The Delhi High Court has declined to interfere with the Patent Office’s decision rejecting a patent application filed by Hirotsu Bio Science Inc, a Japanese company, for a cancer detection technique based on a worm’s response to odours from human biological samples.
Court Finds Statutory Bar Under the Patents Act
Justice Tejas Karia, on Saturday, upheld the August 2023 order issued by the Assistant Controller of Patents and Designs. The court ruled that the claimed invention falls squarely within the exclusion set out under Section 3(i) of the Patents Act, 1970, which bars patent protection for diagnostic, therapeutic, and treatment methods for humans or animals.
Diagnostic Nature of the Claimed Invention
While examining the scope of the invention, the court observed that the proposed method was not limited to a preliminary or screening-stage assessment. Instead, it functioned as a general diagnostic process for detecting cancer. Consequently, the court concluded that the application directly attracted the statutory prohibition under Section 3(i).
Details of the Patent Application
As reported by Business Standard, the patent application concerned an in vitro cancer detection method using the behavioural response of the nematode Caenorhabditis elegans. According to the applicant, the worms exhibit attraction towards cancer-specific odours present in biological samples such as urine. The company claimed that this behavioural response enables early detection of multiple cancer types.
Applicant’s Argument on Diagnostic Exclusion
Hirotsu Bio Science argued that its invention did not qualify as a diagnostic method under the Act. It contended that the technique merely indicated cancer risk and did not involve clinical decision-making or treatment by medical professionals. Moreover, the company emphasized that the process operated entirely outside the human body, thereby placing it beyond the scope of Section 3(i).
Court Rejects Narrow Interpretation of Section 3(i)
However, the High Court rejected this argument, clarifying that the applicability of Section 3(i) does not depend on who performs the method. The court reasoned that restricting the exclusion only to procedures carried out by medical practitioners would undermine the provision’s intent. Such an interpretation, it noted, would allow fully automated diagnostic methods to become patentable, defeating the statutory purpose.
Appeal Dismissed, Patent Refusal Affirmed
Finding no legal infirmity in the Patent Office’s reasoning, the Delhi High Court dismissed the appeal. As a result, it affirmed the rejection of Hirotsu Bio Science Inc’s patent application.