Hirotsu Bio Science Inc filed a national phase patent application No. 201617022947 on July 4, 2016, titled “Cancer Detection Method Using Sense of Smell of Nematode” based on PCT application dated December 10, 2014, claiming a method using Caenorhabditis elegans nematodes' chemotaxis to detect cancer odors in biological samples like urine ex vivo, with nematodes attracting to cancer patient samples and avoiding healthy ones.
Request for examination filed October 31, 2017, First Examination Report issued August 19, 2020 citing objections, reply with amended claims December 28, 2020, hearing notices with objections under Sections 2(1)(j), 3(i), 3(j), and 10(4), hearing April 11, 2023 after adjournments, post-hearing submissions May 26, 2023 with further amendments, but application rejected August 29, 2023 under Section 3(i) as diagnostic method.
Appellant appealed under Section 117A arguing it's mere detection not diagnosis, in vitro not practiced on body, citing spec paras [0027]-[0028] and cases like EMD Millipore and Chinese University of Hong Kong. Respondent countered it's diagnostic as identifies disease via signs in samples, extends to in vitro per EPO G 1/04 criteria including data collection, comparison, deviation finding, and clinical attribution.
Court reasoned Section 3(i) excludes diagnostic methods, and absence of "practiced on body" phrase means it covers both in vivo and in vitro per Chinese University of Hong Kong case; method involves sample collection, nematode behavior analysis via chemotaxis index, repetition for accuracy yielding high sensitivity/specificity (95%/81%), leading to cancer presence conclusion akin to diagnostic processes in Sequenom, thus excluded under 3(i); no need to examine other grounds. Appeal dismissed, impugned order upheld.
Law Point:
The term "diagnostic" under Section 3(i) of the Patents Act, 1970 extends to both in vivo and in vitro methods, as the provision lacks the limiting phrase "practised on the human or animal body" unlike EPC Article 52: (Para14, 17).
Case Title: Hirotsu Bio Science Inc Vs Assistant Controller of Patents and Designs :17.01.2026: C.A.(COMM.IPD-PAT) 45/2023 :2026:DHC:421 : Hon'ble Mr. Justice Tejas Karia
[Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation]
[Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi]
