{"id":5179,"date":"2021-05-15T07:03:38","date_gmt":"2021-05-15T07:03:38","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=5179"},"modified":"2021-05-15T07:03:40","modified_gmt":"2021-05-15T07:03:40","slug":"patent-compulsory-licensing","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/patent-compulsory-licensing\/","title":{"rendered":"What is the Concept of Patent Compulsory Licensing?"},"content":{"rendered":"\n<p>In simple words, Patent compulsory licensing is an approval given to a third party by the Government to sell, make, or use a specific product or use a specific process that has been patented without the requirement of the patent owner\u2019s permission. The provisions concerning compulsory licensing are given in the <strong><em>Indian Patents Act, 1970<\/em><\/strong><sup><a rel=\"noreferrer noopener\" href=\"https:\/\/ipindia.gov.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup><strong><em> <\/em><\/strong>and in the TRIPS Agreement at the global level. Although this works against the Patent owner, usually compulsory licenses are only considered in some cases of health and national emergency. There are some vital conditions that should be fulfilled if the Government desire to issue a compulsory license in favour of someone.<\/p>\n\n\n\n<p>Under\nthe Patents Act, 1970, the provisions of compulsory licenses are precisely\nprescribed under Chapter XVI. The circumstances that need to be fulfilled are\nprescribed under Section 84-92 of the Indian Patents Act, 1970. Scroll down to\ncheck more information regarding Patent Compulsory Licensing.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3a55c14a0bc\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><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-6a3a55c14a0bc\"  aria-label=\"Toggle\" \/><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:\/\/swaritadvisors.com\/blog\/patent-compulsory-licensing\/#Section_84_Patent_Compulsory_Licensing\" title=\"Section\n84: Patent Compulsory Licensing\">Section\n84: Patent Compulsory Licensing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/blog\/patent-compulsory-licensing\/#Global_Viewpoint_on_Patent_Compulsory_Licensing\" title=\"Global Viewpoint on Patent Compulsory Licensing\">Global Viewpoint on Patent Compulsory Licensing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/blog\/patent-compulsory-licensing\/#What_are_the_Impacts_of_Patent_Compulsory_Licensing\" title=\"What\nare the Impacts of Patent Compulsory Licensing?\">What\nare the Impacts of Patent Compulsory Licensing?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/swaritadvisors.com\/blog\/patent-compulsory-licensing\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Section_84_Patent_Compulsory_Licensing\"><\/span>Section\n84: Patent Compulsory Licensing<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After the expiration of 3 years from the date of <strong><a href=\"https:\/\/swaritadvisors.com\/patent-registration\" class=\"text-primary\">Patent Registration<\/a><\/strong>, any individual interested can file an application to the Controller for the issuance of compulsory license on Patent of the following grounds, namely: <\/p>\n\n\n\n<ul><li>That the patented creation or\nan invention is not available to the general public at an affordable price;<\/li><li>The sensible requirements of\nthe public concerning the patented invention have not been satisfied;<\/li><li>&nbsp;That the patented creation or an invention is\nnot worked in the Indian boundary.<\/li><\/ul>\n\n\n\n<p>According\nto Section 84, any individual interested or already the owner of the license\nunder the Patent Act can request the Controller for the issuance of compulsory\nlicense on the expiration of 3 years, when the aforementioned conditions are\nsatisfied.<\/p>\n\n\n\n<p><strong><em>However,\ncompulsory licensing may also be granted when:<\/em><\/strong><\/p>\n\n\n\n<ul><li>Section 92 A \u2013 For exports,\nunder exceptional conditions;<\/li><li>Section 92A \u2013 In the case of\nnational crisis, the extreme necessity of public&nbsp; non-commercial use by the notification of the\nCentral Government of India;<\/li><li>Section 92 A (1) \u2013 To a nation\nthat has enough or no manufacturing power in the sector of pharmaceutical to\naddress public health.<\/li><\/ul>\n\n\n\n<p>Moreover,\nsuch licenses are also issued by the Controller under Section 92, as stated in\nthe notification furnished by the Central Government if there is either a\nnational crisis or extreme necessity or in case of public non-commercial use.<\/p>\n\n\n\n<p>The\nController considering some more factors such as the invention\u2019s nature, the potential\nof the applicant to use the product for public advantage and the reasonability,\nbut the ultimate discretion lies with him to issue the compulsory license. Even\nafter compulsory licensing is granted to a third party, the owner of a Patent\nstill has rights over the Patent, consisting of a right to be paid for the product\u2019s\ncopies made under the compulsory licensing.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Global_Viewpoint_on_Patent_Compulsory_Licensing\"><\/span>Global Viewpoint on Patent Compulsory Licensing<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>This\noccurrence of licensing is a massively debated issue. Many developing nations\nare giving significance to the compulsory license because of the deficiency and\noverpriced of the medicines, and they are endlessly granting more and more\nPatent compulsory licenses. The developed nations of the United States of\nAmerica (USA), Europe are opposing this viewpoint as it would make innovation\nhard for the pharmaceutical entities.<\/p>\n\n\n\n<p><strong><em>The\nfirst case of Patent Compulsory License in India<\/em><\/strong>:\nThe first case of licensing was granted by the <strong><em>Indian Patent Office in 2012<\/em><\/strong>\nto an Indian entity known as <strong><em>Natco Pharma <\/em><\/strong>for the common\nproduction of Bayer Corporation\u2019s Nexavar. Al the three situations of <strong><em>Sec\n84 <\/em><\/strong>were satisfied that the public&#8217;s affordable requirement was not\nsatisfied, and that it was not available at a reasonable price and that the\npatented invention was not worked across India.<\/p>\n\n\n\n<p>Such\nmedicines are used for treating kidney &amp; liver cancer and one month\u2019s worth\nof dosage price of around Rs. 2.8 lakh. <strong><em>Matco Pharma<\/em><\/strong> provided to sell it\naround for Rd 9000, making this certainly lifesaving drug simply accessible to\nall society\u2019s party and not just the rich people. The Government took this\ndecision for the betterment of the general public. But, it was heavily arraigned\nby the pharmaceutical companies as they felt the compulsory license shouldn\u2019t\nhave been given.<\/p>\n\n\n\n<p>But,\nNatco Pharma is paying the royalties to Bayer at 6% of the rate of all sales on\na quarterly basis as per the guidelines prescribed by the <strong><em>UNDP (United Nations Development\nProgramme)<\/em><\/strong>. In January 2013, the Indian Ministry of Health approved\nthree anti-cancer drugs, trastuzumab, dasatinib, and ixabepilone, for\ncompulsory licenses. This will permit the Government to sell drugs at a notably\nlower cost and will also enable the people who can&#8217;t afford the drugs\noriginally access to such drugs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Impacts_of_Patent_Compulsory_Licensing\"><\/span>What\nare the Impacts of Patent Compulsory Licensing?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some areas that will be impacted by the compulsory license:<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/05\/image001.png\" alt=\"What are the Impacts of Patent Compulsory Licensing?\" class=\"wp-image-5181\" width=\"457\" height=\"460\" srcset=\"https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/05\/image001.png 914w, https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/05\/image001-150x150.png 150w, https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/05\/image001-298x300.png 298w, https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/05\/image001-768x772.png 768w\" sizes=\"(max-width: 457px) 100vw, 457px\" \/><\/figure><\/div>\n\n\n\n<ol><li><strong><em>Competition and<\/em><\/strong>\n<strong><em>Price<\/em><\/strong>:\nCompulsory Licensing will raise the number of companies manufacturing generic medicines.\nTherefore, the supply of medicines will go up, and the price will come down.\nThis will also force the inventor nations to introduce pricing of their Patent\nModule distinctively so that they can stand on the market.<\/li><li><strong><em>Innovation<\/em><\/strong>:\nIn underdeveloped nations, the innovation of pharmaceutical entities will be\nless or low as they will be more dependent on generic drugs. They will prefer\ngetting the compulsory license to a generic drug rather than funding R&amp;D\nindividually, which is often a very costly thing. Further, research-based\npharmaceutical industries will not launch Patent Module in the advancing\nnations as there is always the risk of Patent losing and losing money in\nresearch. <\/li><li><strong><em>Patients<\/em><\/strong>:\nPatients will get medicines at a remarkably lower rate. Also, the big\npharmaceutical companies often introduce plans such as free access to medicine\nto safeguard their Patents in the advancing nations. <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The provisions of compulsory licensing should be used reasonably as it is an irregularity and flexibility to the common Patent Rule. The provisions and comes mid-way; neither full Patent security is granted nor is it opposed altogether. It directly affects innovation funding, and unrestricted use of this provision may result in international pharmaceutical companies being unsure of introducing new medicines in other nations. Therefore, the companies have to fix the price of their patented module as per their nation&#8217;s financial status if they want to safeguard their products from compulsory licensing. This licensing has become the desire for economically challenged patients in underdeveloped nations. India requires such provisions owing to the financial situation of the majority population. However, the challenge is that, on the one hand, it has to obey the worldwide standards of Patent protection, and on the other side, it has to protect public health. <\/p>\n\n\n\n<p><strong>Read our article:<\/strong> <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/patent-filing-procedure-in-india\/\">A Complete Guide on Patent Filing Procedure in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In simple words, Patent compulsory licensing is an approval given to a third party by the Government to sell, make, or use a specific product or use a specific process that has been patented without the requirement of the patent owner\u2019s permission. The provisions concerning compulsory licensing are given in the Indian Patents Act, 1970[1] [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5180,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[55],"tags":[643],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/5179"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=5179"}],"version-history":[{"count":8,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/5179\/revisions"}],"predecessor-version":[{"id":5191,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/5179\/revisions\/5191"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/5180"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=5179"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=5179"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=5179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}