According to the patent legislation of the Russian Federation, the strains of microorganisms can be patented only as inventions.
The main difference from a procedure for patenting inventions is that, before filing an application for the defence of the strain of the microorganism, the strain should be deposited preliminary in the All-Russian National Collection of Industrial Microorganisms. The exceptions are the strains prepared using the genetic engineering techniques, i.e. the recombinant strains. At the same time, it should be taken into account that the depositor must be the same person, who will act as an applicant for obtaining a patent.
For the better understanding, let us consider in more detail the peculiarities of the examination of the inventions referring to the strain of the microorganism, the relevant terms and definitions.
The strain of the microorganism is the first subject matter of wildlife, which has obtained legal protection as an invention. Therefore, using an example of this subject matter, which is equated to technical solutions, it is possible to consider the common patterns of patenting the natural biological subject matters as a whole.
The term “microorganism” covers yeast, bacteria, higher fungi, actinomycetes, bacteriophages, unicellular algae, viruses, protozoa, etc.; the cell lines of plants and animals, including the continuous somatic cell lines of vertebrata, shall be equated to the microorganisms.
A strain is a pure culture of the microorganism recovered from a specific source or obtained as a result of mutations.” The cell populations belonging to the same strain of the microorganism have almost the same set of the properties.
In connection with the specifics of the subject matter under consideration, the description of the invention, which refers to the strain of the microorganism, must contain the following information: the place or the source of the recovery of the strain, the method of the recovery; the method of preparing; the collection that has implemented the deposition of the strain; how and with the help of what microbiology manual the claimed strain has been identified; the cultivation conditions (the temperature, the pH medium, the duration of cultivating on various media, etc.); the properties, the characteristics of the strain or the product produced by it, allowing the invention to be used in a specific field.
The analysis of patentability of the strain always begins with an assessment of industrial applicability, that is, the analysis of a possibility of the implementation of the invention according to the description of the subject matter in the application materials. In relation to the subject matter “a strain of a microorganism,” this analysis begins with the assessment of the possibility of preparing it in principle, its guaranteed repeated reproduction, as well as the possibility of maintaining the viability of the claimed strain during the patent effect period and the realization of the claimed purpose or the manifestation of the specific properties providing the technical result of the invention. It is believed that if the method or the means to prepare the strain of the microorganism are not sufficiently described in the application, then in this case it is necessary to deposit the invention in order to implement it.
Depositing the strain of the microorganism is transmitting its sample to the collection for the purpose of the registration, storage, defence against the illegal use, as well as providing the sample in accordance with established rules. In this case, depositing is one of the conditions for confirming the ability to implement the invention, which refers both to the strain of the microorganism directly, and to other inventions, in which the new strains recovered from the natural sources or obtained due to the traditional mutagenesis are used. Depositing must be implemented before the date of filing the application.
It is important to note that, depending on the tasks to be solved during depositing, the different forms of depositing are stipulated: storage, storage with warranty and depositing for the purposes of the patent procedure. It is the last type of depositing that is stipulated for the cases, when it is planned to file an application for a patent, and only this type of depositing complies with the purposes of patenting, as it guarantees the safety of the deposit and other requirements.
When filing an application for the inventions referring to the strains, the methods or the means based on the new strains, the implementation of the procedure of depositing is mandatory in terms of the ability to implement the invention. The application materials should include obligatory a copy of the certificate on depositing the strain issued by the depository collection. It should reflect the following information: a name of the strain (the taxonomic characteristics – a genus and a species in Latin), a name of the depositor, the author's designation of the strain assigned by the authors, with which the strain enters the collection for depositing, a full name and a location of the depository collection that has implemented depositing the strain, the authorized person’s signature certified by the collection’s stamp, a registration number of the deposited strain assigned by the depositary collection, as well as a type of depositing “for the purposes of a patent procedure,” a date of depositing the strain of this collection, which must precede the date of filing the application for the invention. In exceptional cases, the date of issue of the certificate may be a little later than the date of filing the application. Such depositing shall be considered to be completed legally, if the applicant can confirm the fact of transmitting the strain to the collection before filing the application according to the documents of sending his sample by post. Such information, together with the certificate on depositing, may serve as a basis for recognizing the ability to implement the invention and its compliance with the condition of industrial applicability at the date of filing the application.
Depositing for the purposes of a patent procedure may be implemented to the collection, which is the International Depositary Authority (IDA) under the Budapest Treaty on the international recognition of depositing microorganisms for the purposes of a patent procedure (Budapest, April 28, 1977), or to the Russian collection authorized for depositing for the purposes of a patent procedure and complying with the requirements relevant for such collections, which guarantees the maintenance of the viability of the subject matter being deposited during at least the patent effect period.
The following should be filed for depositing the strain of the microorganism: a letter requesting such depositing; a passport for the strain being transmitted; the culture samples.
The strains must undergo checking for pureness and viability, which takes 10-20 working days. In case of a positive result of the check, the deposited strain shall be assigned a registration number, which can be used for its identification later. The date of the entry of a pure and viable sample, as well as a complete set of the documents shall be considered the date of depositing.
Thus, one of the basic requirements to the applications for strains of microorganisms and the subject matters equated to them, the viability of which may be lost due to some objective reasons, and the reproduction is not guaranteed, is the implementation of depositing in specialized collections.