{"id":23606,"date":"2021-01-07T12:30:06","date_gmt":"2021-01-07T07:00:06","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=23606"},"modified":"2024-11-19T12:10:04","modified_gmt":"2024-11-19T06:40:04","slug":"patent-protection-for-drug-industry-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/","title":{"rendered":"A Note on the Patent Protection for Drug Industry in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Indian\ndrug industry has witnessed huge success in the past few years due to its\nprompt adoption of evolving technology. Indian pharmaceutical sector comprises\nof privately-held entities that have secured increased dominance in the\ndomestic market.<\/p>\n\n\n\n<p>The reason\nbehind their success is the favorable government policies &amp; absence of\nforeign counterparts. However, the recent changes in government policies have\nopen the door for foreign direct investment. By doing this, the government is\nnow enabling overseas companies to step forward in the domestic market.<\/p>\n\n\n\n<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 ez-toc-toggle\" style=\"cursor:pointer\">Page 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: #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><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/#Indian_Drug_Industry_in_the_Market\" >Indian Drug Industry in the Market<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/#Overview_on_the_Patent_Law_in_India\" >Overview on the Patent Law in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/#Applicability_of_Patent\" >Applicability of\nPatent<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/#Compulsory_Licensing_Under_Patent_Act\" >Compulsory\nLicensing Under Patent Act<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/#What_is_the_Impact_of_the_World_Trade_Organization_WTO_on_Pharmaceutical_Patents\" >What is the Impact of the World Trade Organization (WTO) on Pharmaceutical Patents?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/patent-protection-for-drug-industry-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Indian_Drug_Industry_in_the_Market\"><\/span>Indian Drug Industry in the Market<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Indian\ndrug industry is a prominent example of an industry that is encouraged to\nrevisit its strategies and business structures as Indian enables foreign\nplayers to enter market. Factors such as intellectual property have emerged as\nthe weakest link in the drug industry due to the eroded legislation framework. <\/p>\n\n\n\n<p>Efforts\nare being made to inculcate some flexibility to that disparity by strengthening\nthe existing laws. The Indian government is endeavoring to lay the foundation\nof a patent regime that is in sync well with the technological advances and\nglobal commitments.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_on_the_Patent_Law_in_India\"><\/span>Overview on the Patent Law in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Patent\nrights came into existence way back in the year 1856. And about a century\nlater, in 1970, the patent act 1970 was implemented, nullifying the preceding\nlegislations. Our country is a member of the Paris Convention and the Patent\nCooperation Treaty. <\/p>\n\n\n\n<p>As per the Patent Act, the invention or discovery that does not adhere to uniqueness and usefulness cannot be subjected to <a href=\"https:\/\/corpbiz.io\/patent-registration\"><strong>patent registration<\/strong><\/a>. The same Act has provided the list of rundown that cannot be considered as the patented inventions. These are as follows;-<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter is-resized\"><img decoding=\"async\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/A-foreign-company-which-is-aspiring-of-embarks-and-performing-business-activities-in-India-the-foreign-entities-can-enter-in-any-of-below-discussed-ways-1.png\" alt=\"Overview on the Patent Law in India\" class=\"wp-image-23608\" width=\"464\" height=\"470\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/A-foreign-company-which-is-aspiring-of-embarks-and-performing-business-activities-in-India-the-foreign-entities-can-enter-in-any-of-below-discussed-ways-1.png 985w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/A-foreign-company-which-is-aspiring-of-embarks-and-performing-business-activities-in-India-the-foreign-entities-can-enter-in-any-of-below-discussed-ways-1-296x300.png 296w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/A-foreign-company-which-is-aspiring-of-embarks-and-performing-business-activities-in-India-the-foreign-entities-can-enter-in-any-of-below-discussed-ways-1-768x780.png 768w\" sizes=\"(max-width: 464px) 100vw, 464px\" \/><\/figure><\/div>\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Applicability_of_Patent\"><\/span>Applicability of\nPatent<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>With\nregards to drugs, in the case of substances being used as an edible item,\nmedicines prepared by a chemical process, the patent is only applicable to the\nprocesses instead of the medicine or substances. Therefore, drugs\/medicines do\nnot come under the canopy of patent protection.<\/p>\n\n\n\n<p>In 1970, the government of India came up with a new Patent Act, which kept pharmaceuticals and agrochemical products out of the reach of the patent regime. The exclusion was done to impart a sense of self-reliance among the Indian <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug <\/strong><\/a>producers.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Impact on the Absence of Protection for Pharmaceuticals<\/h3>\n\n\n\n<p>The\nabsence of protection for the pharmaceutical produce and agro-based chemical\nhad a considerable impact on the drug industry and resulted in the development\nof expertise addressing the reverse engineering of medicines that are\npatentable globally except India.&nbsp;<\/p>\n\n\n\n<p>As a\nresult of this, the drug industry in India thrives promptly by developing a\nvariant of medicines patented for the local market and eventually proceeds\ndynamically into the global market with conventional drugs as soon as the\ninternational patent expired. Additionally, the Patent Act renders ample protection\nfor preventing the abuse of patent rights and provides seamless access to\ndrugs.&nbsp;<\/p>\n\n\n\n<p>The terms\nof patents in case of method or processes of manufacture of a substance to be\nused as a medicine for a period of seven years from the filing date or five years\nfrom the date of patent registration, whichever is earlier. Patents for all\nother invention is issued for a timeline of 14 years for the filing date of the\npatent, except shown to be invalid.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Compulsory_Licensing_Under_Patent_Act\"><\/span>Compulsory\nLicensing Under Patent Act <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>Patent Act<\/strong> also encloses the provision related to compulsory licensing. After completing the three-year timeline from the date of securing the patent, any individual intended to work the patented invention might apply for a compulsory license w.r.t invention. <\/p>\n\n\n\n<p>The controller\nof patents might ask the patent holder to render such a license based on the\nterms as may be deemed fit, only if he\/she is satisfied that the prerequisite\nof the public w.r.t patented invention has not been made or that the patented\ninvention is not available to the masses at a nominal price.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">&nbsp;Provision for Licenses of Right<\/h3>\n\n\n\n<p>Apart from\nthe compulsory licensing, the patent Act encloses a provision for licenses of\nright, wherein the government can, after the completion of the three years from\nthe date of securing the patent, apply for an order that the patent may be approved\nwith the terms &#8220;licenses of right&#8221;, depending on the prerequisite of\nthe public w.r.t the patented invention have not been fulfilled, or the\npatented invention is not available to the masses at a nominal price.&nbsp;<\/p>\n\n\n\n<p>Patents\nfor specific substances that are not deemed food items or medicine but have the\npotency to be transformed into the same are considered to be endorsed with the\nterm &#8220;license of right&#8221; promptly on the expiration of three years\ntimeline from the date of securing a patent.&nbsp;<\/p>\n\n\n\n<p>Such an\nactivity helps any person willing to work on the patented invention request the\npatentee to issue a license. The granting of the license will depend on the\nmutual consent of the involved parties. If the involved parties find it hard to\nagree upon the terms of the license, they can approach the controller of a\npatent for the settlement.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_Impact_of_the_World_Trade_Organization_WTO_on_Pharmaceutical_Patents\"><\/span>What is the Impact of the World Trade Organization (WTO) on Pharmaceutical Patents?&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nestablishment of the WTO has led to a massive paradigm shift in world trade.\nThe agreement of Trade-related Intellectual Property Rights was settled amid\nUruguay round trade negotiations of the General Agreement on Tariffs and Trade\n(GATT). <\/p>\n\n\n\n<p>The pharmaceutical\nindustry was the only reason for incorporating intellectual property issues\ninto the GATT framework. In the year 1994, India agreed to comply with the GATT\nrequirements as well as the provisions under the TRIPS.&nbsp;<\/p>\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>India thereby needs to comply with the standards under the TRIPS agreements related to patents and the pharmaceutical industry. India&#8217;s patent legislation must incorporate the provisions for the availability of pharmaceutical products, patents, and process inventions. Patents are to be granted for a timeline of not less than 20 years to any invention of a pharmaceutical product.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/abuse-of-patent-right-with-respect-to-drugs\/\">Lets Understand the Abuse of Patent Right with respect to Drugs<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Indian drug industry has witnessed huge success in the past few years due to its prompt adoption of evolving technology. Indian pharmaceutical sector comprises of privately-held entities that have secured increased dominance in the domestic market. The reason behind their success is the favorable government policies &amp; absence of foreign counterparts. However, the recent [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":23611,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[282],"tags":[1401],"acf":{"service_id":"20"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":3291,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23606"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=23606"}],"version-history":[{"count":23,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23606\/revisions"}],"predecessor-version":[{"id":67252,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23606\/revisions\/67252"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/23611"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=23606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=23606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=23606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}