Affect of Features of a Microorganism Strain on a Scope of Exclusive Rights

Abstract

Introduction. A launch of larger number of pharmaceutical preparations based on recombinant products and biotechnologies leads to determine a strategy for protection of exclusive rights for subjects implemented into manufacturing process, including strains of microorganism-producers.

Aim. To define a possibility and a protection scope of microorganism strain as intellectual property subjects at a step of research, development and launch of pharmaceutical preparations, including biotechnological products.

Materials and methods. The materials of the study were available publications in peer-reviewed journals on thematic queries based on keywords of the selected topic, official websites, regulatory legal acts, regulating the procedure for patenting subjects in the Russian Federation and foreign countries.

Results and discussion. A brief review of regulatory acts on registration of a strain as an intellectual property subject is presented. It was defined features of a microorganism strain for patenting and for establishing an infringement of patent rights in the territory of Russian and foreign countries. A possible scope of patent rights for strains is indicated.

Conclusion. The problems raised upon protecting strains as intellectual property subjects as well as possibilities of strain registration as exclusive right subjects are defined.