KYMAB LIMITED Vs. THE ASSISTANT CONTROLLER OF PATENTS & DESIGNS: UNDER DILEMMA OF METHOD FOR TREATMENT PERTAINING TO A NON-HUMAN MAMMAL
(T) CMA (PT). No.200 of 2023
[OA/SR.118/2020/PT/CHN]
An Appeal was filed dated September 26, 2024 in the Madras HC pertaining to the order passed on May 29, 2020 for rejecting the Indian Patent Application bearing no.10716/CHENP/2012. The Madras HC overturned the abovementioned order approbate by the Assistant Controller of Patent & Designs classified as “ANIMAL MODELS AND THERAPEUTIC MOLECULES” standing out as patent ineligible under Section 3(i) of The Patents Act, 1970. The said application was derived from the PCT application bearing PCT/GB2011/050019. The Madras HC determined that the Assistant Controller of Patents & Designs had equated method of producing an antibody with a method of treatment. Moreover, the Madras HC found that the Assistant Controller of Patents & Designs had breached principles of natural justice by citing Section 3(i) as a ground for refusal without raising it as an objection in the First Examination Report and later mentioning in the Hearing Notice thereof. This case will analyse the Controller’s passed order and fare in light of Madras HC’s decision in the Chinese University of Hong Kong case.
Factual Basis of the Matter
The Appellant had filed a PCT application with 103 claims later pertaining to issuance of First Examination Report (FER) dated 14.05.2018 in which the objections were raised on grounds of novelty, inventive step, sufficiency of disclosure, clarity & conciseness, definitiveness and patent-ineligibility under Section 3(e), 3(j) and 3(d) of The Patents Act, 1970. A Submission for the issued FER was filed on 12.02.2019. The reply dealt with each objection raised in the FER. Also, the appellant deleted several claims and submitted amended claims 1 to 7 in response which was followed by hearing notice dated 19.12.2019. The hearing notice included objections under Section 10(4), Section 59, Section 3(i) and Section 2(1)(ja). The appellant also responded to the hearing notice on 06.03.2020 which involved a clear and descriptive response alongwith the amended claims 1-6 (the current claims) were submitted. The Appellant was disgruntled with the decision and appealed to the Madras HC, primarily arguing that the refusal order violated principles of natural justice concerning Section 3(e), 3(j), 3(d) and contending that Section 3(i) was not applicable to the claimed invention.
Analysis and conclusion
The Learned counsel pointed out that the claimed invention provides, inter alia, a process for the generation in non-human mammals of antibodies that comprise a human immunoglobulin variable region and further provides non-human animal models for the generation of such antibodies. In this connection, it is relied upon the recitals in internal pages 28 and 29 of the complete specification. In response to the contentions, it is submitted on behalf of the respondent that the claimed invention is not in respect of specific antibodies. Instead, it is submitted that it is merely in respect of a method of administering antigens in transgenic mice. Consequently, it is contended that it qualifies as a method of treatment of animals, which is patent ineligible under Section 3(i). As regards objections raised earlier on grounds such as lack of novelty, inventive step and sufficiency of disclosure, it is submitted that the appellant amended its claims by deleting the objectionable claims.
The operative portion of the impugned order rejecting the monopoly claims of the appellant, includes the 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.”
In order to better apprise 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).
When the object and scope of the claimed invention, as reaped 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 of Section 3(i), 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. Lastly, the ground on which the claimed invention was rejected in the order was completely unsustainable. Since, this was the only ground on which the patent application was rejected; the decision was passed in favor of KYMAB Limited thereof.
Name: Mitul Korat
Designation: Patent Agent & Advocate
Date: November 29, 2024
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