In two recent judgments, Imclone LLC V. Assistant Controller of Patents and Designs and Genmab A/S V. Assistant Controller of Patents and Designs, both dated 06.03.2024, the Madras High Court delved into the nuances of section 3(c) of the Patents Act, 1970, particularly exploring the extent of application of the terms “mere” and “occurring in nature” to different limbs of the section.
The central question before the Court in both the cases was to decide whether the production of a synthesized non-living substance (rarely occurring in nature), especially a monoclonal antibody, by using recombinant technology, qualifies for patent protection or not? Should a patent applicant establish that such non-living substance never occurs in nature?
The applications filed by Imclone LLC (bearing number 5808/CHENP/2007) and Genmab A/S (bearing number 4718/CHENP/2007) claimed a monoclonal antibody produced by the use of hybridoma technology. Patent grant in both the applications was refused by the Patent Office under section 3(c) of the Patents Act, asserting mainly that the claimed inventions were a discovery of a naturally existing molecule/substance, reproduced by standard methods and known techniques.
Section 3(c) of the Patents Act excludes from patentability “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature”. Deviating from the view expressed by the Delhi High Court in Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs, the Madras High Court observed that the qualifier “mere” in section 3(c) is limited to “discovery of a scientific principle” and does not extend to “the discovery of any living thing or non-living substance occurring in nature”.
The Court noted that the pre-amended text of Section 3(c) was originally limited to the mere discovery of scientific principles or the formulation of abstract theories. The Court noted that in the first limb of Section 3(c) which dealt with discovery the adjective “mere” was added before the noun “discovery” to underscore that something more than a discovery of a scientific principle may fall outside the scope of patent exclusion. However, because the second limb of section 3(c) does not deal with discovery with the formulation of an abstract theory, if the intention were to apply the adjective “mere” to the second limb, it should have been placed before the noun “formulation”. The Court opined that a construction where the adjective “mere” is interpreted to reach and qualify, the third limb introduced by the Amendment Act of 2002, namely, “discovery of any living thing or non-living substance occurring in nature” would be rather strained in a scenario where the adjective “mere” does not reach and qualify the second limb but qualifies the third.
The Court opined that since the noun “discovery” in the third limb is intended to apply both to living things and non-living substances occurring in nature, the adjective “mere” could not extend to this limb as otherwise even a “living thing” could fall outside the scope of patent exclusion if it were more than a mere discovery.
The Court highlighted the legislative intent of limiting the applicability of the qualifier to the first limb of section 3(c) while noting that “mere” was placed only before the first limb unlike section 3(d) which uses the qualifier “mere” in each limb of the provision.
The Court further remarked that the qualifier “occurring in nature” does not apply to “living things” but only to the nearest reasonable referent “non-living substances” as the extension of “occurring in nature” to “living things” would create redundancy.
Regarding the patent eligibility of monoclonal antibodies, the Court noted that “Both the use of the noun “discovery”- which implies finding something which already exists and not producing, engineering or making something – and the use of the present continuous form “occurring in nature” indicate that the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature.” The Court distinguished between man-made non-living substances that are novel (invented) and those that are not novel (produced), emphasizing that the real challenge with regard to a patent application in respect of a synthesized non-living substance is establishing novelty or technical advance and not patent eligibility; that section 2(1)(j) hurdle and section 3(c) exclusion is clearly not intended for such non-living substances. Therefore, the Court held that patent ineligibility cannot be countenanced merely because the organism of origin specified in the sequence listing is homo sapiens, unless the discovery is a previously unknown natural antibody.
In conclusion, the Hon’ble Court held that non-living substances occurring in nature or isolated from nature are not eligible for patents, but a synthetic version of a rarely occurring substance, crucial for treating illness when produced in large quantities is not excluded if other criteria such as novelty or technical advance are satisfied. Both the claimed inventions were directed to proceed to grant.
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