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Botanical Drug IP
Phynova is developing medicines from single plants and formulations of extracts from different plants, in given ratios, to obtain novel combinations which exhibit therapeutic effects.
Patent claims are directed to the single or combined extracts (a complex mix which can be characterised based on "markers", the starting materials and the precise method of extraction) are analogous to claims to an NCE (i.e. they characterise the specifics of the extract which is responsible for the safety and efficacy).
So far as is possible, Phynova will obtain patent and possibly plant variety rights to protect its drug candidates. In addition, in the event its licencees are successful in obtaining regulatory licences to market the botanical drugs, further protection will be afforded through confidentiality of regulatory data.
A plant variety right provides 25 years of exclusivity from grant to the proprietor of a new variety. The exclusivity precludes others from reproducing or selling the plant and any harvested material obtained from the unauthorised use of propagated material. By developing novel varieties which are rich or absent in given chemicals, Phynova hopes to add a further layer of protection.