Patentability of Microorganisms in India
The Indian Patent Act, Section 3(j) states that plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not patentable which indicates that the microorganisms are not under the purview of the subject matter of non-patentable inventions.
India has allowed patenting of microorganisms but the Patent Act does not provide a definition of the term “Microorganisms”.
Further, Section 3(c) of the Act states that the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature are not patentable.
Although section 3(j) has not brought out the clear picture of patentability of microorganisms which arises a doubt whether naturally occurring microorganisms are patentable, it has to be read with section 3(c) to conclude that the discovery of microorganisms is not patentable since it does not satisfy the contents of section 2(j) which defines invention as a new product or process involving an inventive step and capable of industrial application.
But genetically modified microorganisms that result in enhancement of its known efficacies are patentable as it also complies with section 3(d) which specifically states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of the substance” does not make it eligible for being patented.
An isolated new microorganism with practical use will be novel over the known existing microorganism and has utility if it is sufficiently different from other microorganism which has been known for that use. A sample of the micro-organism has to be deposited under the Budapest Treaty with an International Depository Authority (IDA). Under this Treaty, if a sample of the micro-organism is deposited with one IDA, the enablement requirement is deemed to be satisfied in all of the countries that have signed the Treaty. As per section 10(4) (d) (ii) of the Indian Patent Act, 1970 , the microorganism if not being described fully and is not available to public the said microorganism is to be deposited before the IDA under the Budapest Treaty before filing of application in India. All the characteristics of the microorganisms and details of depositary institutions along with accession number shall be mentioned in specification for correctly identifying the same.
It is concluded that the discovery of naturally occurring microorganism is not patentable while the genetically modified microorganism and the isolated and purified form of new microorganism is patentable.
