Anavex Life Sciences Corp (AVXL)

[Investor2014]

I must admit I overlooked that bit even I have been across it in depth some years back before the latest patent applications.

Since the original Vamvakides patent on the A2-73 compound assigned to Anavex has long expired there is no option but to try for an inventive step over the original patent. E.g. Crystalline form of A2-73: Crystal forms of tetrahydro-n,n-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride, processes of making such forms, and their pharmaceutical compositions

and Alzheimer's dosage related patent mentioned in the 10-K: Composition and method for treatment of Alzheimer's disease that includes ANAVEX2-73. Method of treatment of Alzheimer's disease using pharmaceutical compositions comprising ANAVEX2-73 according to an intermittent dosage regimen.

I don't know that anybody incl. Anavex would see the A2-73 Plus Donepezil as necessary or preferred treatment and thus that patent ANAVEX2-73 AND CERTAIN ANTICHOLINESTERASE INHIBITORS COMPOSITION AND METHOD FOR NEUROPROTECTION is not of much practical use.

It may be that other POs have not accepted the dosage scheme idea as an inventive step and hence only protection from that patent in the U.S.

In practise though AND specifically related to Alzheimer's with the above protection it would be quite daring, but possible, for someone else to simply use the original Vamvakides form of A2-73. But in doing so avoiding a dosage scheme not encompassed in the Anavex patent and not in combination with Donepezil and family of drugs.

Note that A2-73 may end up protected for: Neurodevelopmental disorder therapy assuming that application is granted. This would cover the original form of the A2-73 compound, but for a new area of use/utility and hence an inventive step, hopefully.

With reference to the Crystalline form Anavex is now also attempting to repair the IP protection for: A19-144, A2-73 and certain anticholinesterase inhibitor compositions and method for anti-seizure therapy.

So although not perfect and therefore rightly mentioned in the 10-K, the IP protection of A2-73 isn't absent but with some risk.

If approved in the US there is the short term FDA granted Marketing Exclusivity and maybe similar provisions elsewhere. No doubt A3-71 programme has been kicked off now in the hope that it will prove a clinically useful and approved compound round about when marketing exclusivity for A2-73, if approved, will expire.

All this may well explain the lack of partnering and/or acquisition attempts/news at least until hopefully these recent patent applications are granted.