In an intriguing analysis by the Madras High Court (MadHC) on 26 September 2024 in the case of Kymab Limited v. Assistant Controller of Patents & Designs, the court set aside the rejection of Kymab Limited’s patent application by the Assistant Controller. It determined that methods for the production of antibodies through the genetic modification of non-human animals are patentable, clarifying that they do not fall under the exclusions outlined in Section 3(i) of the Patent Act 1970. This post will examine the trends of the courts regarding Section 3(i) over the past years and analyse the implications of the MadHC’s decision.
But first, what is Section 3(i) of the Patents Act, 1970? Essentially, this provision restricts the granting of patents for any “method of treatment.” To be exact, Section 3 (“What are not inventions”) reads as follows: “The following are not inventions within the meaning of this 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.”
Understanding Kymab’s Patent Application and the Court’s Analysis
Kymab’s patent application regarding a process for generating antibodies in non-human mammals (application no. 10716/CHENP/2012, derived from PCT/GB2011/050019 (here)) was rejected by the Assistant Controller on May 29, 2020. As per the documents submitted by Kymab to the Controller, it is a method for producing antibodies or antibody chains specific to a desired antigen that involves immunising a non-human mammal genetically modified to contain human antibody gene segments, allowing for the generation of chimeric or fully humanised antibodies. The patent application was for this method, and neither the judgement nor the IP Patent Search Documents (refer the Form 2 for the patent application here) mention a specific use of these antibodies. The title of the patent application itself seems to indicate that this method is for ‘therapeutic purposes and diagnosis.’
For this application, while the initial grounds for opposition were numerous, they were narrowed down over the course of the hearings. Ultimately, the application faced rejection primarily under Section 3(i).
The heart of the court’s analysis can be found in paragraphs 9 and 10 of the judgment. The MadHC noted that the analysis of Section 3(i) reveals that processes for treating animals are patent-ineligible only if they have one of three aims:
i) to eliminate disease in the animal,
ii) to enhance the animal’s economic value, or
iii) to improve the economic value of their products.
It noted that the term “similar” in Section 3(i) suggests that animal treatments could be akin to medicinal or therapeutic methods used for humans. This is illustrated with the example of treating cattle for foot and mouth disease, which clearly falls under the category of disease elimination and thus becomes patent-ineligible. Similarly, treatments aimed at improving milk quality or wool production enhance the economic value of both the animals and their products, rendering them ineligible for patent protection as well.
After providing several well-detailed examples and analyses, the MadHC then examined whether the claimed invention fit into one of the three categories required for the second limb of Section 3(i) to apply to the current application. It noted that, unlike the aforementioned examples, the claimed invention describes a process for generating antibodies in non-human mammals, which does not aim to treat the animals for disease or to increase their market value (since it is not intended to sell such transgenic mice at higher prices). Instead, the focus is on the antibodies produced, which are not considered products of the mice themselves. Unlike meat or milk, antibodies result from a specific immune response rather than being intrinsic to the animal. Therefore, the MadHC held that the rejection of the patent application on these grounds was unjustified, and the applicant was entitled to a patent grant.
An interesting aspect is the court’s failure to analyse the utility of the method for which the patent is being sought. While there is extensive discussion regarding the use of the animal’s product and whether that product is intrinsic to the animal, the court does not consider how the produced antibodies might have economic value beyond their connection to the animal or explore their potential use cases. Given that the purpose of the antibodies does seem to be for therapy, overturning the controller’s decision for a bar under Section 3(i) calls for a more robust ratio by the MadHC, however, the court didn’t even call for the utility of this method to be shown. The court should have at least acknowledged that, since the antibodies do not provide any utility to the animal itself and do not enhance its economic value for alternative uses, this clarity would have significantly strengthened the court’s assertions. Addressing these points would have offered a more comprehensive perspective on the implications of the patent application. [Side Note: This article (here) on IAM is a great read for anyone interested in the trends of antibody patent grants in India.]
To Be Or Not To Be (an Exception to Patents)?
There seems to be a trend among the courts dismissing rejections of patents under Section 3(i), whether on interpretative grounds, as seen in the current case, or on technical grounds, such as in the case of Bayer Pharm Aktiengesellschaft v. Controller General of Patents, ( Delhi High Court June 2024). In that case, the Court observed that the composition of a multiphase contraceptive formulation in the application pertained exclusively to a product rather than a process. It concluded that the mere inclusion of unit numbers of components in the independent claim does not render the application a method of treatment under Section 3(i), as it did not refer to a disease, treatment, or mode of administration of the composition itself.
Another notable case addressing the same issue is Societe Des Produits Nestle SA vs. The Controller (covered astutely by Mr. Amit Tailor here), decided in June 2023. In this case, the DHC examined whether “treatment” solely refers to a “method of treatment” under Section 3(i). Citing the University of Miami case, the DHC clarified that simply using the term “treatment” in a claim does not automatically classify it as a method claim. Instead, the phrase “for the treatment” can define the composition or product itself rather than a method performed by a physician, concluding that a reference to a composition does not equate to a method of treatment.
Moreover, I previously wrote (here) about a decision on 5th February 2024 (Arthrogen GmbH vs. Controller General of Patents) by a Single Bench (SB) of the Delhi High Court (DHC), which overturned a prior ruling by the Controller General of Patents that classified the “method of producing protein-enriched blood serum” as a method of treatment. The DHC found that the Controller had incorrectly equated the production of a novel substance with a method of treatment, leading to the revocation of the patent refusal for Arthrogen GmbH’s technique using gold particles.
The MadHC has also come into focus, particularly regarding Section 3(i) cases, especially since it interpreted the scope of “diagnostic” in the landmark decision of the Chinese University of Hong Kong and Sequenom, Inc. v. The Assistant Controller of Patents and Designs in 2023 (discussed in our Annual IP Developments Compilation here). The SB was praised for providing an interpretation of the term for the first time. The SB categorised the section into two distinct, self-contained limbs— the first dealing with human beings and the second with animals. The SB then drew a distinction between the two, noting that the second limb refers to “any process for a similar treatment of animals” aimed at either disease eradication or enhancing their economic value and that of their products. The Court concluded that since the latter two purposes do not apply to humans, this limb does not extend to them. It also reasoned that the disjunctive ‘or’ separates the two limbs. However, this case failed to discuss the second limb in more detail, as the focus primarily shifted to the first limb. Nevertheless, it was certainly useful for classifying the definition into two limbs, a method that has been referred to and replicated in the present case as well.
The extant MadHC judgment is another drop in the bucket of upcoming jurisprudence that supports confining the scope of Section 3(i)’s applicability and furthering the observations made in Chinese University. The courts are working to ensure that inventions for diagnostic tools remain strictly within the bounds of Section 3(i).
Interestingly, there seems to be a pattern emerging where applications falling outside the scope of Section 3(i) are appearing more frequently. This may be attributed to the inconsistencies among controllers in different jurisdictions, as well as the differing approaches taken by controllers and courts in applying Section 3(i) during application reviews.
Does this suggest that the courts are narrowing the interpretation of Section 3(i) too much? Well, a more relaxed interpretation might risk discouraging patents for these important technologies. The confined approach adopted by the courts in recent years appears to be more appropriate, ensuring that Section 3(i) does not hinder applications deserving of a patent, while at the same time not narrowing the section so much so as to easily allow non-patentable subject matter through the filter.