There are several paradigms created through advances made in biotechnology that have brought innovations in the healthcare, agriculture, and industry sectors. These inventions need proper intellectual property protection.
The patent laws in India for biotechnological innovations are the Patents Act, 1970 and the Patents Rules, 2003. These patents are encouraging innovations while keeping a balance between intellectual property rights and accessibility of such vital technologies by the people.
In 2019, the Supreme Court of India reopened one of the largest cases on biotechnology in India. A gene technology of Monsanto, used in the production of but cotton, had been patented. The companies in India producing seeds claimed that the patent was invalid. The dispute has since affected every patent applicant’s perception of biotechnology patents in India.
This case illustrates a simple truth. Indian patent law embraces genuine innovation. But it also draws hard lines around nature, living things and medicine. This guide explains those lines and the challenges faced by biological inventions in India regarding patentability. And how to work with them.
Why Biotech Patents in India Face a Different Test
Biological inventions first have to clear three hurdles. Then they’ve got to jump through a second set of hoops under Section 3. This additional layer makes patentability of biological inventions more difficult in India than in many other jurisdictions.
Additionally, The Indian Patent Office biotech examiners in the Indian Patent Office follow specific guidelines for biotechnology applications. The guidelines distinguish between naturally occurring and man-made substances. Consequently, a strong application must show human intervention clearly. Key hurdles include:
- Exclusions under Sections 3(b), 3(c), 3(d), 3(i), 3(j) and 3(p)
- Sufficiency of disclosure and microorganism deposit.
- Source disclosure and compliance with the Biological Diversity Act, 2002
Section 3(c): Discovery Versus Invention
Section 3(c) excludes the ‘mere discovery’ of any living or non-living substance occurring in nature. So finding a bacterium in soil is not an invention. Isolating the bacterium does not change the result. Discovery versus invention in Indian biotechnology patenting: the difference is human intervention.
Are Gene Sequences Patentable Under the Indian Patent Act?
Section 3(c) includes a naturally occurring gene sequence isolated alone. A synthetic or modified sequence, however, may be eligible. Often, where complementary DNA (cDNA), engineered vectors and codon-optimised sequences demonstrate a clear technical advance, they pass. Gene patenting in India is therefore based on the inventor’s action on the sequence.
The Monsanto litigation muddied the waters. A Division Bench of the Delhi High Court in 2018 held that a gene sequence would be a part of a plant under Section 3(j). The Supreme Court later overturned that decision on procedural grounds. So, the debate is still open. Applicants should draft carefully:
- Claim the sequence together with its function and use.
- Claim the construct, vector or host cell instead of the bare gene.
- Add methods of producing the sequence in a lab setting.
Section 3(j): Plants, Animals and Microorganisms
Section 3(j) does not include plants and animals, in whole or any part. Further, it excludes essentially biological processes for producing or propagating plants and animals. Interestingly enough, the provision excludes microorganisms from this exclusion. Hence, a microorganism patent in India can succeed where a plant or animal claim fails.
However, the carve-out is limited. A naturally occurring microorganism is still subject to Section 3(c). A genetically modified microorganism, by contrast, is much more likely to pass on much firmer ground. When treading Section 3(j) exclusions for plants and animals in India, applicants should bear in mind that plant varieties are protected under the Protection of Plant Varieties and Farmers’ Rights Act, 2001.
Microorganism Patent India: Deposit and Disclosure
Microorganism Claims have a rule that comes from section 10(4)(d). The above-stated rule requires the applicant to make a deposit of the strain of the microorganism with an authorised International Depositary Authority in accordance with the Budapest Treaty. India has been a signatory to the Budapest Treaty since 2001. It implies that the strain will have to be specified, its accession number will have to be provided and the date of deposit at a culture collection facility, like Microbial Type Culture Collection (MTCC), Chandigarh.
Microorganism Claims should also contain information regarding the source and origin of the sample. The failure of a proper deposit may lead to rejection of the application even if all other parts meet the criteria.
Section 3(d): The Efficacy Hurdle
Section 3(d) of the Patent Act stipulates that no patent may be granted for the new form of a known substance unless it is more efficacious, and it also extends to new uses for known substances. There can be no other interpretation of Section 3(d) than that which the Supreme Court gave in Novartis AG vs. Union of India (2013). The court interpreted “efficacy” in this context to mean “therapeutic efficacy”, and hence, changes in the physical properties of the known substance would not suffice. There are implications of this provision for innovations in biotechnology. Biosimilar compounds, antibody variants and polymorphs and salts are commonly rejected for failing the test.
Section 3(i) Treatment Method Exclusions
Section 3(i) excludes processes for the medicinal, surgical, curative, diagnostic or therapeutic treatment of humans. It applies the same rule to animals. It also excludes similar processes that make plants disease-free or raise their economic value.
Patent Eligibility of Recombinant DNA and Monoclonal Antibodies
Recombinant products generally fare better than natural ones. A recombinant protein, plasmid or host cell shows human intervention. As a result, patent eligibility of recombinant DNA and monoclonal antibodies is realistic in India. Courts also accepted live vaccines in Dimminaco AG v. Controller of Patents (2002). That case confirmed that products with living components can be patentable
Synthetic Biology Patents
Synthetic biology patents present a fringe issue in Indian law in that the act does not contain a specific provision for them. As such, the examination process looks to other sections when considering engineered pathways, minimal genomes and designer organisms. With that said, Sections 3(c), 3(j) and 3(b) are all pertinent.
Nevertheless, there is potential for the area to be a growth sector in the country. This is due to the fact that synthetic constructs are demonstrably different to their natural counterparts. Moreover, engineered metabolic pathways offer tangible industrial advantages.
Inventive Step Requirements for Modern Biotech Innovations
Indian law defines an inventive step as a technical advance or economic significance that is not obvious to a skilled person. In biotech, the “skilled person” knows standard techniques. For example, cloning, PCR and CRISPR editing are routine tools. Hence, a claim that merely applies them to a new target may be obvious.
Conclusion
Biotech patents in India reward careful drafting. The law does not block innovation. Rather, it filters out natural discoveries, plain new forms and treatment methods. Therefore, applicants who show real human effort, solid data and clean compliance can succeed.
The field keeps evolving as courts, examiners and policymakers respond to gene editing and synthetic biology. Consequently, early legal advice pays off. A well-planned strategy protects the invention and speeds up commercialisation. For any kind of guidance, kindly contact Intellect Bastion LLP!
FAQs
1. What makes a biological invention eligible for a patent in India?
A biological invention must meet three core tests. It must be novel, involve an inventive step and be capable of industrial application. In addition, it must avoid every exclusion in Sections 3 and 4 of the Patents Act, 1970. Human intervention is the common thread. Therefore, applicants should show how their work differs from nature.
2. How does Section 3(c) impact isolated natural substances and gene sequences?
Section 3(c) excludes anything that has been discovered or naturally occurs. Consequently, a gene, protein, or microbe that has been isolated from its natural environment is not patentable subject matter. Isolated and purified forms of the substances do not affect the outcome.
In contrast, modified forms may be subjected to patent protection. Thus, a cDNA, codon-optimised, and engineered sequences as well as constructs can be patented. It is recommended that an applicant submits the claims to the modified form of the substance or construction along with the host cell and the technical effect it produces.
3. Can genetically modified microorganisms be patented in India?
Yes, they can. Section 3(j) expressly excludes microorganisms from its ban on plants and animals. Still, the microorganism must pass the other tests. Natural strains remain barred by Section 3(c). Applicants must also deposit the strain with a recognised International Depositary Authority under the Budapest Treaty, such as MTCC in Chandigarh.
4. What are the strict legal boundaries under Section 3(j) regarding plants, animals and seeds?
Section 3(j) excludes plants and animals in whole or in any part. It also covers seeds, varieties and species. Furthermore, it bars essentially biological processes for producing or propagating plants and animals.
Consequently, a plant cell line or a plant part may face rejection. The Monsanto litigation shows how contested the boundary is for gene sequences in plants. Plant varieties do have another route. They can seek protection under the Protection of Plant Varieties and Farmers’ Rights Act, 2001. Alternatively, applicants can claim a non-biological technical process or a transformed microorganism.
5. What role do the Biological Diversity Act and traditional knowledge play in Indian biotech patent applications?
The Biological Diversity Act, 2002, which connects patents to India’s biological resources, requires that the applicant discloses the source and geographic origin of the material. Moreover, according to Section 6, for an invention that uses Indian biological resources, the NBA’s approval is required, and this must be obtained before the grant.
Patents on traditional knowledge pose a different set of issues. Section 3(p) of the Act, which specifies that anything that is “essentially traditional knowledge” is not patentable. Moreover, there is a requirement that, before granting a patent, the patent office checks the Traditional Knowledge Digital Library for the presence of prior art. However, since the recent changes to the patent law in 2023 made some adjustments to compliance procedures, it is necessary to check the current requirements when applying.
Author: Shubhra Pandey
