{"id":75350,"date":"2021-01-04T18:25:32","date_gmt":"2021-01-04T12:55:32","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=75350"},"modified":"2021-01-05T15:38:42","modified_gmt":"2021-01-05T10:08:42","slug":"impact-of-diluting-disclosure-requirement-in-patent-rules-2003","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/impact-of-diluting-disclosure-requirement-in-patent-rules-2003\/","title":{"rendered":"Impact of Diluting disclosure requirement in Patent Rules, 2003"},"content":{"rendered":"<p><b><span data-contrast=\"none\">Synopsis:\u00a0<\/span><\/b><span data-contrast=\"none\">The dilution of patent working disclosure rules obstructs the success of India\u2019s compulsory licensing regime.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">Background\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">According to the new Patent Rules, 2020, licensees are\u00a0<\/span><b><span data-contrast=\"none\">no longer required to annually submit to the Patent Office<\/span><\/b><span data-contrast=\"none\">\u00a0disclosing the degree to which they have commercially worked or made the patented inventions available to the public in the country.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">What were the requirement of disclosure in Patent Rules, 2003?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:360,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The purpose of granting patents itself is to ensure that the inventions are operated in India and are made available to the public in adequate amounts at rational prices.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"20\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">The information about\u00a0<\/span><b><span data-contrast=\"none\">the degree at which these patentees are operating in India<\/span><\/b><span data-contrast=\"none\">\u00a0is very important to check abuse of patent monopoly. For example, excessive pricing or scare supply of the invention<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"20\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"2\"><b><span data-contrast=\"none\">Courts have refused a temporary ban in cases<\/span><\/b><span data-contrast=\"none\">\u00a0charging violation of a patent which has not been operated in India.\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:1440,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"20\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><b><span data-contrast=\"none\">Section 146 (2)<\/span><\/b><span data-contrast=\"none\">\u00a0asks every licensee to submit to the Patent Office an annual statement explaining the extent to which they have worked the invention in India was not found in patent laws.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"20\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"2\"><b><span data-contrast=\"none\">\u00a0The disclosure is to be made in the Form 27<\/span><\/b><span data-contrast=\"none\">\u00a0format as suggested under the Patent Rules, 2003.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:1440,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b><span data-contrast=\"none\">Irregularities and PIL filed<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"21\" aria-setsize=\"-1\" data-aria-posinset=\"5\" data-aria-level=\"1\"><b><span data-contrast=\"none\">The amendment to the form was made after a PIL<\/span><\/b><span data-contrast=\"none\">\u00a0was filed by\u00a0Shamnad\u00a0Basheer before the Delhi High Court in 2015. The PIL was about the non-filing and defective filing of Form 27 by licensees and wanted an action against the violators.\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"21\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\"><b><span data-contrast=\"none\">The PIL also called for a reform of Form 27<\/span><\/b><span data-contrast=\"none\">\u00a0because the information it sought was totally insufficient to determine the level of the working of the patent.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"21\" aria-setsize=\"-1\" data-aria-posinset=\"7\" data-aria-level=\"1\"><span data-contrast=\"none\">Court directed the government to bring an amendment to strengthened the patent working disclosure rules.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"21\" aria-setsize=\"-1\" data-aria-posinset=\"8\" data-aria-level=\"1\"><span data-contrast=\"none\">However, after 2 years, instead of strengthening, government introduced an amendment that dilutes the disclosure requirements.\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"none\">How government changed the disclosure requirement?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The amendment in patent laws has considerably weakened it and is defeating the whole purpose of the amendment exercise. The requirement of submitting a lot of important information was removed. The form now requires the patentees to provide only for the following information:\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"22\" aria-setsize=\"-1\" data-aria-posinset=\"9\" data-aria-level=\"1\"><b><span data-contrast=\"none\">Firstly,<\/span><\/b><span data-contrast=\"none\">\u00a0whether the invention has worked or not and the revenue generated from it (manufacturing and importing). Reasons for the invention not working and the steps being taken towards it to make it work.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"22\" aria-setsize=\"-1\" data-aria-posinset=\"10\" data-aria-level=\"1\"><b><span data-contrast=\"none\">Secondly,<\/span><\/b><span data-contrast=\"none\">\u00a0they don\u2019t have to provide data about the amount of the invention manufactured in India and imported which is vital for proper assessment.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"22\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"2\"><b><span data-contrast=\"none\">Licensees can just self-certify<\/span><\/b><span data-contrast=\"none\">\u00a0that they\u2019ve worked the patent without having to prove the claim with the data on how they\u2019ve done it, including through licensing\/sub-licensing the patent.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:1440,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"21\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"2\"><b><span data-contrast=\"none\">For instance,<\/span><\/b><span data-contrast=\"none\">\u00a0the disclosure of this data by Bayer in Form 27 played a crucial role in grant of India\u2019s first compulsory license to Natco for the anti-cancer drug Sorafenib\/Nexavar.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:1440,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b><span data-contrast=\"none\">What are its impacts?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"23\" aria-setsize=\"-1\" data-aria-posinset=\"11\" data-aria-level=\"1\"><span data-contrast=\"none\">Doing away with the condition of providing inventions for public requirement at a reasonable price, will have negative impacts on the affordability of new medicines in India.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"23\" aria-setsize=\"-1\" data-aria-posinset=\"12\" data-aria-level=\"1\"><span data-contrast=\"none\">Doing away with the condition to disclose price and demand will make it difficult to assess the quantum of invention made available to the public in sufficient quantity and at an affordable price.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"none\">Conclusion<\/span><\/b><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:360,&quot;335559739&quot;:200,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25aa\" data-font=\"Noto Sans Symbols\" data-listid=\"23\" aria-setsize=\"-1\" data-aria-posinset=\"13\" data-aria-level=\"1\"><span data-contrast=\"none\">The government must reconsider its amendments as it is going to\u00a0<\/span><b><span data-contrast=\"none\">impact public interest<\/span><\/b><span data-contrast=\"none\">. Some inventions may remain inaccessible to public because of the lack of information. Such lack of accessibility in case of patented medicines could have adverse consequences for public health of the country.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Synopsis:\u00a0The dilution of patent working disclosure rules obstructs the success of India\u2019s compulsory licensing regime.\u00a0 Background\u00a0\u00a0 According to the new Patent Rules, 2020, licensees are\u00a0no longer required to annually submit to the Patent Office\u00a0disclosing the degree to which they have commercially worked or made the patented inventions available to the public in the country.\u00a0 What&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/impact-of-diluting-disclosure-requirement-in-patent-rules-2003\/\">Continue reading <span class=\"screen-reader-text\">Impact of Diluting disclosure requirement in Patent Rules, 2003<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":75358,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1230,1351,1310,9],"tags":[1436],"class_list":["post-75350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-9-pm-daily-articles","category-daily-news","category-daily-news-updates","category-public","tag-st_7","entry"],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2021\/01\/Impact-of-Diluting-disclosure-requirement-in-Patent-Rules-2003.jpg?fit=1280%2C720&ssl=1","views":{"total":0,"cached_at":1700773639,"cached_date":1704834319},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/75350","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=75350"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/75350\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media\/75358"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=75350"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=75350"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=75350"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}