Another pharmaceutical patent refusal came under the Indian judicial scanner, when in Kemin Industries, Inc. vs The Controller of Patents [ CMA(PT). No.46 of 2024], the Controller refused to grant the patent [Application no.201617013577] for an invention titled "Use Of Ferulic Acid Esterase To Improve Performance In Monogastric Animals". On appeal, the Madras High Court overturned the Controller's decision of rejecting the patent application on finding that the refusal order issued under Sections 3(d), 3(i), and 2(1)(j) of the Patents Act, 1970, was unsustainable.
The principal method claims, which was refused by the Controller, read as:
"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, comprising the step of adding 20 units per kg to 200 units per kg of a ferulic acid esterase produced from bacteria to the animal feed, wherein the ferulic acid esterase is supplemented the main chain degrading enzymes, and wherein said main chain degrading enzymes are cellulase, xylanase, glucanase and amylase."
Subject Matter of Refused Claim
According to the Court, the subject matter of this claim rested in respect of a method of reducing, by 20% to 80%, the main chain degrading enzymes necessary to extract a given amount of apparent metabolizable energy from a diet comprising feed formulated for a monogastric animal. The claimed method comprises the step of adding 20 units per kg to 200 units per kg of an FAE produced from bacteria to the animal feed, wherein the FAE is supplemented with four main chain-degrading enzymes, namely, cellulase, xylanase, glucanase and amylase.
Applicability of Section 3(i)
For testing the applicability of Section 3(i), the Court looked at the judgment of this Court in Kymab Limited vs the Assistant Controller of Patents & Designs, 2024:MHC:3498 (Kymab), and relied upon by the respondent with regard to the interpretation of Section 3(i) in relation to animals. The Court observed that "the text of the provision discloses that the first limb pertains to forms of treatment of human beings. The second limb relates to processes for a similar treatment of animals."
In Kymab, the Court considered the language of Section 3(i) in relation to animals and observed as follows:
"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."
Coverage of Section 3(i)
In order to better appreciate the scope of Section 3(i) in relation to animals, the Court considered the following 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. "
The Court also observed that 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).
Analysis of the present case
The Court observed that in the present case, the claim was in respect of a method of reducing, by a specified percentage, the main chain-degrading enzymes necessary to extract metabolizable energy from animal feed. Furthermore, this method involved producing FAE from bacteria, supplementing it with four main chain-degrading enzymes, and adding it to animal feed. The Court stated that the monopoly claim was in respect of a method of extracting metabolizable energy more efficiently from animal feed by deploying FAE supplemented with the four enzymes mentioned above. It therefore concluded that this was clearly not a method for treating animals, as exemplified by the illustrations in Kymab, or even otherwise.
Interpreting the Reach of Section 3(i)
In this case, the Court went on to observe that if the claim had pertained to a method of administering a drug or feed to an animal or bird - for instance, poultry - 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).
The Court ruled that "Section 3(i) 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."
The Court in this case also observed that:
"Section 3(i), which is intended to exclude from patent protection any process for the treatment of human beings or animals (albeit for the three purposes mentioned therein) so as to sub-serve the underlying public policy of not permitting monopoly-based barriers to methods of treatment, is not designed to exclude from patent protection inventions like the claimed invention." [emphasis added]
On the Applicability of Section 3(d)
On the refusal based on the ground that it is a mere discovery of a known process based on comparing the claimed invention with prior arts D1 and D2, the Court asserted that Section 3(d) consists of three limbs. The first two limbs deal with known substances, and the Court noted that for purposes of this case, only the third limb was relevant. The Court observed that the third limb applied to the mere use of a known process, machine or apparatus, and it contains a built-in exemption filter if such known process results in a new product or employs at least one new reactant.
Since the refusal order relied on the teachings of the prior art D1 and D2, the Court examined the disclosure in D1 and D2 more closely and found that the claimed process of the appellant is not disclosed in either D1 or D2. Looking at the claimed process, the Court concluded that the process described by the claim deploys more than one new reactant. It was held that the claimed invention is not excluded from patent protection by virtue of Section 3(d) of the Patents Act.
On Inventive Step
The Court also looked into the reason given by the Controller to reach the conclusion that the claimed invention was obvious in view of the combined reading of D1 and D2. On examining the D1, the Court found that "the combination of feruloyl esterase or FAE with xylanase is clearly taught therein. Conspicuous by its absence in prior art D1 is a reference to the other three enzymes forming the subject of the sole claim of the claimed invention." The Court noted that the claimed invention is in respect of the combination of four specific NSP-modifying enzymes, namely, cellulase, xylanase, glucanase and amylase.
The Court noted that the appellant demonstrated the synergistic effect arising from such a combination in Table 7 and in Figures 7 and 8, providing experimental data to establish an increase in body weight and a lower FCR, respectively.
Consequentially, the Court held that:
"Especially in the absence of any evidence of a limited set of options, with regard to the NSP modifying enzymes, I conclude that the deployment of a particular combination by the appellant constitutes an inventive step, and conclusions to the contrary in the impugned order are untenable."
Takeaways
In this case, the Court interpreted the provisions of Section 3(i), ruling that these exclusions are not applicable 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. The Court clarified that monopoly-based barriers to methods of treatment covered under Section 3(i) are not designed to exclude from patent protection inventions like the claimed invention. This opened new patenting avenues for the grant of a patent on similar animal feeds as claimed in this case.
The Court also held that the deployment of a particular combination by the appellant constitutes an inventive step, and conclusions to the contrary in the impugned order are untenable. Setting aside the impugned order dated July 19, 2022, the Court directed that Patent Application No. 201617013577 shall proceed to grant. This grant for a patent for a method of supplementing an animal feed will now open new patenting opportunities for similar inventions.
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