Summary: In a recent decision, the Madras High Court has clarified the scope of exclusion from patentability under Section 3(i) of the Indian Patents Act, 1970, pertaining to methods of treatment for animals, among other things.
We have been tracking various exceptions to patentability in this column, which are contained in Section 3 of the Indian Patents Act, 1970 (the 'Act'). One exception deals with methods of treatment for humans and animals, contained in Section 3(i) of the Act. Recently the Madras High Court had the occasion to study the scope of this exception in its decision in KYMAB Ltd v. The Assistant Controller of Patents & Designs ((T) CMA(PT).No.200 of 2023), which is the subject of the present note.
Section 3(i) of the Act 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 decision in question deals with processes for treatment of animals, as provided in Section 3(i).
Background
The case involved Indian Patent Application No.10716/CHENP/2012. After a First Examination Report was issued, and a hearing held thereafter, in response to objections raised by the Indian Patent Office (IPO), the Applicant submitted an amended claim set containing six claims. The independent claim related to a method for producing an antibody or antibody heavy or light chain specific to a desired antigen by immunizing a non-human mammal with the desired antigen. However, the IPO rejected the amended application, leading to the present appeal against the Order.
The Order while stating "The present invention pertains to a method for producing an antibody or antibody heavy or light chain specific to a desired antigen that essentially involves the treatment of immunizing a non-human mammal i.e., mouse with the desired antigen. Hence. The amended claims are not allowed u/s 3(i) of The Patents Act" rejected the claims.
Court's Analysis and Decision
The Court referred to its decision in The Chinese University of Hong Kong and another v. The Assistant Controller of Patents & Designs (CMA (PT) No.14 of 2023), where Section 3(i) was primarily discussed from the perspective of a claimed invention relating to humans, which we have discussed here earlier (https://www.obhanandassociates.com/blog/patentability-of-diagnostic-methods-in-india/). That decision contained an extensive semantic analysis of the phrasing of Section 3(i), including an explanation of when the provision would apply to treatments for animals.
From its analysis in the earlier decision, in the present case, the Court stated that, it follows that Section 3(i) would only be attracted in relation to a process of treatment of animals if such treatment is for any of the following three purposes:
- to render them free of disease;
- to increase their economic value; or
- to increase the economic value of their products.
According to the Court, the use of the adjective "similar" to qualify the noun "treatment" in the second limb of Section 3(i) indicates that the form of treatment could be analogous to forms such as medicinal, surgical, curative, prophylactic, diagnostic or therapeutic, which are enumerated in the first limb of Section 3(i) in the context of treatment of human beings.
The Court then provided some examples that would fall under the scope of section 3(i).
- treatment of cattle to cure foot and mouth disease;
- treatment of cows to improve the quality or quantity of milk; and
- treatment of sheep to improve the quality of wool or to increase wool output from the fleece.
The Court also noted that the Guidelines for Examination of Biotechnology Applications for Patents issued by the Indian Patent Office also provides similar examples.
The Court noted the Application under consideration provided a process for the generation in non-human mammals of antibodies that comprise a human Ig variable region, and further provided non-human animal models for the generation of such antibodies. The Court said that a combined reading the detailed description and the claims makes it clear that the method described by the claimed invention is not targeted at treating the mice so as to render them free of disease. Equally, it is not intended to increase the economic value of such mice so as to sell such transgenic mice at higher prices.
The Court then considered the question whether these antibodies may be construed as products of such mice, whose economic value is enhanced by the method described by the invention. The Court noted that meat, hair, skin, milk and the like are clearly intrinsic parts of or secretions of an animal and, therefore, qualify as products of such animal. Antibodies, by contrast, are typically produced in response to antigens. In this case, the antigens were administered to the mice after substantially modifying the genome of the mice so as to generate non-murine antibodies. According to the Court, such non-murine antibodies clearly do not qualify as products of mice. The Court, therefore, set aside the Order and allowed the Application to proceed to grant.
The decision of the Court is highly welcome as it clarifies the legal position in relation to Section(i). The guidance will ensure consistent analysis of claims in similar cases by the Indian Patent Office.
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