{"id":5935,"date":"2021-06-08T08:45:52","date_gmt":"2021-06-08T08:45:52","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=5935"},"modified":"2021-06-08T08:47:45","modified_gmt":"2021-06-08T08:47:45","slug":"biotechnology-patents-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/biotechnology-patents-in-india\/","title":{"rendered":"An Overview of Biotechnology Patents in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The inventions regarding biotechnology are essential for the development or advancement of human beings. The biotechnology inventions have branched out to different fields &amp; resolved several problems. The Patent Office issues guidelines concerning biotechnology Patents in India intending to set up identical and consistent practices for the examination of biotechnology Patents applications. The guidelines linked with the biotechnology Patent were planned to aid the examiners &amp; controllers of the Patent Office to achieve consistency in issue <a href=\"https:\/\/swaritadvisors.com\/patent-registration\" class=\"text-primary\"><strong>Patent Registration<\/strong><\/a> to the candidates. The guidelines set by the Patent Office are subject to time to time modification based on the explanations by a Court of Law, legal alterations, and valuable concepts from the investors.<\/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-6a3a9ae571e7c\" 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-6a3a9ae571e7c\"  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\/biotechnology-patents-in-india\/#What_are_the_Biotechnology_Patents\" title=\"What\nare the Biotechnology Patents?\">What\nare the Biotechnology Patents?<\/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\/biotechnology-patents-in-india\/#History_of_the_Biotechnology_Patents_in_India\" title=\"History\nof the Biotechnology Patents in India\">History\nof the Biotechnology Patents 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:\/\/swaritadvisors.com\/blog\/biotechnology-patents-in-india\/#Provisions_Concerning_Biotechnology_Patents_in_India\" title=\"Provisions\nConcerning Biotechnology Patents in India\">Provisions\nConcerning Biotechnology Patents in India<\/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\/biotechnology-patents-in-india\/#What_are_the_Requirements_for_Procuring_Biotechnology_Patents_in_India\" title=\"What\nare the Requirements for Procuring Biotechnology Patents in India?\">What\nare the Requirements for Procuring Biotechnology Patents in India?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/swaritadvisors.com\/blog\/biotechnology-patents-in-india\/#What_is_not_Patentable_under_Biotechnology_Patents\" title=\"What is\nnot Patentable under Biotechnology Patents?\">What is\nnot Patentable under Biotechnology Patents?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/swaritadvisors.com\/blog\/biotechnology-patents-in-india\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Biotechnology_Patents\"><\/span>What\nare the Biotechnology Patents?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Biotechnology\ninventions are a wide area of biology concerning living organisms &amp;\nsystems, or derivatives thereof, to amend or make products or processes for\nparticular uses. The main behind the first Act of the Patent, Thomas Jefferson,\ndoesn&#8217;t have any concept that life forms can also become a subject matter for\nprotection under Patent. <\/p>\n\n\n\n<p>In\nthe case of Diamond v Anand Chakrabarty, a biochemist at General Electric (GE)\ndeveloped a genetically altered organism that has the ability to decompose\ncrude oil. Firstly, the application of the Patent of the inventor was refused.\nHowever, later on, an appeal was made, and the court granted the Patent to the\ninventor with an order expressing that the inventor claim is not to up till now\nunknown natural phenomenon; however, a non-naturally occurring composition or\nmanufacture of matter a product of human resourcefulness.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"History_of_the_Biotechnology_Patents_in_India\"><\/span>History\nof the Biotechnology Patents in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Patent act in India was approved in the year 1856. Since then, the Patent Act was altered and changed many times. In 1970, one significant modification came into action which fulfilled the international norms of patentability of an invention covering originality, industrial application, and inventive step. However, the altered version of the <strong>Patent Act, 1970<\/strong><sup><a href=\"https:\/\/www.indiacode.nic.in\/handle\/123456789\/1392?locale=en\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup>, doesn\u2019t comprise anything particular regarding the invention concerning biotechnology and the protection of such biotechnology inventions.<\/p>\n\n\n\n<p>Simultaneously,\nthe EU and US Patent office &amp; courts were observing an increase in the\nnumber of biotechnology inventions &amp; applications of Patent for the same.\nTherefore, a massive demand for an amendment concerning the Biotechnology\nPatents in Indian came into effect in 2002 to clearly comprise microbiological,\nbiotechnological, and biochemical processes within the meaning of potentially\npatentable methods.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Provisions_Concerning_Biotechnology_Patents_in_India\"><\/span>Provisions\nConcerning Biotechnology Patents in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\n<strong><em>sections\nof the Patents Act, 1970, <\/em><\/strong>which are emphasised for the inspection of\napplications concerning biotechnology Patents in Indian and related fields, are\nas follows:<\/p>\n\n\n\n<ol><li><strong><em>Section 2 (1) (a):<\/em><\/strong>\nThis provision concerning inventive steps, originality, and industrial\napplicability of processes or products.<\/li><li><strong><em>Section 3 (b):<\/em><\/strong>\nThis provision is related to inventions contrary to morality or which cause\nserious prejudice to the animal, human, or plant life or environment or health.<\/li><li><strong><em>Section 3 (c)<\/em><\/strong>:\nThis provision is concerning the discovery of any non-living or living\nsubstance occurring in nature.<\/li><li><strong><em>Section 3 (d)<\/em><\/strong>:\nThis provision is concerning to mere discovery of a new form of a known\nsubstance which doesn\u2019t outcome in the improvement of known efficiency or mere\ndiscovery of any new property or new use for a well-known substance.<\/li><li><strong><em>Section 3 (e)<\/em><\/strong>:\nThis provision concerning mere admixture results only in the properties\naggregation.<\/li><li><strong><em>Section 3 (h):<\/em><\/strong>\nThis provision concerning the agriculture and horticulture method.<\/li><li><strong><em>Section 3 (i)<\/em><\/strong>:\nThis provision concerning the method of diagnosis &amp; treatment.<\/li><li>&nbsp;<strong><em>Section 3 (j):<\/em><\/strong> This provision\nconcerning plants &amp; animals in overall or any part thereof other than\nmicro-organisms; however, comprising seeds, species and varieties, crucially\nbiological processes.<\/li><li><strong><em>Section 3 (k)<\/em><\/strong>:\nThis provision is concerning computer programs per se and algorithms,\nmathematical methods.<\/li><li><strong><em>Section\n3 (p)<\/em><\/strong>: This provision concerns the inventions that are,\nin effect, conventional knowledge.<\/li><li><strong><em>Section 10 (4)<\/em><\/strong>:\nThis provision is concerning the competence of disclosure and the best method\nof performing the invention.<\/li><li><strong><em>Section\n10 (5)<\/em><\/strong>: This provision is concerning the unity of\ninvention &amp; clarity, succinctness &amp; claims support.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Requirements_for_Procuring_Biotechnology_Patents_in_India\"><\/span>What\nare the Requirements for Procuring Biotechnology Patents in India?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some basic requirements for Procuring Biotechnology Patents in India:<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" loading=\"lazy\" width=\"602\" height=\"372\" src=\"https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/06\/image-5.png\" alt=\"Requirements for Procuring Biotechnology Patents\" class=\"wp-image-5936\" srcset=\"https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/06\/image-5.png 602w, https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/06\/image-5-300x185.png 300w\" sizes=\"(max-width: 602px) 100vw, 602px\" \/><\/figure><\/div>\n\n\n\n<ul><li><strong><em>Patentable Subject Matter<\/em><\/strong>:\nThe extent of the qualified subject matters is very extensive broad in India.\nIn India, any product or any process, despite the technology, is a patentable\nmatter. But, the Patents Act, 1970 furnishes a long list of inventions that are\nmislaid from being a patentable subject matter, which also comprises some type\nof biotechnology inventions.<\/li><\/ul>\n\n\n\n<p><strong><em>The\nexpelled subject matters are as follows:<\/em><\/strong><\/p>\n\n\n\n<ol><li>Finding of living things&nbsp; occurring in nature;<\/li><li>Medical treatment methods;<\/li><li>The animals &amp; plants\noverall or any part thereof comprising seeds; species, varieties, and mostly\nthe biological processes for production or propagation of the animals &amp;\nplants;<\/li><li>Embryonic stem cells &amp;\nhumans;<\/li><li>Genetically altered\nmulti-cellular organisms comprising humans, plants, animals, and their parts.<\/li><\/ol>\n\n\n\n<p>Other\nthan this, the micro-organisms &amp; micro-biological procedures are a\npatentable subject matter under Biotechnology Patents in India. Gene and DNA\nsequences having disclosed functions are considered the patentable matter in\nIndia.<\/p>\n\n\n\n<ul><li><strong><em>Originality<\/em><\/strong>:\nThe Patent Act doesn&#8217;t have any apparent provisions concerning the uniqueness\nof biotechnology inventions in India. The majority of creations concerning\nbiotechnology are products or goods of nature essentially present in the living\norganisms. Therefore, such products can be clarified as discoveries and are not\npatentable according to the Patent Laws of India. The Manual of Patent Practice\nand Procedure furnishes that some biological substances like recombinant DNA,\nplasmids, and manufacturing processes such substances are entitled to being\npatentable in India, furnished that these substances are produced by\nsubstantive intervention for human beings.<\/li><li><strong><em>Morality<\/em><\/strong>:\nUnder the provisions of&nbsp; Section 3(b) of\nthe Patent Act, 1970 furnishes that when the primary use of an invention of\ndiffering to public morality or can also cause severe prejudice to the animal,\nhuman, and plant health &amp; life or the environment, so such an invention\nwill not be permitted to obtain Patent Registration in India. The Manual of\nPatent Office Procedure &amp; Practise furnishes that nay biological material\nand the method of making the same which is competent of causing severe\nprejudice to the human, animal, or plant lives &amp; health and also the use of\nsuch invention would be contrary to the public morality &amp; order will not be\npermitted to get patented in India.<\/li><li><strong><em>Industrial Applicability<\/em><\/strong>:\nIt is vital to be proven that the inventor&#8217;s invention can be made, can be used\nin at least one ground of activity and can be reproduced with the\nindistinguishable characteristics as many times as needed for an invention to\nbe industrially applicable in India. Since the Patent Act doesn&#8217;t deliver any\nparticular mention concerning the applicability of industry of Biotechnology\nPatents in India, it is sensible to apply the general standards of industrial\napplicability to the inventions concerning biotechnology.<\/li><\/ul>\n\n\n\n<p>If\nany inventions of biotechnology can be prepared and used in an industry and can\nalso be duplicated as many time as needed, such inventions, therefore, fulfil\nthe necessities of industrial applicability in India. The guidelines in the\nManual Patent Procedure and Practise deliver for examining biotechnology. The\nguidelines concerning gene &amp; DNA sequences furnish if the functions of such\nsequences are not disclosed. These sequences don\u2019t fulfil the industrial applicability\nnecessity for Biotechnology Patent in India.<\/p>\n\n\n\n<ul><li><strong><em>Enablement<\/em><\/strong>:\nFor biotechnology inventions in India, which tells biological substance or\nmaterial in the full specification, the law delivers for the provisions for the\nstatement of such biological materials or substances at a well-known depository\nin India. The Manual of Patent Practice &amp; Procedure needs the invention to\nbe mentioned entirely in the specification by the inventor. Such specifications\nhave to be submitted by the inventor to enable any individual skilled in\nsimilar art to be able to accomplish the invention by reading the full\nspecification.<\/li><li><strong><em>Inventive Step<\/em><\/strong>:\nThe Manual of Patent Practices &amp; Procedures has established certain\nguidelines for the assessment of the inventive step of the invention in <strong><em>Chapter\n8, Para 08.03.03<\/em><\/strong>. An inventor&#8217;s invention should hold an inventive step\nso as to be entitled to Patent protection.<\/li><\/ul>\n\n\n\n<p><strong><em>According\nto the Act, an invention will have a creative step that involves the following:<\/em><\/strong><\/p>\n\n\n\n<ul><li>Technically advanced as\ncompared to present knowledge;<\/li><li>Having economic importance;<\/li><li>Both.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_not_Patentable_under_Biotechnology_Patents\"><\/span>What is\nnot Patentable under Biotechnology Patents?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nfollowing things are not patentable in India:<\/p>\n\n\n\n<ol><li>The inventor\u2019s invention is\nagainst the public morality or order, damaging to the plants, animals, or\nhumans life or environment as per Patents Act (Section 3 (b));<\/li><li>The invention concerning the\nfinding of living things or non-living substances or materials in nature as per\nSection 3 (c) of the Act;<\/li><li>The invention concerning\nparticular methods of horticulture or agriculture as per Section 3 (h) of the\nAct;<\/li><li>The invention concerning the\nanimals &amp; plants in whole or any parts thereof other than the\nmicro-organisms however comprising seeds, varieties, and species as per section\n3 of the Act;<\/li><li>The invention regarding any\nfundamentally biological processes for the propagation of plants and animals as\nper Section 3 (j) of the Act;<\/li><li>The invention comprises\nconventional knowledge as per Section 3 (p) of the Act.<\/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>In the current time, patenting of biotechnology inventions is a noteworthy factor because of its investment &amp; research-intensive nature. The current case laws clearly conclude that the biological materials or substances which are designed in labs &amp; were earlier not available in the natural environment have earned some patentability right. Therefore, for the safety of the inventor&#8217;s right and interest of patentability, the biotechnology Patents in India was introduced. The filing process for the approval of the biotechnology Patents in India is complex and lengthy. You can also contact an expert who will guide you in Patent Registration in India.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/patent-infringement-letter\/\">Patent Infringement Letter- An Overview\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The inventions regarding biotechnology are essential for the development or advancement of human beings. The biotechnology inventions have branched out to different fields &amp; resolved several problems. The Patent Office issues guidelines concerning biotechnology Patents in India intending to set up identical and consistent practices for the examination of biotechnology Patents applications. The guidelines linked [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5938,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[55],"tags":[688],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/5935"}],"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=5935"}],"version-history":[{"count":13,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/5935\/revisions"}],"predecessor-version":[{"id":5950,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/5935\/revisions\/5950"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/5938"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=5935"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=5935"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=5935"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}