways if you want. The damages are too great and I should not have to tell you that courts can be uncertain. You are not risking your company on trying to game plan on how not to infringe by writing not for CVD or any other novel ideas folks come up with.
Not happening. I am confident on this. Won't keep writing on this but it's comical how much has been discussed about how this case does not pertain to Amarin. Comical. I assure you big pharma is aware of how it keeps generics at bay until fully resolved.
Damages are too significant. End of story.
I disagree. But you sold so peace.
Um given his resume I think he is quite familiar with the GSK v. Teva ruling. he used to work at Teva.
Hikma CEO. See his bio and post work experience below. He used to be President of the generics business of Teva.
https://www.hikma.com/media/1408/sigurdur-olafsson-appoint-chief-executive-officer-of-hikma.pdf
Further background on Sigurdur OlafssonMr Olafsson has significant international experience in the pharmaceutical industry. He was most recently President and Chief Executive Officer of the Gl obal Generic Medicines Group of Teva Pharmaceuticals, a position he held from 2014 to 2016. From 2012 to 2014, he was President of Actavis. Prior to this, he wasExecutive Vice President, Global Generics, at Actavis plc (Watson) from 2010 to 2012; and CEO of theActavis Group from 2008 to 2010. From 2003 to 2008, he held positions of increasing responsibility withinthe Actavis Group, including Deputy CEO, Vice President of Corporate Development and CEO of ActavisInc. US. From 1998 to 2003, he held positions of increasing responsibility with Pfizer’s Global R&Dorganization in the UK and US. From 1994 to 1998, he served as Head of Drug Development for OmegaFarma in Iceland. He currently serves as a member of the board of directors for Elucida Oncology andPfenex Inc.
That's incorrect. If the CAFC reverses, and Supreme Court takes up the case and reverse the CAFC where does that leave the generics....
hint: with a billion in damages due to lost profits.
it's the uncertainty that you're not getting that will sideline the generics until this case is fully resolved.
lost profits are in the billions.
the supreme court has reversed the CAFC on numerous occasions.
an en banc ruling signals to the Supreme Court this case is important.
Then GSK will appeal to the Supreme Court. What does this mean...more delays for the generics.
The FDA law blog article mentioned that this case could go on for years.
Please don't repost my posts as if you wrote them.
Thanks
Why are you posting old messages of mine as if you wrote them?
Very weird.
Hikma is still sick over the GSK v. Teva ruling.
They didn't have a good Friday on Oct. 2nd when that ruling came out.
Unless Teva is denied an en banc hearing. GSK v. Teva won't be known by 4th quarter. LOL. Courts don't move that fast.
Plus the holidays are coming up. Then there's a likely appeal to Supreme Court.
Lost profits in Amarin's case would be in the billions. Hikma general counsel is well aware of what is at stake. LOL
Maybe the generics launch on a small scale but it won't be meaningful in terms of derailing AMRN in USA market. Also, generics won't be able to get significant economies of scale from whatever they produce. The generics have to be so circumspect going forward as a result of the Teva ruling. It's a game changer.
The lost profits / damages here are huge.
Oh the irony: we needed a speedy resolution to our case at one point and now it's the generics who need a speedy resolution. Unfortunately cases move through the court system at a slow pace. GSK v. Teva was argued last September 2019 and the ruling came out a year later. Good luck with en banc that will take more time and then an eventual appeal to Supreme Court....we are talking years. LOL
Tick tock tick tock......Amarin will benefit from more delays.
Pauline Newman delivered in a major way for AMRN shareholders.
What's good for the goose is good for the gander.
The Supreme Court has a high opinion of Judge Newman. I'm sure she wrote her opinion in the Teva case so it could withstand further judicial scrutiny and be upheld. You can't argue facts afresh at the appellate level. She called this out in her ruling. Even if en banc is granted, her ruling could still prevail. Moreover, the Supreme Court could see things the way she did. The Supreme Court, remember, is more conservative now.
Amarin is in a great position re: the generics after Friday's ruling. It was a game changer. What Markman and others fail to see is the biggest risk that generics face if they launch while this is still being decided in the courts. Those damages are in the billions in our case.
And best believe the generics saw the FAQ that came out this morning. I'm sure our lawyers already put them on notice. LOL They are on notice about launching.
You could cross a highway blindfolded and survive, but more than likely you are not going to try it because the risk of death is too great. That's where the generics are right now.
Thank Judge Pauline Newman.
https://www.ipwatchdog.com/2019/07/16/consider-courage-judge-newman-federal-circuit/id=111312/
You have intel that Markman Advisors is working with Amarin management?
GSK acquisition of Amarin would be interesting especially since they are involved in the suit with Teva. Oh the irony.
They could just wait till the last minute to appeal to Supreme Court if Teva wins on an en banc hearing. The goal would be to just delay delay delay to preserve USA value for Amarin. It's genius and yet so crafty.
Or they could even settle with Teva and this ruling would stand thereby assuring they would have USA market for REDUCE-IT.
Time is our friend. We have the ball.
You can't score without the ball.
The GSK v. Teva case is great for Amarin. See analysis of it from Cooley Law Firm below. This case may be stuck in the courts for years through a future appeal and possibly the Supreme Court. The more it is tied up / delayed the greater uncertainty generics have about what this means in terms of liability / lost profit / billions of damages. Essentially the longer they have to stay on the sidelines from having a material presence in the USA market.
No bueno especially for those smaller generics (Hikma & Dr. Reddy's).
This is like the sports analogy of just running out the clock. Delay delay delay...you can't score if you don't have the ball.
https://www.cooley.com/news/insight/2020/2020-10-06-gsk-v-teva-induced-infringement-liability-despite-skinny-label
See this excerpt from the analysis:
Consequences for generic drug and biosimilar cases going forward
Brand manufactures in post-launch cases now have a roadmap to seek damages for induced infringement even when the generic has expressly carved-out the infringing use from its FDA-approved label. Applying the majority's reasoning, brands can build a circumstantial case to demonstrate inducement by pointing to evidence beyond the label, including external communications that generally announce equivalence between the generic and brand drugs; testimony that physicians know of and rely on such communications; and the generic's knowledge of possible revenue from off-label infringing uses. In light of the GSK decision, brands will seek to develop evidence to prove that generics know they will profit from infringing sales even if they don't include them on their skinny label.
Generics and biosimilars pursuing a skinny label strategy to carve out patented treatment methods of an otherwise unpatented drug should carefully evaluate all external communications, promotional materials and market predictions for evidence implying the generic can or will be used for the infringing method of use. This evaluation is further complicated in situations where the FDA requires the inclusion of certain information on the drug label that could serve as additional evidence of inducement. Several existing cases may inform the steps a generic or biosimilar manufacturer could consider to avoid induced infringement liability, such as express negative statements in their label and/or marketing stating that the product is not approved for the infringing method of use.27
Teva has already stated it will appeal the decision and may seek en banc review by the full Federal Circuit. Either party might seek Supreme Court review of any future appellate ruling, giving the high court the opportunity to revisit induced infringement liability for the first time since their 2011 Global-Tech decision. Due to the timeline remaining for appeals and the importance of clear standards on this issue for the industry, expect stakeholders to utilize the majority and dissenting opinions for months if not years to come.
Take home lessons for the biopharmaceutical industry
Brand manufactures and reference sponsors may more aggressively pursue induced infringement claims in skinny label cases. Proposed jury instructions that would require proof of direct, proximate causation between the defendant and the infringing physician's conduct will be challengable under GSK.
Generic drug and biosimilar manufacturers pursuing skinny label strategies should scrutinize all aspects of their promotional materials, market predictions, other content of labels and any other external communications, to ensure they will not trigger liability under GSK's view of acceptable evidence for induced infringement.
As further appeals continue, the standards for induced infringement liability in post-launch cases will likely remain unsettled for months to come.
Do you really think most investors / Wall Street read all 50 pages of the ruling and understand it?
And the ruling did not mention Amarin so you have to connect the dots. There was one analyst from Citi who understood it.
Game changer.
Delays are our friend. Generics have to be very careful because circumstantial evidence plus lost profit damages mean they are out of business.
Btw: do you realize Amarin per the Teval ruling could decide which generic it goes after for lost profits. We are looking at you Hikma. Come on down lol. Hikma will want no part of that lawsuit.
Some judges are lazy. They may pass on an en banc for Teva not to mention the holidays are coming up. Who likes working over the holidays.
Teva indicated they will ask for an en banc hearing, but en banc hearings are rarely granted. Even if they get it, it does not mean Teva will prevail. All this means more time / delay for generics. And if en banc is denied, it’s game over for generics. Clock is ticking. 2020 is pretty much over.
The dissent said Teva would have been better off staying out the market completely. Lost profits for Amarin would be in the billions.
No generic CEO is risking that because that could be the end of his / her company. Too much risk. Big pharma knows this.
This was a monumental ruling from Judge Newman. Game changer.
It's not about if we would win a suit based on the new Teva ruling but whether it's enough to forestall a generic entry.
Hikma's market cap is $6 billion. What do you think the lost profits would be for Amarin if a court ruled Hikma or another generic infringed? Me thinks greater than or close to Hikma's market cap.
There's not a generic CEO out there who is going to risk that until the Teva ruling is fully adjudicated and final. Whether that is through an en banc or all the way to the Supreme Court.....too much uncertainty to risk entering to lose your entire business. Last Friday's ruling was a game changer. It's not about whether a generic or Amarin would prevail based on the Teva ruling, it's about the risk / threat of what a bad outcome looks like. For the generics especially those like Hikma and Dr. Reddy's who are small fries....that risk could be game over / bankruptcy if a court finds infringement.
Judge Newman said all you need is circumstantial evidence. I don't see generics launching till the Teva ruling is fully adjudicated.
For Amarin any delay is good because it forestalls a generic entry. No generic......more profit for Amarin. USA market is far from dead.
Wall Street and most investors still have not connected the dots. Courts sometimes move at a glacial pace. In this instance time is on our side. The Teva ruling was huge. And I'm sure the suppliers to the generics are aware of it as well. They are not contracting in huge amounts until fully adjudicated. Too much risk.
The good thing about the dissent is that Prost showed her political bent hand.
Judge Newman subtly called her out on this saying this is not the role of the court but Congress. Judge Newman said:
"Nor is this appeal a policy debate about whether GSK
made enough money from carvedilol in past years, and
therefore should not be permitted to enforce its patent on
its discovery of this novel method of prolonging life for
persons with congestive heart failure. The implications of
the dissent’s position are vast, and if enforcement of
patents on new discoveries varies with the extent to which
the patentee has profited from past discoveries, this is a policy matter for Congress, not a factor in judicial review
of jury verdicts."
I believe Judge Newman is also speaking to other members of the court with her statement above.
Thank you and the team for working on this. I imagine this is a herculean effort. We just want to see it submitted before the court rules.
We would hate to see all of your work go to waste. Good and submitted may be better than perfection and not making it in time.
Thanks again.
Thanks and sounds great. Watch the clock as they could rule on Amarin's filing sooner than Friday.
I suggest you get a lawyer to help you understand the implications of the Teva / GSK case decision.
Many lawyers on this board see things far differently than you do based on their reading of the ruling.
The generics entire business model is at stake if they launch. Just look up the market caps of Hikma and Dr. Reddy's.
The implications are huge and it's clear you are missing the bigger picture.
btw: you do realize Teva is one of the larger generics and they just got body slammed by Judge Newman. Judge Newman indicated all you need is circumstantial evidence of infringement. But the larger point is who is going to risk the damages that could wipe out your entire company.
Ask a lawyer to help you understand the case.
And I suggest you reread the section on damages and lost profits and then ask yourself what are lost profits in this case if generics are found liable (hint: in the billions). Then look at the market caps of Hikma and Dr. Reddy's.
Game changer.
I hope you get the amicus in before the court rules on the en banc filing.
Just be mindful of the time with the amicus. The court could rule on Amarin's filing at any time.
Can you spell this out more the implications of this? What this would mean?
Judge Newman came through for us and for patent holders. She recognized the gamesmanship these generics were playing trying to back door their way into the larger label indications.
Judge Newman is well respected on that court and she put the kabosh / body slam on Teva. She even admonished the dissent by saying the dissent's views are policy views and are Congress's territory not the courts. Ouch. That was a stern rebuke.
I suggest you read the ruling as opposed to guessing. It's all there.
Teva argued that it could not be liable for induced
infringement because it had deliberately omitted, or
“carved out” from its 2007 label, reference to congestive
heart failure.
It's even better than that: generic Vascepa and Vascepa are therapeutically equivalent.
Skinny labels were gutted today.
Just unreal.
“It was ultimately more costly for Teva to sell an unpatented drug for unpatented uses than it would have been to stay out of the market altogether,” Circuit Judge Sharon Prost said in dissent.
Let me translate this: You're gonna get sued and it is gonna cost you a hell of a lot of money so you're better off going after another product.
The Teva case is directly on point. Teva's label mentioned hypertension not congestive heart failure (the patented method) of GSK's drug. But these drugs are therapeutically equivalent. Guess what: still infringement.
Again skinny label completely gutted.
This ruling is a must read this weekend.
From the dissent opinion which does a good job of laying out the ramifications of what this all truly means:
"The Majority thereby allows one patented method to discourage generics from marketing skinny labels—thus, slowing, rather than
speeding, the introduction of low-cost generics."
The skinny label in our case is the Marine Indication that is not patented thanks to Judge Du. Our patented method in this case is the REDUCE-IT indication. Generic Vascepa and Vascepa are therapeutically equivalent.
Checkmate.
The generics thought they had us but then this ruling dropped today. It's a must read.
Read the ruling. They are therapeutically equivalent, which based on this ruling means infringement.
I would encourage everyone to read the Glaxo v. Teva ruling this weekend. If March 30th was dooms day for Amarin shareholders, we should be celebrating today. The majority opinion completely gutted skinny labels. This was huge for Amarin today and I think its significance was lost on the market.
I don't see how the generics can launch now based on this ruling. Well they could launch but they would be buying themselves a very expensive damage suit down the road, which would benefit Amarin quite nicely. The ruling even makes it known that even though there were other generic infringers who were also selling their product, the generic sued could be the one responsible for lost profits. So much for claiming hey others were infringing too.
We needed a win and I think we got it today. The sword of Damocles will be now hanging over the generics who try to enter and infringe on REDUCE-IT.
Also read the dissent opinion. The dissent clearly shows what the Majority opinion now means for skinny labels.
From the dissent opinion:
According to the Majority, the “content” of Teva’s skinny label alone is sufficient to prove induced infringement—even though Teva’s skinny label did not encourage, promote, recommend, or even suggest the patented method.
In other words you don't need anything more than the content of the label to show infringement.
Checkmate.
Great point. How long do you think it will take for generics to realize they are being rope a dope'd with endless litigation?
Today's Glaxo v. Teva ruling was big. Those damages could be quite discouraging from a risk reward standpoint.
This ruling should have a chilling effect on the generics considering the damages they would have to pay but with our legal team and management I won't count on it. They don't appear to be the most proactive / preemptive group. Less appears to be more with our management.
They first need to show us they can find the right jurisdiction to file an infringement case. Hint: it ain't the 9th circuit. SMH
A first year law student could have recognized to stay away from the 9th circuit.
This ruling should be used to our advantage but again with this management team don't bank on it.
Great post!
Textbook case for destruction of shareholder value.
LOL. Now that was funny. Looks like management is going to milk this as long as they can and keep their nice corporate jobs and salary.
Exactly. The Marine Indication did not balloon overnight. The historical numbers will suggest otherwise. Even if you apply a modest growth factor to it you are not going to get REDUCE-IT numbers.
Are you sure about that? The MARINE indication has existed for some time. Meaning it is a defined population. Let's not act like it suddenly got bigger. And let's not pretend the generics are really interested in just serving this population. What is important for purposes of infringement is their conduct.
If they are suddenly producing an amount of generic Vascepa that is greater than the Marine population / indication on monthly / annual basis what does that tell you? This population did not all of a sudden become bigger overnight. It's always existed. What has become larger is REDUCE-IT population. Producing an amount larger than the Marine Indication would suggest to me they are infringing on the REDUCE-It indication.
I imagine scripts going forward would tell the tale of the tape in terms of what is truly going on. In terms of infringement it's akin to what the late Supreme Court Justice Potter once said about porn:
"I know it when I see it."
Pay attention to "conduct" of the generics and what would be deemed inducing infringement of the pioneer patent for REDUCE-IT.
The generics have approval for the Marine Indication (TGs of 500 and greater). Lets say the population of this very high TG group is Y million. I don't know the exact figure. If the generics are producing Y times X multiple to serve this group that would seem they are going after a larger population (REDUCE-IT). They don't have approval for that.
I imagine historical prescriptions could shed light on population of Marine TG group. Amarin's own materials say this is a niche population.
Prescription numbers going forward would be telling in more ways than one. The numbers would not lie.
This is what JL was alluding too when he said they would be infringing on the REDUCE-IT patent. Amarin needs to be more vocal about this to Wall Street.