Scope of Section 3(i): An analysis on diagnostic methods of treatment

Patentability of methods of treatment is a contested subject matter worldwide. Article 27 of the World Trade Organisation’s Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, provides flexibility to its Member States by giving them liberty to decide whether patents may be granted to “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.” The USA, Australia and New Zealand are the only TRIPS members that allow patenting of such matter.
 

Utilizing the flexibility provided by TRIPS, India has opted to categorise said methods and related subject matter under the ambit of non-patentable inventions. Accordingly, in India, Section 3(i) of the Patents Act, 1970 (‘Act’), as amended, excludes from  patentability  “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”[See endnote 1 ]. 
 

The European Patent Office (EPO), under Article 53(c) of the European Patent Convention (EPC), excludes only “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods”. Therefore, the method of treatment by surgery or therapy and diagnostic methods practised on human or animal body are excluded, while methods outside the body and products for medical use are allowable subject matter under Article 53; and subsequent medical use of known products is also allowable under Article 54 of the EPC [See endnote 2 ] [See endnote 3 ] [See endnote 4].

2. Inventions claiming therapeutic methods: 2770/MUMNP/2010 (relating to use claims and method of treatment claims using Lanosta-8,24-dien-3-ols); 4773/DELNP/2006 (relating to multiphasic medicament and dosage as recited); 5040/DELNP/2008 (relating to combination vaccination regime and administration regime to pig); 2609/DELNP/2011 (relating to claimed invention being performed on human body with administration of curcumin followed by in vivo retinal imaging); 3112/DELNP/2006 (relating to composition for a single administration formulation and dosage form given in vivo against ionizing radiation exposure).
 

3. Inventions claiming diagnostic methods: 1086/MUMNP/2011 (relating to ‘a method of diagnosing liver fibrosis in a human subject, obtaining a blood sample from a human subject suspected of having liver fibrosis…’); 6616/DELNP/2010 (relating to biomarkers for COPD diagnosis to determine course of treatment).

As defined in Manual of Patent Office Practice and Procedure, “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,” [See endnote 5] which is distinct from an assay to assess (i.e., determining a value indicative of presence or amount in a sample with no bearing on disease) an analyte. Therefore, diagnostic methods are intended to ascertain the presence (or absence) of a disease; and are decisive for treatment decisions in otherwise symptomatic patients.
 

Further, as recited, Section 3(i) of the Act does not encompass detection tests, e.g., a screening test, wherein the primary purpose is early detection or risk factors of a disease which may never lead to a disease and are merely susceptibility markers in otherwise healthy individuals as well as prediction methods for progression rather than diagnosis in already diagnosed diseased individuals, since it has no bearing on developing methods for further course in therapy. Hence, detection tests, e.g. for screening, and prognostic methods for assessment of disease progression are fundamentally different from diagnostic methods of treatment.

The interpretation and scope of Section 3(i) of the Act has not been judicially tested and the practice varies in the IPO. An assay method for detecting an analyte in a biological sample removed from a body may be interpreted, if supported by the specification of the application for a patent, as an in vitro detection method as opposed to a diagnostic method of treatment. In the absence of judicial interpretation and guidance, there have been instances of various applications being granted and, also rejected by the IPO.
 

Successful applications like 363/DELNP/2009, Patent No. 278579, where addition of a disclaimer, “wherein the assay is not a method of diagnosis of an ailment associated with a human being and/or animal,” led to grant; 731/DELNP/2010, Patent No. 298259, where explanation that it is “a method of determining a value indicative of…viral infection in an untreated whole blood sample,” led to grant; 843/DEL/2006, Patent No. 299791, where deletion of the phrase “by a method as claimed in claim 1,” led to grant; 853/MUM/2012, Patent No. 285429, where recitation as an in vitro method for analysing a sample {in the body fluids of a patient (i.e. human being)} for the presence of Bacillus anthracis, led to grant; 1974/MUMNP/2011, Patent No. 298524, where deletion of the word ‘diagnostic’ and the phrase ‘providing a sample of a bodily fluid from said subject suffering from a primary non-infectious disease’, led to grant.   
 

In contrast, some applications were rejected for being excludable subject-matter under Section 3(i) of the Act, e.g., 52/DELNP/2010, relating to determining the correlation between HBP levels and prediction of severe sepsis, was interpreted as a method of diagnosis, since the claims were directed at using a composition for diagnosis rather than the composition itself and amendment thereof was prohibited under Section 57 read with Section 59 of the Act.
 

Another application, 1492/CHENP/2010, relating to a method of detecting the presence or absence of a Chikungunya virus (CHIK) strain in a biological sample, was also refused under Section 3(i) of the Act. In that case, a fair reading of the specification implied that the detection method of invention stops at presence or absence of an immune complex, but nowhere does it recite the presence of the immune complex confirms or diagnoses a person as having been affected by CHIK. Further, during prosecution, an argument that it is not a diagnostic method of treatment to render humans free of disease was made, but a possible future use by a doctor for diagnosis was admitted. It was further argued that reading the provision under Section 3(i) of the Act should be done in its entirety and not choosing the ‘diagnostic…method of treatment…’ selectively, while disregarding the qualifier ‘to render them free of disease or increase their economic value or that of their products’. Equating the ambit of Section 3(i) of the Act to Article 53(c) of the EPC, and an argument that Section 3(i) of the Act concerns only to methods that are performed directly on human or animal body, was not accepted by the IPO and ultimately led to the refusal of this application.
 

Further, in application 4981/DELNP/2008, the invention was found to be novel, inventive and otherwise patentable, but was refused under Section 3(i) of the Act. The invention relating to an in vitro method for detecting fragmentation of an adiponectin receptor, where the presence or absence of certain soluble fragments of the adiponectin receptor in bodily fluids was interpreted as predictive of disease and hence categorised as a diagnostic method of treatment. However, no definition was provided for the diseased state and neither anything related to the same was claimed as such in the application. The IPO refused the grant of the application by stating that Section 3(i) of the Act makes no distinction between in vitro and in vivo methods.

In view of the exemplary cases above, in contrast to the EPO provision applying Article 27 of TRIPS, by reciting additional methods of treatment and ending with a non-limiting recitation of “or other treatment,” the IPO, under Section 3(i) of the Act, makes for a blanket exclusion on any methods of treatment, but no direction is given for screening methods, probability methods, i.e., prognosis, or assay of analytes without any bearing on diagnosis or treatment. Further, no distinction is made between diagnostic methods performed ‘in vivo’ versus ‘in vitro’, and it is interpreted differentially. The recitation, “render them free of disease or to increase their economic value or that of their products” under Section 3(i) of the Act is sometimes interpreted as implied without any basis for the same being present in the claims or specification of an application and it further adds to the ambiguous interpretation.
 

It appears beneficial to provide arguments and basis from the specification of an application for a patent to support that the claimed methods and compositions relate to detection rather than diagnosis or treatment of a disease. Also helpful is establishing and exemplifying that the claimed invention relates to routinely performed assays in laboratories with an aim to provide support to medical research, to improvise on currently used detection methods and to study the comparative results of two or more methods involved in detection of similar type of biomolecule in a sample.

In the light of the above, a foundational and formidable jurisprudence and interpretation in the courts of law is required to reduce the ambiguity and discrepancy in interpretation of Section 3(i) of the Act. Simultaneously, with the global environment heading towards dynamic biotechnological and medical innovation supported by incentives to the innovators in terms of patenting, Indian patent law needs to find a balance between public health, socio-economic growth of the country, along with support to medical technological innovation to be competent and survive at the global scale.
 

While there is a need for reprimanding and discouraging exclusivity over the commercial use and exploitation of inventions at the interface with human and animal life and health, there is a need to drive medical innovation to combat the ever-changing and challenging landscape of virulent pathogens, lifestyle changes and environmental exposures underlying maladies. Indian patent law provides conditional allowance in this sphere of innovation, strongly discouraging claiming of mostly any method of treatment. The realm of what as a method may be patentable in the field of medical technology and pharmaceuticals seems highly ambiguous and is unlikely to be settled in the near future.

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Endnotes:

1. http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf
2. https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar53.html
3. General Hospital Corp/Hair removal method T 383/03 (2005) OJEOPO 159
4. EP Board of Appeals T0144/83
5. http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_28_1_manual-of-patent-office-practice_and-procedure.pdf