Intellectual Property - INDIA
KamlatechContact Us
  • Intellectual Property: Patent, Design, Trademark, Copyright
  • The Patent Act 1970
    • Section 1
    • Section 2
    • Section 3
    • Section 4
    • Section 6
    • Section 7
    • Section 8
    • Section 9
    • Section 10
    • Section 11
    • Section 11A
    • Section 11B
    • Section 12
    • Section 13
    • Section 14
    • Section 15
    • Section 16
    • Section 17
    • Section 18
    • Section 19
    • Section 20
    • Section 21
    • Section 25
    • Section 26
    • Section 28
    • Section 29
    • Section 30
    • Section 31
    • Section 32
    • Section 33
    • Section 34
    • Section 35
    • Section 36
    • Section 37
    • Section 38
    • Section 39
    • Section 40
    • Section 41
    • Section 42
    • Section 43
    • Section 44
    • Section 45
    • Section 46
    • Section 47
    • Section 48
    • Section 49
    • Section 50
    • Section 51
    • Section 52
    • Section 53
    • Section 54
    • Section 55
    • Section 56
    • Section 57
    • Section 58
    • Section 59
    • Section 60
    • Section 61
    • Section 62
    • Section 63
    • Section 64
    • Section 65
    • Section 66
    • Section 67
    • Section 68
    • Section 69
    • Section 70
    • Section 71
    • Section 72
    • Section 73
    • Section 74
    • Section 75
    • Section 76
    • Section 77
    • Section 78
    • Section 79
    • Section 80
    • Section 81
    • Section 82
    • Section 83
    • Section 84
    • Section 85
    • Section 86
    • Section 87
    • Section 88
    • Section 89
    • Section 90
    • Section 91
    • Section 92
    • Section 92A
    • Section 93
    • Section 94
    • Section 99
    • Section 100
    • Section 101
    • Section 102
    • Section 103
    • Section 104
    • Section 104A
    • Section 105
    • Section 106
    • Section 107
    • Section 107A
    • Section 108
    • Section 109
    • Section 110
    • Section 111
    • Section 113
    • Section 114
    • Section 115
    • Section 116
    • Section 117
    • Section 117A
    • Section 117B
    • Section 117C
    • Section 117D
    • Section 117E
    • Section 117F
    • Section 117G
    • Section 117H
    • Section 118
    • Section 119
    • Section 120
    • Section 122
    • Section 123
    • Section 124
    • Section 124A
    • Section 124B
    • Section 125
    • Section 126
    • Section 127
    • Section 128
    • Section 129
    • Section 130
    • Section 131
    • Section 132
    • Section 133
    • Section 134
    • Section 135
    • Section 136
    • Section 137
    • Section 138
    • Section 139
    • Section 140
    • Section 141
    • Section 142
    • Section 143
    • Section 144
    • Section 145
    • Section 146
    • Section 147
    • Section 148
    • Section 149
    • Section 150
    • Section 151
    • Section 153
    • Section 154
    • Section 155
    • Section 156
    • Section 157
    • Section 157A
    • Section 158
    • Section 159
    • Section 160
    • Section 162
  • The Patent Rules 2003
    • Rule 1
    • Rule 2
    • Rule 3
    • Rule 4
    • Rule 5
    • Rule 6
    • Rule 7
    • Rule 8
    • Rule 9
    • Rule 10
    • Rule 11
    • Rule 12
    • Rule 13
    • Rule 14
    • Rule 15
    • Rule 16
    • Rule 17
    • Rule 18
    • Rule 19
    • Rule 19A
    • Rule 19B
    • Rule 19C
    • Rule 19D
    • Rule 19E
    • Rule 19F
    • Rule 19G
    • Rule 19H
    • Rule 19I
    • Rule 19J
    • Rule 19K
    • Rule 19L
    • Rule 19M
    • Rule 19N
    • Rule 20
    • Rule 21
    • Rule 22
    • Rule 23
    • Rule 24
    • Rule 24A
    • Rule 24B
    • Rule 24C
    • Rule 25
    • Rule 26
    • Rule 27
    • Rule 28
    • Rule 28A
    • Rule 29
    • Rule 30
    • Rule 31
    • Rule 32
    • Rule 33
    • Rule 34
    • Rule 35
    • Rule 36
    • Rule 37
    • Rule 55
    • Rule 55A
    • Rule 56
    • Rule 57
    • Rule 58
    • Rule 59
    • Rule 60
    • Rule 61
    • Rule 62
    • Rule 63
    • Rule 63A
    • Rule 66
    • Rule 67
    • Rule 68
    • Rule 69
    • Rule 70
    • Rule 71
    • Rule 72
    • Rule 74
    • Rule 74A
    • Rule 75
    • Rule 76
    • Rule 77
    • Rule 78
    • Rule 79
    • Rule 80
    • Rule 81
    • Rule 82
    • Rule 83
    • Rule 84
    • Rule 85
    • Rule 86
    • Rule 87
    • Rule 88
    • Rule 90
    • Rule 91
    • Rule 92
    • Rule 93
    • Rule 94
    • Rule 95
    • Rule 96
    • Rule 97
    • Rule 98
    • Rule 99
    • Rule 100
    • Rule 101
    • Rule 102
    • Rule 103
    • Rule 103A
    • Rule 104
    • Rule 105
    • Rule 106
    • Rule 107
    • Rule 108
    • Rule 109
    • Rule 110
    • Rule 111
    • Rule 111A
    • Rule 112
    • Rule 113
    • Rule 114
    • Rule 115
    • Rule 116
    • Rule 117
    • Rule 118
    • Rule 119
    • Rule 120
    • Rule 121
    • Rule 121A
    • Rule 122
    • Rule 123
    • Rule 124
    • Rule 125
    • Rule 126
    • Rule 127
    • Rule 128
    • Rule 129
    • Rule 129A
    • Rule 130
    • Rule 131
    • Rule 132
    • Rule 133
    • Rule 134
    • Rule 135
    • Rule 136
    • Rule 137
    • Rule 138
    • Rule 139
  • The Design Act 2000
    • Section 1
    • Section 2
    • Section 3
    • Section 4
    • Section 5
    • Section 6
    • Section 7
    • Section 8
    • Section 9
    • Section 10
    • Section 11
    • Section 12
    • Section 13
    • Section 14
    • Section 15
    • Section 16
    • Section 17
    • Section 18
    • Section 19
    • Section 20
    • Section 21
    • Section 22
    • Section 23
    • Section 24
    • Section 25
    • Section 26
    • Section 27
    • Section 28
    • Section 29
    • Section 30
    • Section 31
    • Section 32
    • Section 33
    • Section 34
    • Section 35
    • Section 36
    • Section 37
    • Section 38
    • Section 39
    • Section 40
    • Section 41
    • Section 42
    • Section 43
    • Section 44
    • Section 45
    • Section 46
    • Section 47
    • Section 48
  • The Copyright Act 1957
    • Section 1
    • Section 2
    • Section 3
    • Section 4
    • Section 5
    • Section 6
    • Section 7
    • Section 8
    • Section 9
    • Section 10
    • Section 13
    • Section 14
    • Section 15
    • Section 16
    • Section 17
    • Section 18
    • Section 19
    • Section 19A
    • Section 20
    • Section 21
    • Section 22
    • Section 23
    • Section 24
    • Section 26
    • Section 27
    • Section 28
    • Section 28A
    • Section 29
    • Section 30
    • Section 30A
    • Section 31
    • Section 31A
    • Section 31B
    • Section 31C
    • Section 31D
    • Section 32
    • Section 32A
    • Section 32B
    • Section 33
    • Section 33A
    • Section 34
    • Section 35
    • Section 36
    • Section 36A
    • Section 37
    • Section 38
    • Section 38A
    • Section 38B
    • Section 39
    • Section 39A
    • Section 40
    • Section 40A
    • Section 41
    • Section 42
    • Section 42A
    • Section 43
    • Section 44
    • Section 45
    • Section 46
    • Section 47
    • Section 48
    • Section 49
    • Section 50
    • Section 50A
    • Section 51
    • Section 52
    • Section 52A
    • Section 53
    • Section 53A
    • Section 54
    • Section 55
    • Section 56
    • Section 57
    • Section 58
    • Section 59
    • Section 60
    • Section 61
    • Section 62
    • Section 63
    • Section 63A
    • Section 63B
    • Section 64
    • Section 65
    • Section 65A
    • Section 65B
    • Section 66
    • Section 67
    • Section 68
    • Section 68A
    • Section 69
    • Section 70
    • Section 71
    • Section 72
    • Section 73
    • Section 74
    • Section 75
    • Section 76
    • Section 77
    • Section 78
    • Section 79
  • The Trademark Act 1999
    • Section 1
    • Section 2
    • Section 3
    • Section 4
    • Section 5
    • Section 6
    • Section 7
    • Section 8
    • Section 9
    • Section 10
    • Section 11
    • Section 12
    • Section 13
    • Section 14
    • Section 15
    • Section 16
    • Section 17
    • Section 18
    • Section 19
    • Section 20
    • Section 21
    • Section 22
    • Section 23
    • Section 24
    • Section 25
    • Section 26
    • Section 27
    • Section 28
    • Section 29
    • Section 30
    • Section 31
    • Section 32
    • Section 33
    • Section 34
    • Section 35
    • Section 36
    • Section 36A
    • Section 36B
    • Section 36C
    • Section 36D
    • Section 36E
    • Section 36F
    • Section 36G
    • Section 37
    • Section 38
    • Section 39
    • Section 40
    • Section 41
    • Section 42
    • Section 43
    • Section 44
    • Section 45
    • Section 46
    • Section 47
    • Section 48
    • Section 49
    • Section 50
    • Section 51
    • Section 52
    • Section 53
    • Section 54
    • Section 55
    • Section 56
    • Section 57
    • Section 58
    • Section 59
    • Section 60
    • Section 61
    • Section 62
    • Section 63
    • Section 64
    • Section 65
    • Section 66
    • Section 67
    • Section 68
    • Section 69
    • Section 70
    • Section 71
    • Section 72
    • Section 73
    • Section 74
    • Section 75
    • Section 76
    • Section 77
    • Section 78
    • Section 91
    • Section 94
    • Section 97
    • Section 98
    • Section 101
    • Section 102
    • Section 103
    • Section 104
    • Section 105
    • Section 106
    • Section 107
    • Section 108
    • Section 109
    • Section 110
    • Section 111
    • Section 112
    • Section 113
    • Section 114
    • Section 115
    • Section 116
    • Section 117
    • Section 118
    • Section 119
    • Section 120
    • Section 121
    • Section 122
    • Section 123
    • Section 124
    • Section 125
    • Section 126
    • Section 127
    • Section 128
    • Section 129
    • Section 130
    • Section 131
    • Section 132
    • Section 133
    • Section 134
    • Section 135
    • Section 136
    • Section 137
    • Section 138
    • Section 139
    • Section 140
    • Section 141
    • Section 142
    • Section 143
    • Section 144
    • Section 145
    • Section 146
    • Section 147
    • Section 148
    • Section 149
    • Section 150
    • Section 151
    • Section 152
    • Section 153
    • Section 154
    • Section 155
    • Section 156
    • Section 157
    • Section 158
    • Section 159
  • Patent Case
    • Air Purifier Biomoneta
    • Patentability
Powered by GitBook
On this page
Edit on GitHub
  1. Patent Case

Patentability

Section 3(c) of the Patents Act, 1970

Introduction

This article discusses the decision of the Hon’ble High Court of Madras on an appeal ((T) CMA (PT) No.126 of 2023) filed by Imclone LLC (‘Appellant’) seeking to set aside an order passed by the Assistant Controller of Patents and Designs (‘Respondent’) refusing the grant of the Appellant’s patent application under Section 3(c) of the Patents Act, 1970. The High Court, after considering the facts of the case, decided that the assessment of the claimed invention by the Respondent was erroneous and directed that the application proceed to grant, since the other objections raised in the FER were subsequently dropped pursuant to deletion of corresponding claims or on provision of a satisfactory explanation. This article specifically focuses on the opinion of the High Court with respect to the assessment of inventions under Section 3(c).

Facts of the case

The Appellant filed an ordinary patent application titled RECEPTOR ANTAGONISTS FOR TREATMENT OF METASTATIC BONE CANCER bearing an application number 5808/CHENP/2007 (‘Application’). The initially filed claims were drawn towards recombinant antibodies or antibodies fragments that bind to human PDGFRα (Platelet-derived growth factor receptor alpha). In the First Examination Report (‘FER’), the Respondent had raised objections under various Sections of the Act, including the objection on non-patentability under Section 3(c) of the Act, apart from additional objections regarding non-patentability under Sections 3(i) and 3(j) of the Act. The Respondent finally refused to grant the Application on the ground of non-patentability under Section 3(c) of the Act. Aggrieved by the decision of the Respondent, the Appellant filed the appeal.

The Appellant's counsel began by briefly describing the role of PDGFRα in bone cancer, especially metastatic cancer, followed by a detailed explanation of the process for producing the recombinant antibody (IMC-3G) which targets the specific epitope on and prevents ligand binding at the receptor site. Referring to specific paragraphs of the complete specification, the Appellant’s counsel argued that the claimed human anti-PGDFRα antibodies were not isolated from nature but were generated using standard hybridoma technology. Further, it was emphasized that the human body does not produce an antibody to PGDFRα, since it is necessary for human embryonic development; thus, any naturally occurring antibody would have arrested embryonic development. With respect to the interpretation of Section 3(c) of the Act, the Appellant’s counsel referred to the following judgements from the erstwhile Intellectual Property Appellate Board:

1. Paragraph 8 of Biogaia AB v. Controller of Patents and Designs, to support the proposition that non-living substances occurring in nature or isolated from nature are not patent eligible, whereas any genetically modified microorganism or nucleic acid sequence is not excluded from patentability, if other criteria such as novelty, inventive step and industrial applicability are satisfied,

2. Paragraph 9 of The University of British Columbia v. Controller of Patents, to support the contention that a non-human monoclonal antibody does not attract Section 3(c) of the Act.

3. Paragraph 12 of Health Protection Agency v. The Controller General of Patents and another, to support the argument that a substance created with human intervention does not fall within the scope of Section 3(c) of the Act.

Thus, the Appellant’s counsel concluded that since the Patent Office had granted patents to monoclonal antibodies in the past, the rejection of the application under Section 3(c) of the Act violates the principle of equality.

The Respondent’s counsel, on the other hand, argued that the claimed antibodies were isolated from human beings. Further, the counsel referred to the sequence listing and pointed out that sequences recited in the claims specify the organism of origin of the sequence as homo sapiens. With regards to the applicability of Section 3(c) of the Act on the claimed invention, the Respondent’s counsel contended that the Appellant had generated already known and naturally occurring antibodies using standard hybridoma technology, which is not novel; moreover, no recombination was seen in the sequence listing. The Respondent’s counsel also provided arguments with respect to the IPAB orders listed by the Appellant.

Thereafter, the Appellant’s counsel, by way of rejoinder, submitted that the transgenic mice used for producing the claimed antibodies were produced by knocking out the murine immune system and inserting human genes. Such mice were immunised subcutaneously with PAE (porcine aortic endothelial) cells that express PGDFRα. Splenocytes from mice were then isolated and fused with myeloma cells. By this process, the antibodies were produced. Thus, it cannot be said that the antibodies were isolated from human beings and accordingly, the claimed invention cannot fall within the ambit of Section 3(c) of the Act. The Appellant’s counsel also highlighted that Section 3(c) of the Act was amended in 2002 to introduce the words ‘or discovery of any living thing or non-living substance occurring in nature’ and the same cannot be interpreted with reference to Section 3(d) of the Act, which was amended in 2005. Referring to the judgement of the Delhi High Court in Diamond Star Global Sdn. Bhd. v. Joint Controller of Patents and Designs, 2023, the Appellant’s counsel asserted that the qualifier ‘mere’ in Section 3(c) of the Act also applies to ‘discovery of any living thing or non-living substance occurring in nature’.

Discussion and decision

The High Court began with a summary of the scientific terms, concepts and principles that are germane for an understanding of the dispute. Against this background, the High Court traced the evolution of Section 3(c) of the Act. The Ayyangar Committee Report of 1959 served as the basis for the Patents Act of 1970. In paragraph 328 of this report, the Committee held that discoveries are universally not patentable; this was justified by the argument that an invention is the creation of something that did not previously exist, but a discovery is the process by which something already existing is found. Section 3(c) of the Act before the amendment of 2002 only had two limbs which barred the patenting of ‘the mere discovery of a scientific principle or the formulation of an abstract theory’. The first limb dealt with discovery and the second with the intellectual exercise of formulating an abstract theory. Further, the qualifier ‘mere’ before the noun ‘discovery’ in the first limb clarified that something more than a discovery of a scientific principle, may be patentable; this qualifier was not added in the second limb regarding the formulation of an abstract theory.

Post the amendment of the Act in 2002, a third limb was introduced in Section 3(c) of the Act, that is, ‘discovery of any living thing or non-living substance occurring in nature’. It is important to note that the adjective ‘mere’ was not placed before the noun ‘discovery’ in the third limb. The High Court emphasized that, in ordinary grammar and as per the principles of statutory construction, a modifier, like the word ‘mere,’ would apply to the entire series of nouns or verbs in the case of a straightforward parallel construction; in other cases, it would be limited to the closest reasonable referent. Further, the noun ‘discovery’ as recited in the third limb is applicable to both living things and non-living substances occurring in nature. This additionally supports the contention that the adjective ‘mere’ is not applicable to this limb since it means that even a ‘living thing’ could fall outside the scope of patent exclusion if there is something more than mere discovery. Even in the Patents (Second Amendment) Bill 1999 (Bill No.49), the adjective ‘mere’ was not used in the context of barring the patentability of discoveries of any living thing or non-living substance occurring in nature. The High Court mentioned that Section 3(d) of the Act also uses the adjective ‘mere’ before each of the limb therein. Thus, considering the above, the adjective ‘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 High Court then delved into the phrase ‘occurring in nature’ recited in the third limb of Section 3(c) of the Act. Based on the ordinary rules of syntax, the High Court opined that if the phrase ‘occurring in nature’ were to be applicable to ‘living thing’, the construction of the provision should have been 'the discovery of any living or non-living thing occurring in nature'; however, that is not the case. Moreover, the expansion of ‘occurring in nature’ to ‘living thing’ would result in a redundancy considering the current level of knowledge. In this view, the High Court held that the expression ‘occurring in nature’ in the third limb of Section 3(c) of the Act only qualifies the nearest reasonable referent, that is, ‘non-living substance’.

The High Court also discussed provisions similar to Section 3(c) of the Act in US, touching upon the US Supreme Court decisions in Sidney A. Diamond v. Ananda M. Chakrabarty (Chakrabarty), 1980 (man-made bacterium were considered patentable), Mayo Collaborative Services, dba Mayo Medical Laboratories v. Promotheus Laboratories Inc., (process claims regarding the dosage level of thioprine drugs were considered non-patentable), Association for Molecular Pathology et al v. Myriad Genetics et al, 133 S.Ct. 2107 (2013), (an invention for discovery of the precise location and sequence of two human genes was patent-ineligible, whereas a synthetically created complementary deoxyribonucleic acid (cDNA) was patent eligible).

The High Court then shed light on subject matter that would fall within the scope of ‘discovery of any ... non-living substance occurring in nature’ as recited in Section 3(c) of the Act. The High Court asserted that use of the noun ‘discovery’ (which implies finding something which already exists and not producing, engineering or making something) and the present continuous form ‘occurring in nature’ indicate that Section 3(c) of the Act would only apply to a process of finding a hitherto undiscovered non-living substance by identifying and isolating it from nature. However, the High Court maintained that clearing the bar of Section 3(c) of the Act does not guarantee the grant of a patent. For the grant of a patent, the Applicant would be required to establish novelty, inventive step and industrial applicability, and that the invention does not fall within the scope of other exclusions in Section 3 of the Act.

The High Court considered the arguments presented by both the Appellant and the Respondent’s counsels. In light of the interpretation provided by the Court of Section 3(c) of the Act, it was held that the contention that the claimed antibody is naturally occurring solely because the sequence listing describes the organism as Homo Sapiens, lacks support. This inference would be justified only if the Appellant had discovered/found a hitherto unknown antibody and isolated it from nature. Further, the High Court stated that the claimed antibody was undoubtedly not isolated from a human being but was engineered in the manner described in the specification of the application. Briefly, the transgenic mice were generated by deleting murine genetic material from mice and replacing the same with human genetic material in the mice. Thereafter, an engineered antigen was injected into the mice. Subsequently, material extracted from the spleen of the mice was fused with myeloma cells by the hybridoma process, which resulted in the claimed antibody. In view of these facts, the High Court concluded that the claimed invention did not fall within the ambit of Section 3(c) of the Act, setting aside the impugned order and directing the grant of the application.

Conclusion

In deciding this case, the High court has provided more clarity to the language of Section 3(c) of the Act and what inventions may fall within the scope of said Section. Whether Indian Controllers will examine patent applications to determine the applicability of Section 3(c) of the Act more efficiently in view of this order remains to be seen.

PreviousAir Purifier Biomoneta

Last updated 11 months ago

Source:

https://www.lakshmisri.com/insights/articles/patentability