Clarifying Patent Law: Madras High Court Redefines Limits of Section 3(I) in Kemin Case

By Rinku Dutta & Peeyush Pandey

Introduction

Section 3(i)[1] of the Indian Patents Act, 1970 (hereinafter referred to as “the Act”) provides statutory limitations for certain inventions that cannot be patentable, specifically those that are related to the treatment of humans or animals. This provision of Section 3(i) excludes processes related to 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”, from patenting in India. In a recent judgment delivered by the Hon’ble Madras High Court in Kemin Industries Inc. v. Controller of Patents[2] dated March 18, 2025 clarified the interpretation of Section 3(i), explaining the eligibility for treatment-related inventions of animals/humans.

BRIEF OVERVIEW OF THE CASE:

This case is based on an appeal filed by Kemin Industries Inc. under Section 117-A of the Patents Act, 1970, against the order of refusal of its patent application 201617013577 by the Indian Patent Office (IPO). Kemin Industries Inc. is a US-based global biotechnology company involved in supplying specialty ingredients across various sectors, such as, human and animal health nutrition, food technologies, etc. The Indian patent application 201617013577 was filed by the applicant, Kemin Industries Inc., on April 19, 2016, titled as, “USE OF FERULIC ACID ESTERASE TO IMPROVE PERFORMANCE IN MONOGASTRIC ANIMALS” with the Indian Patent Office, which was published in patent journal dated August 31, 2016. A first examination report (FER) issued by the Controller of Patents, IPO, on September 27, 2019, cited objections pertaining to lack of novelty, lack of inventive step, sufficiency of disclosure, and clarity and conciseness. A FER response was filed on March 27, 2020, by the applicant to overcome the objections raised in the FER. Subsequently, a hearing notice was issued by the Controller dated May 06, 2021, citing the objections regarding lack of inventive step, scope, sufficiency of disclosure, and non-patentability u/s 3(d) and 3(i) of the Patents Act, 1970.

The details of the subject patent application are provided in the table below:

CLAIMED INVENTION AND GROUNDS FOR CONTROLLER’S REJECTION:

An order was passed by the Controller of Patents dated July 19, 2020, rejecting the application on the grounds such as lack of inventive step and non-patentability under Section 3(d) and Section 3(i) of the Patents Act.  The claimed invention pertains to a method of feeding to improve significant metabolizable energy and performance of poultry, by supplementing ferulic acid esterase (FAE) produced from bacteria, along with 20% to 80% of main chain degrading enzymes, namely, cellulase, xylanase, glucanase, and amylase.

The Controller of Patents held that the invention involved a method for the treatment of animals, thereby falling under Section 3(i) of the Patents Act. Additionally, due to the absence of any efficacy data, the claimed method in the alleged invention is a mere discovery of a known process, thereby falling under Section 3(d) of the Patents Act, and not patentable. Further, the controller stated that the claimed subject matter lacks inventive step with regard to the cited documents D1, and D2 in combination with common general knowledge, since it is obvious for a person skilled in art to make a feed diet containing ferulic acid esterase and with or without main chain degrading enzymes for a better digestion of plant cell wall containing non-starch polysaccharides.

SUBMISSIONS MADE BY THE LEARNED COUNSEL OF THE APPELLANT:

An appeal has been filed by the Applicant (hereinafter referred to as ‘Appellant’) before the High Court of Madras under 117A against the order passed by the Controller of Patents (hereinafter referred to as ‘Respondent’). The Appellant has made the following submissions in the appeal:

• Efficacy Data and Inventiveness of the invention: The enzymatic activity provided in the Table 1 and Table 7 of the complete specification provides the efficacy data, demonstrating that the release of ferulic acid is the highest for FAE when in combination with all four enzymes (i.e., prototype I + FAE), resulting into the synergistic effect. This combination to achieve such a result was not known in the prior art and was not obvious to a person skilled in the art. Further, the cited documents D1 and D2 fail to teach the combination of FAE and all the main chain-degrading enzymes, rather, the combined teaching of D1 and D2 is limited only to FAE and xylanase. Therefore, the claimed invention satisfies the requirements of inventive step under Section 2(1)(ja) of the Patents Act, 1970.
• Section 3(d) Exclusion: The claim of the alleged invention does not relate to the use of a known process under section 3(d), as it employs more than one new reactant, since all the enzymes are not known from the prior known references. Therefore, the claimed invention can’t be excluded from patent protection under Section 3(d).
• Section 3(e) Exclusion: The claimed invention is directed to a method of supplementing an animal feed and not a method of treating animals. The provision of Section 3(i) only applies to a process for the treatment of human beings or animals to render them free of diseases. In this regard, the claimed invention pertaining to providing nutrition to animals, and therefore excluded from the ambit of Section 3(i).

SUBMISSIONS MADE BY THE LEARNED COUNSEL OF THE RESPONDENT:

In response to the appellant’ contentions, the following submissions are made by the Learned Counsel for the respondent:

• The cited document D1 and D2 teaches the combination of FAE and xylanase and obvious using the common general knowledge and involves the mere use of a known process.
• The claimed invention pertaining to the method for treatment of animals to increase their economic value. Specifically, the method results in fattening of the poultry to which the animal feed is administered. Additionally, the judgment in Kymab Limited v. the Assistant Controller of Patents & Designs, 2024:MHC:3498 (hereinafter referred as Kymab case) was relied upon of the same court, which addresses the similar issue.

JUDGMENT PASSED BY THE COURT:

The Hon’ble High Court delivered its judgment after a comprehensive analysis of the scope of the invention based on its sole claim and the grounds for rejection of the patent application by the Controller of Patents. The Hon’ble High Court, upon careful review of the claims, held that the invention does not fall within the scope of a treatment process as outlined under Section 3(i).  The claims of the purported invention do not constitute a method for treating animals, as illustrated in the Kymab case or by any other example. Section 3(i) only excludes the patenting of any process for the treatment of a human or animal being. It was also stated that, “if the claim had pertained to a method of administering a drug or feed to poultry 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)”. The court concluded that the claimed invention pertaining to a method of supplementing animal feed, resulting in improving the economic value of the poultry and enhancing the nutritional benefits as well, therefore, the invention does not fall under the scope of section 3(i).

It was further stated by the Hon’ble Court that, the cited document D1 only discloses the combination of FAE and xylanase, but do not mention the other three enzymes. D2 teaches the combination of FAE and the enzymes, xylanase and glucanase, but does not provide any hint for the combination of all four enzymes along with FAE. The respondent also failed to prove how this knowledge is part of common general knowledge. Therefore, the claimed invention constitutes an inventive step as per the Patents Act.

Furthermore, the claimed invention discloses the combination of FAE along with four enzymes. Not all four enzymes are disclosed in any of the prior art literatures, even in combination with the cited documents, thereby introducing new reactants. Consequently, the invention relates to a new process and shall not be excluded from patent protection under section 3(d).

CONCLUSION

The Madras High Court in this case of Kemin Industries Inc. vs The Controller of Patents, redefines the interpretation of section 3(i), offering clarification on the method of treatment and innovative processes involving animal feed and nutrition. Any invention that relates to a process of preparing feed or involving animal improvements in animal nutrition or feed composition does not qualify as a method of treatment to render the animal free of disease and does not fall under section 3(i). This interpretation offers significant clarity for inventions related to the treatment of animals, affirming that non-therapeutic improvements in animal products or processes are not necessarily barred under section 3(i) and can be eligible for patent protection.

[1] Section 3(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.

[2] Access full judgment at https://indiankanoon.org/doc/74027572/