Hirotsu Bio Science Inc v Assistant Controller of Patents and Designs (2026)

Summary

“This is an Appeal under Section 117A of the Patents Act, 1970 (‘Act’) against the order dated 29.08.2023 (‘Impugned Order’) issued by Assistant Controller of Patents and Designs (‘Respondent / Controller’) under Section 15 of the Act rejecting the grant of patent in the Patent Application No. 201617022947 titled as ‘CANCER DETECTION METHOD USING SENSE OF SMELL OF NEMATODE’. (‘Subject Application’).” (para 1) “The inventor of the present invention has found that cancer can be detected by using the chemotaxis of nematodes based on the olfaction thereof or the response of olfactory neuron.” (para 9) The Controller held that “Section 3(i) excludes both in vivo and in vitro methods” (para 10). Claim 1 claimed “An in vitro method for detecting cancer”, and the appellant submitted that “the present invention is directed to detection, that is, identifying cancer-specific odour responses in biological samples outside the human body and it does not amount to diagnosis, which requires medical correlation, interpretation, and clinical judgment” (para 11).

The Court held that “Section 3(i) of the Act does not differentiate between the in vivo and in vitro processes” (para 17) and that “as per the Complete Specification, the claimed method can detect cancer, including early-stage cancer, with a high rate of accuracy” (para 23). It recorded that “the Court in The Chinese University of Hong Kong (supra), stated that even screening test would qualify as ‘diagnostic’ for purposes of Section 3(i) of the Act if it identifies the disease, disorder or condition albeit subject to confirmation by definitive tests” (para 32), and held that “the invention claimed in Subject Application would fall under the Section 3(i) of the Act” (para 33), that “it is immaterial who performs the method” (para 35) and that “the claims cannot be read contrary to specifications” (para 36). “Accordingly, the Appeal is dismissed and the Impugned Order dated 29.08.2023 is upheld.” (para 40)

What the court decided

1. In vivo and in vitro processes. Of Natera v Assistant Controller of Patents and Designs (2025), the Court held: “Contrary to the submission of the Appellant, the Paragraph No. 79 of Natera Inc. and Anr. (supra) clearly notes that the Section 3(i) of the Act” (“Patents Act, 1970”) “does not make any distinction between in vivo or in vitro processes. Both The Chinese University of Hong Kong (supra) and Natera Inc. and Anr. (supra) have clearly interpreted that Section 3(i) of the Act prohibits both in vivo and in vitro processes. Therefore, Section 3(i) of the Act does not differentiate between the in vivo and in vitro processes.” (para 17) “The Paragraph Nos. 51 and 52 of The Chinese University of Hong Kong (supra) interpret the provision of not to limit the scope of the word ‘diagnosis’ under the Section 3(i) of the Act to in vivo cases only. As per the said decision, the in vitro cases should also fall under the scope of the Section 3(i) of the Act.” (paras 17, 24)
2. Reading the complete specification. “To understand the present invention, it is important to peruse the Complete Specification of the Subject Application to determine the object and the detail of the method claimed.” (para 18) “The Complete Specification under the title ‘Effect of the Invention’ states that the method of the present invention under the Subject Application also involves the collection and analysis of samples.” (paras 18–19)
3. What the specification discloses. “The method involves the repetition of the analysis to be performed on the specimen, and the mean of the repeated chemotaxis index value is calculated. This would increase the accuracy of the result.” (para 20) Of the specification, “the following can be asserted”: “Based on the repetition of the analysis to be performed on the specimen, the outcome / result is highly accurate.” “The invention relates to a method of detecting cancer involving the steps like collection of data, comparison of the data with standard values, and that leads to a conclusion based on the result.” (para 22) “Therefore, as per the Complete Specification, the claimed method can detect cancer, including early-stage cancer, with a high rate of accuracy. Therefore, the claimed method leads to the detection of cancer.” (paras 20, 22–23)
4. Tests that need further testing. The Court recorded: “The Paragraph No. 55 of The Chinese University of Hong Kong (supra) also states that if the invention in question is incapable of identifying the existence or non-existence of a disease / disorder condition and further, testing would be required for such purpose, it would be outside the purview of Section 3(i) of the Act. The same is also reiterated in Paragraph No. 94 of Sequenom Inc. & Anr. (supra), wherein the Court held that the patent office has itself been inconsistent by granting patents for some in vitro diagnostic-related processes while rejecting others.” (para 25)
5. Positive and negative diagnoses. Of Sequenom v Controller of Patents (2025), the Court recorded that “Under Paragraph Nos. 100 and 101 of the decision in Sequenom Inc. & Anr. (supra), the Court held that since the extremely accurate test has 98.6% sensitivity and 99.8% specificity, it leads to conformity. It emphasized that when the language of Section 3(i) of the Act uses the word diagnostic, it would include both positive and negative diagnoses. Accordingly, since there is a tangible result achieved by the test which is being performed, it would defeat the purpose of Section 3(i) of the Act if a patent is granted. The application cannot be held to be patentable merely because the test does not confirm the presence of a particular medical condition.” It quoted the holding that “While there can be no doubt that the subject invention could be a useful invention, the mere fact that it is an in vitro method would by itself be insufficient to make the invention patentable, so long as the purpose of the process is to diagnose a medical condition.” (para 30)
6. The diagnostic process. “The term ‘diagnostic process’ has been explained in Paragraph No. 79 of Natera Inc. and Anr. (supra), wherein the Court held that the manner in which the diagnosis is performed would not be patentable. The Court further observed that with the help of examples that the manner of checking blood pressure using different tools, the process of checking glucose levels, the manner of doing a swab test etc., would not be patentable.” (para 31) “In the same way, in the present invention, the method leads to the identification of cancer with high accuracy.” (paras 31–32)
7. Screening tests. “Additionally, the Court in The Chinese University of Hong Kong (supra), stated that even screening test would qualify as ‘diagnostic’ for purposes of Section 3(i) of the Act if it identifies the disease, disorder or condition albeit subject to confirmation by definitive tests.” The passage reproduced from that judgment reads: “if the screening test identifies the disease, disorder or condition albeit subject to confirmation by definitive tests, it would still qualify as ‘diagnostic’ for purposes of Section 3(i) because the provision does not use the qualifier ‘definitive.’” (para 32)
8. Screening and general diagnosis. “Therefore, based on the discussion of the Complete Specification, it is inferred that the Complete Specification of the Subject Application provide 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. Therefore, the invention claimed in Subject Application would fall under the Section 3(i) of the Act.” (para 33)
9. Embodiments in the specification. “Further, Paragraph No. 50 of The Chinese University of Hong Kong (supra) also supports the above view.” The passage reproduced from The Chinese University of Hong Kong v Assistant Controller of Patents & Designs (2023) reads: “Although the claims delimit the scope and ambit of the monopoly claim, the embodiments set out in the complete specification can and should be examined to assess whether the process is per se diagnostic.” and “it cannot be concluded that the process described by the claimed invention is not diagnostic because neither definitive nor comprehensive diagnosis is a prerequisite to qualify as diagnostic.” (para 34)
10. Who performs the method. “The Appellant argued that the diagnostic methods require the skill and knowledge of the physician or surgeon to analyze and interpret symptoms, while in the case of detection, the result is not accompanied by a discussion. 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 is kept limited to only methods practiced by medical practitioners as the application would be patentable even if the method would be completely autonomous.” (para 35)
11. Claims and the specification. “The Appellant’s averment to the effect that specifications can expand or limit the scope of claims is not applicable in the present case because there is a contrast between the import of the specifications versus the import of the amended claims. Even assuming that the amended claims claim only screening, the claims cannot be read contrary to specifications. In The Chinese University of Hong Kong (supra), it was held that to proceed to examine the claims in the context of the specification, it is necessary to determine whether it specifies a process for making a diagnosis for treatment. Therefore, the contention of the Appellant that the determination diagnosing method should be on the basis of claims and not specification cannot be accepted.” (para 36)
12. Disclaiming definitive diagnosis. “The proposed amended Claim No. 1 read as ‘…wherein the determination that the subject has cancer or cancer risk is used as supporting documentation for a preliminary screening or medical examination, and not as a definitive medical diagnosis…’. However, the Complete Specification shows that the screening claimed in amended Claim No. 1 results in highly accurate results in identification of the cancer. Therefore, the proposed claims cannot be allowed under Section 3(i) of the Act.” (para 37)
13. Claim 10 on cancer types. “Further, the independent Claim No. 10 claims an in vitro method for identifying cancer types.” (para 38) “The independent Claim No. 10 would proceed/use the cancer detection method claimed in Claim Nos. 1 to 4. Therefore, if proposed Claim Nos. 1 to 4 are not acceptable under Section 3(i) of the Act, the independent Claim No. 10 would also not be acceptable.” (paras 38–39)
14. Claim 5 on olfactory receptors. “The proposed amended Claim No. 5 read as ‘a method for identifying an olfactory receptor in nematodes for use in the detection method.’” (para 38) “As regards the independent Claim No. 5, the Impugned Order rightly held that the said method is a one of the preparatory steps of the claimed diagnostic method as mentioned in Claim No. 1, which decides the identification of nematodes that is to use in the cancer detection method and in isolation, it is of no use.” (paras 38–39)
15. Steps of a diagnostic method. The Controller had held that the “claimed method clearly a diagnostic method and in involves all the essential steps of a diagnostic methods viz.” “the examination phase involving collection of data,” “comparison of these data with standard values,” “the finding of any significant deviation, i.e., a symptom, during the comparison, and” “the attribution of the deviation to a particular clinical picture, i.e., the deductive medical decision phase.” (para 10) The Court held: “The Impugned Order rightly noted the steps involved in the Subject Application while providing reasons for the claimed method to be a diagnostic method.” (paras 10, 40)
16. Disposition. “Accordingly, the Appeal is dismissed and the Impugned Order dated 29.08.2023 is upheld.” (para 40)

Subsequent treatment

• Appealed — The appellant’s Letters Patent Appeal, LPA 173/2026, against the Assistant Controller of Patents and Designs was listed before a Division Bench of the Delhi High Court (V. Kameswar Rao and Manmeet Pritam Singh Arora JJ) on 17 July 2026; no decision, and no later judicial treatment, traced as of 10 October 2026.