The Patent eligibility of diagnostic methods in India must cross the bar on its patentability introduced in 2002 amendments when after the word “prophylactic”, the words “diagnostic, therapeutic” were inserted. If we see the amended section 3(i), we will find it has two limbs, the first being (a) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings, and the second being, 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. Both limbs are separated by disjunctive ‘or’. This means that each limb of Section 3(i) is distinct and self-contained. We may say that the first limb deals with human beings, and the second limb speaks about animals.
In the Chinese University of Hongkong case, the Madras High Court rejected the contention “that the word “diagnostic” in Section 3(i) should be confined to treatment of human beings to render them free from disease.” the reason that in section 3(i) ” the treatment is provided not only to free/cure a person of disease but also for prophylactic purposes, to alleviate pain, prevent aggravation of or to better manage a condition or disorder.” This reasoning added a new dimension to the scope of the term ‘diagnostic’. The Court questioned the IPO Manual guidelines for limiting the allowability of the diagnostic to in vitro methods alone.”
When we look at the construction of clause (i), we will find that the phrase any treatment of human beings goes well with expressed individual terms set out as medicinal, surgical, curative, prophylactic, and therapeutic. The Court further observed that “The enumeration of multiple forms of treatment followed by the generic “or other treatment” also indicates that the word “treatment” is intended to be construed widely.” But when we see the term ‘diagnostic’ that is also clubbed with the other terms ‘medicinal, surgical, curative, prophylactic, and therapeutic’, we find it odd.
Interpretation of the Term “Diagnostic”
The Madras High Court, in this case, delved deeper into the understanding of the term “diagnostic’ and stated that:
“24. …………………… “Diagnosis, in the context of medical science, is a method of identifying the existence or non-existence of a disease or disorder or condition and/or the site, extent, severity or other aspects thereof.”
Adding further, the Court concluded that:
“Undoubtedly, such identification per se cannot be construed as a form of treatment. Consequently, the expression “any process for the diagnostic treatment of human beings” does not make complete sense, unlike in the case of the forms of treatment dealt with in Section 3(i) and discussed in the preceding paragraph.”
This means that the diagnostic is not, per se, a form of treatment. It indicates that the process or method of diagnosis falls short of treatment. When the Court looked at the scope and extent of the diagnostic process /methods, the Court noted that. –
“25. Diagnosis – whether by physical examination and/or an analysis of symptoms, or by use of diagnostic devices or running laboratory tests – is an essential pre-requisite for rational treatment. Sometimes, the link between diagnosis and treatment is close and immediate, such as, typically, in the case of coronary angiography and angioplasty, whereas, at other times, there could be a long interval between diagnosis and, for example, treatment by surgery.”
It is not intended to be clubbed with other terms with which it is juxtaposed. The Court found the contention of the appellant convincing that “diagnostic” should be limited to diagnostic processes that disclose pathology for the treatment of human beings. The Court ruled that the invention claimed in this case is not excluded under Section 3(i) of the Act, the refusal order of the Controller was reversed, and the patent was granted for the invention “Fetal Genomic Analysis from a Maternal Biological Sample.”
‘In Vivo’ Vs ‘In Vitro’
When the Court examined the different purposes for which testing of human beings may be carried out, the Court found that self-imposed exception by IPO on the in vivo diagnostic process is not supported by the language of section 3(i). The Court categorically stated that. –
“26. I now turn to the contention that such diagnostic processes should be confined to in vivo diagnosis. The text of Section 3(i) was amended by Act 38 of 2002 by including the words “diagnostic, therapeutic”. As is evident from the language of Section 3(i), there is no indication therein that the word “diagnostic” should be confined to in vivo diagnosis. Even if the net were to be cast wider, I find nothing in the language of Section 3 or in any other provisions of the Patents Act that lead to the inference that the expression ‘diagnostic’ should be confined to in vivo diagnosis.” [Emphasis added]
Unable to find any support from the statement of reason in the Patent Bill leading to the amendment of section 3(i) and looking at article 27 (3)(a) of the TRIPS as the reason for its introduction, the Court concluded that:
“Therefore, I conclude that the travaux préparatoires of Article 27(3)(a) also does not support exempting in vitro diagnostic processes or methods from patent ineligibility.” [Emphasis added]
The Examination Guideline at Crossroad with Intended Exceptions
The Court examined the patent office guidelines regarding the exception to patentability and observed that while earlier versions of the patent manuals of practice and procedure limit patent ineligibility to in vivo diagnosis, nothing in the presently applicable final manual or guidelines supports the construction that in vivo diagnostic methods are excluded.
“29. As regards the contention that a narrow interpretation was placed on Section 3(i) by the Patent Office, as exemplified by its manuals, I find that both the Draft and Final Manual of 2005 exclude patent eligibility only in respect of in vivo diagnostic methods. Likewise, paragraph 4.9.14 of the 2008 Manual and paragraph 08.03.06.08 of the 2010 Manual also contain substantially similar language. Such language is, however, not present in the 2019 Manual, which defines diagnostic methods as follows:
“(e) 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.” After defining diagnostic methods in the above manner, the 2019 Manual provides several examples of subject matter excluded under Section 3(i). Among such further examples is diagnosis practised on the human or animal body. The 2013 Guidelines are in identical language. Thus, while earlier versions of the patent manuals of practice and procedure limit patent ineligibility to in vivo diagnosis, nothing in the presently applicable final manual or guidelines supports the construction that in vivo diagnostic methods are excluded. Besides, it should be borne in mind that the manuals of the Patent Office are not determinative of the scope of Section 3(i), and, at most, they are indicative of the manner in which the Patent Office understood the provision.
Differentiating article 52(3) of EPC and Section 3(i)
The Court also finds the argument of the appellant unconvincing to support exemption to be limited to in vivo diagnosis as the Court differentiated the two provisions viz. article 52(3) of EPC and section 3(i) of Indian Patent Act 1970 and observed:
“The fact that Section 3(i), in contrast to Article 52(4) of the EPC, does not contain the expression “practised on the human or animal body”, reinforces the conclusion that the expression “diagnostic” in Section 3(i) extends both to in vitro and in vivo diagnosis. This leads to the issue of whether all the steps involved in diagnosis should be involved in a process for it to qualify as a diagnostic process.”
The Court differentiated the EPC provision from the provisions of section 3(i) of the Indian Patent Act and observed that:
“By taking note of the above and recognising that Section 3(i) differs materially from Articles 52(4) and 53(c) of the EPC inasmuch as Section 3(i) excludes from patent eligibility any process for the diagnostic treatment of human beings, whereas Article 52(4) and 53(c) exclude only diagnostic methods practised on the human body, “
The Court concluded that. –
“the word “diagnostic” should receive a construction which is in consonance with text and context. Such construction does not call for curtailment by limiting the scope of “diagnostic” to in vivo or definitive diagnosis. Equally, expansion is not called for by extension to any process relating to or of some value in diagnosis.”
Meaning of the phrase ‘other treatment of human beings’
The Court also looked at the expression ‘other treatment of human beings’ in the context of the diagnostic methods exception as stipulated under section 3(i). The Court observed that this expression points in the direction of examining embodiments or use cases of processes to determine if they are diagnostic. The Court also cautioned that it should not be lost sight of the fact that patent eligibility is decided at the threshold by examining claims that could have multiple use cases. The Court observed that the embodiments of a claimed invention are relevant only for the purpose of ascertaining whether the process of the claimed invention per se points to a diagnosis for treatment. If such a process does not uncover pathology for any reason, it would not be diagnostic for purposes of Section 3(i).
“42. The language of Section 3(i) uses the expression “diagnostic…or other treatment of human beings” and thereby appears to point in the direction of examining embodiments or use cases of processes to determine if they are diagnostic. Nonetheless, it should not be lost sight that patent eligibility is decided at the threshold by examining claims that could have multiple use cases. Consequently, in the context of diagnostic processes, I am of the view that the embodiments of a claimed invention are relevant only for the purpose of ascertaining whether the process of the claimed invention per se points to a diagnosis for treatment. If such process does not uncover pathology for any reason, it would not be diagnostic for purposes of Section 3(i).”
Testing Vs Diagnosis
In this case, the Court investigated the medical process of testing, where testing is carried out in the course of clinical trials to ascertain the efficacy of drugs on multiple parameters such as safety, potency, toxicity, side effects, contraindications and so on. In personalised medicine, such testing may be done to understand the propensity of particular ethnic or racial groups to develop specific diseases or disorders. In both situations, such testing is not for treatment but to identify patterns. Skin type testing is undertaken to decide on cosmetic processes and products. Citing these illustrations, the Court observed that. –
“The methods or processes adopted in the above three illustrations may potentially also be used in relation to medical treatment. Therefore, from the perspective of deciding a patent application, use cases are relevant only for the limited purpose of ascertaining whether the claimed invention can per se uncover pathology and form the basis of treatment.”
Screening Vs Diagnosis
The Court also drew a distinction between screening and diagnosis. The Court observed that such distinction is typically made on the basis that asymptomatic persons are screened, persons at risk of any disease, disorder, or condition are put through preliminary tests for early diagnosis and symptomatic persons are put through diagnostic tests. Whether such screening of asymptomatic persons would qualify as diagnostic for purposes of Section 3(i)? The Court laid the rule for such determination that if a screening test is capable of identifying the existence or non-existence of a disease, disorder or condition and/or the site, extent, severity or other aspects thereof for treatment of human beings, irrespective of whether the person concerned is symptomatic or asymptomatic, such screening test would qualify as a diagnostic test.
The Court made it clear that the label used for the test—be it screening or anything else—is not determinative. In other words, a screening test capable of identifying the existence or non-existence of a disease, disorder, or condition would qualify as a diagnostic method irrespective of whether it is performed on a symptomatic or asymptomatic person. Additionally, the Court also investigated the distinction between screening and diagnosis on the basis that diagnostic tests are required to confirm the results of screening tests.
In the context of non-invasive prenatal testing (NIPT), the court observed that if the screening test identifies the disease, disorder, or condition, albeit subject to confirmation by definitive tests, it would still qualify as “diagnostic” for purposes of Section 3(i) because the provision does not use the qualifier “definitive.”
Standards Laid by Court for Examining Diagnostic Exceptions
In this case, the court laid down clear standards to be followed by the patent examiner to reach the conclusion of the exception to the patentability of the diagnostic methods. The Court stated that the claims relating to diagnostic methods must be examined in the context of the complete specification to determine whether it specifies a process for making a diagnosis for treatment. The person skilled in the art, including medical doctors, should read the claims along with specifications to arrive at such a determination. If a person’s skill in art concluded that a diagnosis for treatment may be made, even if such diagnosis is not definitive, it would be patent ineligible. In contrast, if a diagnosis for treatment cannot be made, it would be patent eligible.
“…….. the standard I propose is to examine the claims, in the context of the complete specification, to determine whether it specifies a process for making a diagnosis for treatment. Such determination should be made by assuming that a person(s) skilled in the art, including a medical doctor, examines the claims and completes the specification. If it is concluded that a diagnosis for treatment may be made, even if such diagnosis is not definitive, it would be patent ineligible, whereas, if the diagnosis for treatment cannot be made, it would be patent eligible.”
The Court further stated that:
“What is determinative, therefore, of whether a process is diagnostic is to ask the question whether the process is inherently and per se capable of identifying the disease, disorder or condition for treatment of the person.” [Emphasis Added]
Takeaways
This landmark case examined the exceptions covered under diagnostic processes or methods under section 3(i) in detail. The determining factor for such exclusion is whether a process is diagnostic to ask the question of whether the process is inherently and per se capable of identifying the disease, disorder, or condition for treatment of the person. Such capability of the process should be determined by assuming that a person(s) skilled in the art, including a medical doctor, examines the results. If the person(s) skilled in the art would not be in a position to diagnose the disease, disorder or condition, as the case may be, on the basis of the process because the process is not designed to diagnose diseases, disorders or conditions, such process, whether labelled as screening or anything else, would not qualify as diagnostic for purposes of Section 3(i).
The Court ruled that the invention claimed in this case is not excluded under Section 3(i) of the Act, the refusal order of the Controller was reversed, and the patent was granted to the appellant for the invention claiming Fetal Genomic Analysis from a Maternal Biological Sample. The Court also cautioned that the line of demarcation between diagnostic and non-diagnostic tests may not always be bright and could occasionally blur. However, the examiner can look for sufficient support for the situation in the text and the immediate context of the expression “diagnostic” in Section 3(i) to reach a well-reasoned decision.
This case laid down certain guiding rules for determining diagnostic methods exceptions for the Controller. The Controller General may issue suitable instructions to update the Patent Office guidelines for determining diagnostic method exceptions under section 3(i). No doubt, the Controller would be required to make this determination on a case-by-case basis. Expert opinion to understand the implication of this decision and to know into which category the claimed invention falls would be helpful for the applicant seeking patents for inventions relating to diagnostic methods likely to face objections under section 3(i).
