Monoclonal antibodies and Patents – How the Madras High Court interpreted Section 3(c)

Genmab A/S (hereafter referred to as the “Applicant” or the “Appellant”) filed an appeal before the Madras High Court, against a refusal order issued by the patent office (“Respondent”) for the Applicant’s Indian Patent Application No. 4718/CHENP/2007 titled “Antibodies against CD38 for treatment of multiple myeloma”.

Background

A First examination report (FER) was issued by the Asst. Controller of Patents and Designs on 27 February 2013 which included objections relating to obviousness of the invention based on prior arts D1 to D7, patent ineligibility under Sections 3(c), 3(e), 3(i), and 3(j) of the Patents Act, 1970, and non-compliance with Section 10(4) of the Act. In response, the applicant submitted an amended set of claims on 17th January 2014 along with a response to the FER.

However, in the hearing notice issued on 9th April 2014, the controller maintained many of the objections set out in the FER and, in particular, raised an objection that the amended claims fell within the scope of Section 3(c) of the Patents Act. Pursuant to the hearing, the Applicant amended the claims further, but the same was rejected by the Controller through an order dated 30 May 2016.

In the refusal order, the Controller stated that the objections listed in the hearing notice had not been complied with and that the invention in particular was not patentable under section 3(c) of the Act.

Claims of the application

The refused application included a total of two independent claims and twenty-seven dependent claims. The independent claims of the application read as follows:

“1. An antibody binding to human CD38 comprising human light chain and human heavy chain variable regions, wherein the light chain variable region comprises a VL CDR1 having the sequence as set forth in SEQ ID No:13, a VL CDR2 having the sequence as set forth in SEQ ID No:14 and a VL CDR3 having the sequence as set forth in SEQ ID No:15, and the heavy chain variable region comprises a VH CDR1 having the sequence as set forth in SEQ ID No:18, a VH CDR2 having the sequence as set forth in SEQ ID No:19 and a VH CDR3 having the sequence as set forth in SEQ ID No:20, and wherein said antibody is 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:11 and SEQ ID No:16, respectively.

  1. An antibody binding to human CD38 comprising human light chain and human heavy variable regions, wherein the light chain variable region comprises a VL CDR1 having the sequence as set forth in SEQ ID No:13, a VL CDR2 having the sequence as set forth in SEQ ID No:14 and a VL CDR3 having the sequence as set forth in SEQ ID No:15, and the heavy chain variable region comprises a VH CDR1 having the sequence as set forth in SEQ ID No:18, a VH CDR2 having the sequence as set forth in SEQ ID No:19 and a VH CDR3 having the sequence as set forth in SEQ ID No:20.”

Court’s analysis:

The Court first proceeded to determine the issue pertaining to the interpretation of section 3(c). In interpreting the same, the court placed particular emphasis on the words “mere”, “discovery of any”, and “non-living substance occurring in nature” as they appear in the section.

By juxtaposing section 3(c) with its pre-amended text, and interpreting the provisions of section 3(c), as per the ordinary rules of grammar, the immediate statutory context, and the legislative history of amended clause, the Court came to the conclusion that that the qualifier “mere” used in section 3(c) is confined to the nearest reasonable referent i.e., “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 acknowledged that this was in deviation from the interpretation adopted by the Delhi High Court in Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Design, 2023 SCC OnLine Del 1879.

The Delhi High Court in Diamond Star v. Joint Controller had arrived at an interpretation that the word “mere”, as used in the opening part of the said Clause would apply both to the first part, i.e. “discovery of a scientific principle or the formulation of an abstract theory” as well as to the second part, i.e. “discovery of any living thing or non-living substances occurring in nature”.

The court then took up the phrase “occurring in nature” to determine if the phrase would also apply to the expression “living thing”. Relying on landmark decisions such as Mayo Medical Laboratories v. Promotheus Laboratories Inc.(Mayo), 2012 SCC OnLine US SC 28 and In Association for Molecular Pathology et al v. Myriad Genetics et al, 133 S.Ct. 2107 (2013), the court concluded that the expression “occurring in nature” only qualifies for the nearest reasonable referent i.e., “non-living substance”.

The court further emphasized that the real challenge with regard to a patent application in respect of a synthesized non-living substance, especially a monoclonal antibody, is establishing novelty or technical advance and not patent eligibility. For such purposes, the sequence of the antibody, especially the CDRs, may need to be compared with known antibody sequences.

Since the Respondent relied on the fact that the description of the organism in the sequence listing was Homo sapiens, the court further discussed the Standard 25 established by WIPO for filing sequences. Standard 25 outlines the mandatory and optional information that must be included along with sequence listing. It also specifies that this information should be provided with a numerical identifier [213].

The Appellant during their arguments had pointed out that because 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 Court held that the Controller’s conclusion that the claims pertain to the discovery of an antibody or non-living substance occurring in nature cannot be supported solely because the organism in the sequence listing is Homo sapiens. This conclusion would only be valid if the appellant had discovered and isolated a previously unknown antibody from nature.

Finally, the court analysed the objections with regard to lack of inventive step and noted that the appellant had agreed to delete claims 4,7,10-15,18 and 19. Considering that these were the only claims in respect of which the inventive step objections was raised, with their deletion, the claimed invention was in order for grant.

Conclusion

In conclusion, the court held that non-living substances occurring in nature or isolated from nature are not eligible for patents. However, a synthetic version of a substance that rarely occurs in nature and is required to be produced in large quantities for the treatment of serious illnesses, is not excluded from patent eligibility if other criteria such as novelty or technical advancement are satisfied.

Citation: Genmab A/S v. Assistant Controller of Patents and Designs, Madras High Court, Decided on 15.12.2023, Pronounced on 06.03.2024.

Authored by Dr. Vasundhara Paliwal, Patent Team, BananaIP Counsels

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