{"id":135433,"date":"2025-06-12T07:56:39","date_gmt":"2025-06-12T02:26:39","guid":{"rendered":"https:\/\/www.bananaip.com\/intellepedia\/?p=135433"},"modified":"2025-06-12T07:56:39","modified_gmt":"2025-06-12T02:26:39","slug":"diagnostic-methods-pathology-per-se","status":"publish","type":"post","link":"https:\/\/www.bananaip.com\/intellepedia\/diagnostic-methods-pathology-per-se\/","title":{"rendered":"Section 3(i) Rejections Reversed: Diagnostic Methods Must Disclose Pathology Per Se"},"content":{"rendered":"

Section 3(i) of the Indian Patents Act, 1970 prohibits patenting of diagnostic methods aimed at treating diseases in humans or animals. However, the absence of a clear statutory definition for \u201cdiagnostic method\u201d has led to inconsistent interpretations by the Indian Patent Office (IPO). This ambiguity was recently addressed by the Madras High Court in two decisions involving The Chinese University of Hong Kong v. Assistant Controller of Patents and Designs (CUHK-I<\/a>\u00a0and\u00a0CUHK-II<\/a>, hereafter, the \u201cCUHK decisions\u201d). The Court clarified that the exclusion under Section 3(i) applies only to inventions that inherently and directly disclose a pathological condition specifically for the purpose of treatment.<\/p>\n

This case note examines two subsequent decisions of the Madras High Court, both arising from appeals against the rejection of patent applications under Section 3(i). In both cases, the Court remanded the matters to the IPO for fresh consideration in accordance with the refined interpretation of Section 3(i) laid down in the CUHK decisions.<\/p>\n

Case I – The Chinese University of Hong Kong v. The Assistant Controller of Patents and Designs<\/h5>\n

In this case, The Chinese University of Hong Kong (\u201cCUHK\u201d) challenged the rejection of its patent application titled \u201cDetection of Genetic or Molecular Aberrations Associated with Cancer\u201d. The IPO had refused the application on grounds that the claimed invention was not patentable under Sections 3(i), 3(k) and 10(4) of the Act.<\/p>\n

CUHK argued that the rejection under Section 10(4) was procedurally flawed, as no such objection had been raised in either the First Examination Report (FER) or the hearing notice. The rejection under Section 3(k) was also challenged for lacking substantive reasoning or analysis on whether the claims constituted a \u2018computer programme\u00a0per se<\/em>.\u2019<\/p>\n

Regarding Section 3(i), CUHK contended that the IPO had failed to consider the principles laid down in earlier CUHK decisions and asserted that its invention did not\u00a0per se<\/em>\u00a0disclose pathology.<\/p>\n

The Court found merit in CUHK\u2019s contentions. It observed that the objection under Section 10(4)(c) had been raised for the first time in the impugned order, thereby violating principles of natural justice. It also noted that the rejection under Section 3(k) lacked adequate reasoning, with no proper analysis of whether the claim constituted a computer programme\u00a0per se<\/em>. Regarding Section 3(i), the Court observed that the IPO had failed to assess whether the invention directly disclosed pathology or merely enabled disease detection.<\/p>\n

Accordingly, the Court set aside the IPO\u2019s decision and remanded the matter to a different officer for de novo consideration, directing that a reasoned order be passed after giving CUHK a fair opportunity to respond to all objections, including the Section 10(4)(c) objection.<\/p>\n

Case II – University of Washington v. The Assistant Controller Of Patents And Designs<\/h5>\n

This case concerned the rejection of Indian Patent Application No. 201747006075, titled \u201cMethods of Determining Tissues and\/or Cell Types Giving Rise to Cell-Free DNA and Methods of Identifying a Disease or Disorder Using Same.\u201d The FER raised multiple objections under Sections 3(d), 3(i), and 3(k), and the application was ultimately rejected solely under Section 3(i), as it pertained to detection of tumor-derived cell-free DNA (cfDNA) in a biological sample.<\/p>\n

The University of Washington (\u201cUW\u201d) challenged the rejection, arguing that the method did not\u00a0per se<\/em>\u00a0disclose pathology, since the presence of cfDNA alone was not sufficient to diagnose a disease or disorder.<\/p>\n

The Madras High Court agreed with UW and found that the rejection order lacked any discussion of whether the invention inherently disclosed pathology. It reiterated that not every method relevant to diagnosis falls within Section 3(i); rather, the exclusion applies only where the invention\u00a0per se<\/em>\u00a0reveals diagnostic conclusions to a person skilled in the art.<\/p>\n

Accordingly, the Court set aside the impugned order and remanded the matter for fresh consideration by a different officer. The IPO was directed to reassess the application within four months and issue a reasoned order after affording UW a fair opportunity to be heard.<\/p>\n

Conclusion<\/h5>\n

The Court remanded both matters for fresh consideration in light of the clarified interpretation of Section 3(i). It reaffirmed that, for a process to be excluded as a \u2018diagnostic method\u2019 under Section 3(i) of the Patents Act, it must itself disclose or determine pathology\u00a0per se<\/em>.<\/p>\n

Citations<\/h5>\n

The Chinese University of Hong Kong vs The Assistant Controller Of Patents And Designs, (H.C. Madras March 13, 2025), CMA(PT)\/48\/2024<\/p>\n

Available at:\u00a0https:\/\/indiankanoon.org\/doc\/37795927\/<\/a><\/p>\n

University Of Washington vs The Assistant Controller Of Patents And Designs, (H.C. Madras March 13, 2025), CMA(PT)No.40 of 2023<\/p>\n

Available at:\u00a0https:\/\/indiankanoon.org\/doc\/184473926\/<\/a><\/p>\n

Article and Accessibility Review: Gaurav Mishra<\/p>\n","protected":false},"excerpt":{"rendered":"

In two recent decisions, the Madras High Court reversed patent application rejections under Section 3(i), clarifying that only diagnostic methods disclosing pathology per se fall within the exclusion. The Court remanded matters for fresh review, ensuring fair consideration and reasoned decisions by the IPO.<\/p>\n","protected":false},"author":6,"featured_media":135445,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":176,"footnotes":""},"categories":[6],"tags":[8377,42,50,8378,5733],"class_list":["post-135433","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-intellectual-property","tag-diagnostic-methods","tag-indian-patent-office","tag-patent-law","tag-pathology-disclosure","tag-section-3i"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/135433","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=135433"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/135433\/revisions"}],"predecessor-version":[{"id":135441,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/135433\/revisions\/135441"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media\/135445"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=135433"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=135433"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=135433"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}