The court ruled that the method for detecting cancer using nematodes falls under the diagnostic exclusion of Section 3(i) of the Patents Act, 1970, rendering it non-patentable.
In a significant ruling, the Delhi High Court, presided over by Justice Tejas Karia, has upheld the decision of the Assistant Controller of Patents and Designs to reject a patent application filed by Hirotsu Bio Science Inc. The application, titled "Cancer Detection Method Using Sense Of Smell Of Nematode," was deemed non-patentable under Section 3(i) of the Patents Act, 1970, which excludes diagnostic methods from patentability.
Hirotsu Bio Science Inc had filed an appeal challenging the impugned order dated August 29, 2023, which denied the grant of a patent for their innovative method of detecting cancer through the olfactory behavior of nematodes. The company argued that their invention was directed towards detection, a process distinct from diagnosis, as it involved identifying cancer-specific odour responses in biological samples outside the human body.
The court, however, found that the claims made by Hirotsu Bio Science Inc fell within the diagnostic exclusion stipulated in Section 3(i) of the Patents Act. Justice Karia noted that both in vitro and in vivo diagnostic methods are covered under this exclusion, and the claimed method involved several steps typical of diagnostic processes, including data collection, comparison with standard values, and medical decision-making.
In its analysis, the court referred to the Complete Specification of the subject application, which detailed the method's high accuracy in detecting cancer, including early-stage cancers. The court emphasized that the claims, when read in conjunction with the specifications, clearly indicated a diagnostic process, thereby confirming the non-patentability under Section 3(i).
The court also highlighted previous judgments, including those in "The Chinese University of Hong Kong" and "Natera Inc.," which supported the view that Section 3(i) does not distinguish between in vivo and in vitro processes, thereby reinforcing the diagnostic exclusion for both types of methods.
Despite the appellant's argument that the method was an independent process not requiring the skill of a physician or surgeon, the court maintained that the process's purpose was diagnostic, aimed at identifying the presence or risk of cancer. Consequently, the appeal was dismissed, and the impugned order was upheld, reaffirming the statutory exclusion of diagnostic methods from patentability.
This ruling serves as a critical reminder of the limitations imposed by Section 3(i) of the Patents Act, 1970, and underscores the importance of distinguishing between diagnostic and non-diagnostic processes in patent applications.
Bottom Line:
Patent Law - Section 3(i) of the Patents Act, 1970 - Claims for an in vitro method for detecting cancer using nematodes' olfactory behavior as an indicator were held non-patentable as they fall within the diagnostic exclusion under Section 3(i) of the Act.
Statutory provision(s): Section 3(i) of the Patents Act, 1970
