Genmab A/S v Assistant Controller of Patents and Designs (2024)

Summary

“The appellant assails an order dated 30 May 2016 by which Indian Patent Application No.4718/CHENP/2007 ... was rejected.” (para 1) The application was “in respect of an invention titled ‘Antibodies against CD38 for Treatment of Multiple Myeloma’” (para 2), and in the hearing notice the respondent “raised the objection that amended claims 1-44 fall within the scope of Section 3(c) of the Patents Act.” (para 3) In the impugned order “the respondent concluded that the DNA and protein of claims 1-24 and 25, respectively, were from homo sapiens as per the sequence listing. Hence, it was held that the antibody claimed is the discovery of a naturally existing molecule/substance and, therefore, not patent eligible under section 3(c) of the Patents Act.” (para 4)

The Court held that “the qualifier ‘mere’ is confined to the nearest reasonable referent ‘discovery of a scientific principle’” (para 15), 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 20). It held that “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.” (para 26) On inventive step, “I find that there is no basis to the conclusion that the claimed invention either lacks technical advancement over the cited prior art or that it would have been obvious to a person skilled in the art.” (para 29) “For reasons discussed above, the objections on the basis of Section 3(c) and lack of inventive step are overruled. Consequently, the impugned order cannot be sustained and is hereby set aside.” (para 31) The Court directed “that the claimed invention proceed to grant on the basis of the claims submitted with the written submissions before the respondent” (para 31), and “(T)CMA(PT)No.134 of 2023 is disposed on the above terms without any order as to costs.” (para 32)

What the court decided

1. The scope of section 3(c). The Court held that “the expression ‘occurring in nature’ in the third limb of Section 3(c) only qualifies the nearest reasonable referent ’non-living substance’” (para 16), 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 19–20), and that “Section 3(c) is confined to patent exclusions or ineligibility and passing through such filter does not guarantee the grant of patent” (paras 16, 19–20)
2. The sequence listing. “Since the respondent relied on the fact that the description of the organism in the sequence listing is homo sapiens, some explanation is necessary for the appreciation of this contention and to put it in perspective. 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 24) “The appellant does not dispute that the organism of origin was listed as homo sapiens with regard to the SEQ ID’s regarding which claims were made. Instead, the explanation of the appellant is that only three options are available as regards numeric identifier ... namely, organism, artificial and unknown. Because the antibody was developed from the transgenic HuMab Mouse platform based on human germline sequence, the appellant states that the annotation ‘homo sapiens’ was specified in numerical identifier ... as the most similar or homologous. Significantly, the appellant contends that this does not establish that the monopoly claim is over a naturally occurring antibody.” (para 25) The Court held: “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 24–26)
3. Inventive step. “In support of the conclusion that the claimed invention lacks an inventive step, apart from stating that the organism of origin of the CDR sequences is natural, the respondent also concluded that no comparative data was provided. On perusal of the complete specification, the affidavits discussed above and the cited prior arts, I find that there is no basis to the conclusion that the claimed invention either lacks technical advancement over the cited prior art or that it would have been obvious to a person skilled in the art.” (para 29) “In this connection, it should also be noticed that the prior art cited herein was also cited either in the International Search Report (ISR) or in proceedings before the European Patent Office(the EPO) or the United States Patent Office (the USPTO). While this is not dispositive, it is a material consideration.” (para 29)
4. Disposition. “For reasons discussed above, the objections on the basis of Section 3(c) and lack of inventive step are overruled. Consequently, the impugned order cannot be sustained and is hereby set aside.” (para 31) “Since all the other objections in the FER” (“first examination report”) “were subsequently dropped pursuant to the deletion of corresponding claims or on provision of a satisfactory explanation, in view of the above conclusion, I direct that the claimed invention proceed to grant on the basis of the claims submitted with the written submissions before the respondent, i.e. claims 1-29, subject to the deletion of claims 4,7,10-15,18 and 19. The claims shall be refiled after renumbering for such purpose.” (para 31) “(T)CMA(PT)No.134 of 2023 is disposed on the above terms without any order as to costs.” (paras 31–32)

What the court did not decide

Of the remaining ground, the Court said: “All that remains is to consider the objection relating to non-compliance with Section 10(4)(c).” (para 29) “Without acquiescing in the validity of this objection, in the written submissions, the appellant has agreed to delete claims 4,7,10-15,18 and 19, which are the only claims in respect of which these objections were raised. With the deletion of these claims, this objection is rendered moot.” (para 30)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 10 October 2026.