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dukesking

09/24/21 7:07 PM

#355533 RE: Number sleven #355531

NS, Thanks for the follow up and the great explanation.
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Meowza

09/24/21 8:13 PM

#355535 RE: Number sleven #355531

Thanks for the post, I enjoyed reading it.

If H falls on their face attempting to invalidate, what are the repercussions regarding R-It regulatory rexclusivity?

(after the fourth R i decided to lean into it)
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north40000

09/24/21 9:55 PM

#355545 RE: Number sleven #355531

The present civil action filed by Amarin in Delaware is a standard patent infringement suit without H-W overtones. You correctly observe that H et al have the opportunity to plead non infringement as well as patent(s) invalidity. You may want to rethink the idea of a 2nd H-W suit being filed before R-I patents with CVD indication coverage expire in the 2030s.

Perhaps I do not understand your position as you present it.
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sts66

09/27/21 6:27 PM

#355697 RE: Number sleven #355531

Hikma cannot challenge R-IT patents before ANDA exclusivity ends this Dec, then there's a 30 month stay before FDA will accept an ANDA challenging R-IT patents. All Hikma can argue is whether they are infringing R-IT patents or not, cannot argue the patents are invalid - to do otherwise would allow them to bypass that 30 month hurdle.