Patentable subject matter exclusions are litigious subject matter in most countries. While many of the categories of exclusion are common across jurisdictions, there are a few provisions that exhibit divergent positions or interpretations. One such exclusion category is the ‘method of treatment’ exclusion. While it is widely understood and recognized that claims relating to methods of treatment ought not be patented, what amounts to a method of treatment and when such a method is excluded from patentability, is contested in many matters.
Section 3(i) of the Indian Patents Act (‘Act’) 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”. In assessing method of treatment claims, an approach that the Indian patent office takes is to see if the method involves “administering” the composition/antigen to humans or animals, without making consideration on whether the method is a treatment method falling within the meaning of section 3(i) or not.
Albeit the purpose of section 3(i) has always been to protect doctors and other medical practitioners from potential infringement liability and prevent monopoly over methods practiced by such medical professionals. Methods for developing in vivo platforms such as mouse models for drug discovery or antibody generation have faced rejections in the past.
However, the recent judgment by the Hon’ble Madras High Court in Kymab Limited (Appellant) Vs. The Assistant Controller of Patents & Designs (Respondent) ([OA/SR.118/2020/PT/CHN]) (‘Kymab’) has, to some extent, provided clarity on the scope and interpretation of section 3(i) of the Act.
BACKGROUND OF THE CASE
The Appellant filed a national phase PCT Application at the Indian Patent Office (‘IPO’). The Indian Patent Application No. 10716/CHENP/2012 (‘application’), titled “ANIMAL MODELS AND THERAPEUTIC MOLECULES”, directed towards a method for producing chimeric antibodies using genetically modified non-human mammal, i.e. mouse. The method as claimed in the independent claim 1 of the application included immunizing the non-human mammal with an antigen and recovering the antibodies. During prosecution, the claims were objected under section 3(i) of the Act on the ground that they are directed to “method of treatment for animals”. The Appellant argued that the claimed method is a “method for production of antibodies” and not a “method of treatment of animal”. However, the Patent Office deemed the claims as patent ineligible and refused the application. Following which the Appellant filed an appeal under section 117-A of the Act to set aside/quash the order passed by the respondent and direct grant of Indian Patent Application No.10716/ CHENP/ 2012.
KEY QUESTION BEFORE THE COURT
The central issue was whether the claimed invention ̶ a process for producing chimeric antibodies in a genetically modified mouse by immunizing the mouse with an antigen ̶ was patent ineligible under the provision of section 3(i) of the Act.
Although independent claim 1 includes various limitations and steps, from the refusal order, it appears that the considerations made by the Indian patent office in concluding that the method attracts section 3(i) is mostly based on the step of “immunizing” the mouse, included in the claim.
- Interpretation of Section 3(i)
Previously, Indian Courts have in many occasions provided clarity on the boundaries of section 3(i) at various levels. For example, in the matter of Societe Des Produits Nestle SA Vs. The Controller of Patents and Design and Ors the Court clarified that just the expression “for use in treatment” in the claims does not attract an objection under section 3(i). In another example, in the matter of Arthrogen Gmbh Vs. Controller General Of Patents, Designs And Trademarks and Ors. (05.02.2024 – DEOR) the Court clarified the difference between a “method of treatment” as under section 3(i) and a “method for producing a substance or composition which may have a specific use in a method of surgery, therapy or diagnosis“.
Among the recent cases, the Court’s judgement in the matter of Chinese University of Hong Kong v. Assistant Controller of Patents (‘Chinese University’), also relied upon in the matter of Kymab, especially favours innovations in the field of biotechnology.
In particular, the Court highlighted that section 3(i) of the Act contains two limbs which are distinct and self-contained, and separated by the disjunctive “or”:
- First limb: deals exclusively with the processes in humans.
- Second Limb: deals with similar processes in animals, and further outlines three specific purposes of treatment that are excluded:
- to render them free of disease: For example- Methods of treating cattle for foot-mouth disease, would be excluded.
- increase their economic value: For example- Administering a treatment to cows to improve the yield of milk or enhance their market value, would be excluded.
- that of their products: For example- Treatment of sheep to improve the quality of wool produced by the sheep would also be excluded.
From the considerations made in the judgement, it can be said that the Court’s interpretation in respect of the second limb dealing with animals is narrower as compared to that of the first limb dealing with humans. In that, the scope of the second limb is limited by the specific purpose of treatment as identified therein. Hence, it may be safe to say that, in animals, as long as the treatment method is not falling within the specified purpose, there is a possibility for consideration.
- Key Findings by The Court in the Instant Case
The following conclusions were made by the Court:
- The claimed invention is not a method of treatment
The Court held that the invention was not to treat the mouse to render them free of disease or increase their economic value. Instead, it focused on generating a chimeric antibody by immunization.
- Non-murine antibodies are not products of a Mouse
The Court clarified that products like “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, on the other hand, being generated in response to antigens, do not qualify as a product of the animal.
The Court ruled that rejecting the claimed invention for a patent on the basis that it is a method of treatment is unsustainable, and the patent application proceeded to grant.
CONCLUSION
To some extent, this judgement clarifies that a method, in animals, involving “immunization” or “administration” may not always fall within the ambit of section 3(i), and some considerations may be made on the specific purpose of the claimed method. India will surely see more judicial precedents interpreting the scope of patentable subject matter exclusions as we encounter newer and nuanced technologies.