{"id":305777,"date":"2023-10-26T15:00:17","date_gmt":"2023-10-26T09:30:17","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=305777"},"modified":"2023-11-02T16:30:32","modified_gmt":"2023-11-02T11:00:32","slug":"scope-diagnostic-s-3i-patents-act-not-limited-in-vivo-or-specific-diagnosis-madras-high-court","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2023\/10\/26\/scope-diagnostic-s-3i-patents-act-not-limited-in-vivo-or-specific-diagnosis-madras-high-court\/","title":{"rendered":"Scope of \u2018Diagnostic\u2019 processes in S. 3(i) of Patents Act is not limited to in vivo or specific diagnosis: Madras High Court"},"content":{"rendered":"
\n

Madras High Court:<\/span> In an appeal filed under Section 117<\/a> of the Patents Act, 1970<\/a> , praying to set aside the order dated 31-03-2021 passed by the Assistant Controller of Patents & Design (‘Controller’) holding that the claimed subject matter of Claims 1-12 of the Patent Application fall outside the scope of Section 3(i)<\/a> of the Patents Act, 1970<\/a> and is thus liable to proceed to grant and to publish the grant in the journal, Senthilkumar Ramamoorthy, J. while setting aside the impugned order, granted patent to the Chinese University and American Company related to an invention determining foetal fraction.<\/h3>\n

Background:<\/p>\n

The appellants claim priority from multiple U.S. Provisional Applications for IN 4812, which is the national phase filing derived from a Patent Cooperation Treaty (PCT) application in respect of a claimed invention entitled “Fetal Genomic Analysis from a Maternal Biological Sample”.<\/p>\n

IN 4812 was originally filed with 44 claims. The appellants received the First Examination Report (FER) on 29-11-2012 raising multiple objections, including objections under Sections 2(1)(j)<\/a>, 2(1)(ja)<\/a>, 3(i)<\/a> and 10(5)<\/a> of the Patents Act, 1970<\/a>. The appellants contended before the Authority that the determination of the foetal fraction does not diagnose a disease and therefore, the claimed invention is not a diagnostic method.<\/p>\n

The Assistant Controller of Patents examined the issue of applicability of Section 3 of the Patents Act to the claimed invention and reached the conclusion that amended claims 1 to 12 are not patent-eligible under Section 3(i) of the Patents Act because the said claims qualify as a diagnostic method, as it is a process of diagnosing that the foetus is suffering from genetic or other diseases.<\/p>\n

Analysis:<\/p>\n

The Court took note of Section 3(i) of the Patents Act and said that each limb of Section 3(i) is distinct and self-contained, as the first limb deals with human beings and the second with animals. Secondly, the disjunctive ‘or’ separates the two limbs. Further, the second part of Section 3(i) deals only with the treatment of animals and thereafter sets out three objects and purposes of treatment. When viewed in isolation, the first purpose “to render them free of disease” could apply to human beings. However, the first and the second limbs deal with distinct subjects; they are separated by the disjunctive “or”; and the pronoun “them” is used after the antecedent “animals”, thus, the said pronoun is referable only to the last antecedent “animals” and not to human beings. Further, the treatment is provided not only to free\/cure a person of disease but also for prophylactic purposes, to alleviate pain, prevent aggravation of or to better manage a condition or disorder. Thus, the Court rejected the contention that the word “diagnostic” in Section 3(i) should be confined to treatment of human beings to render them free from disease. While viewing the word ‘diagnostic’ in association with “forms of treatment”, the Court said that it should be limited to diagnostic processes that disclose pathology for the treatment of human beings.<\/p>\n

Concerning the contention that diagnostic processes should be confined to in vivo<\/span> diagnosis, the Court said that in Section 3(i), there is no indication that the word ‘diagnostic’ should be confined to in vivo<\/span> diagnosis.<\/p>\n

After taking note of Clause 3(a) of Article 27 of the TRIPS Agreement, the Court listed the following which enables members to exclude from patent eligibility : ‘diagnostic, therapeutic and surgical methods for the treatment of ‘humans or animals’. Thus, Article 27(3)(a), indicates that the diagnostic method should be for the treatment of humans or animals. Further, no other limitation or restriction on the scope of the expression “diagnostic methods” is discernible from Article 27(3)(a). Therefore, the Court concluded that the travaux préparatoires<\/span> of Article 27(3)(a) also does not support exempting in vitro diagnostic processes or methods from patent ineligibility.<\/p>\n

The Court noted that the earlier versions of the patent manuals of practice and procedure limit patent ineligibility to in vivo<\/span> diagnosis, however, there is nothing in the current applicable final manual or guidelines which supports the construction that in vivo diagnostic methods are excluded. It said that the manuals of the Patent Office are not determinative of the scope of Section 3(i) and, at most, they are indicative of the manner in which the Patent Office understood the provision.<\/p>\n

Moreover, the Court said that Section 3(i) uses the word “diagnostic” in juxtaposition with forms of treatment, such as medicinal, surgical and therapeutic, and in association with the words “other treatment of human beings’ thus, Section 3(i) differs materially from Articles 52(4) and 53(c) of the European Patents Convention (‘EPC’) because it excludes from patent eligibility any process for the diagnostic treatment of human beings, whereas Article 52(4) and 53(c) exclude only diagnostic methods practised on the human body. Thus, as per the Court the word “diagnostic” should receive a construction which is in consonance with text and context. Such construction does not call for curtailment by limiting the scope of “diagnostic” to in vivo<\/span> diagnosis or definitive diagnosis. Equally, expansion is not called for by extension to any process relating to or of some value in diagnosis.<\/p>\n

The Court suggested that the claims must be examined in the context of the complete specification, to determine whether it specifies a process for making a diagnosis for treatment. Such determination should be made by assuming that a person(s) skilled in the art, including a medical doctor, examines the claims and complete specification. If it is concluded that a diagnosis for treatment may be made, even if such diagnosis is not definitive, it would be patent ineligible, whereas, if diagnosis for treatment cannot be made, it would be patent eligible.<\/p>\n

Concerning the issue that there is a case to exclude certain types of tests from the ambit of the expression “diagnostic” in Section 3(i), the Court said that the embodiments of a claimed invention are relevant only for the purpose of ascertaining whether the claimed invention per se points to a diagnosis for treatment. If such a process does not uncover pathology for any reason, it would not be diagnostic for purposes of Section 3(i). Further, it concluded that from the perspective of deciding a patent application, use cases are relevant only for the limited purpose of ascertaining whether the claimed invention can per se uncover pathology and form the basis of treatment.<\/p>\n

On the distinction between diagnosis and screening, the Court held that if a screening test can identify the existence or non-existence of a disease, disorder or condition and\/or the site, extent, severity or other aspects for treatment of human beings, irrespective of whether the person concerned is symptomatic or asymptomatic, such screening test would qualify as a diagnostic test.<\/p>\n

The Court after examining the basic science behind non-invasive prenatal testing, and on examining claims 1 and 9 of the amended claims, said that the claimed invention is per se incapable of identifying the existence or otherwise of a disease, disorder or condition and further testing would be required for such purpose. It provides an indicator, foetal fraction, which is relevant for further testing to arrive at a diagnosis. Thus, it held that the scope of ‘diagnostic’ in Section 3(i) should not be unduly curtailed by limiting it to in vivo<\/span> or definitive diagnosis. However, its scope should not be unduly expanded by implying the words “relating to” diagnosis. Further, it held that the determination of foetal fraction is related to ‘diagnosis’ but is not ‘diagnostic’.<\/p>\n

Further, the Court said that with a view to incentivise inventors in these cutting-edge areas, without compromising on the public policy, exclusion from patent eligibility of methods of diagnosis and treatment adopted by medical doctors, there is a need to consider options such as restricting the scope of the expression ‘diagnostic’ in Section 3(i) to in vivo<\/span> processes and counter balancing by providing for compulsory licensing.<\/p>\n

[Chinese University of Hong Kong v Assistant Controller of Patents & Designs, 2023 SCC OnLine Mad 6372, decided on 12-10-2023<\/span>]<\/p>\n\n

Advocates who appeared in this case :<\/p>\n

For Appellants:<\/span> Advocate Vindhya S. Mani, Advocate Kiran Manokaran, Advocate Vaishali Joshi, Advocate Sheerabdhinath<\/p>\n

For Respondent:<\/span> SPC S.Diwakar<\/p>\n

Amicus curiae:<\/span> Advocate Adarsh Ramanujan<\/p>\n

Buy Patents Act, 1970  HERE<\/a><\/h3>\n

\"patents<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

“The line of demarcation between diagnostic and non-diagnostic tests may not always be bright and could blur on occasion; even so, there is sufficient support both in the text and immediate context of the expression “diagnostic” in Section 3(i)”<\/p>\n","protected":false},"author":67512,"featured_media":298865,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[3,10],"tags":[62280,33482,2567,55196,62282,62283,30661,62281,62284],"class_list":["post-305777","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-casebriefs","category-highcourts","tag-in-vivo-diagnosis","tag-invention","tag-Madras_High_Court","tag-novelty","tag-patent-eligibility","tag-patent-ineligibility","tag-patents-act","tag-s-3i-patents-act","tag-scope-of-diagnostic"],"yoast_head":"\nScope of 'Diagnostic' processes in S. 3(i) Patents Act not limited 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Mani* and Ritwik Sharma** Cite as: 2023 SCC OnLine Blog Exp 86","rel":"","context":"In "Experts Corner"","block_context":{"text":"Experts Corner","link":"https:\/\/www.scconline.com\/blog\/post\/category\/experts_corner\/"},"img":{"alt_text":"Demystifying Non-Patentability","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/12\/diagnostice-method.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/12\/diagnostice-method.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/12\/diagnostice-method.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/12\/diagnostice-method.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":309533,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/12\/17\/controller-failed-identify-basis-concluding-non-disclosure-madras-high-court-directs-grant-patent\/","url_meta":{"origin":305777,"position":2},"title":"Controller failed to identify basis for concluding non-disclosure: Madras HC directs to proceed application for grant of patent","author":"Apoorva","date":"December 17, 2023","format":false,"excerpt":"Madras High Court said that the appellants have given complete specifications which also capture the results of the evaluation of the claimed invention against the parameters of penetration, nutrient permeability and root penetration test.","rel":"","context":"In "Case Briefs"","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"madras high court","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":310076,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/12\/25\/madras-high-court-distinguishes-between-date-of-assignment-date-of-declaration-patent-applications\/","url_meta":{"origin":305777,"position":3},"title":"Madras High Court distinguishes between date of assignment and date of declaration in patent applications","author":"Apoorva","date":"December 25, 2023","format":false,"excerpt":"Madras High Court directed the Controller of Patents and Designs to decide the patent application on merits and in accordance with law.","rel":"","context":"In "Case Briefs"","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"madras high court","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/08\/madras-high-court.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":370432,"url":"https:\/\/www.scconline.com\/blog\/post\/2025\/12\/20\/intra-court-appeal-in-patent-disputes-not-maintainable-madras-hc\/","url_meta":{"origin":305777,"position":4},"title":"Intra-court appeal not maintainable in patent disputes; Commercial Courts Act overrides Letters Patent of High Court: Madras High Court","author":"Soumya Yadav","date":"December 20, 2025","format":false,"excerpt":"\u201cAny expansion of the scope of the Commercial Courts Act would defeat its objectives, and there is no ambiguity regarding appeals from decrees of Commercial Courts and Commercial Divisions under Section 13 of the Commercial Courts Act.\u201d","rel":"","context":"In "Case Briefs"","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"intra-court appeal patent disputes","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/12\/intra-court-appeal-patent-disputes.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/12\/intra-court-appeal-patent-disputes.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/12\/intra-court-appeal-patent-disputes.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2025\/12\/intra-court-appeal-patent-disputes.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":324672,"url":"https:\/\/www.scconline.com\/blog\/post\/2024\/06\/19\/madras-high-court-affirms-rejection-of-iit-m-patent-on-method-of-doping-potassium-for-lack-of-inventive-step\/","url_meta":{"origin":305777,"position":5},"title":"Madras High Court affirms rejection of IIT-M Patent on \u2018Method of Doping Potassium\u2019, for lack of inventive step","author":"Apoorva","date":"June 19, 2024","format":false,"excerpt":"Madras High Court concluded that without any experimental data to compare the costs of using filtrate material, which requires frequent changing, vis-a-vis using an external reagent, the economic significance of the claimed invention cannot be established. Thus, the claimed invention lacks an inventive step under Section 2(1)(ja) of the Patents\u2026","rel":"","context":"In "Case Briefs"","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"Madras High Court","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/02\/Madras-High-Court.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/02\/Madras-High-Court.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/02\/Madras-High-Court.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/02\/Madras-High-Court.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/305777","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/67512"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=305777"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/305777\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/298865"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=305777"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=305777"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=305777"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}