This article was originally published by IAM Media.
The term 'microorganism' includes yeast, bacteria, higher fungi, bacteriophages, unicellular algae, viruses and protozoa, among others. The cell lines of plants and animals are also defined as microorganisms.
When analysing patentability, it is crucial to examine how the invention will be implemented by describing the subject in the application materials. An analysis of the strain of microorganism begins with an assessment of the fundamental possibility of obtaining it, its guaranteed repeated production and the possibility of maintaining the viability of the claimed strain during the patent term. Further, there is an assessment of the purpose of the strain and the certain properties that determine the technical effect. It is generally held that if the method or means of obtaining a strain of a microorganism is not sufficiently disclosed in the application materials, then a deposit is necessary in order to ensure the implementation.
A deposit of a strain of a microorganism is the transfer of a sample to a specific collection for the purpose of registration, storage, protection from unlawful use and issue of a sample in accordance with established rules. In this case, the deposit is one of the conditions for supporting the implementation of the invention, which relates both directly to the strain of the microorganism and to other inventions that use new strains isolated from natural sources or obtained by traditional mutagenesis. The deposit must be made before the filing date of the application.
Different forms of deposit are available – storage, safekeeping and a deposit for the purposes of the patent procedure. It is this last type of deposit that fulfils the purposes of patenting, since it guarantees the safety of the deposit and the provision of other requirements.
The description of the method for obtaining a strain without providing information about its deposit can be considered sufficient for the implementation of the invention only in relation to strains obtained using genetic engineering techniques (ie, recombinant strains) that can be designed and implemented on the basis of the information given in the application materials. In other cases (ie, strains isolated from natural sources and obtained as a result of random mutations), the deposition of the strain is mandatory. Deposition for recombinant strains is possible, but not obligatory.
Similar conclusions can be made with regard to applications in Russia for plant or animal cell lines, biological products and vaccines in which the strain (active ingredient) is new, not known from a prior art and impossible to reproduce according to the description on the application.
In claims in Russia relating to a strain of a microorganism, the following fundamental elements must be included:
- its generic and specific name in Latin;
- its registration number assigned by the depositary collection; and
- its purpose
The purpose of a strain should be understood not only in terms of its utilitarian purpose for solving a specific technical problem, but also as a characteristic of its biological properties.
If the strain is natural, then a certificate of deposit must be submitted.