In the case of Kymab Limited v. Assistant Controller of Patents & Designs, the Madras High Court set aside the rejection of Kymab Limited’s patent application (No. 10716/CHENP/2012) by the Assistant Controller of Patents.
Patent Application and Rejection
The patent application related to “Animal Models and Therapeutic Molecules” and derived from PCT/GB2011/050019, which initially contained 103 claims. The patent was rejected by the Assistant Controller on May 29, 2020, primarily under Section 3(i) of the Patents Act, 1970, which excludes methods of treatment for animals.
Kymab Limited filed the application to patent a process for generating antibodies in non-human mammals that contain human immunoglobulin variable regions. The First Examination Report (FER) issued on May 14, 2018, raised objections concerning novelty, inventive step, and patent ineligibility under Sections 3(d), 3(e), and 3(j). The appellant responded by amending and reducing the claims. After a hearing notice in December 2019, Kymab submitted further amendments, and the claims were narrowed to six. Despite this, the Assistant Controller rejected the application under Section 3(i), reasoning that the invention related to a method of treating animals, making it patent-ineligible under Section 3(i).
Court’s Decision
The Madras High Court carefully examined whether the claims fell under the scope of Section 3(i), which bars patents for processes involving the treatment of animals to render them free of disease or to increase their economic value. The court concluded that Kymab’s invention did not involve treatment aimed at curing disease in animals or improving their economic value. Instead, the invention related to the production of antibodies via genetically modified animals, which were not intrinsic products of those animals.
Consequently, the court found that the rejection under Section 3(i) was not justified. It allowed the appeal, directing the Assistant Controller to proceed with granting the patent based on the amended claims 1 to 6. The Court stated that the previous objections, including those relating to novelty and inventive step, had been addressed through the amendments.
Scope of Section 3(i)
The relevant paragraphs that discuss the scope of Section 3(i) read as follows:
“7. The operative portion of the impugned order rejecting the monopoly claims of the appellant, including the above extracted independent claim 1, is as under:
“2. The objections of the said hearing notice were discussed during the hearing. Regarding objection to amended claims 1-6, applicant has made submission which was found not persuasive in view of following observations.
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.
Consequently, the outstanding objection of the said hearing notice is maintained and claims 1-6 are not allowed. This application for grant of patent is refused under Section 15, The Patents Act, 1970.”
8. Given the reason for rejection, it is necessary to set out Section 3(i) of the Patents Act:
“(i) 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.”
In The Chinese University of Hong Kong, I discussed Section 3(i) primarily from the perspective of a claimed invention relating to human beings. In paragraph 21 thereof, Section 3(i) was analysed as follows:
“21. Section 3(i) contains the following two limbs:
a. any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings; or
b. 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.
In my view, each limb of Section 3(i) is distinct and self-contained. I draw this conclusion for the following reasons. First, the first limb deals with human beings and the second with animals. Secondly, the disjunctive ‘or’ separates the two limbs. Thirdly, the second limb opens with the expression “any process for a similar treatment of animals” and proceeds to set out three purposes of treatment: to render them free of disease or increase their economic value or that of their products. Of these, the latter two purposes are clearly inappropriate and inapplicable to human beings because treatment of human beings is never intended to increase their economic value or that of products produced by them. Thus, it is clear that the second part of Section 3(i) deals only with the treatment of animals and thereafter sets out three objects and purposes of treatment. When viewed in isolation, the first purpose ‘to render them free of disease’ could apply to human beings. However, keeping in mind that the first and the second limbs deal with distinct subjects; they are separated by the disjunctive ‘or’; and the pronoun ‘them’ is used after the antecedent ‘animals’, I conclude that said pronoun is referable only to the last antecedent ‘animals’ and not to human beings. Apart from the above reasons, it bears mention that treatment is provided not only to free/cure a person of disease but also for prophylactic purposes, to alleviate pain, prevent aggravation of or to better manage a condition or disorder. Hence, I reject the contention that the word ‘diagnostic’ in Section 3(i) should be confined to treatment of human beings to render them free from disease.”
9. From the above analysis, it follows that Section 3(i) would be attracted in relation to a process for the treatment of animals provided such treatment is for any of the following three purposes:
i. To render them free of disease;
ii. To increase their economic value; or
iii. To increase the economic value of their products;
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. In order to better appreciate the scope of Section 3(i) in relation to animals, it is profitable to consider illustrations. If cattle were to be subjected to treatment to cure such animals of foot and mouth disease, it would clearly qualify as a method of treatment to free such animals of disease and, therefore, patent ineligible under Section 3(i). If cows were subjected to treatment for purposes of improving the quality of milk or for purposes of increasing the quantity of milk that such cows are capable of producing, both the economic value of such cows and that of its products would increase, thereby bringing it within the scope of the exclusion. Similarly, if sheep were to be subjected to some form of treatment to improve the quality of wool or to increase wool output from the fleece, it could result both in an increase in the economic value of the sheep and its produce. Substantially similar illustrations are set out in the Biotechnology Applications’ Guidelines and, in all these cases, the method of treatment would fall within the ambit of Section 3(i).
10. By bearing in mind these illustrations, I turn to the background of the complete specification, wherein the claimed invention is described as under:
“The present invention provides, inter alia, a process for the generation in non-human mammals of antibodies that comprise a human Ig variable region, and further provides non-human animal models for the generation of such antibodies.”
When the object and scope of the claimed invention, as gleaned from the complete specification and the current claims, is examined for the purpose of determining whether it is aimed at fulfilling any of the three purposes specified at paragraph 9 above, it is abundantly 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 only aspect remaining for consideration is whether these antibodies may be construed as products of such mice, whose economic value is enhanced by the method described by the invention. 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. Such non-murine antibodies clearly do not qualify as products of mice.
Consequently, the ground on which the claimed invention was rejected in the impugned order is completely unsustainable. Since this was the only ground on which the patent application was rejected, the appellant is entitled to a grant.”
Citation: Kymab Limited v. Assistant Controller of Patents & Designs, O.A./SR.118/2020/PT/CHN, CMA(PT) No. 200 of 2023 (H.C. Madras Sept. 26, 2024). Available at: http://indiankanoon.org/doc/62838050/, visited on Oct. 4, 2024.
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