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Re: anders2211 post# 259259

Wednesday, 07/15/2020 3:15:43 PM

Wednesday, July 15, 2020 3:15:43 PM

Post# of 461204
Question for Anders:

Best I can tell, if the secondary 2-73 patents don't hold, then FDA approval would give a 5 year exclusivity use for the drug, with 7 years for Rett or other orphans -- is that right?

But I think 3-71 was patented only in 2014, therefore expiring in 2034.

So would this be the strategy:

For AD, get 2-73 approval and then 3-71 approval within the 2-73 exclusivity period. Assuming 3-71 is better, that would protect AVXL AD market to 2034;

For PDD, plan within the 5 year window (assuming 3-71 will be limited to AD);

For Rett, live with a 7 year window;

Do as many preclinical workups now for other possible 2-73 indications in order to set up future 5 year windows for other CNS possibilities, in descending order of market size;

Pursue other orphan drug applications, if commercially useful.

Finally, what are the ground rules for foreign patents? Is there a central EU patent office, or is it by each country? In general, what could AVXL hope to get in way of legal protections for 2-73 and 3-71?

Thanks
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