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Patenting of medical methods is prohibited in India according to Section 3 (i) of the Indian Patent Act, which states that “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.” This flexibility has been conferred by TRIPS in its Article 27(3) which states that “members may also exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals”.
Among various medical methods as described in Section 3 (i), such as surgical and therapeutic methods, the patentability of diagnostic methods, in particular, has been questionable and is not objectively interpreted.
This article tries to focus on understanding the Indian patent scenario with respect to the patenting of diagnostic methods and providing some key points for more efficient protection of the same.
The Indian “Manual of Patent Office Practice and Procedure” describes that Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Further, the Manual explains that the determination of general physical state of an individual (for example a fitness test) is not considered to be diagnostic if it is not intended to identify or uncover pathology. Thus, the diagnostic methods excluded from Patentability include methods which determine or identify existence of a disease or disorder. However, if a method does not include the identification of a disease or disorder, then the method would be patentable. Had this been the case, the scope of diagnostic methods excluded from patentability would have been construed very narrowly. However the Indian Patent Act provides flexibility in a form such that only diagnostic methods practiced on the living body are not patentable and the diagnostic methods performed on tissues or fluids which have been permanently removed from the body are not be excluded, that is the in-vitro methods are patentable.
Thus, the Patent Scenario in Indian is similar to European Patent Law where according to Article 52(4) of the EPC, in-vitro diagnostic methods are found to be patentable. However, the exact scope of such exclusion is not clearly defined at the moment due to the lack of interpretation of the Courts unlike in Europe where the extent of the auspices of patentable subject matter is litigated a large number of times in Courts. Under US Patent Law, all medical methods including Diagnostic Methods are patentable.
Additionally, under the Indian Patent Law, there have been instances when the examiners have rejected the in-vitro diagnostic methods too under the pretext of Section 3 (d) of the Act citing lack of inventive step involving “mere use of a known process”.
For example, if the detection method per se, as well as the biomarker in the sample, are already known and the proposed invention only identifies the use of the marker in the detection of a disease, there are high chances that the method would not be patentable. Thus, where the method involves a novel biomarker or one or more novel detection method steps, the chances of patentability become high. Indian Granted Patent IN 228031, for example, claims a rapid method for heat mediated ELISA characterized in using activated solid support for the detection of minute quantities of biomolecules such as an antigen, antibody, etc. The method has a profound technical advancement of reduction in the total time required for ELISA to around 3 h. Another Indian granted Patent IN 223553 claims an in vitro method of determining an expression level of a plurality of genes in the sample consisting of gene No. 1 to 562 in predicting the prognosis of a biological condition in animal tissue. The Indian Patent IN 220274 claims a method for detecting a risk of gastroesophageal reflux disease on assaying the analytes pepsinogen I, fasting gastrin-I7, and a marker for Helicobacter pylori infection. Another Indian Patent claims a method for detecting antibodies to INGAP 104-118 peptide contacting test samples with the peptide bound to the solid support. The Indian Patent IN 233723 claims a new Scintillation Proximity Assay for the detection of peptidoglycan synthesis. Thus we have seen that all these granted patents describe one or more novel procedural steps in the diagnostic methods described therein. However, subject to the lack of the exact scope, the patenting of diagnostic methods in India is still decided more often on a case-by-case basis.
The diagnostic methods are patentable in Indian provided they are not practiced on living body and are performed on tissues or fluids which have been permanently removed from the body. Further, for the best protection, either the biomarker or any of the steps involved in the method should be novel, involving “inventive step” and deviating away from the “mere use of the known process” rejection. The scope of the Patentability of Diagnostic methods in India is still not clearly defined due to the lack of the interpretation of the Courts unlike in Europe where the extent of the auspices of patentable subject matter is litigated a large number of times in Courts.