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Re: bas2020 post# 83858

Monday, 12/12/2016 9:58:44 PM

Monday, December 12, 2016 9:58:44 PM

Post# of 459512
Yes. My understanding is that no other competitor in the U.S. (the most desirable drug market in the world) will be able to copy the chemical entity (AVXL 2-73) during the FDA exclusivity periods whether it be straight New Chemical Entity (NCE) or chemical entity for Orphans Designation. And let's face it: What other company is as far along as Anavex on its FDA trials for this drug.

Moreover, other competitors may be spooked or blocked patent wise because (1) Anavex has an assignment of from both inventors of the invention although one inventor was controversial or possibly contesting his assignment (U.S. patent statutes only require an assignment from one of the two inventors -- remember the SA article about that?) (2) It is my understanding that Anavex has a U.S. Patent Application on file for AVXL 2-73 mono-therapy alone (per Orveko -- where is Orveko?) that may be revived at any time.

And, Anavex I am sure has calculated the FDA exclusivity the periods as you say to arrive at something like 7-9 years exclusivity based on FDA exclusivity alone without U.S. patent protection that you and I know Anavex is bound to be pursuing along many lines -- not only in the U.S. but also elsewhere. Anavex has competent patent counsel. I believe it is reasonable to think AVXL 2-73 will have more exclusivity through patents as well as the U.S. FDA exclusivity I have mentioned.



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