Section 3(i) of the Indian Patents Act makes patent ineligible “any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or 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”. Two recent Madras High Court decisions, in respect of two separate appeals filed by the same Appellant, Chinese University of Hong Kong [CMA (PT) No. 14 of 2023 and CMA(PT) No. 1 of 2023] have deliberated upon the scope of “diagnostic” under Section 3(i) of the Patents Act, 1970. In both the cases, the Court, held that the word “diagnostic” in Section 3(i) of the Patents Act, should be construed, to consider processes that uncover pathology for the treatment of human beings, as being patent ineligible.
Madras High Court paving the way for interpreting the scope of Section 3(i)
For interpreting Section 3(i), the Court considered that it can be categorised into two distinct and self-containing limbs — first one dealing with human beings and the second with animals:
- Any process for the medical, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings; or
- 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 second limb opens up with the expression “any process for a similar treatment of animals” involving either of the three purposes such as rendering them free of disease; or increasing their economic value or the economic value of their products. The Court held that as two of the three purposes i.e. to increase their economic value, or that of their products, are not applicable to humans, the second limb does not extend to humans. In view of the above, the Court held that the word “diagnostic” cannot be confined to treatment of human beings to render them free of disease. Nevertheless, considering the fact that Section 3(i), in its first limb, uses the word, “diagnostic” in juxtaposition with various forms of treatment, such as medicinal, surgical, and therapeutic; and in association with the expression “other treatment of human beings”, the Court held that the word “diagnostic” should be construed in association with the accompanying words (noscitur a sociis). The word “diagnostic” in Section 3(i) of the Patents Act, was therefore construed, to consider processes that uncover pathology for the treatment of human beings, as being patent ineligible. In other words, a claimed process can considered to be “diagnostic” and patent ineligible, if it, per se, is capable of identifying the disease, disorder or condition for treatment of the person.
For such a determination of patent eligibility /ineligibility, the examiner would need to examine the claims in the context of the complete specification, to determine whether it specifies a process for making a diagnosis for treatment. In such a determination, the following should also be taken into account:
- The determination is to be made assuming that a person skilled in the art, including a medical doctor, examines the claims and the complete specification;
- Even if the diagnosis is not definitive, it would be patent ineligible;
- If the claimed process does not uncover pathology for any reason, it would not be diagnostic, like testing of particular ethnic or radical group to understand the propensity of such group to develop specific disease or disorder;
- The label used for the test, screening or diagnosis, is immaterial, if a screening test is capable of identifying the existence or non-existence of a disease or disorder or condition and/or the site, extent, severity or other aspects thereof for treatment of human being, irrespective of whether the person concerned is symptomatic or asymptomatic, would qualify as a diagnosis;
- Even if the screening test identifies a disease, subject to confirmation by definitive tests, it would still qualify as “diagnostic” and therefore patent ineligible.
‘Diagnostic’ in Section 3 (i) NOT confined to in-vivo diagnosis
The Draft Manual of Patent Office Practice and Procedure of 2005, Manual of Patent Office Practice and Procedure 2008 and 2010, distinguished, in-vitro methods, from in-vivo methods, and indicated that in-vitro methods are patent eligible. However, the recent 2019 Patent Manual does not support such construction to draw any distinction between in-vitro and in-vivo diagnostic methods. The Court also followed the recent 2019 Patent Manual and found that there is nothing in the language of Section 3 that would lead to the inference that the expression ‘“diagnostic” in Section 3 (i) should be confined to in-vivo diagnosis. In making such a conclusion, the Court also relied upon the distinction in the language of Section 3(i) of the Indian Patents Act and Article 53(c) of the EPC, wherein Section 3(i) does not include the expression “practiced on the human or animal body”
The distinction between the two appeals
The first case, decided by the Madras High Court [CMA (PT) No. 14 of 2023] involved identification of a “foetal fraction”, i.e., the proportion of cell-free foetal DNA in the biological sample. In this, a biological sample is drawn from a female subject, and such sample is tested with a view to identify the foetal fraction. Foetal fraction should not be less than 4% to enable further testing, for identifying any chromosomal aberrations. Until said testing is done further, pathology is neither discovered, nor presents any opportunity for treatment. Accordingly, the Court found this invention to be incapable of identifying any disease, disorder, condition, and therefore, was considered patent eligible.
In contrast, the second case [CMA (PT) No. 1 of 2023], involved a “prenatal diagnosis of a sequence imbalance”. Like the first case, this case also involves drawing a biological sample from a female subject. Such sample is, however, tested to determine the size distribution of the nucleic acid molecules. The patent specification provides that a shift in the size distribution can signify an imbalance and a diagnosis of foetal aneuploidy can be made. Since, the results of this invention could be used by a person skilled in the art to conduct further specific diagnosis, this makes the claimed invention patent ineligible under Section 3(i) and different from the first case. A medical practitioner, after a positive result for chromosomal aneuploidy, is likely to opt for definitive diagnostic tests/tools as well, however, this as per the Court does not make the subject matter patent eligible, “because neither definitive nor comprehensive diagnosis is a prerequisite to qualify as diagnostic” under Section 3(i) of the Patents Act.
Inconsistencies in the practise of the examiners
Presently, there are inconsistencies in the approaches adopted by the patent examiners of the Indian Patent Office while granting or refusing patent application on diagnostic methods. This inconsistency has also been acknowledged by the Hon’ble Judge deciding the two appeals. The Delhi HC will also hear two appeals filed by Sequenom Inc & Anr., and Emd Millipore Corporation and provide its interpretation in respect of Section 3(i). The decision in the Delhi High Court appeals is likely to come out in the next three to six months. Hopefully, with these decisions, and the upcoming decision of the Delhi High Court, the missing consistency can be achieved.
For further information, please contact:
Swati Sharma,Partner, Cyril Amarchand Mangaldas
swati.sharma@cyrilshroff.com
