Upholding the patent office's August 2023 order, the Delhi High Court has definitively rejected a patent application by Japanese firm Hirotsu Bio Science Inc. The company sought exclusive rights for an "in vitro method for detecting cancer" that leverages the behavior of the nematode Caenorhabditis elegans, which are reportedly attracted to cancer-specific odors in samples like urine.
Legal Rationale
Justice Tejas Karia's ruling emphasized Section 3(i) of the Indian Patents Act. This section explicitly excludes methods used to diagnose, prevent, or treat diseases in humans or animals from being patentable. The court reasoned that the process claimed was a general diagnostic method for cancer, not merely a preliminary screening tool as the company had argued.
The firm contended that its technique operated entirely outside the human body and did not involve clinical judgment, differentiating it from non-patentable medical diagnoses. However, the court dismissed this distinction, stating it is immaterial who performs the method. The ruling clarifies that autonomous diagnostic methods are also subject to the prohibition under Section 3(i).
This decision reinforces India's stance on the patentability of medical diagnostic procedures and sets a precedent for similar applications in the future. Advocates Kshitij Saxena, Saransh Vijayvargiya, and Daksh Oberoi represented Hirotsu Bio Science, while Advocates Manisha Agarwal and Nipun Jain appeared for the Assistant Controller of Patents and Designs.
