{"id":10498,"date":"2025-10-21T10:55:03","date_gmt":"2025-10-21T10:55:03","guid":{"rendered":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/?p=10498"},"modified":"2025-10-21T11:00:08","modified_gmt":"2025-10-21T11:00:08","slug":"diagnostic-processes-and-patent-eligibility","status":"publish","type":"post","link":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/","title":{"rendered":"Diagnostic Processes and Patent Eligibility"},"content":{"rendered":"<h2><span class=\"ez-toc-section\" id=\"EMD_Millipore_Corporation_Vs_Assistant_Controller_of_Patents_and_Designs_%E2%80%93_Case_Summary\"><\/span>EMD Millipore Corporation Vs Assistant Controller of Patents and Designs &#8211; Case Summary<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h2 id=\"case-fact\"><span class=\"ez-toc-section\" id=\"Fact\"><\/span>Fact<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The appellant, <b>EMD Millipore Corporation<\/b>, a U.S.-based corporation, filed a patent application bearing No. 1026\/DEL\/2012 in India on <b>3rd April 2012<\/b> titled <i>&#8220;Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules.&#8221;<\/i> The invention concerns a method for the quantitative analysis of biomolecules in various types of samples, including human plasma, food, cosmetics, and environmental samples using infrared spectroscopy.<\/p><div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #0c0c0c;color:#0c0c0c\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #0c0c0c;color:#0c0c0c\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#EMD_Millipore_Corporation_Vs_Assistant_Controller_of_Patents_and_Designs_%E2%80%93_Case_Summary\" >EMD Millipore Corporation Vs Assistant Controller of Patents and Designs &#8211; Case Summary<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Fact\" >Fact<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Procedural_Detail\" >Procedural Detail<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Dispute\" >Dispute<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Detailed_Reasoning\" >Detailed Reasoning<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Analysis_of_Section_3i\" >Analysis of Section 3(i)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Clarifications_by_the_Court\" >Clarifications by the Court<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Examination_of_the_Appellants_Invention\" >Examination of the Appellant\u2019s Invention<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Conclusion\" >Conclusion<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Amendment_of_Claims\" >Amendment of Claims<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Decision\" >Decision<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Case_Summary\" >Case Summary<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Disclaimer\" >Disclaimer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.legalserviceindia.com\/Legal-Articles\/diagnostic-processes-and-patent-eligibility\/#Written_By\" >Written By<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>The appellant claimed priority from a U.S. patent application and amended the claims multiple times during prosecution, finally seeking patent protection for a technical innovation. The key object of the invention was to improve efficiency in IR spectroscopic analysis by reducing repeated calibration and enabling reuse of calibration data.<\/p>\n<p>Despite amendments to overcome objections, the Assistant Controller of Patents and Designs refused the application by order dated <b>18th February 2021<\/b> on the ground that the claims fall under the non-patentable subject matter exclusion of <b>Section 3(i)<\/b> of the <b>Indian Patents Act, 1970<\/b>, which excludes diagnostic processes from patentability.<\/p>\n<h2 id=\"procedural-detail\"><span class=\"ez-toc-section\" id=\"Procedural_Detail\"><\/span>Procedural Detail<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The appellant challenged the refusal under <b>Section 117A<\/b> of the Patents Act before the <b>High Court of Delhi<\/b>. The appeal proceeded through multiple hearings from 2021 onwards. The court sought additional reports from the patent office concerning the novelty and inventive step of the claims.<\/p>\n<p>A significant issue considered was the correct interpretation and scope of the exclusion clause under Section 3(i) of the Act, which bars patentability of diagnostic methods. The court appointed an <b>Amicus Curiae<\/b> to assist with submissions on complexity related to the interpretation of Section 3(i).<\/p>\n<p>The matter involved detailed examination of foreign jurisprudence, including decisions from the <b>European Patent Office (EPO)<\/b> on exclusions for diagnostic methods. Judgment was reserved in December 2024 and pronounced in October 2025.<\/p>\n<h2 id=\"dispute\"><span class=\"ez-toc-section\" id=\"Dispute\"><\/span>Dispute<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The fundamental dispute centered on whether the subject invention qualifies as a diagnostic process excluded from patentability under Section 3(i) of the Patents Act or whether it qualifies as a patentable technical method.<\/p>\n<ul>\n<li>The appellant contended that the invention was an innovative technical process improving IR spectroscopic quantitation applicable across industries and should not be barred.<\/li>\n<li>The respondent argued that the invention was a diagnostic method within the scope of Section 3(i) and thus non-patentable, emphasizing that the exclusion applies broadly to diagnostic methods regardless of their <i>in vivo<\/i> or <i>in vitro<\/i> nature.<\/li>\n<\/ul>\n<p>Issues surrounding the legislative history of Section 3(i), international obligations under TRIPS, and Indian patent policy balancing innovation and public health were also debated.<\/p>\n<h2 id=\"detailed-reasoning\"><span class=\"ez-toc-section\" id=\"Detailed_Reasoning\"><\/span>Detailed Reasoning<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The court undertook a comprehensive examination of the legal framework, including Indian patent law, legislative history, and international precedents.<\/p>\n<h3 id=\"section-3i-analysis\"><span class=\"ez-toc-section\" id=\"Analysis_of_Section_3i\"><\/span>Analysis of Section 3(i)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The court noted that Section 3(i) of the Patents Act excludes:<\/p>\n<blockquote><p>\u201cAny process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.\u201d<\/p><\/blockquote>\n<p>The appellate court analyzed the corresponding provisions in foreign jurisdictions such as:<\/p>\n<ul>\n<li>The UK&#8217;s Patents Act 1977<\/li>\n<li>Article 53(c) EPC 2000<\/li>\n<li>Jurisprudence from the EPO\u2019s Enlarged Board of Appeal (notably Case G 000104)<\/li>\n<\/ul>\n<p>The court emphasized that diagnostic methods excluded under these laws are typically multistep processes involving:<\/p>\n<ol>\n<li>Examination<\/li>\n<li>Data gathering<\/li>\n<li>Comparison<\/li>\n<li>Symptom detection<\/li>\n<li>Clinical decision-making practiced directly on the human or animal body<\/li>\n<\/ol>\n<h3 id=\"clarifications\"><span class=\"ez-toc-section\" id=\"Clarifications_by_the_Court\"><\/span>Clarifications by the Court<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>It was clarified that the exclusion&#8217;s purpose was to free medical practitioners from patent constraints when applying core diagnostic procedures requiring professional judgment and bearing health risks.<\/p>\n<p>However, patentability is not barred for diagnostic tools, instruments, or technical processes that do not themselves constitute a diagnostic method practiced on the living body.<\/p>\n<h3 id=\"invention-analysis\"><span class=\"ez-toc-section\" id=\"Examination_of_the_Appellants_Invention\"><\/span>Examination of the Appellant\u2019s Invention<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The court thoroughly examined the appellant&#8217;s patent claims and specifications, observing that the invention was directed to an <b>in vitro technical process<\/b> using infrared spectroscopy for biomolecular quantitation on samples including cosmetics, food, water, and fuels.<\/p>\n<h2 id=\"conclusion\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The court concluded the invention did not involve any step constituting diagnosis for curative purposes or clinical decision-making performed on or practiced on a human or animal body.<\/p>\n<p>The method improved the technical aspect of IR spectroscopic measurement rather than the intellectual exercise of diagnosis itself. Furthermore, the court noted that the patent had been granted in jurisdictions including the United States and Europe, where comparable exclusions exist, supporting its patentability.<\/p>\n<p>The role and intent of Section 3(i) were revisited in light of legislative history and international trade commitments under TRIPS. The court held that the section was intended to exclude medical procedures requiring practitioner skill and direct interaction with the patient, but not to bar patents on inventions involving technical methods or devices that facilitate analysis or diagnostics without constituting a disallowed diagnostic method.<\/p>\n<h3 id=\"amendment-issue\"><span class=\"ez-toc-section\" id=\"Amendment_of_Claims\"><\/span>Amendment of Claims<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The court also discussed the permissibility of claim amendments during appeals under <b>Section 59<\/b> of the Act, confirming that amendments clarifying or narrowing claims within the original disclosure are allowed. The appellant&#8217;s amendments were found to be within permissible limits and did not expand the scope of the invention.<\/p>\n<h2 id=\"decision\"><span class=\"ez-toc-section\" id=\"Decision\"><\/span>Decision<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The appeal was allowed. The impugned order refusing the patent application was set aside, as the claimed invention does not fall within the exclusion of Section 3(i) of the Patents Act.<\/p>\n<p>The court directed the patent office to proceed with the grant of the patent to the appellant after completion of formalities. The exclusion applies narrowly to core diagnostic processes practiced on the human or animal body and does not extend to technical innovations or in vitro processes.<\/p>\n<p>The appellant&#8217;s method for IR-based quantitation of biomolecules therefore qualifies for patent protection.<\/p>\n<p>The court relied heavily on the <b>Enlarged Board of Appeal, EPO decision G 000104<\/b>, setting out the multi-step definitional framework for diagnostic methods and the distinction between <i>in vivo<\/i> diagnostic processes and technical methods or tools.<\/p>\n<p>In sum, the judgment clearly elucidates the boundary between non-patentable diagnostic processes and patentable technical innovations, guiding future patent prosecution in medical technology fields in India.<\/p>\n<h2 id=\"case-summary\"><span class=\"ez-toc-section\" id=\"Case_Summary\"><\/span>Case Summary<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"6\">\n<tbody>\n<tr>\n<th>Case Title<\/th>\n<td>EMD Millipore Corporation Vs Assistant Controller of Patents and Designs<\/td>\n<\/tr>\n<tr>\n<th>Order Date<\/th>\n<td>9th October 2025<\/td>\n<\/tr>\n<tr>\n<th>Case Number<\/th>\n<td>C.A.COMM.IPD-PAT 7\/2021<\/td>\n<\/tr>\n<tr>\n<th>Neutral Citation<\/th>\n<td>2025:DHC:8928<\/td>\n<\/tr>\n<tr>\n<th>Court<\/th>\n<td>High Court of Delhi at New Delhi<\/td>\n<\/tr>\n<tr>\n<th>Hon&#8217;ble Judge<\/th>\n<td>Justice Prathiba M. Singh<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 id=\"disclaimer\"><span class=\"ez-toc-section\" id=\"Disclaimer\"><\/span>Disclaimer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.<\/p>\n<h2 id=\"author\"><span class=\"ez-toc-section\" id=\"Written_By\"><\/span>Written By<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Advocate Ajay Amitabh Suman<\/b>, IP Adjutor (Patent and Trademark Attorney), High Court of Delhi<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMD Millipore Corporation Vs Assistant Controller of Patents and Designs &#8211; Case Summary Fact The appellant, EMD Millipore Corporation, a U.S.-based corporation, filed a patent application bearing No. 1026\/DEL\/2012 in India on 3rd April 2012 titled &#8220;Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules.&#8221; The invention concerns a method for the quantitative analysis<\/p>\n","protected":false},"author":56,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"two_page_speed":[],"_jetpack_memberships_contains_paid_content":false,"_joinchat":[],"footnotes":""},"categories":[21],"tags":[28],"class_list":{"0":"post-10498","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-intellectual-property","7":"tag-top-news"},"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/10498","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/users\/56"}],"replies":[{"embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/comments?post=10498"}],"version-history":[{"count":0,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/posts\/10498\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/media?parent=10498"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/categories?post=10498"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.legalserviceindia.com\/Legal-Articles\/wp-json\/wp\/v2\/tags?post=10498"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}