An appeal was filed by Genmab A/S (hereinafter “Applicant” or “Appellant”) against an order dated May 30, 2016, which had rejected its’s Indian Patent Application No.4718/CHENP/2007. The application claimed priority from US Application No.60/667,579 dated April 1, 2005. A first examination report was received on February 27, 2013, and various objections were raised in view of certain prior arts and the patent application was considered not patentable under Section 3(j), 3(e), 3(i) and 3(c). The appellant revised its claims while responding to the examination report, leading to a hearing. However, the application was rejected as the application was thought to lack any inventive step, and patent ineligible under Section 3(c)[1].
Objections raised by Controller with respect to Section 3(c):
The application, in addition to certain other aspects, claimed antibodies (monoclonal antibodies) binding to human CD38[2]. The claimed antibodies were defined in terms of parts of its protein sequence or in terms of the nucleic acid encoding the protein. DNA and protein sequences were enlisted in a sequence listing, which identified the various sequences with specific sequence IDs. In the sequence listing, the sequences defining the antibodies, under <213> contained “Homo Sapiens”[3]. The Controller therefore held that the antibody claimed is the discovery of a naturally existing molecule/ substance (existing in humans/ Homo Sapiens), and, therefore, not patent eligible under Section 3(c) of the Patents Act.
The Appellant disagreed with the reasoning and filed an appeal against the refusal, mainly on the following grounds:
- The claimed antibodies were produced by substantial human intervention and cannot directly be isolated from nature and isolating this class of antibodies from the human population was impossible;
- Numerous patents were granted by the Indian Patent Office for monoclonal antibodies;
- Antibody production process involved immunising transgenic mice (Manmade) with immunogens, which are artificially produced by modifying the human CD38 antigen and the antibody was produced by fusing the extract from the transgenic mice with an immortal myeloma through hybridoma process;
- As the antibody was developed from the transgenic HuMab mouse platform based on human germline sequence, the annotation ‘Homo Sapiens’ was specified in numerical identifier [213] as the most similar or homologous.
- The transgenic mouse enzymes played a role in determining the final composition of the antibody by the introduction of somatic hyper mutations, so there were differences between the sequence of antibody and the closest human germline sequence.
The Madras High Court on reviewing the facts of the case and considering the language of Section 3(c) allowed the appeal. As per the Madras High Court Judgement, a non-living substance, if man-made and novel, cannot be considered as discovered. The court also stressed that the real challenge regarding a patent application in respect of synthesised non-living substance, especially a monoclonal antibody, is establishing novelty or technical advance and not patent eligibility.
In arriving at the above finding, the first issue that the Court delved into is the interpretation of clause (c) of Section 3[4] (dividing it into three limbs), and noted at least the following observations: –
- The said provision prior to its amendment was as under: “the mere discovery of a scientific principle or the formulation of an abstract theory”.
- The Ayyangar Committee report, in paragraph 328 was of the view that discoveries are universally not patentable. The rationale being that a discovery is a process by which something already in existence is found, whereas an invention is the creation of something that was not in existence previously.
- 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.
- The Court noted that the second limb does not deal with discovery, but 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” in such limb.
- About the third limb: “discovery of any living thing or non-living substance occurring in nature”, the Court held thatit would be a strained construction to conclude that the adjective “mere” does not reach and qualify the second limb but qualifies the third.
According to the Hon’ble Court, another aspect to be noticed is that if Parliament intended to apply the qualifier, it is likely that the word “mere” would have found place before the word “discovery” in the third limb. It should also be noticed that clause (d) of Section 3, which also uses the qualifier “mere” uses it in each limb of the provision. Hence, the text, interpreted as per the rules of grammar, the immediate statutory context, and the legislative history of the 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.” The Court in this regard deviated from the interpretation of the Delhi High Court in Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs.
The next aspect that the Court delved into is the impact of the phrase “occurring in nature”. As per Court, 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’. Thus, 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”, indicating that the exclusion under the said provision will only apply to the process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature.
With regard to Section 3(c) of the Patents Act, the Court held that the Controller’s conclusion that the claims are in respect of 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. Such conclusion would be justified only if the appellant had discovered/ found a hitherto unknown antibody and isolated it from nature. The Court agreed with the Appellant that antibody production is an elaborate process involving immunising transgenic mice with immunogens, which are artificially produced by modifying the human CD38 antigen, and the antibody is produced by fusing the extract from the transgenic mice with an immortal myeloma through the hybridoma process. Thus, isolating this class of antibodies from the human population was impossible. Also, the appellant used the annotation ‘homo sapiens’ in the numerical identifier [213] of the sequence listing as the most similar or homologous as per Standard 25 of WIPO, which prescribes that mandatory information includes information relating to the organism from which the nucleotide or amino acid sequence originates. Based on the above reasons, the Court decided that the claimed invention was eligible under Section 3(c) of the Patents Act.
A similar conclusion was made by the Court in Immunas Pharma, Inc. Vs. Controller of Patents and ImClone LLC Vs. Controller of Patents.
The appellant had agreed to delete claims 4, 7, 10-15, 18 and 19, which were the only claims in respect of which objections related to non-inventiveness were raised. With the deletion of these claims, the Court believed that the respondent’s objections were irrelevant and the patent application was worthy of grant.
[1] Section 3(c) of the Patents Act, “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature”
[2] Claims 1 and 2 as examples of various claims of Genmab’s application are reproduced below:
1. An antibody binding to human CD38 encoded by
(i) human light chain and human heavy chain nucleic acids comprising nucleotide sequences in their variable regions as set forth in SEQ ID No:1 and SEQ ID No:6, respectively;
(ϋ) human light chain and human heavy chain nucleic acids comprising nucleotide sequences in their variable regions as set forth in SEQ ID No:11 and SEQ ID No: 16, respectively;
(iii) human light chain and human heavy chain nucleic acids comprising nucleotide sequences in their variable regions as set forth in SEQ ID No:21 and SEQ ID No:26, respectively; or
(iv) human light chain and human heavy chain nucleic acids comprising nucleotide sequences in their variable regions, which are conservative sequence modifications of the sequences as set forth in (i), (ii) or (iii).
2. An antibody binding to human CD38 comprising a VH CDR3 having the sequence as set forth in SEQ ID No: 10.
[3] As per WIPO standard certain information is mandatory in a sequence listing for every sequence listed and mandatory information relating to the organism from which a nucleotide or amino acid sequence originates is required to be provided against the numerical identifier [213].
[4] 3(c) – “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”
