Biological Materials Patent in India
Mansi Gaur, Lexgin IP
Patents related to biological material in India are definitely possible. In the Indian Patent Act 1970, there is a special segment regarding plants and animals because those already exist in nature. So, when you file your patent application, you need to attach an application for patents on innovations incorporating biological materials that must specify this application of biological matter. There is no definition of biological materials in the Indian Patents Act 1970; however, the European Convention provides assistance by stating that biological materials comprise anything that has genetic information and is capable of self-replication.
A significant revision was made in 1970 that complied with the requirements for patentability, including novelty, inventive step, and industrial applicability. The demand to update the Indian Patent Act to include biotech patentability gained section in India at the same time as the legal practitioners and courts in the US and EU were experiencing an increase in the number of biotechnology inventions and patent applications. In order to specifically include biochemical, biotechnological, and microbiological processes in the scope of potentially patentable methods, an amendment was made in 2002.
Process to patent biological material:
Biological materials come in a wide variety, but they can only be patented if they’ve been:
- Acquired form their natural habitat,
- Produced by R-dna technology like hybrid seeds.
Additionally, techniques and procedures that employ or test biological agents are patentable.
What is a Biological Deposit?
In that scenario, a “biological deposit” can satisfy the best mode criterion by sufficiently explaining the invention, its use or functioning, and the procedure to be followed. Furthermore, biological data deposited and included in the disclosure could be utilized to back up a claim interpretation that goes beyond what is expressly stated in the specification.
Deposit of biological material:
If the biological material indicated in the specification is not accessible to the general public and cannot be accurately described in accordance with the Act’s provisions, the applicant is required by Part 10(4) and Rule 13(8) of the Patent Act to deposit it. Under the Budapest Treaty, the substance should be deposited with a global depository authority.
India’s international depository authority are the Microbiology Culture Collection in Pune and the Microbiology Culture Collections and Gene Bank in Chandigarh. In relation to biological material employed in the specification, the applicant is required to provide information.
Sequence listing:
The most crucial element of any biological innovation is the sequence listing. It has to do with the listing of amino acids and nucleotides. Nucleotide and/or amino acid information must be submitted electronically. But you will need to pay the cost for the corresponding number of pages. Inside the case of biotechnology-related inventions, pertinent sequence listing numbers must be provided in the specification at the proper location. Sequence listings should be provided electronically as well.
Biological Material that can be patentable:
- Vectors and mutants.
- Transgene and recombinant technology
- Gene Transformation
- Isolated bacteria, yeast, fungi, microalgae, protozoa, plasmids, viruses, prions, and other prokaryotes
- Organoids, cell lines, and hybridomas
- Expression systems and genetic vectors
- Cell organelles, isolated proteins, and polypeptides
- Enzymology or microbiology equipment or procedures
- microorganism or enzyme compositions
- Using enzymes or fermentation to create a particular chemical or combination
- techniques for measuring or evaluating enzymes or microorganisms
- processes that release, separate, purify, or clean materials utilizing enzymes or microorganisms
- The process of producing food or beverages using microorganisms.
Conclusion:
It is obvious that India is exploring the topic of patentability for living forms and biotechnology. There is an urgent need to protect inventors’ interests given the increasing amount of research and innovation taking place in this area and the rich biodiversity that India is home to. India must provide its innovators and ideas with the tools they need to compete on a global scale, despite the fact that few claims are really taken into account and that these decisions are often made on a case-by-case basis with no clear-cut rules.
