Editing Genes, Testing Laws: Synthetic Biology and India’s IPR Crossroads

Olivia Nahak is a 4th-year law student studying at the Sister Nivedita University, Kolkata

Introduction

A major breakthrough occurred in 2012 with the introduction of a tool that enabled us to cut and paste the very code of life – the CRISPR-Cas9. Concepts once deemed fictional became tangible through this tool. Curing genetic diseases, engineering hardier crops, or even creating cancer-resistant treatments became a reality rather than something imaginary. But a major question arose regarding this tool – who is its owner?

This question led CRISPR-Cas9 to spark intense patent disputes in modern science. On one hand, Jennifer Doudna and Emmanuelle Charpentier’s research revealed the tool’s basic potential. While on the other hand, Feng Zhang at the Broad Institute managed to prove that this tool could be useful in living cells. Significant commercial interests, global recognition, and the future of gene editing were at stake in determining the winner of the patents. The case was not only dragged on for years in the courtroom, but also resulted in problems outside the courtroom. The lack of clarity led to uncertainty among startups, scientists, and investors, which hindered progress. Hence, from just being uncertain about the patent’s rightful owner, the case actually slowed down the fast spread of CRISPR from labs to real-world use.

The CRISPR case shows that when the law is unclear, even major scientific advances can slow down. If researchers are unsure about the rightful owner of a technology, they hesitate to use it. Investors also become cautious, and companies delay the development of new products. The issue was not with the CRISPR itself, but with the lack of clear legal guidance.

Now this is exactly the kind of risk that India should be alarmed about. CRISPR-Cas9 is a classic example of synthetic biology- an area that still lacks clear laws in India. The country’s growth in biotech is fast, marked by stronger institutional frameworks and increasing emphasis on coordinated research.  However, even with such potential, India still faces patent law issues; many synthetic biology inventions fall under Section 3(i) and 3(j) of the Patents Act, 1970, which may be rejected, and in the absence of a more coherent regulatory framework, these patent hurdles could hamper innovation. Global cases like CRISPR demonstrate the need for clarity in specific laws. Thus, as India still lacks proper laws on synthetic biology, a key question needs to be addressed: How should India’s patent laws handle synthetic biology while preventing biopiracy?

Patentability Challenges

Synthetic biology is about reprogramming living organisms for various tasks, like making medicines or improving crops. However, these innovations encounter legal complexities when seeking patent protection in India.

Certain limits are evident in the Patents Act,1970. Beginning with section 3(c) of the act, which excludes naturally found DNA, meaning that “discoveries of living or non-living substances occurring in nature” cannot be patented. Further, section 3(j) doesn’t allow plants, animals, and essential biological processes to be patented. Lastly, section 3(k) excludes algorithms and computer programs, thereby creating doubts about bioinformatics or gene-editing software. Undoubtedly, these provisions are meant for protecting public interest, but there still remains a doubt regarding the nature of synthetic biology: is it “natural” or “man-made”?

Globally, courts have attempted to clarify this issue. In the Myriad Genetics case, natural DNA was declared unpatentable but allowed a patent for lab-made DNA. Modified sequences are granted patents by the European Patent Office if novelty and industrial use are proved. Indian courts have addressed this issue in cases like Dimminaco AG v. Controller of Patents, 2002 where a live vaccine was granted a patent, thereby supporting innovation. Whereas, in Novartis v. Union of India, 2013, the evergreening of a cancer drug was rejected, thereby protecting access.

Hence, it is evident that synthetic biology in India remains in a grey area. Excessive restrictions could discourage international investment, whereas unfettered liberty could lead to biopiracy and ethical backlash. Therefore, the loophole is clear, i.e., India needs to close this policy gap by clarifying the extent of patents over engineered life without compromising public interest and biodiversity. Till then, synthetic biology will continue to navigate unclear regulations.

Ownership and Biopiracy

It is crucial to understand the reason behind India’s sensitivity towards biopiracy.

It all started with the Neem, Turmeric, and Basmati cases, where foreign entities sought to monopolize these valuable resources. India fought back, which led to the enactment of the Biological Diversity Act,2002, with its Access and Benefit Sharing (ABS) rules. These rules allow foreign players to use India’s genetic resources, but they have to share its benefits, like profits or technology, with India. This ensured fair treatment of traditional knowledge and native biological resources.

However, in the digital era, with the introduction of a new tool, ABS is compromised- the Digital Sequence Information (DSI). This can be exemplified by the case of an apple. An apple has DNA, and when this DNA is written and stored in digital form, it is nothing but DSI. Now the question is, why are ABS rules compromised due to DSI? This is because, according to ABS rules, one can “physically” acquire genetic resources, but through DSI, anyone can just download the apple’s DNA details and use it to create their own products, without ever touching the apple. As a result, ABS rules won’t apply here.

This matters because under the Convention on Biological Diversity(CBD), biological resources are defined broadly to include organisms, parts of organisms, and their genetic material. An apple, being a part of an organism (Malus domestica), qualifies as a biological resource, and when its DNA becomes DSI, it can be accessed globally without obtaining the physical material. India’s 2019 CBD submission notes that this breaks the connection between the genetic resource and its source country, making traceability difficult and weakening benefit-sharing under ABS rules.

On the international level, COP15’s Kunming-Montreal Global Biodiversity Framework has included DSI under its ABS rules, thereby ensuring that future DSI use should also provide benefits to source countries. Similarly, India’s recent amendment, the Biological Diversity (Amendment) Act, 2023, has included DSI under benefit-sharing. However, concerns remain because such rules were made with limited public consultation and have some limitations around medicinal plants, which may weaken the protection of community rights, as discussed in the paper Analysis Of The Biological Diversity (Amendment) Act, 2023: A Legislative Comment.

Biosafety vs Innovation

India has consistently grappled with the challenge of balancing innovation and safety concerns. An example of this would be the GM mustard (DMH-11) case, where a genetically modified mustard hybrid was developed. Supporters encouraged it by saying that the crop was safe and essential for reducing India’s edible oil imports, whereas critics pointed out a lack of transparency in the approval process and concerns for biodiversity loss (A Damodaran). It became clear that innovation and biosafety were often at odds.

But closer examination suggests that finding a balance is possible. In pharma, India already uses compulsory licensing to prevent monopolies, and the same could be utilized in the case of essential biotech innovations as well. Moreover, patent pools and open-source biology models promote knowledge sharing while incentivizing innovation.

Hence, patents don’t necessarily result in an absolute monopoly. If biosafety checks stay strong and farmers’ rights and public-interest tools like compulsory licensing are prioritized, synthetic biology has enough potential to grow in India without harming farmers or the environment. 

Comparative Lessons and Policy Path

India can draw valuable insights from other countries in managing biotech. The Bayh-Dole Act in the US allows patents on publicly funded research by universities and firms. Moreover, it provides the government with a “march-in right” to intervene in cases where a company has monopolized life-saving technologies. This highlights the country’s framework for preventing monopolies. India may consider a similar approach and try including any public interest clauses in its laws, like the march-in rights. Section 84 of the Patents Act, 1970, already provides for compulsory licenses, and the same could be applied to publicly funded synthetic biology or genetic research in India.

Europe’s approach to ethical licensing is particularly noteworthy. Here, universities and research centres put social-use conditions on biotech patents before licensing (Helen P Azyu and Avishek Chakraborty). Though it is an academic concept rather than a standard practice, it ensures that innovation doesn’t come at the cost of society. Similarly, India can also balance innovation and public safety if it utilises its already existing compulsory licensing in case of biotech innovations as well.

Moreover, there is also a need for a unified regulatory body for biotechnology in India. Currently, India’s biotechnology regulation is divided among GEAC, RCGM, and NBA, which is a very fragmented framework. To streamline this, the Biotechnology Regulatory Authority of India (BRAI) Bill, 2013, was proposed as a single-window regulator for replacing fragmented departments. However, it was never enacted due to reduced state powers, lack of transparency, and centralization (Kiruthika). Hence, India could reconsider the BRAI Bill and make necessary changes for maximum effectiveness.

Lastly, an important example is Brazil, which explicitly includes DSI in its ABS rules, thereby safeguarding its genetic database. India has already adopted a similar approach, but it should also prioritize effective implementation and learn from Brazil’s experience.

Conclusion

Synthetic biology offers both opportunities and risks for India. The country has strong laws like the Biodiversity Act, 2002, and the PPVFR Act, but these were enacted before DSI or algorithm-based gene editing emerged. Thus, the legal regime must be updated to address the challenges posed by emerging technologies. Additionally, patent monopolies, if left unchecked, could limit farmer rights and public access to innovations.

To address these gaps, India should adopt specific policy measures. First, the Biological Diversity Act and its Rules should be amended to include a clear statutory definition of synthetic biology and lay down explicit procedures for DSI access and benefit-sharing. Second, the Patents Act can introduce a public-interest based clause for publicly funded biotech research, ensuring accessibility while still rewarding innovation. Further, the government can revive the BRAI Bill with improved transparency provisions and clarified federal-state roles, creating a single-window authority for biosafety and product approvals. Lastly, India should mandate that all research institutions adopting CRISPR or similar technologies follow uniform risk-assessment and reporting standards to strengthen traceability.

The way forward is evident: India must implement measures like defining synthetic biology in law, making enforcement of DSI rules clearer, using compulsory licensing in biotech, and creating a unified biotech regulator. Through this, India can mitigate the risk of compromising biodiversity and forfeiting innovation benefits. Ultimately, the responsibility lies with India to safeguard its national resources.