{"id":629,"date":"2014-03-12T07:43:28","date_gmt":"2014-03-12T07:43:28","guid":{"rendered":"https:\/\/sagaciousresearch.com\/blog\/?p=629"},"modified":"2022-09-30T11:36:22","modified_gmt":"2022-09-30T11:36:22","slug":"novartis-ag-v-union-india-patent-case","status":"publish","type":"post","link":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case","title":{"rendered":"\u201cNovartis AG v Union of India\u201d Patent Case"},"content":{"rendered":"\n

In 2006, the Indian patent office had rejected the patent application for Novartis cancer drug<\/a>, \u201cGlivec\u201d on grounds that \u2013<\/p>\n\n\n\n

–<\/strong>    The original molecule imatinib was in public domain before 1995\u2014the cut-off year for grant of drug patents in India; and<\/p>\n\n\n\n

–<\/strong>     The crystal form did not demonstrate any enhanced efficacy to treat the disease.<\/p>\n\n\n\n

Later, Novartis challenged this decision before High Court at Madras stating that –<\/p>\n\n\n\n

1.  <\/strong>Section 3(d) is unconstitutional as it violates the provision of the TRIPS agreement; and<\/p>\n\n\n\n

2.  <\/strong>Indian patent act doesn’t define the term ‘efficacy’ and provides unguided power on the Controller.<\/p>\n\n\n\n

Court\u2019s Decision & Its Repercussions <\/strong><\/p>\n\n\n\n

In the rulings (by both Madras high court in 2006 and the apex court in April 2013), it was declared that –<\/p>\n\n\n\n

–    An incremental innovation in case of a drug product is patentable only if it demonstrates \u201cenhanced therapeutic efficacy<\/strong>\u201d.<\/p>\n\n\n\n

–    In case of any conflict between the norms and the patents act of 1970 and its rules, the act and rules will prevail<\/p>\n\n\n\n

So although the court\u2019s decision established that the Novartis’ patent application<\/a> for the beta-crystalline form of Imatinib Mesylate (polymorph B) did not pass the test of section 3(d), it failed to clearly define the scope of enhanced efficacy <\/strong>as well as rationalize why subject matter lacks enhanced efficacy.<\/p>\n\n\n\n

Thus, some amendments in the existing norms were much needed to bring in clarity that what counts as \u201cenhanced efficacy\u201d. <\/p>\n","protected":false},"excerpt":{"rendered":"

In 2006, the Indian patent office had rejected the patent application for Novartis cancer drug, \u201cGlivec\u201d on grounds that \u2013 –    The original molecule imatinib was in public domain before 1995\u2014the cut-off year...<\/p>\n","protected":false},"author":1,"featured_media":26553,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"coauthors":[],"class_list":["post-629","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"acf":[],"yoast_head":"\n\u201cNovartis AG v Union of India\u201d Patent Case - Sagacious IP<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u201cNovartis AG v Union of India\u201d Patent Case - Sagacious IP\" \/>\n<meta property=\"og:description\" content=\"In 2006, the Indian patent office had rejected the patent application for Novartis cancer drug, \u201cGlivec\u201d on grounds that \u2013 –    The original molecule imatinib was in public domain before 1995\u2014the cut-off year...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\" \/>\n<meta property=\"og:site_name\" content=\"Sagacious IP\" \/>\n<meta property=\"article:published_time\" content=\"2014-03-12T07:43:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-09-30T11:36:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2100\" \/>\n\t<meta property=\"og:image:height\" content=\"1400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Vilas Karnake\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Vilas Karnake\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#article\",\"isPartOf\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\"},\"author\":{\"name\":\"Vilas Karnake\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/person\/dfeb95b9b8a912029481236e877fc2a8\"},\"headline\":\"\u201cNovartis AG v Union of India\u201d Patent Case\",\"datePublished\":\"2014-03-12T07:43:28+00:00\",\"dateModified\":\"2022-09-30T11:36:22+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\"},\"wordCount\":253,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#organization\"},\"image\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg\",\"articleSection\":[\"Articles\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\",\"url\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\",\"name\":\"\u201cNovartis AG v Union of India\u201d Patent Case - Sagacious IP\",\"isPartOf\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg\",\"datePublished\":\"2014-03-12T07:43:28+00:00\",\"dateModified\":\"2022-09-30T11:36:22+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage\",\"url\":\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg\",\"contentUrl\":\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg\",\"width\":2100,\"height\":1400,\"caption\":\"Novartis\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/sagaciousresearch.com\/blog\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u201cNovartis AG v Union of India\u201d Patent Case\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#website\",\"url\":\"https:\/\/sagaciousresearch.com\/blog\/\",\"name\":\"Sagacious IP\",\"description\":\"Blog\",\"publisher\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/sagaciousresearch.com\/blog\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#organization\",\"name\":\"Sagacious IP\",\"url\":\"https:\/\/sagaciousresearch.com\/blog\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/06\/cropped-cropped-cropped-sagacious-ip-logo80-1-1.png\",\"contentUrl\":\"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/06\/cropped-cropped-cropped-sagacious-ip-logo80-1-1.png\",\"width\":481,\"height\":80,\"caption\":\"Sagacious IP\"},\"image\":{\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/person\/dfeb95b9b8a912029481236e877fc2a8\",\"name\":\"Vilas Karnake\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/person\/image\/d7edb6a9166e3680603701ae9e10e107\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/363be32d5f469b83f76184b09a333c02c746a62144121a8dcfc89b20ff076462?s=96&d=initials&r=g&initials=vk\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/363be32d5f469b83f76184b09a333c02c746a62144121a8dcfc89b20ff076462?s=96&d=initials&r=g&initials=vk\",\"caption\":\"Vilas Karnake\"},\"url\":\"https:\/\/sagaciousresearch.com\/blog\/author\/sagacious_blog\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u201cNovartis AG v Union of India\u201d Patent Case - Sagacious IP","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case","og_locale":"en_US","og_type":"article","og_title":"\u201cNovartis AG v Union of India\u201d Patent Case - Sagacious IP","og_description":"In 2006, the Indian patent office had rejected the patent application for Novartis cancer drug, \u201cGlivec\u201d on grounds that \u2013 –    The original molecule imatinib was in public domain before 1995\u2014the cut-off year...","og_url":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case","og_site_name":"Sagacious IP","article_published_time":"2014-03-12T07:43:28+00:00","article_modified_time":"2022-09-30T11:36:22+00:00","og_image":[{"width":2100,"height":1400,"url":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg","type":"image\/jpeg"}],"author":"Vilas Karnake","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Vilas Karnake","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#article","isPartOf":{"@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case"},"author":{"name":"Vilas Karnake","@id":"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/person\/dfeb95b9b8a912029481236e877fc2a8"},"headline":"\u201cNovartis AG v Union of India\u201d Patent Case","datePublished":"2014-03-12T07:43:28+00:00","dateModified":"2022-09-30T11:36:22+00:00","mainEntityOfPage":{"@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case"},"wordCount":253,"commentCount":0,"publisher":{"@id":"https:\/\/sagaciousresearch.com\/blog\/#organization"},"image":{"@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage"},"thumbnailUrl":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg","articleSection":["Articles"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#respond"]}]},{"@type":"WebPage","@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case","url":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case","name":"\u201cNovartis AG v Union of India\u201d Patent Case - Sagacious IP","isPartOf":{"@id":"https:\/\/sagaciousresearch.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage"},"image":{"@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage"},"thumbnailUrl":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg","datePublished":"2014-03-12T07:43:28+00:00","dateModified":"2022-09-30T11:36:22+00:00","breadcrumb":{"@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#primaryimage","url":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg","contentUrl":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2014\/03\/10-1.jpg","width":2100,"height":1400,"caption":"Novartis"},{"@type":"BreadcrumbList","@id":"https:\/\/sagaciousresearch.com\/blog\/novartis-ag-v-union-india-patent-case#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/sagaciousresearch.com\/blog\/"},{"@type":"ListItem","position":2,"name":"\u201cNovartis AG v Union of India\u201d Patent Case"}]},{"@type":"WebSite","@id":"https:\/\/sagaciousresearch.com\/blog\/#website","url":"https:\/\/sagaciousresearch.com\/blog\/","name":"Sagacious IP","description":"Blog","publisher":{"@id":"https:\/\/sagaciousresearch.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/sagaciousresearch.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/sagaciousresearch.com\/blog\/#organization","name":"Sagacious IP","url":"https:\/\/sagaciousresearch.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/06\/cropped-cropped-cropped-sagacious-ip-logo80-1-1.png","contentUrl":"https:\/\/sagaciousresearch.com\/blog\/wp-content\/uploads\/2022\/06\/cropped-cropped-cropped-sagacious-ip-logo80-1-1.png","width":481,"height":80,"caption":"Sagacious IP"},"image":{"@id":"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/person\/dfeb95b9b8a912029481236e877fc2a8","name":"Vilas Karnake","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/sagaciousresearch.com\/blog\/#\/schema\/person\/image\/d7edb6a9166e3680603701ae9e10e107","url":"https:\/\/secure.gravatar.com\/avatar\/363be32d5f469b83f76184b09a333c02c746a62144121a8dcfc89b20ff076462?s=96&d=initials&r=g&initials=vk","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/363be32d5f469b83f76184b09a333c02c746a62144121a8dcfc89b20ff076462?s=96&d=initials&r=g&initials=vk","caption":"Vilas Karnake"},"url":"https:\/\/sagaciousresearch.com\/blog\/author\/sagacious_blog"}]}},"_links":{"self":[{"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/posts\/629","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/comments?post=629"}],"version-history":[{"count":1,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/posts\/629\/revisions"}],"predecessor-version":[{"id":631,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/posts\/629\/revisions\/631"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/media\/26553"}],"wp:attachment":[{"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/media?parent=629"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/categories?post=629"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/tags?post=629"},{"taxonomy":"categories","embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/categories?post=629"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/sagaciousresearch.com\/blog\/wp-json\/wp\/v2\/coauthors?post=629"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}