Published June 27, 2024

The field of biotechnology has experienced explosive growth in recent years. This dynamic discipline sits at the crossroads of biology and technology, offering various applications designed to improve human life and the environment.

One of the key pillars of modern biotechnology is its growing reliance on intellectual property rights (IPRs). These IPRs, such as patents, play a crucial role in the field. They enable innovators to recover their investments, maintain control over their technology’s usage, and generate revenue through licensing or product sales, fostering a culture of innovation in biotechnology.

This reliance on IPRs empowers researchers and companies in biotechnology to continually push the boundaries of science. While India boasts a broad scope for patentable subject matter, biotechnology inventions face specific exclusions outlined in the Patents Act. This creates a complex landscape for innovators.

However, Indian Law draws a clear ethical line. Genetically modified multicellular organisms, including plants, animals, and even humans (or their parts), are not patentable. Human beings, embryonic stem cells, and methods of medical treatment are also excluded.

Striking the balance of innovation and access in biotech patents

The rapid advancement of biotechnology in the new millennium presents a unique challenge: keeping pace with the evolving legal landscape regarding patents. Unlike many other industries, biotechnology pushes the boundaries of what can be patented, raising complex questions about ownership and access.

However, the potential consequences of overly broad patents could be severe, restricting access to fundamental scientific knowledge and hindering future discoveries. This underscores the urgent need to strike a delicate balance between incentivizing innovation and ensuring access to these building blocks.

Landmark cases shape the landscape

The landmark Chakrabarty case in the US (1980) is a prime example. The US Supreme Court’s ruling, that a genetically engineered bacterium could be patented, established a precedent. The court emphasized that human invention, not naturally occurring phenomena, is patentable. This decision paved the way for patenting other human-made creations, like the Harvard oncomouse – a valuable tool for cancer research.

Beyond the specific challenges of subject matter in biotechnology, patent applications must still meet the standard requirements of novelty, non-obviousness, inventive step, and utility. Novelty ensures the invention is truly new, not an existing technology. Non-obviousness requires the invention to be a non-trivial step forward, not something readily apparent to someone skilled in the field. The inventive step builds on this concept, demanding a level of creativity that goes beyond the expected. Finally, utility dictates that the invention has a practical application and provides a tangible benefit.

The Kolkata High Court’s Dimminaco case is another example of how courts navigate these complexities. As the biotechnology field continues to develop, the audience, as biotechnology professionals, legal experts, and policymakers, will likely play a critical role in ensuring a legal framework that fosters innovation while safeguarding the broader societal good. Going forward, patent law must adapt to ensure patents serve as a tool for progress, not a barrier to future scientific breakthroughs.

Challenges that policymakers face for biotechnology patents

Biotechnology patents hold immense potential for medical breakthroughs but raise complex ethical and social concerns. These concerns include access to healthcare, genetic privacy, innovation, cultural rights, environmental sustainability, social justice, and global health equity.

Biotechnology patents can be a double-edged sword. While they incentivize research and development, they can also limit access to essential healthcare products. Patents grant inventors temporary monopolies, potentially leading to high prices and restricting access for those who need it most. Furthermore, patents can perpetuate monopolies, hinder competition, and exploit indigenous knowledge that may have formed the basis for the invention.

Policymakers face the challenge of balancing incentivizing innovation and ensuring public access to critical technologies. Mechanisms like compulsory licensing, where governments allow generic versions of patented drugs to be produced, can help ensure affordability and accessibility. Additionally, fostering cooperation and open science initiatives can diminish the negative impacts of monopolies while driving further innovation.

Balancing ethical considerations and sustainability

Biotechnology advancements must not only be groundbreaking but also adhere to the principles of social justice and environmental sustainability. Ethical considerations need to be integrated throughout the research and commercialization processes. This includes ensuring fair access to these technologies, minimizing environmental impact, and respecting the rights of indigenous communities.

State governments have a crucial role to play in conserving natural resources, protecting traditional knowledge associated with them, and safeguarding the rights of indigenous communities. Clear legislation is needed to guarantee these rights and prevent exploitation. Additionally, specialized tribunals with traditional knowledge experts could be established to efficiently resolve disputes and prevent corporations from obtaining patents through unethical means.

By implementing these solutions, we can ensure that biotechnology patents fuel innovation for the greater good while upholding ethical principles and promoting social justice.

Rashmita Das, LL.M.

Written by Rashmita Das, LL.M.

Content Strategist, United & United

United & United

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