While the Indian Patents Act, 1970 permits patenting of diagnostic products such as kits and devices, claiming of methods of diagnosis is barred under section 3(i).
Indian outlook in patenting diagnostic methods
In India, the Indian Patent Act, 1970 excludes diagnostic and treatment methods from patentability under section 3(i), in line with India’s socialist policy aiming to prevent monopolies that could hinder public access to affordable healthcare. However, there are uncertainties and ambiguities in the assessment of patentability.
In India, while the exclusion of diagnostic and treatment methods from patentability under section 3(i) of the Patent Act, 1970, aligns with India’s socialist policy aiming to prevent monopolies that could hinder public access to affordable cutting-edge healthcare, ambiguities and uncertainties regarding its patentability loom large in the field of medical diagnostics. The Manual of Patent Office Practice and Procedure defines diagnostic methods broadly, encompassing even the oft-used routine “fitness test” (see below) in its ambit:
“Diagnostic methods: Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Determination of the general physical state of an individual (e.g. a fitness test) is considered to be diagnostic.”
The current lack of clarity in evaluating patentability for diagnostic methods often means that the decision is at the discretion of the Patent Office, leading to significant confusion and inconsistency.
Twin tales by same applicant: Why was patent granted in one and refused in the other?
Two recent decisions of the Madras High Court concerning independent appeals to assert against the refusal of two patent applications filed by the same applicant ‘The Chinese University of Hong Kong’ provide much needed clarity on the scope of “diagnostic” under section 3(i) of the Patents Act, 1970
In both the cases, the Court held that the term “diagnostic” should be interpreted to include processes that identify pathology for the treatment of human beings.
Comparison of the amended independent claim 1 in written submissions of both applications:
| IN4863/CHENP/2012
IPO’s decision: refused u/S 15 Refusal affirmed by court |
IN4812/CHENP/2012
IPO’s decision: patent granted on merits post favourable Appeals decision |
| Preamble of as-filed claim:
A method for measuring a sequence imbalance in a biological sample obtained from a pregnant female subject, wherein the biological sample includes nucleic acid molecules that are part of nucleic acid sequences, the nucleic acid molecules from the fetus and the pregnant female subject, the method comprising: |
Preamble of as-filed claim:
A method of determining at least a portion of the genome of an unborn fetus of a pregnant female, the fetus having a father and a mother being the pregnant female, and the father having a paternal genome with paternal haplotypes and the mother having a maternal genome with maternal haplotypes, the method comprising: |
| Change in preamble of claim submitted with written submissions:
A non-diagnostic in vitro method for measuring a sequence imbalance in a biological sample from a pregnant female subject, wherein the biological sample includes nucleic acid molecules that are part of nucleic acid sequences, the nucleic acid molecules from the fetus and the pregnant female subject, the method comprising: |
Change in preamble of claim submitted with written submissions:
A method of determining a fractional concentration of fetal DNA in a biological sample taken from a pregnant female, the fetus having a father and a mother being the pregnant female, wherein the biological sample contains a mixture of maternal and fetal nucleic acids, the method comprising: |
In the case of the refused application IN4863/CHENP/2012 for “Size based genomic analysis,” the claimed invention relates to measuring sequence imbalance in a biological sample from a pregnant woman by analyzing nucleic acids to detect foetal chromosome aneuploidy as determined by the Controller during the prosecution by relying on para 0006, 0007 and 0009 of the specification. Interestingly, during the prosecution, the applicant had also amended the preamble of independent claims as “A non-diagnostic in vitro method for measuring a sequence imbalance in a biological sample from a pregnant female subject,” however, the Controller’s refusal order asserted that the “the said claims are for the method of detecting fetal chromosomal aneuploidy which is a diagnostic method.” The court affirmed the Controller’s decision and further deemed the method patent ineligible under section 3(i).
On the other hand, in case of IN4812/CHENP/2012 for “Foetal Genomic Analysis from a Maternal Biological Sample,” the claimed invention describes a non-invasive prenatal screening test that determines the “fractional concentration” of fetal DNA in a maternal sample. The court noted that the method is not diagnostic as it does not identify any disease or condition but merely determines the percentage of fetal genome, serving as a marker for further examination rather than a diagnosis itself. As a result, the court deemed the method patentable.
In coming to its decision, the court identified and analysed the two limbs of section 3(i) that distinguish to treatment of human beings and treatment of animals as:
“(a) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings; or
(b) any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.”
The court then deliberated on the distinction between diagnosis and treatment, stressing that the term “diagnostic” should not be construed in isolation but should be understood noscitur a sociis, i.e. in association with the accompanying words of section 3(i) read as a whole. Thus, it should only be used in conjunction with other phrases related to treatment, to exclude procedures that reveal pathology for providing therapy.
Further, referring to article 27 of the TRIPS agreement, the court also concluded that the travaux préparatoires of Article 27(3)(a) also does not support exempting in vitro diagnostic processes or methods from patent ineligibility.
Remarkably, referring to the EPO Guidelines and subsequent decisions of the Technical Board of Appeal of the EPO (EboA) the court agreed with the Appellants that the word “diagnostic” should be confined to in vivo diagnosis; and that a process would not qualify as diagnostic unless all four below-mentioned method steps in diagnosis are involved:
Step i. the examination phase involving the collection of data,
Step ii. the comparison of such data with standard/reference values,
Step iii. the finding of any significant deviation, i.e. a symptom, during the comparison, and
Step iv. the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase.
Moreover, the court also proclaimed that patent eligibility under section 3(i) is unaffected by the distinction between screening and diagnosis, regardless of whether individuals are asymptomatic or symptomatic. If such process does not uncover pathology for any reason, it would not be diagnostic for purposes of Section 3(i).
These decisions have brought in much-needed clarity to innovators. Further, from the ensuing discussions it is evident that if diagnostic process detects a disease or condition that must be treated, it is not eligible for a patent protection. Further, methods involving biological samples that do not uncover pathology for any reason would not be diagnostic for purposes of section 3(i). A compelling case though of a notable exemption is when a diagnostic method involves electronic devices equipped with processors, memory, and disease detection units such as ‘system and method for detecting’ abnormalities say in a medical image, featuring an electronic system and an integrated approach for method for identifying abnormalities.
