{"id":22572,"date":"2020-12-22T15:09:43","date_gmt":"2020-12-22T09:39:43","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=22572"},"modified":"2024-11-19T11:28:07","modified_gmt":"2024-11-19T05:58:07","slug":"how-can-one-have-the-right-to-buy-pharmaceutical-drug","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/how-can-one-have-the-right-to-buy-pharmaceutical-drug\/","title":{"rendered":"How can one have the Right to Buy Pharmaceutical Drug?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">With an introduction of the product patent regime, a wide range of pharmaceutical drug\/products can be patented in India. Before applying for <a href=\"https:\/\/corpbiz.io\/patent-registration\"><strong>patent registration<\/strong><\/a>, one must carefully take into consideration the criteria of patentability. <\/p>\n\n\n\n<p>Once acquired, patent rights can be\ntransferred through assignment or licensing to other persons or companies. &nbsp;It has to be ensured whether the prospective\ndrug\/formulation (either manufactured or imported to India) qualifies as the\ndrug since there are the different rules and procedures for drugs in the Indian\nmarket for using drugs. <\/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\/how-can-one-have-the-right-to-buy-pharmaceutical-drug\/#Types_of_Pharmaceutical_Drug_Patents_in_India\" >Types of Pharmaceutical Drug Patents in India<\/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\/how-can-one-have-the-right-to-buy-pharmaceutical-drug\/#License_for_Export_of_Patented_Pharmaceutical_Drug_under_section_92A\" >License for Export of Patented Pharmaceutical Drug under\nsection 92A<\/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\/how-can-one-have-the-right-to-buy-pharmaceutical-drug\/#Import_and_Registration_of_the_Drugs\" >Import and Registration of the Drugs<\/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\/how-can-one-have-the-right-to-buy-pharmaceutical-drug\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Pharmaceutical_Drug_Patents_in_India\"><\/span>Types of Pharmaceutical Drug Patents in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Pharma industry is the most intense &#8220;knowledge-driven&#8221; industry. Pharmaceutical research is also very costly and unpreddictable in its nature. The outcome of the research can be in the form of a new, inventive, and useful product or process. <\/p>\n\n\n\n<p>In this highly competitive market, pharmaceutical drug companies must protect their inventions from any unauthorized commercial use by acquiring patent rights over the invented product or process. Pharmaceutical patents in India can be further classified under following categories. The classification is based on the list of Pharma patents provided by the Indian patent office on its website.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">a) Drug Compound Patents<\/h3>\n\n\n\n<p>These patents claim a drug compound by its\nchemical structure per se. These patent claims are usually referred to as\nMarkush type claims. A Markush claim is a claim with multiple\n&#8220;functionally equivalent&#8221; chemical entities allowed in one or more\nparts of the drug compound. Drug compound patents provide the broadest possible\nprotection to the company&#8217;s product since other companies are not allowed to\nprepare such a drug by any route of synthesis or produce\/ sell any formulation\ncomprising this drug before the expiry of said patent.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">b) Formulation\/ Composition Patents<\/h3>\n\n\n\n<p>These patents claim a specific technology\nto prepare a formulation and\/or quantity of its key ingredients. For example,\nfollowing ayurvedic anti-retroviral composition for Acquired Immuno Deficiency\nSyndrome treatment was claimed in the Indian patent.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">c) Synergistic combination Patents<\/h3>\n\n\n\n<p>Drug synergy occurs when there are two or\nmore drugs interact with each other to enhance one or more effects of those\ndrugs. Patents can be obtained on new synergistic combinations of the drugs.<\/p>\n\n\n\n<p>A medicament comprising a PDE inhibitor,\nwhich is to be administered orally, from the PDE4 inhibitors group combined\nwith a G2 adrenoceptor agonist in fixed or free combination. Wherein, the PDE\ninhibitor is roflumilast, a pharmacologically tolerable salt of roflumilast\nand\/or the N-oxide of roflumilast and the G2 adrenoceptor agonist is salmeterol\nor a pharmacologically tolerable salt thereof.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">d) Technology Patents<\/h3>\n\n\n\n<p>These type of patents are based on the\ntechniques used to solve specific technology-related problems like\nstabilization, taste masking, increase in solubility, etc. A pharmaceutical\nformulation having a masked taste, the masking of which persists during the\nadministration of the formulation, in particular in the form of a suspension in\nan aqueous vehicle, characterized in that it comprises at least of these\nfollowing elements:-<\/p>\n\n\n\n<ul>\n<li>A cellulosic polymer which is\nsoluble in organic solvents but practically insoluble in water, regardless of\nthe pH; <\/li>\n\n\n\n<li>An alkaline agent of organic\nnature or an alkaline salt, which is pharmaceutically acceptable; <\/li>\n\n\n\n<li>An adsorbent agent.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">e) Polymorph Patents<\/h3>\n\n\n\n<p>Polymorphs are different physical forms or\ncrystal structures of an already known compound. Polymorphs are usually\nprepared to reduce impurities or increase the stability of the compounds.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">f) Biotechnology patents<\/h3>\n\n\n\n<p>Biotechnology involves a use of living\norganisms or biological materials in the preparation of pharmaceutical\nproducts. Biotechnology patents cover a wide range of diagnostic, therapeutic,\nand immunological products. For example, human serum albumin-free Interferon\nsolution containing an interferon-alpha, a non-ionic detergent, a buffer for\nadjusting pH 4.5-5.5, benzyl alcohol, and optionally an agent.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">g) Process patents<\/h3>\n\n\n\n<p>A process patent does not claim the product\nper se; rather, it only covers the new and inventive process to produce the\nparticular product. For example, L-lactone of formula 3,6- dialkyl-5,6-dihydro-4-hydroxy-2h-pyran-2-one.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"License_for_Export_of_Patented_Pharmaceutical_Drug_under_section_92A\"><\/span>License for Export of Patented Pharmaceutical Drug under\nsection 92A<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><em><strong>Section 92A of the Patents Act, 1970<\/strong><\/em> states that a compulsory license may be issued for manufacture and export of patented pharmaceutical products to the country having insufficient or no manufacturing capacity in the pharmaceutical industry for the concerned product to address public health problems, provided that such country has granted a compulsory license or allowed the importation of patented pharmaceutical products from India. On receipt of the application, the Controller must grant a compulsory license solely for manufacturing and exporting of the concerned pharmaceutical product to such country under the specified terms and conditions.<\/p>\n\n\n\n<p>This provision addresses the countries&#8217;\npublic health concerns having insufficient or no manufacturing capacity in the\npharmaceutical sector to implement the TRIPS council&#8217;s decision on <strong><em>Para\n6 of the Doha Declaration on TRIPS Agreement and Public Health. <\/em><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Availability of Compulsory License as per Provision<\/h3>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" width=\"1000\" height=\"591\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Availability-of-Compulsory-License-as-per-Provision.png\" alt=\"Availability of Compulsory License as per Provision\" class=\"wp-image-22574\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Availability-of-Compulsory-License-as-per-Provision.png 1000w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Availability-of-Compulsory-License-as-per-Provision-300x177.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Availability-of-Compulsory-License-as-per-Provision-768x454.png 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure><\/div>\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Import_and_Registration_of_the_Drugs\"><\/span>Import and Registration of the Drugs <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>It is mandatary that no new drug (including\nFixed-Dose Combination of two or more drugs) will be imported or manufactured\nfor sale unless the authorised Licensing Authority approves it. The term <strong><em>&#8216;new\ndrug&#8217; is defined under the Rule 122E<\/em><\/strong> of the Patent Rules. It is also\nprovided in the Rule 122E that a new drug will continue to be considered when\nany new drug exists for a period of 4 years from a date of its first approval.<\/p>\n\n\n\n<p>The  Licensing Authority is <strong><em>Central Drugs Standard Control Organization<\/em><\/strong> for obtaining <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug license<\/strong><\/a> or for the approval of import and manufacturing of new drugs. Apart from the import and manufacturing of new drugs, any person who intends to import drugs into India, such a person has to obtain a Registration Certificate and Import License from the Licensing Authority. The regulatory compliances does not restrict to drugs and apply to manufacture sites based overseas.<\/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> The Pharmaceutical Drug is a large and successful business, being the third-largest in the world. Many of the companies sell out the generic drugs at lower prices. Generic medicines are those which function like drugs from large brands but at the lower costs. Hence, thorough <a href=\"https:\/\/corpbiz.io\/due-diligence\"><strong>due diligence<\/strong><\/a> is required to be undertaken by every company before entering into the Indian Pharmaceutical Industry. <\/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\/significance-of-drug-patent-in-india\/\">Everything you need to know about Significance of Drug Patent in India\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>With an introduction of the product patent regime, a wide range of pharmaceutical drug\/products can be patented in India. Before applying for patent registration, one must carefully take into consideration the criteria of patentability. Once acquired, patent rights can be transferred through assignment or licensing to other persons or companies. &nbsp;It has to be ensured [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":22586,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[1349],"acf":{"service_id":"98"},"authorName":"Soumya Bajpai","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/01\/0.jpg","authorDescription":"Soumya has done LLB (Hons) and has a 2+years experience in writing. Her main interest is in reading judgments, new enactments and amendments taking around in law. She always strives to bring the best to work that she does.","postViews":4039,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/22572"}],"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\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=22572"}],"version-history":[{"count":23,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/22572\/revisions"}],"predecessor-version":[{"id":67229,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/22572\/revisions\/67229"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/22586"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=22572"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=22572"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=22572"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}