The Delhi High Court has rejected a plea by Japanese firm Hirotsu Bio Science Inc challenging the dismissal of its patent application for a cancer detection method that uses a worm’s response to the smell of human biological samples [Hirotsu Bio Science Inc v Assistant Controller of Patents and Designs].
Justice Tejas Karia upheld the patent office’s order and ruled that the invention falls within the prohibition under section 3(i) of the Indian Patents Act.
Section 3(i) excludes from patentability any methods used to diagnose, prevent or treat diseases in humans or animals.
“The process sought to be patented is not limited to just a screening process for diagnosing cancer before it happens, but it also is a general diagnosing method for cancer. Therefore, the invention claimed in Subject Application would fall under the Section 3(i) of the Act,” the Court observed.
Hirotsu Bio Science had approached the High Court challenging an order of the Assistant Controller of Patents and Designs, who had rejected the application in August 2023.
The company’s application concerned an “in vitro method for detecting cancer” using the behaviour of the nematode Caenorhabditis elegans. According to the company, the worms are attracted to cancer-specific odours in samples such as urine, allowing for early detection of multiple cancers.
The firm argued that the invention merely provided a preliminary detection tool and did not amount to medical diagnosis, which is non-patentable under the law. It contended that diagnostic methods require clinical judgment by medical professionals, whereas its technique operated entirely outside the human body and simply indicated cancer risk.
However, the court rejected this distinction.
"This Court is of the view that it is immaterial who performs the method. In such a situation, it would be challenging if this section [section 3(i) of the Indian Patents Act] is kept limited to only methods practiced by medical practitioners as the application would be patentable even if the method would be completely autonomous,” the Court said.
Ultimately, the Court dismissed the appeal and upheld the patent office’s order.
Advocates Kshitij Saxena, Saransh Vijayvargiya and Daksh Oberoi appeared for Hirotsu Bio Science.
Advocates Manisha Agarwal and Nipun Jain represented the Assistant Controller of Patents and Designs.
[Read Judgment]