Routes to patent method of treatment/diagnostic claims in India

The patentability of methods of treatment and diagnosis is a contentious issue worldwide. Article 27 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement gives Member states the power to decide the patentability of "diagnostic, therapeutic and surgical methods for the treatment of humans or animals." Only three Member states -the United States of America, Australia and New Zealand, allow such subject matter to be patentable. In India, s 3(i) of the Patents Act 1970 bars the patentability of?"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."

It has been held that three things are needed to be satisfied for the bar under s 3(i), Patent Act 1970, to apply:

• Any process for the medicinal, surgical, curative, prophylactic [diagnostic therapeutic] or other treatment;
• The process or the treatment should be directed to either live human beings or live animals, and
• The process or the treatment should be such as to render either the human beings or animals free of disease or possessed of increased economic value for themselves or their products.[1]

Patentability of Medical Treatments in India

The basis of exempting surgical, medical, and therapeutic methods from patentability is based on a person's constitutional right to life. The legislature has expressly excluded the subject matter from the purview of patentability to respect human rights and ensure fair and proper treatment. However, it is essential to note that the Act does not prohibit patenting products used in treatment, whether medical instruments or pharmaceutical compositions. For example, a device for detecting antibodies to HIV in human serum was considered patentable for the device's technical features as opposed to the method of using the device to detect the antibodies.?[2]??However, an application for a 'kit for the treatment of infertility for women having several dosages of FSH' was excluded under Section 3(i) of the Act because the product was only being utilised as a medical procedure.[3]

The Manual of Patent Office Practice and Procedure[4]?defines diagnosis as 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." Diagnostic methods are therefore intended to determine the presence of a disease and are a decisive step in treating diseases. However, S 3(i) of the Act does not bring within its purview detection tests like screening tests. A fundamental difference between diagnosis and screening methods is early detection or risk factors, which may or may not result in disease and are merely predictive. Examples of applications claiming diagnostic methods that have been rejected include diagnosing liver fibrosis in a human subject, obtaining a blood sample from a human subject suspected of having liver fibrosis[5]?and a method relating to biomarkers for COPD diagnosis to determine the course of treatment.[6]

The wording of a claim can play a critical factor in determining whether an application is granted. For example, an 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 the grant of a patent.[7]?Further, an application explaining that it is "a method of determining a value indicative of…viral infection in an untreated whole blood sample" also led to a grant.[8]?Terms such as "diagnose" and "obtaining a test sample" should be avoided. For example, where the term ‘diagnostic method' was amended as “in vitro method” and the phrase 'providing a sample of a bodily fluid from said subject suffering from a primary non-infectious disease', was deleted from the claim, the objection under s. 3(i) was withdrawn and a patent was granted.[9]???Identifying the process to be "in-vitro" in the claim of the invention can also help overcome the hurdle of s 3(i), as also illustrated in an application for an?in vitro?method for analysing a sample for the presence of?Bacillus?anthracis.[10]

The latest version of the MPOPP explicitly states that applying substances to the body for purely cosmetic purposes is not therapy. An application claiming a computer-assisted colorimetric make-up method for camouflaging skin colour deviations was patentable as it was purely cosmetic and did not relate to treating a disease in any way.[11]?In a case decided before the publication of the updated version of the MPOPP, an application to modify the eye colour by forming an annular channel in the human eye by a surgical blade or laser technique by slitting the cornea of the eye was rejected even though the application claimed the process was not surgical and only to enhance the aesthetic value. The application was rejected on the ground that the claimed method needs much precision to carry out such a complex procedure by an expert surgeon.[12]?This shows that each application is assessed comprehensibly, and the wording of the claim is not necessarily determinative. To demonstrate that a method claim is purely cosmetic and, therefore, patentable, it must be demonstrated that the treatment does not result in the curing or prevention of any disease or condition in any manner. Cleaning oral surfaces was held to fall under s 3(i) as it involved a curative and prophylactic process of treatment of cavities.[13]

The term disease is not defined, which often raises the question of whether the term includes lifestyle disorders. However, an application for a method of discovering compounds suitable for the treatment and or prophylaxis of obesity was considered a diagnostic method within the meaning of s 3(i) and, therefore, not patentable.?[14]

Recent events have demonstrated the need for medical technological innovation to be competent and survive globally. The current landscape in India strongly discourages claiming methods of treatment or diagnosis. While clever drafting can help overcome some hurdles, there is a need for more precise guidance to incentivise investments in the sector.

[1]?Benitec Australia Ltd.'s patent application No. IN/PCT/2000/00169/DEL

[2]?693/Kol/2007 ; see also 1553/DEL/1996

[3]?404/MUMNP/2005

[4]?Manual of Patent Office Practice and Procedure (version 3, 26th November, 2019)

[5]?1086/MUMNP/2011?

[6]?6616/DELNP/2010

[7]?363/DELNP/2009, Patent No. 278579

[8]?731/DELNP/2010, Patent No. 298259

[9]?1974/MUMNP/2011

[10]?853/MUM/2012, Patent No. 285429

[11]?IN 201917045923

[12]?1376/DELNP/2007

[13]?IN8930/DELNP/2008

[14]?195/MUMNP/2003

Author: Anand Barnabas