Immunas Pharma Inc v Assistant Controller of Patents and Designs (2024)

Summary

“The appellant assails an order dated 29 December 2017 by which Indian Patent Application No.5542/CHENP/2010 ... was rejected.” (para 1) The application was “in respect of an invention titled ‘Antibody Capable of Binding Specifically to A-beta Oligomer and Use Thereof’”, and in prosecution “the claim was restricted to a single antibody labelled as 6E4.” (para 2) By the impugned order “the respondent confirmed the Section 3(c) objection” and held “that the antibody 6E4, which is the subject of the patent claim, was discovered and, hence, not patent-eligible.” (para 4)

The Court held that “the qualifier ‘mere’ is confined to the nearest reasonable referent ‘discovery of a scientific principle’” (para 13), that “the expression ‘occurring in nature’ in the third limb of Section 3(c) only qualifies the nearest reasonable referent ’non-living substance’” (para 14), and that “the exclusion will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature” (para 18). “The real challenge with regard to a patent application in respect of a synthesized non-living substance, especially a monoclonal antibody, is establishing novelty, technical advance and not patent eligibility.” (para 19) The Court found that “the antibody of the claimed invention was undoubtedly not isolated from a human being, but was engineered” (para 21) and concluded “that the claimed invention is not excluded from patent protection under clause (c) of section 3. Consequently, the impugned order cannot be sustained and is hereby set aside.” (para 24) It directed “that the claimed invention proceed to grant on the basis of the current claims” (para 25), and “(T)CMA(PT)No.118 of 2023 is allowed on the above terms without any order as to costs.” (para 26)

What the court decided

1. The first two limbs. “Prior to its amendment by Act 38 of 2002, the provision was as under” and read “(c) the mere discovery of a scientific principle or the formulation of an abstract theory” (para 11). “The first limb dealt with discovery and the second with the intellectual exercise of formulating an abstract theory. The qualifier ‘mere’, which is an adjective, was added before the noun ‘discovery’ in the first limb to underscore that something more than a discovery of a scientific principle, such as the production of a novel device that operates on such scientific principle, may fall outside the scope of patent exclusion. Because the second limb does not deal with discovery but to the formulation of a abstract theory, if the intention were to apply the adjective ‘mere’ to the second limb, it should have been placed before the noun ‘formulation’ in such limb.” (paras 11–12)
2. The modifier canon. “What about the third limb: ‘discovery of any living thing or non-living substance occurring in nature’? To begin with, it would be a strained construction to conclude that the adjective ‘mere’ does not reach and qualify the second limb but qualifies the third. The ordinary rule of grammar and, therefore, one of the principles of statutory construction is that a modifier, such as the word ‘mere’, would qualify the entire series of nouns or verbs if such series is a straightforward parallel construction, whereas, it would be restricted to the nearest reasonable referent otherwise. For instance, if the second limb did not exist and Section 3(c) had been framed as follows: the mere discovery of a scientific principle or of any living thing or non-living substance occurring in nature, both the adjective ‘mere’ and the noun ‘discovery’ would have applied to both limbs as the phrase would not make sense otherwise. Reference may be made to Reading Law, The Interpretation of Legal Texts, Antonin Scalia and Bryan Garner, 2012 Edition, Thomson/West, for an illuminating discussion on these principles of interpretation.” (para 12) “Hence, the text, interpreted as per the ordinary rules of grammar, the immediate statutory context, and the legislative history of amended clause (c) of section 3 point to the same conclusion, i.e. that the qualifier ‘mere’ is confined to the nearest reasonable referent ‘discovery of a scientific principle’ and does not extend to ’the discovery of any living thing or non-living substance occurring in nature.’ For reasons set out above, I deviate from the interpretation of the Delhi High Court, in this regard, in Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs, 2023 SCC OnLine Del 1879.” (paras 12–13)
3. Discovery of a living thing. “Another aspect to be noticed, in this regard, is that the noun ‘discovery’ in the third limb is intended to apply both to living things and non-living substances occurring in nature. This is a pointer, albeit not conclusive, that the adjective ‘mere’ does not extend to this limb as otherwise even a ’living thing’ could fall outside the scope of patent exclusion if there is something more than mere discovery.” (para 13)
4. Occurring in nature and living things. “The next aspect to which I turn my attention is the impact of the phrase ‘occurring in nature’. Does it also apply to the expression ’living thing’? The ordinary rules of syntax would indicate the following structure if the intention were to extend ‘occurring in nature’ to ’living thing’: ’the discovery of any living or non-living thing occurring in nature’. Even otherwise, given the current state of science, the extension of ‘occurring in nature’ to ’living thing’ would create a redundancy that cannot ordinarily be imputed to Parliament. Thus, I conclude that the expression ‘occurring in nature’ in the third limb of Section 3(c) only qualifies the nearest reasonable referent ’non-living substance’.” (para 14)
5. Man-made non-living substances. “Reverting to Indian law, as noticed earlier, Section 3(c) uses the expression ‘occurring in nature’ to qualify ‘discovery of a non-living substance.’ While it could be argued that this qualifier is only intended to underscore that the exclusion would not apply to a non-living substance that is man-made, in my view, said explanation does not withstand close scrutiny because such non-living substance, if man-made and novel, would not be discovered; it would be created or invented. If man-made but not novel, it would be produced and not discovered. It would also not surmount the Section 2(1)(j) hurdle and the Section 3(c) exclusion is clearly not intended for such non-living substances.” (para 17) “What is the sequitur of the use of the expression ‘occurring in nature’: would a synthetic version of a substance that rarely occurs in nature but is required to be produced in large quantities for the treatment of serious illnesses qualify for or be excluded from patent protection? Should a patent applicant establish that such non-living substance never occurs in nature? The text of clause (c) of Section 3 contains guidance.” (para 17) “The statutory prescription is ‘discovery of any ... non-living substance occurring in nature’. 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.” (paras 17–18) “While reaching this conclusion, I take on board the presumption in statutory construction that redundancy should not be imputed to Parliament, and that the expression ‘occurring in nature’ should not be robbed off all meaning and purpose.” (paras 17–18)
6. Eligibility and grant. “Ultimately, it should not be lost sight of that Section 3(c) is confined to patent exclusions or ineligibility and passing through such filter does not guarantee the grant of patent.” (para 18)
7. Synthesized non-living substances. “The real challenge with regard to a patent application in respect of a synthesized non-living substance, especially a monoclonal antibody, is establishing novelty, technical advance and not patent eligibility. For such purpose, the sequence of the antibody, especially the CDRs, may need to be compared with known antibody sequences. The patent applicant may also be required to establish that it does not fall within other exclusions in Section 3, such as sub-section (d) thereof, and further satisfy the requirements of Section 2(1)(j) of the Patents Act.” (para 19)
8. Obiter. Width of antibody claims. “Although not a concern in this case because of the nature of claims, the other legitimate concern from the Indian Patent Office perspective, in the context of monoclonal antibodies, could be to closely examine the width of claims so as to ensure that very broad claims focused entirely or largely on functionality are not allowed because that could impede instead of fostering inventiveness in future.” (para 19)
9. Hybridoma technology. “The response of the respondent was that hybridoma technology is well known and that the use of such process cannot be construed as inventive.” “The appellant does not, however, assert inventiveness in the use of hybridoma technology. Inventiveness is asserted with regard to the production of a monoclonal antibody, which targets a specific epitope.” (para 21)
10. The sequence listing. “Every patent application in respect of substances such as antibodies is required to be accompanied by a sequence listing.” “At the relevant point of time, Standard 25 was applicable. Standard 25 prescribes the mandatory and optional information that should be provided in the sequence listing. Such mandatory information includes information relating to the organism from which the nucleotide or amino acid sequence originates and setting out the sequence.” (para 22) “The appellant does not dispute the respondent’s contention that the organism of origin was listed as homo sapiens in the sequence listing, including the SEQ IDs in respect of which claims were made.” “In light of the conclusions drawn on the interpretation of Section 3(c) of the Patents Act, the contention of the respondent that the claims are in respect of the discovery of an antibody/non-living substance occurring in nature cannot be countenanced merely because the organism specified in the sequence listing is homo sapiens. As discussed earlier, such conclusion would be justified only if the appellant had discovered/found a hitherto unknown antibody and isolated it from nature.” (paras 22–23)
11. The engineered antibody. The appellant “relied on internal page 16 of the complete specification” (para 20), which states that “Balb-c mice are immunized with 2.5 ug of either the A-beta 1-42 oligomer emulsified using complete Freund’s adjuvant by injecting the antigen into their foot pad” and that “Hybridomas are produced from the inguinal lymph node by fusion with Sp2/O-Ag14 cells using polethylene Glycol 1500” (para 20). The Court held: “From the description set out in the complete specification, the conclusion that follows is that the antibody of the claimed invention was undoubtedly not isolated from a human being, but was engineered in the manner described in internal page 16 of the complete specification.” (paras 20–21) “In light of the disclosures in the complete specification, the conclusion that follows is that the antibody was generated by injecting an engineered antigen into the mice. After doing so, material extracted from the inguinal lymph of the mice was fused with myeloma cells by the hybridoma process. This resulted in the antibody over which the patent claim is made. When all these facts and circumstances are considered cumulatively, in the context of my conclusions on the scope and ambit of Section 3(c) of the Patents Act, I conclude that the claimed invention is not excluded from patent protection under clause (c) of section 3. Consequently, the impugned order cannot be sustained and is hereby set aside.” (paras 20–21, 24)
12. Disposition. “Since all the other objections in the FER” (“first examination report”) “were subsequently dropped pursuant to the deletion of corresponding claims, in view of the above conclusion that the Section 3(c) rejection is untenable, I direct that the claimed invention proceed to grant on the basis of the current claims, which were submitted in course of hearings before the respondent. For the avoidance of doubt, the said claims are set out below”. Claim 1 reads: “An antibody that binds A-beta oligomer, of any one of (1) to (2) below”. (para 25) “(T)CMA(PT)No.118 of 2023 is allowed on the above terms without any order as to costs.” (paras 25–26)

Subsequent treatment

• Followed — In Pioneer Hi-Bred International v Controller of Patents (2026) the Delhi High Court held that “The Madras High Court in Immunas Pharma (supra) examined the ambit and scope of Section 3(c) in the Indian statutory context while also examining the judgments of the US Supreme Court in this regard and the observations will be instructive” (para 15) and, after reproducing paras 17 to 20 of this judgment, that “in light of the aforesaid judgments, there is merit in the contention of the Appellant that Respondent ought to have considered the detailed submissions” (para 17); it held that “the patent application requires complete examination and hence, fresh consideration” and that “this Court has not expressed any opinion on the merits of the case” (para 18).
• No further appeal traced as of 10 October 2026.