{"id":28075,"date":"2024-02-19T06:51:20","date_gmt":"2024-02-19T06:51:20","guid":{"rendered":"https:\/\/edukemy.com\/blog\/?p=28075"},"modified":"2024-02-19T06:51:22","modified_gmt":"2024-02-19T06:51:22","slug":"bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate","status":"publish","type":"post","link":"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/","title":{"rendered":"Bring out the circumstances in 2005 which forced amendment to section 3(d) in the Indian Patent Law, 1970. Discuss how it has been utilized by the Supreme court in its judgment rejecting Novartis patent application for \u201cGlivec \u201c. Discuss briefly the pros and cons of the decision. (250 Words, 15 Marks)"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><a href=\"https:\/\/edukemy.com\/upsc\/upsc-gs-advance-and-mentorship-program-ampcsat?utm_source=Blog&amp;utm_medium=Link&amp;utm_campaign=GS+Advanced\" target=\"_blank\" rel=\"noreferrer noopener\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1280\" height=\"300\" src=\"https:\/\/edukemy.com\/blog\/wp-content\/uploads\/2024\/07\/Attempt-our-Daily-Weekly-Current-Affairs-Quiz-now-8.png\" alt=\"\" class=\"wp-image-43397\" srcset=\"https:\/\/edukemy.com\/blog\/wp-content\/uploads\/2024\/07\/Attempt-our-Daily-Weekly-Current-Affairs-Quiz-now-8.png 1280w, https:\/\/edukemy.com\/blog\/wp-content\/uploads\/2024\/07\/Attempt-our-Daily-Weekly-Current-Affairs-Quiz-now-8-1170x274.png 1170w, https:\/\/edukemy.com\/blog\/wp-content\/uploads\/2024\/07\/Attempt-our-Daily-Weekly-Current-Affairs-Quiz-now-8-585x137.png 585w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" \/><\/a><\/figure><\/div>\n\n\n<p>In 2005, significant circumstances prompted the amendment to Section 3(d) of the Indian Patent Law, 1970. This provision was introduced to address concerns regarding evergreening, a practice where pharmaceutical companies extend patent protection by making minor modifications to existing drugs. The amendment aimed to ensure that patents were granted only for genuine innovations rather than trivial modifications. This became particularly relevant in the case of Novartis&#8217; patent application for &#8220;Glivec,&#8221; a cancer drug. The Supreme Court of India utilized Section 3(d) in its landmark judgment to reject Novartis&#8217; patent application, citing that Glivec did not demonstrate enhanced efficacy over existing formulations, merely involving a modification in the salt form. The court&#8217;s decision was lauded for upholding the intent of the law to promote access to affordable medicines by preventing the monopolization of essential drugs. It set a precedent that prioritized public health over pharmaceutical profits and encouraged innovation in genuinely beneficial drugs. However, the decision also sparked debate over its potential impact on research and development investments. Critics argued that stringent patent laws might discourage pharmaceutical companies from investing in developing new drugs, fearing that their innovations could be easily replicated or rejected under similar circumstances. Balancing the interests of innovation, public health, and accessibility remains a challenge, and the Glivec case serves as a pivotal example in navigating these complex dynamics within the framework of patent law in India.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p><strong>Tag: <\/strong>Issues relating to intellectual property rights.\u00a0\u00a0<\/p><\/blockquote>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_73 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<label for=\"ez-toc-cssicon-toggle-item-6a1f813d26fc6\" class=\"ez-toc-cssicon-toggle-label\"><p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-cssicon\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" 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: #999;color:#999\" 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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a1f813d26fc6\"  \/><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:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#Decoding_the_Question\" title=\"Decoding the Question:&nbsp;&nbsp;&nbsp;\">Decoding the Question:&nbsp;&nbsp;&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#Answer\" title=\"Answer:&nbsp;&nbsp;&nbsp;\">Answer:&nbsp;&nbsp;&nbsp;<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#The_applicant_in_the_present_appeal_contented_on_two_issues\" title=\"The applicant in the present appeal contented on two issues:&nbsp;&nbsp;\">The applicant in the present appeal contented on two issues:&nbsp;&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#In_response_to_the_above_contention_the_Court_held_that\" title=\"In response to the above contention the Court held that:&nbsp;&nbsp;\">In response to the above contention the Court held that:&nbsp;&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#Appraisal_of_the_Decision\" title=\"Appraisal of the Decision:&nbsp;&nbsp;&nbsp;\">Appraisal of the Decision:&nbsp;&nbsp;&nbsp;<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#In_case_you_still_have_your_doubts_contact_us_on_9811333901\" title=\"In case you still have your doubts, contact us on 9811333901.&nbsp;\">In case you still have your doubts, contact us on 9811333901.&nbsp;<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/edukemy.com\/blog\/bring-out-the-circumstances-in-2005-which-forced-amendment-to-section-3d-in-the-indian-patent-law-1970-discuss-how-it-has-been-utilized-by-the-supreme-court-in-its-judgment-rejecting-novartis-pate\/#Visit_our_YouTube_Channel_%E2%80%93_here\" title=\"Visit our YouTube Channel &#8211;&nbsp;here\">Visit our YouTube Channel &#8211;&nbsp;here<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Decoding_the_Question\"><\/span><strong>Decoding the Question:&nbsp;<\/strong>&nbsp;&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>In Intro try to define the patent system.&nbsp;<\/strong>&nbsp;&nbsp;<\/li><li><strong>In Body,<\/strong>&nbsp;&nbsp;<\/li><li><strong>Discuss about Indian Patent Act 1970 and explain Section 3 of the act.<\/strong>&nbsp;&nbsp;<\/li><li><strong>In the second part of the answer you need to discuss the Novartis VS Union of India case and explain how the Supreme court used section 3 of the act to strike down Novartis&#8217; claim.&nbsp;<\/strong>&nbsp;&nbsp;<\/li><li><strong>Try to Conclude with WHO\u2019s Public Health,Innovation and Intellectual Property Rights Report, 2006, with underlining significant of judgement for masses<\/strong>&nbsp;&nbsp;<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Answer\"><\/span><strong>Answer:&nbsp;<\/strong>&nbsp;&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A patent system is a type of contract between the inventor\/creator and authority whereby the creator gets exclusive rights for 20 years in return for disclosing full details of the invention. The main purpose of the patent system is to encourage innovation and eventually result in technological development.\u00a0\u00a0<\/p>\n\n\n\n<p><strong>Indian Scenario: <\/strong>The present Patents Act, 1970 came into force in the year 1972 and amended through the Patent (Amendment) Act 2005. The Amendment to the Act brought following changes:\u00a0\u00a0\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Section 3(d)<\/strong> was introduced and introduced pharmaceutical product patents in India.\u00a0\u00a0\u00a0<\/li><li>The Act 2005 defines what invention is and makes it clear that any existing knowledge or thing cannot be patented.\u00a0\u00a0\u00a0<\/li><li>The provision defines a \u2018novelty\u2019 standard &#8211; which, along with \u2018non-obviousness\u2019 or \u2018inventive step\u2019 and industrial applicability, are the three prerequisites for \u2018patentability\u2019.\u00a0\u00a0\u00a0<\/li><li>\u201cDiscovery\u201d essentially refers to finding something which already existed in nature but was unknown or unrecognized.\u00a0\u00a0\u00a0<\/li><\/ul>\n\n\n\n<p>The most recent case, <strong><em>Novartis AG v Union of India5<\/em><\/strong> decided by the Supreme Court of India in 2013 where the case began in the year 1997 related to drug name <strong>GLIVEC <\/strong>which was slightly a different version of their 1993 patent for ANTI LEUKAEMIA drug.&nbsp; In this case the petitioner challenged the constitutionality of section 3(d) before the High Court at Madras.&nbsp;&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_applicant_in_the_present_appeal_contented_on_two_issues\"><\/span><strong>The applicant in the present appeal contented on two issues:<\/strong>&nbsp;&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>Section 3(d) of the Act is unconstitutional as it violates the provision of the TRIPS agreement.&nbsp;&nbsp;<\/li><li>The Indian patent act doesn&#8217;t define the term &#8216;efficacy&#8217; and provides unguided power on the Controller. Hence it is arbitrary, illogical and vague.&nbsp;&nbsp;<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"In_response_to_the_above_contention_the_Court_held_that\"><\/span><strong>In response to the above contention the Court held that:<\/strong>&nbsp;&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>The WTO&#8217;s Dispute Settlement provides the exclusive remedy and a comprehensive dispute mechanism for violation of TRIPS Agreement. The High Court looked into the conflict between the international law and municipal law and decided that municipal law prevails in such conflict.&nbsp;&nbsp;<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Appraisal_of_the_Decision\"><\/span><strong>Appraisal of the Decision:&nbsp;<\/strong>&nbsp;&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>It was initially considered that such a case can affect the invention zeal in pharma companies and R&amp;D will suffer. Also, clouds of unfavorable conditions for FDI in the pharma sector were expected.&nbsp;&nbsp;<\/li><li>The provision under section 3(d) has been approved by&nbsp; WHO Public Health,Innovation and Intellectual Property Rights Report, 2006, that countries can adopt legislation and examination guidelines requiring a level of inventiveness that<strong> would prevent ever-greening patents<\/strong> from being granted.&nbsp;&nbsp;&nbsp;<\/li><li>Further, Section 3(d) prevents frivolous patenting without neglecting valuable incremental innovations in pharmaceuticals and is very well <strong>compatible with TRIPS agreement<\/strong>.&nbsp;&nbsp;<\/li><\/ul>\n\n\n\n<p>The ruling of the Novartis\u2019s case in Indian patent law represents a major victory for community\u2019s access to inexpensive medicines in developing countries and influences the <strong>access of medicines to the poor.<\/strong>\u00a0\u00a0<\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/edukemy.com\/upsc\/upsc-essay?utm_source=Blog&amp;utm_medium=Banner&amp;utm_campaign=Essay\" target=\"_blank\" rel=\"noreferrer noopener\"><img decoding=\"async\" data-src=\"https:\/\/edukemy.com\/blog\/wp-content\/uploads\/2024\/06\/UPSC-Essay-Course-1280\u00d7300-1-3.svg\" alt=\"\" class=\"wp-image-42688 lazyload\" width=\"781\" height=\"182\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 781px; --smush-placeholder-aspect-ratio: 781\/182;\" \/><\/a><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"block-0852e8d9-d77d-4f32-b617-621718b5dbf9\"><span class=\"ez-toc-section\" id=\"In_case_you_still_have_your_doubts_contact_us_on_9811333901\"><\/span><strong>In case you still have your doubts, contact us on 9811333901.<\/strong>&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p id=\"block-f1a56b80-b7b4-4135-a37b-2aa2660d6bfd\">For UPSC Prelims Resources,&nbsp;<a href=\"https:\/\/edukemy.com\/upsc-cse-prelims-resource-centre\" target=\"_blank\" rel=\"noreferrer noopener\">Click here<\/a><\/p>\n\n\n\n<p id=\"block-ac11dd41-cc2b-4afd-b9df-7cc51084d393\">For Daily Updates and Study Material:<\/p>\n\n\n\n<p id=\"block-3285c649-2f18-4f86-b863-9ca055737fe0\">Join our Telegram Channel &#8211;&nbsp;<a href=\"https:\/\/t.me\/WithEdukemy4IAS\" target=\"_blank\" rel=\"noreferrer noopener\">Edukemy for IAS<\/a><\/p>\n\n\n\n<ul class=\"wp-block-list\" id=\"block-a98aa02f-712e-4117-a211-d368b2ee4be7\"><li>1. Learn through Videos &#8211;&nbsp;<a href=\"https:\/\/bit.ly\/3vOD8sU\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/li><li>2. Be Exam Ready by Practicing Daily MCQs &#8211;&nbsp;<a href=\"https:\/\/bit.ly\/3Q9z2nF\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/li><li>3. Daily Newsletter &#8211; Get all your Current Affairs Covered &#8211;&nbsp;<a href=\"https:\/\/bit.ly\/3bE2y5J\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/li><li>4. Mains Answer Writing Practice &#8211;&nbsp;<a href=\"https:\/\/bit.ly\/3mZuVxl\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"block-e2cb2cad-5b82-4c27-b2a1-13223c909d62\"><span class=\"ez-toc-section\" id=\"Visit_our_YouTube_Channel_%E2%80%93_here\"><\/span>Visit our YouTube Channel &#8211;&nbsp;<a href=\"https:\/\/www.youtube.com\/@ShabbirsEduKemyforIAS\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a><span class=\"ez-toc-section-end\"><\/span><\/h4>\n","protected":false},"excerpt":{"rendered":"<p>In 2005, significant circumstances prompted the amendment to Section 3(d) of the Indian Patent Law, 1970. This provision was introduced to address concerns regarding evergreening<\/p>\n","protected":false},"author":17,"featured_media":28076,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_eb_attr":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[1524],"tags":[2053,142,232,145,140],"class_list":["post-28075","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-upsc-mains-solved-paper-gs-3","tag-indian-patent-law","tag-previous_year_questions","tag-upsc","tag-upsc-mains-question-paper","tag-upsc_preparation_strategy"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/posts\/28075","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/users\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/comments?post=28075"}],"version-history":[{"count":1,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/posts\/28075\/revisions"}],"predecessor-version":[{"id":28077,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/posts\/28075\/revisions\/28077"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/media\/28076"}],"wp:attachment":[{"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/media?parent=28075"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/categories?post=28075"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/edukemy.com\/blog\/wp-json\/wp\/v2\/tags?post=28075"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}