In the case of Kymab Limited vs The Assistant Controller General of Patents, Designs & Trademarks & Anr. [(T) CMA(PT) No. 200 of 2023, judgement dated September 26, 2024], the Madras High Court allowed the Appellant’s prayer to overturn the refusal of their patent application number 10716/CHENP/2012 entitled “Animal Models and Therapeutic Molecules”.

The subject application disclosed inter alia a method for producing antibodies, in a non-human mammal, comprising a human immunoglobulin variable region. The application was refused by the Controller for falling within the scope of Section 3(i) of the Patents Act, 1970, which excludes from patentability “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”.

The Court relied on their earlier judgment in Chinese University of Hong Kong vs The Assistant Controller of Patents & Designs [2023:MHC:4617], wherein it was held that Section 3(i) contains two limbs:

(i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings;

(ii) 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.

The Court had also clarified that the use of the adjective “similar” to qualify the noun “treatment” in the second limb of the provision indicates that the form of treatment could be analogous to those specified for humans. Therefore, any invention that involves medicinal, surgical, curative, prophylactic diagnostic or therapeutic treatment of animals aimed at:

• rendering them free of disease;
• increasing their economic value; or
• increasing the economic value of their products

is ineligible for patent protection.

In the instant case, the Controller was of the view that because the claimed invention essentially involved immunizing a non-human mammal with the desired antigen to produce antibodies, it fell within the scope of Section 3(i) as a treatment of animal. The Appellant, on the other hand, contended that the claimed method did not constitute treatment aimed at rendering the non-human mammal free of diseases or to increase their economic value or that of their products.

The Court noted that the claimed method was aimed at treating the non-human mammal for the purpose of generating antibodies, consequently ruling out the possibility that the purpose of the invention was to render the non-human mammal free of disease or to increase its economic value. While assessing whether the claimed method was aimed at increasing the economic value of the non-human animal’s product, the Court examined whether the antibodies produced could be construed as products of such non-human mammal. The Court observed that the antigens in the claimed invention were administered in the non-human mammal after substantially modifying the genome of the non-human mammal so as to generate non-murine antibodies, and, thus, the produced antibodies do not qualify as products of the non-human mammal.

Ultimately the Court set aside the impugned order and directed the application to be granted.