That's the point that Biobillionair had an extended rant about a few months back.
Judge Du doesn't buy that argument -- in the ruling she says there is literally no overlap, and that is probably factual item #6000 that she was wrong about.
And if it mattered so damned much whether there was one patient in Hayashi, then you'd think it would matter if there were several patients in R-IT over 500 trigs.
The natural reading of "about 500 mg/dL" is "within rounding of 500 mg/dL", which definitely includes a sliver of over 500's.
Feels like a Hail Mary, but there is logic behind it!
North, you raise a great point. There's an overlap between the TG>500 and REDUCE-IT patients, just picture two overlapping circles in a Venn Diagram. So prescribing TG>500 could infringe R-I patents. As a result, FDA shouldn't approve any ANDA.
Dr. Bhatt said there are patients with TG>500 in R-I:
Did some patients in the Reduce-It trial have trigs> “about 500 mg/dL” that were reduced to 500 mg/dL or less?
Would not that trigger (require) a Paragraph IV (VIII) notice by the ANDAs? "If" yes: Do you see any reason: why the ANDA will not submit it? "If" no: Do you see any reason: why the Amarin did not sue them?
More likely the newly OB'd patents do not have any relation with MARINE indication …
north4000... My good man, all I’m saying or my point is: if they get approved then their version will be substituted for Vascepa. Regardless of what the script was written for. It will happen and does happen for so many drugs.
Looks like Hamoa and HDG found something. Let’s hope and pray that it finishes this thing.
I’m seeking damages for pain and suffering. That’s my plan
The three years of exclusivity you're referring to only applies to the new R-IT indication, FDA won't accept ANDAs for R-IT until end of 2022, has nothing to do with MARINE ANDAs. Not really sure what point you're trying to make about did any R-IT patients have TGs of "about 500" as it pertains to this case.