Cancer Diagnosis Through Worms Not Patentable, Rules Delhi High Court

Cancer Diagnosis Through Worms Not Patentable, Rules Delhi High Court

Introduction

The Delhi High Court has reaffirmed the statutory bar on patenting diagnostic methods by rejecting a Japanese firm’s attempt to secure patent protection for a cancer detection technique based on the behavioural response of worms. The Court held that such inventions fall squarely within the exclusion under Section 3(i) of the Patents Act, 1970.

Factual Background

Hirotsu Bio Science Inc., a Japanese biotechnology company, had developed an in vitro method for detecting cancer using the nematode Caenorhabditis elegans. According to the applicant, the worms are attracted to odours associated with cancer in human biological samples such as urine, thereby enabling early detection of multiple cancers. The company claimed that the invention offered a novel, non-invasive screening tool.

Procedural Background

The patent application was rejected in August 2023 by the Assistant Controller of Patents and Designs on the ground that the claimed invention constituted a diagnostic method barred under Section 3(i) of the Patents Act. Aggrieved by this decision, Hirotsu Bio Science approached the Delhi High Court challenging the rejection.

Issues

1. The principal issue before the Court was whether the claimed invention constituted a diagnostic method excluded from patentability under Section 3(i) of the Patents Act, 1970.

Contentions of the Parties

The petitioner contended that its invention was merely a preliminary screening tool and did not amount to a diagnostic method in the strict medical sense. It argued that diagnosis involves clinical judgment by medical practitioners, whereas the claimed method operated entirely outside the human body and only indicated the possibility of cancer.

The patent office, on the other hand, maintained that the invention was inherently a method for diagnosing cancer and therefore fell within the statutory exclusion under Section 3(i).

Reasoning and Analysis

Justice Tejas Karia rejected the petitioner’s attempt to draw a distinction between screening and diagnosis. The Court observed that the claimed process was not confined to early-stage screening but was a general method for diagnosing cancer. It was stated by the Court that, “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.”

The Court further clarified that the applicability of Section 3(i) does not depend on who performs the method. It noted that limiting the exclusion only to methods practiced by medical professionals would defeat the purpose of the provision, as autonomous or laboratory-based diagnostic techniques could otherwise escape the statutory bar. In this context, the Court observed that it is immaterial whether the method is carried out by a doctor, a technician, or an automated system.

Decision

The Delhi High Court dismissed the appeal and upheld the order of the Assistant Controller of Patents and Designs. It conclusively held that the invention claimed by Hirotsu Bio Science Inc. was a diagnostic method barred from patentability under Section 3(i) of the Patents Act, 1970.

In this case the appellant was represented by Mr. Kshitij Saxena, Mr. Saransh Vijayvargiya and Mr. Daksh Oberoi, Advocates. Meanwhile the respondent was represented by Ms. Manisha Agarwal and Mr. Nipun Jain, Advocates.