Scope of Section 3(i)
In a case involving interpretation of Section 3(i) of the Patents Act, 1970, the Delhi High Court has observed that a nuanced interpretation is warranted – one that excludes only those methods which directly implicate professional judgment and involve invasive or high-risk procedures, while allowing for the patenting of ancillary tools, devices, and non-invasive methods, especially those practiced in vitro or outside the human/animal body. According to the Court, such an approach would uphold the delicate balance between incentivising innovation in health-related technology and preserving unhindered access to performing essential medical procedures.
The High Court in this regard observed that the exclusion from patentability should be interpreted narrowly to limit its application to the purpose for which it was incorporated i.e., to ensure that medical professionals are not hindered by concerns of patent infringement in the performance of core clinical tasks that require professional medical expertise and carry health risks.
The Court, in this dispute, was of the view that in interpreting Section 3(i), which uses similar language as Article 53(c) of the European Patent Convention (‘EPC’), the same rationale ought to guide the analysis, i.e., to preserve the freedom of medical practitioners in clinical settings, while still enabling the protection of technical solutions, tools, or methods that are either in vitro or non-clinical in nature.
Accordingly, the Court held that from a plain reading of Section 3(i) it was clear that the intention is to exclude process claims and not product claims. Thus, according to the Court, tools and products irrespective of whether they are in vivo or in vitro are entitled to grant of patent even if they can be used in the process of performing surgery, diagnosis or therapy, provided they satisfy the conditions under Section 2(1)(j) and 2(1)(ja) of the Patents Act.
Patent when/when not can be granted
Further, the Court, on the facts of the case in EMD Millipore Corporation v. Assistant Controller of Patents and Designs, allowed the appeal against rejection of the patent application relating to an improved method for the quantitative analysis of biomolecules using infra-red (IR) spectroscopy. It was noted that the invention does not claim any process for diagnosing a disease or interpreting medical conditions but rather sought protection for a technical method that enhances the efficiency of IR spectroscopic analysis performed in vitro on a removed sample.
It noted that the bio-molecule to be quantitatively analysed could be human plasma or even food substances and other samples such as water samples, sewage samples, cosmetic samples, medical samples or even fuels, and that merely because it is capable of being used for infra-red spectroscopy to be conducted on humans or animals would not exclude the said process or method from patentability as the manner in which the results of the spectroscopy are to be analysed is not being patented.
Observing that the method of conducting the quantization of bio molecules in a new form of infra-red spectroscopy was only sought to be patented, the Court also noted that the core of the subject patent application lied in improving the efficiency and reliability of quantitative analysis using infra-red spectroscopy, by reducing calibration time and avoiding repeated generation of calibration curves. It was thus held that such an in-vitro analytical method, as claimed in the present invention, cannot be excluded from patentability under Section 3(i).
It may be noted that the High Court on the same day, i.e., 9 October 2025, pronounced various other decisions also, reiterating its discussion on the scope of Section 3(i) of the Patents Act, 1970 but with different findings on the patentability of the subject invention in these cases. The Court in these cases [Natera Inc and Anr. v. Assistant Commissioner and Sequenom Inc and Anr. v. Controller] thus upheld the Controller’s view of non-grant of patent for the invention titled ‘Methods for Lung Cancer Detection’ and ‘Process and Compositions for Methylation-Based Enrichment of Fetal Nucleic Acid from a Maternal Sample Useful for Non Invasive Prenatal Diagnoses’.