The recent advancements in biotechnology have led to some innovative inventions, but they also raise challenging questions about patent eligibility, especially when animal models are involved. The landmark KYMAB case brings these issues to the forefront, examining how courts and patent offices interpret biotechnology patents under the Indian Patents Act. This case underscores the difficulties of applying traditional patent laws to rapidly evolving technologies, highlighting Section 3(i) and its implications for biotech innovation.
Interpreting Section 3(i) of the Indian Patents Act
The KYMAB case highlights the interpretive challenges surrounding Section 3(i) of the Indian Patents Act, which states that “any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic, or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” is not eligible for patenting. This provision restricts patents on methods that involve animal treatment, creating a significant obstacle for biotechnology innovations involving animal models.
The KYMAB Case
KYMAB’s patent application, titled “Animal Models and Therapeutic Molecules,” (Application No. 10716/CHENP/2012), sought to protect a method for generating antibodies through genetically modified mice, a technology KYMAB argued was crucial for therapeutic research. Initially, the patent application was rejected under Section 3(i) on the grounds that using genetically modified animals to produce antibodies involved “treatment” aimed at benefiting the animals, which the Assistant Controller deemed ineligible.
However, on appeal, the Madras High Court overturned the Assistant Controller’s decision. Justice Senthilkumar Ramamoorthy clarified that the antibodies produced through this method were not conventional “products” of the animals, such as milk or meat, but were instead the results of a scientific process. He cited a recent decision in The Chinese University of Hong Kong v. Assistant Controller of Patents & Designs (2023), which found that using animals in scientific antibody production does not equate to medical or commercial animal use. The court thus determined that KYMAB’s invention did not fall under Section 3(i) and was eligible for patent protection.
Comparative International Standards
Globally, the approach to biotechnology patenting involving animal models varies. The United States and the European Union, for example, allow patents on similar processes as long as they don’t cover therapeutic treatments for animals. The European Patent Office (EPO) has granted patents for processes involving transgenic animals, provided the intention is scientific advancement rather than improving the animal’s economic value. By comparison, Indian law has historically applied Section 3(i) more strictly, creating barriers for biotech innovators looking to protect their inventions involving animal models. However, the KYMAB ruling may signal a shift toward a more nuanced interpretation of Section 3(i), potentially aligning India’s standards more closely with international practices.
“At Aumirah, we have extensive experience advising clients on the complex intersection of biotechnology and intellectual property. Our expertise across multiple jurisdictions enables us to guide biotechnology companies through regulatory frameworks and help maximize patent protection. By ensuring compliance with both local and international standards, we help clients safeguard their innovations and avoid common regulatory pitfalls, such as those posed by exclusions like Section 3(i) of the Act.”
Opinion and Future Implications
The KYMAB case highlights the evolving nature of patent law in response to rapid advancements in biotechnology. As scientific innovation pushes the boundaries of what constitutes treatment or economic benefit, patent law must adapt to protect genuine innovation while upholding ethical standards. Aumirah sees this intersection as an opportunity for more sophisticated legal interpretations that balance technological progress with clear regulatory frameworks. In our view, India’s interpretation of Section 3(i) could benefit from further refinement, perhaps aligning more closely with international standards to foster innovation in biotechnology.
