In a recent judgement, the Hon’ble High Court of Madras has clarified that a method of supplementing animal feed does not qualify as a method of treatment to render the animal free of disease or to increase their economic value or that of their products as enshrined in Section 3(i) of the Patents Act, 1970 (‘Act’).
Introduction
Section 3(i) of the Act, which bars the patenting of ‘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’ has been the subject of frequent debate during hearings with the Controllers at the Indian Patent Office (IPO) as well as at the High Court level, with several recent judgements clarifying the scope of Section 3(i) of the Act as well as its application in various contexts. For instance, in Bayer Pharm Aktiengesellschaft v. Controller General of Patents & Designs, 2024[1], the Court clarified that Section 3(i) of the Act is applicable to methods of treatment and not products, in The Chinese University of Hong Kong and Sequenom, Inc. v. The Assistant Controller of Patents and Designs (2023)[2], the Court held that ‘the word ‘diagnostic’ should be limited to diagnostic processes that disclose pathology for the treatment of human beings.’, while there have been more than one judgement stating, in no uncertain terms, that the expression ‘treatment of human beings’ as recited in Section 3(i) of the Act encompasses any treatment irrespective of its outcome, that is, whether it cures a human of a disease or condition or not.
This article examines a recent judgement issued by the Hon’ble High Court of Madras adding to the list of judgements exploring the interpretation of Section 3(i) of the Act. The High Court, after considering the facts of the case, decided that the refusal of the claimed invention by the Controller (Respondent) on lack of inventive step under Section 2(1)(ja) of the Act[3] and non-patentability under Section 3(d)[4] and 3(i) of the Act was incorrect and directed that the application be proceeded to grant. This article primarily examines the High Court's interpretation of Section 3(i) of the Act as it pertains to the claimed invention, that is, a method of reducing by 20% to 80% of the main chain degrading enzymes necessary to extract a given amount of the apparent metabolizable energy from a diet comprising feed formulated for a monogastric animal.
Facts of the case
Kemin Industries, Inc. (‘Appellant/Applicant’) filed a patent application titled 'USE OF FERULIC ACID ESTERASE TO IMPROVE PERFORMANCE IN MONOGASTRIC ANIMALS' bearing an application number 201617013577 (‘Application’), on 19 April 2016, which is a National Phase application arising out of PCT application number PCT/US2014/062154. The as-filed claim 1 is reproduced below:
‘A method of improving the apparent metabolizable energy from a diet and performance in an animal, comprising the step of adding an efficacious amount of a ferulic acid esterase to the diet supplemented with or without main chain degrading enzymes.’
A First Examination Report (‘FER’) with a statement of objections was issued against this Application on 27 September 2019. However, no objection under Section 3(i) of the Act was raised by the Controller (Respondent). Amended claims were filed along with a response to the FER on 27 March 2020, wherein claim 1 was amended to recite:
‘A method of improving the apparent metabolizable energy from a diet and performance in an animal, comprising adding 20 U/kg to 200 U/kg of a ferulic acid esterase produced from bacteria to the diet of a monogastric animal supplemented with main chain degrading enzymes, wherein the main chain degrading enzymes are cellulose, xylanase, glucanase and amylase, and further providing that the main chain degrading enzymes are reduced between 20 and 80 percent.’
The Controller issued a Hearing Notice on 6 May 2021, scheduling the hearing on 7 June 2021. The Applicant filed the written submission on 21 June 2021 along with amended claims. The Applicant decided to proceed with a single claim, reproduced hereinbelow:
‘A method of reducing by 20% to 80% of the main chain degrading enzymes necessary to extract a given amount of the apparent metabolizable energy from a diet comprising feed formulated for a mongastric animal, comprising the step of adding 20 U/kg to 200 U/kg of a ferulic acid esterase produced from bacteria to the animal feed, wherein the ferulic acid esterase is supplemented with the main chain degrading enzymes, and wherein said main chain degrading enzymes are cellulase, xylanase, glucanase and amylase.’
On 19 July 2022, the Controller issued a refusal for the Application on the grounds of non-patentability under Section 3(i) of the Act, in addition to lack of inventive step under Section 2(1)(ja) of the Act and non-patentability under Section 3(d) of the Act. The Applicant, aggrieved by the Controller’s decision, proceeded to appeal.
Arguments on behalf of the Appellant and the Respondent
With regard to the refusal under Section 3(i) of the Act, the Appellant’s counsel argued that Section 3(i) of the Act is applicable to a process for the treatment of human beings or animals. On the other hand, the refused claim was directed to a method of supplementing ferulic acid esterase (FAE) with the main chain degrading enzymes, cellulase, xylanase, glucanase and amylase in the diet of monogastric animals, that is, a method of supplementing an animal feed and not a method of treatment. Thus, the claimed invention could not be excluded from patentability under Section 3(i) of the Act.
The Respondent’s counsel rebutted these arguments by asserting that the claimed invention was directed to a process for the treatment of animals so as to increase their economic value, thus falling squarely within the scope of Section 3(i) of the Act. According to the Respondent’s counsel, a thorough reading of the specification would make it abundantly clear that the use of the claimed invention, i.e., administering the supplemented animal feed to poultry would result in the fattening of the poultry. The counsel additionally relied on Kymab Limited v. Assistant Controller of Patents & Designs, 2024[5] (‘Kymab’) to support their contention with respect to the interpretation of Section 3(i) of the Act.
The Appellant’s counsel, by way of rejoinder, reiterated that the exclusions under Section 3(i) of the Act are restricted to methods of treatment of animals, while the claimed invention is not a method of treatment of an animal, adding that the facts of Kymab were different from those of the claimed invention.
With respect to the objection under Sections 2(1)(ja) of the Act, the Appellant’s counsel argued that the claimed invention involved the usage of a combination of cellulase, xylanase, glucanase and amylase, along with FAE, which was not taught or disclosed in any of the cited documents, providing experimental data to show the synergistic effect of the combination of these four enzymes with FAE. Further, in order to rebut the objection raised under Section 3(d) of the Act, the Appellant’s counsel argued that the claimed invention involved more than one new reactant, and hence did not attract any objection under Section 3(d) of the Act. The Respondent’s counsel, in reply, argued that the prior arts taught the combination of FAE and xylanase, which read on the claimed invention and rendered it non-inventive under Section 2(1)(ja) of the Act. Further, the Respondent’s counsel stated that the claimed invention related to a mere use of a known process, and hence fell within the ambit of Section 3(d) of the Act. The Appellant’s counsel, in the rejoinder, referred to data in the specification to show that the unexpected effects were clearly demonstrated therein and the Appellant exercised ingenuity in picking four enzymes and combining them with FAE.
Discussion and decision
The High Court began by revisiting the interpretation of Section 3(i) of the Act provided in Kymab with respect to animals. In Kymab, the High Court had reiterated that Section 3(i) of the Act contained 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.
Thereafter, the High Court held that the use of the adjective ‘similar’ qualify the noun ‘treatment’ in the second part of Section 3(i) of the Act indicates that the form of treatment of animals could be medicinal, surgical, curative, prophylactic, diagnostic or therapeutic, as detailed for human beings in the first part of Section 3(i) of the Act. Against this background, the High Court held that the claimed invention is directed towards a method of extracting metabolizable energy more efficiently from animal feed by deploying FAE supplemented with the four main chain degrading enzymes. In other words, the claimed invention was directed towards a method of improving the availability of metabolizable energy in the animal feed. The High Court held that this is clearly not a method of treating animals, as exemplified by the illustrations in Kymab, or even otherwise. The High Court emphasized that Section 3(i) of the Act cannot be extended to a method of supplementing an animal feed merely because the use of such animal feed may ultimately result in improving the economic value of the animal/poultry to which such feed is administered or that of animal/poultry products such as meat or chicken. Had the claimed invention been directed to a method of administering a drug or feed to an animal or bird, so as to fatten the same and thereby increase either its economic value or that of the meat, it would fall within the scope of Section 3(i) of the Act.
With regards to the refusal of the application under Sections 2(1)(ja) of the Act, the High Court held that the prior arts did not disclose or teach the combination of enzymes which formed the base of the claimed invention and the deployment of a particular combination of enzymes by the Appellant constituted an inventive step. Further, the High Court opined that the claimed invention is in respect of a new process and deploys more than one new reactant. Thus, the claimed invention was eligible for protection under Section 3(d) of the Act.
In view of these facts, the High Court concluded that the claimed invention did not fall within the ambit of Section 3(i) of the Act, as well as Sections 2(1)(ja) and 3(d) of the Act, setting aside the refusal order and directing the grant of the application.
Conclusion
This case is a comprehensible demonstration of the application of Section 3(i) of the Act in view of the order in Kymab for inventions directed to methods of treatment of animals. For Applicants, the judgement provides some direction as to the kind of language that can be used to reduce the chances of receiving an objection under Section 3(i) of the Act. In the instant case, if the PCT claims were directed to an animal feed supplemented by a panel of enzymes, the invention would undoubtedly fall outside the ambit of Section 3(i) of the Act. Even if Applicants intend to pursue a method claim, it is advisable to avoid the use of language such as ‘improving performance in an animal’. This order gives clear guidance to the Controllers and Applicants in formulating patentable subject matter involving supplementation of animal or bird feed.
[The authors are Associate and Executive Director, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys]
[1] Bayer Pharm Aktiengesellschaft v. Controller General of Patents & Designs, 2024, C.A.(COMM.IPD-PAT) 255/2022
[2] The Chinese University of Hong Kong and Sequenom, Inc. v. The Assistant Controller of Patents and Designs, CMA (PT) No.14 of 2023
[3] Section 2(1)(j) in The Patents Act, 1970
[4] Section 3(d) in The Patents Act, 1970
[5] Kymab Limited v. Assistant Controller of Patents & Designs, 2024:MHC:3498
