This article has been written by Sarita Sah pursuing a Remote freelancing and profile building program from Skill Arbitrage.

This article has been edited and published by Shashwat Kaushik.

Introduction

It has been a boon to fields like healthcare, or even agriculture and environmental management, which have been dished out with radical solutions—really holding out hope of solving some of the gut-wrenching problems of humanity. At the same time, the question of their patenting really gets debated across the world, with a host of legal, ethical, and economic considerations getting interwoven into this controversial debate. In India, the biotech patenting landscape is never static, affected as it is by international agreements, domestic laws, and, more recently, government initiatives to promote innovation while still protecting public interest.

Understanding patentability

Patentability, a crucial legal concept in the realm of intellectual property, establishes whether an invention meets the criteria to be granted a patent. By obtaining a patent, the patent holder gains exclusive rights to use and exploit their invention for commercial purposes for a specified period, typically up to 20 years. However, not all inventions are eligible for patents. To be considered patentable, an invention must satisfy specific conditions that ensure its uniqueness, non-obviousness, and practical applicability.

One fundamental condition for patentability is novelty. An invention must be genuinely new and not part of the existing public knowledge. This means that the invention should not have been disclosed or made available to the public in any form before the patent application is filed. The purpose of this requirement is to protect the rights of the inventor and prevent others from claiming ownership of an idea that was already in existence.

Another critical condition is inventive step or non-obviousness. An invention cannot be considered patentable if it is merely an obvious modification or adaptation of existing technology. The invention must demonstrate a level of creativity and inventiveness that would not be readily apparent to a person skilled in the relevant field. This condition ensures that patents are granted only for genuine innovations that contribute to technological progress.

Finally, an invention must possess industrial applicability to be patentable. This means that the invention must have practical use and can be applied in an industrial or commercial setting. The purpose of this requirement is to encourage inventions that have the potential to benefit society through their practical applications.

These patentability requirements can be particularly challenging to satisfy in the case of biotechnological inventions. The inherent nature of biological material and processes often poses unique obstacles. For example, the complexity and variability of biological systems can make it difficult to establish novelty and inventiveness. Additionally, the ethical and regulatory considerations surrounding biotechnology can further complicate the patenting process.

Despite these challenges, biotechnological inventions have the potential to make significant contributions to various fields, including medicine, agriculture, and environmental sustainability. Therefore, it is essential to strike a balance between protecting intellectual property rights and ensuring that these inventions are accessible and available for the benefit of society.

Legal framework of biotechnology patents in India

India has a system of patents governed under the statute called the Indian Patent Act of 1970, with significant amendments made in 2005 in order for it to align with the TRIPS agreement, where under this regime, it introduces product patents for pharmaceuticals and biotechnological invention. Key provisions touching on biotechnology patents include:

• Section 3(b): Excludes those inventions whose use would go contrary to public order or morality or which could be harmful to human, animal, or plant life, health, or the environment.
• Section 3(c): It outlines the exclusion of mere discoveries of scientific principles or abstract theories.
• Section 3(d): It does not permit the patenting of substances known but for new forms, for the new forms only if they increase the efficacies.
• Section 3(j): It makes provisions for the inclusion of plants and animals but excluding microorganisms. Therefore, the patentability of seeds, varieties, and species remains excluded.
• Section 3(k): The provisions of this section of the law exclude from patentability mathematical methods or business modules or algorithms.

These sections therefore approach patents concerning biotechnological inventions in India with extreme caution by moving the tightrope between promoting invention and concerns regarding morals and public health.

Patentability challenges of biotechnological inventions

Moral and ethical issues

Since most biotechnological renditions involve manipulating living organisms, commodification of life forms is fundamentally an ethical issue. To compass this, section 3(b) of the Indian Patent Act provides that an invention, the primary or intended use, which may be potentially against public order or morality, shall not merit patents.

Definition of inventive step and novelty

Determining what is inventive and novel in biotechnology is especially problematic. Many biotechnological inventions are based on naturally occurring processes or genetic sequences; it makes it more complex to determine what is genuinely new or non-obvious.

Patenting life forms

It is an ethical matter that Section 3(j) prohibits patenting of plants and animals and opens potential socio-economic implications. Microorganisms can be patented, so what is the boundary line then?

Biodiversity and traditional knowledge

Unique challenges in India arise, among others, from rich biodiversity and traditional knowledge. On the one hand, these resources need to be safeguarded from biopiracy; on the other hand, innovation needs to be encouraged. The Biological Diversity Act of 2002 will operate along with and in support of the provisions of the Patent Act to avoid conflicting situations.

Current scenario and government initiatives

The Indian Government is well aware of the strengthening role of biotechnology in boosting economic growth and enhancing public health. Indeed, the newer initiatives reflect a lot more openness toward biotechnological innovation:

• National biotechnology development strategy: The Department of Biotechnology has enunciated a strategy in order to give a push to the sector of biotechnology. Policy support, infrastructure development, and skill enhancement are the major ideals that endeavors to position India as a global hub of biotechnology research and development.
• Biotechnology industry research assistance council: BIRAC is a not-for-profit company that helps early-stage biotech enterprises through several activities. It turns out to be a public-private partnership and helps the start-up and SMEs with funding, mentorship, and networking.
• Make in India and Start-up India initiatives: The Make in India and Start-up India initiatives are twin engines that have revolutionised the biotechnology sector in India. These initiatives, launched by the Indian government, aim to create a conducive environment for biotechnology start-ups to flourish.

Easing of regulatory procedures

One of the key challenges faced by biotechnology start-ups is the complex regulatory framework. To address this, the Make in India and Start-up India initiatives have simplified and streamlined regulatory processes. This includes reducing the number of approvals required, fast-tracking the review process, and providing greater clarity on regulations. As a result, biotechnology start-ups can now navigate the regulatory landscape more efficiently, saving time and resources.

Financial incentives

To encourage innovation and growth, the Make in India and Start-up India initiatives offer a range of financial incentives to biotechnology start-ups. These incentives include tax breaks, subsidies, grants, and access to venture capital. This financial support enables start-ups to invest in research and development, expand their operations, and bring new products and services to market.

Access to infrastructure and markets

The Make in India and Start-up India initiatives recognise the importance of infrastructure and market access for biotechnology start-ups. To address this, the government has established biotechnology parks and incubators that provide state-of-the-art facilities and equipment. These facilities enable start-ups to conduct research, develop prototypes, and pilot their products. Additionally, the government has created platforms and networks that connect start-ups with potential investors, industry partners, and customers. This helps start-ups gain visibility, build partnerships, and secure funding.

Impact of the initiatives:

The Make in India and Start-up India initiatives have had a significant impact on the biotechnology sector in India. These initiatives have led to an increase in the number of biotechnology start-ups, attracted foreign investment, and fostered a culture of innovation and entrepreneurship. As a result, India has emerged as a global hub for biotechnology research and development.

• Revision of patent examination guidelines: Periodically, the Indian Patent Office revises guidelines for examination of biotechnological inventions, which clearly define the criteria for patentability and streamline their application process more lucidly.

Comparative perspective

Policies toward patents of biotechnological inventions follow different paths in different countries. In the United States, the Bayh-Dole Act encourages patenting this kind of invention resulting from federally funded research. USPTO policies have been relatively liberal, allowing the filing of patents on isolated genes, genetically modified organisms, and biotechnological processes, provided that they abide by the criteria of novelty, non-obviousness, and utility.

The European Patent Convention aims to provide a balanced approach in this field; allowing for patents on biotechnological inventions but not on plant or animal varieties, or essentially biological processes for producing plants or animals. It has always been important for the EPO to have clarity and explicitness in patent claims to avoid overly broad or ambiguous patents.

In contrast, the cautious stance of India foregrounds the need for balancing innovation with pressing social and ethical concerns like access to medicine, biodiversity protection, and the rights of small farmers and indigenous remnants.

Ethical considerations

Ethical considerations raise a number of very complex questions in the patentability of biotechnological inventions that cover issues related to commodification of life forms, environmental effects, and human/animal welfare.

• Commodification of life forms: Patenting life forms raises various controversial ethical issues related to the control and ownership of genetic resources. Critics spur on the idea that this invention might end up creating a monopoly, limiting access to needed, basic biological materials and technologies.
• Environmental impacts: Biotechnological inventions, even more those involving GMOs, emit in general an environmental impact. Among the ethical considerations, one can include the possible ecological consequences, gene flow to wild populations of the same species, and the sustainability of biotechnological interventions.
• Human and animal welfare: Biotechnological research is very commonly conducted on human and animal subjects, so there are concerns about the care and welfare of these research subjects. Naturally, ethical regulations are of the utmost importance to guarantee the exemplary performance of practices that cause the least harm.

Legal issues

Legal issues include transparent and uniform patent laws, genetic resources and traditional knowledge protection, and efficient enforcement of patent rights.

• Clear and consistent patent laws: The laws must be updated regularly in view of advances in biotechnology for legal certainty and predictability.
• Protection of genetic resources and traditional knowledge: The protection of genetic resources and traditional knowledge is of utmost importance, especially in countries of high biodiverse nature like India, in order to avoid biopiracy and to ensure fair benefit-sharing.
• Enforcement of patent rights: Effective systems of dispute settlement, prevention and control of infringement, and providing adequate means for the exercise of patent grantee’s rights are important for the advancement of innovation.

Social factors

Social factors relate to access and equity, perception and acceptance by society or people, and the impact on the vulnerable groups in society or people.

• Access to and equity in biotechnological developments: A fair share in benefits arising out of the biotechnological developments is a serious concern. In this direction, issues relating to access to genetic testing, biopharmaceuticals, and agricultural biotechnology have to be addressed.
• Public perception and acceptance: The level of public awareness and confidence in the scientific and regulatory bodies affects the acceptance of biotechnological innovations. Creating goodwill necessitates involvement and awareness creation among all stakeholders.
• Impact on vulnerable groups: Pay attention to the prospects the work has on small-scale farmers, indigenous groups, and patients left abandoned suffering from rare health conditions. Policies should safeguard their rights and guarantee that the biotechnological innovations benefit all sections of society.

Future prospects

The issues of patentability are likely to get complicated with progress being made in this field. Areas in which the developments are going to take place in the near future include the following:

• Regulatory harmonisation: The harmonisation of India’s patent laws with international trends would have to be in such a manner that one should ensure that this is without being rigid to address domestic concerns. There is thus a need to harmonise the guidelines of examination, transparency in the procedure followed, and international cooperation.
• Ethics frameworks: Develop good ethical frameworks, especially for technologies like CRISPR, so that a balance can be drawn between innovation and ethical and social considerations.
• Public awareness and participation: Increase public information and involvement in policy discussions to ensure different forms of experience are taken on board.
• Innovation ecosystem: Increase R&D support, public-private partnership mechanisms, and investment in biotechnology startups and SMEs.

Conclusion

The patenting of biotechnological inventions is a fusion of legal, ethical, and social dimensions in one basket. It is perhaps for this very reason that India treads carefully, ensuring that the balance between these competing pulls tilts more in favour of stimulating innovation rather than just protecting private interests or vice versa. Continuous dialogue based on adaptive policies is of utmost importance to navigate the patentability dilemma and achieve optimum social benefits of biotechnological developments for societal applications. Addressing these complex implications will enable the realisation of maximum benefits of genetic testing and other biotechnological innovations, hence improving health outcomes and facilitating sustainable development across the world and in India.

References

• https://ipindia.gov.in/writereaddata/Portal/ev/sections-index.html
• https://www.indiacode.nic.in/bitstream/123456789/2046/4/a2003-18.pdf
• https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008
• https://dbtindia.gov.in/sites/default/files/uploadfiles/Draft%20National%20Biotechnology%20Development%20Strategy%202020-25.pdf
• https://www.birac.nic.in/
• https://www.epo.org/en/legal/epc/2020/EPC_conv_20240401_en_20240401.pdf
• https://www.govinfo.gov/content/pkg/USCODE-2011-title35/html/USCODE-2011-title35-partII-chap18.htm
• https://ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf