north40000
2 days ago
sleven, where do you think that FDA fraud guideline I referenced came from? FDA's creative imagination? Somewhere out in the boondocks? How about 18 U.S.C. 1001 and its predecessors? From questionable, fraudulent conduct of earlier generic companies? Better yet, how about Hazel-Atlas, its predecessors and followers as authority, even binding authority? As an extreme, what about that salad found (from an investigation) to contain deadly mushrooms that a woman is asserted to have served her in-laws this past week?
Number sleven
2 days ago
RMB, If you want to get a better understanding of how Amarin v Hikma is going to play out, read all of the filings from GSK v Teva. We have the same legal representation. That case is a road map. Use a combination theory, label plus inappropriate advertising, to get past the pleading stage. Then go after the validity of the label through expert testimony during the trial. North is correct that the court could invalidate the "skinny label" on the basis of fraud. That issue has not yet been presented.
Sleven,
Birdbrain Ideas
2 days ago
My problem with Crouch's piece is this line: "Doctors have a strong incentive to prescribe the generic version for the patented CV use due to significantly lower costs, leading to broader patient access."
Is that true? I thought, at most, the generic product is 15 percent less expensive than Vascepa. In return for that discount, the customer gets an inferior product, right? Isn't it true that generics only have to be 80 percent or 85 percent of the brand product's quality? And, minus the patented protective coat that enables a Vascepa pill to last three years and never get smelly, the generic pill deteriorates faster.
The "leading to broader patient access" line is silly too. Generic access hasn't led to stimulated sales at all. In fact, they've remained nearly at a standstill since Amarin stopped advertising.
I'm I'm correct, I hope Amarin reaches out to Crouch and educates him about this. Misinformation and an inability to communicate well is a big part of Amarin's problems. That and lack of sales.
north40000
2 days ago
"court can't mandate a label change." But:
1) per Hazel-Atlas, 322 U.S. 238(1944)(the Court exercised its equitable power to order reversal of the judgment of the 3rd Circuit in light of fraud committed in connection with evidence that was relied on to support the opinion accompanying that judgment). Bottom line--Hartford Empire business disappeared to the extent it relied on fraudulently obtained/maintained patents responsible for or originating/forming/supporting that business and business model.
2) FDA can withdraw approval of ANDA(s) and corresponding labels, per its unchallenged authority/power vested by FDA Compliance Policy Guide (CPG) 120.100, when FDA finds fraudulent actions by any company(s) that omitted material information accompanying its request for approval of those ANDAs/labels. Bottom line--generic company business will disappear to the extent it relied on fraudulent evidence to invalidate patents of competitors to subsequently obtain ANDAs and labels to originate/support their business. Dr. Reddy's icosapent ethyl product and label disappeared from CVS/Caremark formulary on or before July 1, 2025. Hikma's and other generics' products and labels must also have disappeared in like manner from CVS/Caremark formulary if, as noticed, Vascepa from Amarin (website) is exclusive and only.on CVS/Caremark formulary.
JRoon71
3 days ago
Sleven, I'm not saying there's no overlap. There is. I agree with that. I'm saying, procedurally, that the court decision in Amarin vs. Hikma only binds Hikma, but cannot automatically enjoin the other generics. It would then require Amarin to sue them.
Although, in the meantime, Amarin could pursue injunctions against the other generics, which I think they would have a very strong argument for, assuming the court agrees with the overlapping indication argument. Or, if the court rules in this way, I would think the generics would feel strong pressure to withdraw.
We just have to hope that, if we win, the court rules in such a way that it puts substantial pressure on the other generics, and does not simply mandate "better labeling" (but allows them to continue marketing generic IPE).
JRoon71
4 days ago
Sleven, it would not "invalidate every generic label" automatically, but it could cause some or all of them to voluntarily withdraw their use, OR, Amarin would need to sue them each individually.
It likely depends on the specific outcome of the trial, and what the language and judgement/damages are.
If the judgement is essentially "fix your marketing language", then it's still open season for generics. If the judgement is far more harsh, then the other generics would likely voluntarily withdraw, as none of them have a huge financial incentive to continue selling Icosapent Ethyl.
Let's also not forget that Hikma is still actively defending the suit, which means they still have a belief that they could win. We are all talking as if an Amarin win is fait accompli.