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ilovetech

09/08/20 11:41 AM

#297395 RE: HinduKush #297378

HDK, The DC court agreed that >500 was a chronic condition to be treated chronically. It did't buy into the Generics claim that Doctors would recommend treatment for only 12 weeks. So Amarin won on infringement. and in the same breath lost on obviousness. Amarin tried to introduce Reduce-it as an extension of Marine, but Du ruled, that since Generics had submitted their ANDA prior to Reduce-it top line, Reduce-it wasn't relevant for the case before the court.

In other words, if you believe Generics would infringe on Reduce-it patents going forward, Amarin is welcome to file a new infringement claim for infringing on the entire Reduce-it data set. I believe HDG confirmed the DC court's ruling on infringement on Marine patents, but moot by invalidating them.

ILT
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oneragman

09/08/20 11:42 AM

#297396 RE: HinduKush #297378

HK, I have thought about this and I recall boiling it down to a statement the generic lawyer said during the appeal. Paraphrasing...EPA lowers triglycerides and this has been known for decades. I really believe this is what the judges heard and believe. You don't have to tell me how wrong that statement is relative to the patents, but I believe in this instance, that's the mindset AMRN has to overcome.
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sts66

09/08/20 4:56 PM

#297487 RE: HinduKush #297378

I'll be damned - TGs > 500 is part of the R-IT label - I did not know that - it also removes the actual indication AMRN filed for in the sNDA, which was reduce CVE risk for patients with TGs 150-499. It never occurred to me that a new indication label would include prior indications too - at first glance it would seem this means generics are infringing on R-IT, but FDA labels and patents are different animals.