The recent case before the Hon'ble High Court of Madras concerning Section 3(i) of the Patent Act brought to light a crucial distinction between "diagnosis" and "diagnostic." The case revolved around whether an invention that involved testing nucleic acid molecules in a biological sample from a pregnant woman to identify the fetal fraction could be considered diagnostic and therefore barred under Section 3(i). This article provides an analytical perspective on the case and the court's decision.

Section 3(i) of the Patent Act:
Section 3(i) of the Indian Patent Act is a significant provision that excludes certain inventions from being patented. "It states that "a method of diagnosis practiced on human beings or animals" is not patentable. The key issue in this case was whether the invention, despite being related to diagnosis, was inherently "diagnostic" in nature?"

The Rejected Patent Application:
The case arose from the rejection of an Indian patent application (No. 4812/CHENP/2012) dated 01.06.2012. The application was denied on the grounds that it fell within the scope of Section 3(i) of the Patents Act. The Assistant Controller contended that the invention was essentially a diagnostic method, making it ineligible for a patent.

The Appellant's Argument:
The appellant argued that the invention did not diagnose a disease but rather focused on identifying the fetal fraction in a biological sample. According to the appellant, this identification was a critical step for subsequent diagnostic testing. The argument revolved around the distinction between the identification of the fetal fraction and the actual diagnosis of diseases, disorders, or conditions.

Court's Decision:
The court's decision was pivotal in this case. It allowed the appeal, emphasizing that the invention involved testing nucleic acid molecules in a biological sample to identify the fetal fraction. This fraction was crucial for further testing to diagnose chromosomal aberrations. However, the court made a critical distinction: the invention itself did not diagnose diseases, disorders, or conditions. Instead, it provided an indicator (the fetal fraction) that was relevant for subsequent diagnostic testing.

Defining "Diagnosis" and "Diagnostic":
The court delved into the meaning of "diagnosis" in the context of medical science. It defined diagnosis as a method of identifying the existence or non-existence of a disease or disorder and its various attributes. However, the court noted that such identification, by itself, cannot be construed as a form of treatment.

The term "diagnostic" in Section 3(i) was juxtaposed with words like "medicinal" and "surgical," which are unquestionably forms of treatment. The court agreed with the appellants that "diagnostic" should not be considered in isolation but rather in conjunction with the accompanying words of Section 3(i) as a whole. The court concluded that "diagnostic" should be limited to processes that reveal pathology for the treatment of human beings.

Determining "Diagnostic" Processes:
The court provided guidance on how to determine whether a test is diagnostic. It posed the question of whether the test is inherently and per se capable of identifying a disease, disorder, or condition for treatment. This determination should be made by assuming that persons skilled in the relevant field, including medical professionals, examine the results. If these individuals would not be able to diagnose the disease or condition based on the process because it is not designed for that purpose, such a process, whether labeled as screening or otherwise, should not qualify as diagnostic under Section 3(i).

Analyzing the Invention:
The court's analysis of the patent application revealed that the invention, as described in claims 1 and 9, involved testing nucleic acid molecules in a biological sample from a pregnant woman to identify the fetal fraction. Medical literature indicated that a fetal fraction of not less than 4% was necessary for further testing to identify chromosomal aberrations. Until this stage was reached, pathology remained undisclosed, and treatment was not possible. Therefore, the invention was inherently incapable of identifying the existence or non-existence of a disease, disorder, or condition. The determination of the fetal fraction related to diagnosis but was not inherently "diagnostic" in nature.

The Concluding Note:
The case presented a complex and nuanced interpretation of Section 3(i) of the Patent Act, highlighting the distinction between diagnosis and diagnostic. The court's ruling clarified that a process should only be considered "diagnostic" if it inherently identifies diseases or conditions, not if it merely provides a step in a diagnostic process.

This decision has significant implications for patent law and the boundaries of what can be patented in the field of medical diagnostics. It sets a precedent for future cases where the distinction between diagnosis and diagnostic is in question, emphasizing the importance of an inherent capability to identify diseases or conditions for an invention to be barred under Section 3(i).

The Case Law Discussed:
Case Titled: The Chinese University of Hong Kong Knowledge Transfer office Vs The Assistant Controller of Patent and Design
Date of Judgement/Order:12/10/2023
Case No. CMA (PT) No.14 of 2023 & CMP No.16669 of 2023
Neutral Citation No: 2023:MHC:4617
Name of Hon'ble Court: High Court of Madras at Chennai
Name of Hon'ble Judge: Senthil Kumar Ramamoorthy, H.J.

Disclaimer:
Information and discussion contained herein is being shared in the public Interest. The same should not be treated as substitute for expert advice as it is subject to my subjectivity and may contain human errors in perception, interpretation and presentation of the fact and issue involved herein.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539