Anavex Life Sciences Corp (AVXL)

[sokol]

Yes, Anavex has competent patent counsel. I believe it is doing the best it can for patent protection. In addition to patent protection, Anavex may obtain some statutory or regulatory exclusivity. If efficacy is proven, Anavex will have some form of exclusivity in the U.S. — possibly elsewhere as well. The U.S. is the most lucrative market.

Patent protection is governed by the Patent and Trademark Office and generally runs 20 years from the date of filing (there may be some extensions of the 20 year period and some I mention below). FDA approval involves varying periods of exclusivity as follows:
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

Of course, it would be best to eliminate any patent challenge whatsoever and to obtain as much patent coverage as possible world wide, but anyway you look at it Anavex has significant exclusivity.