{"id":10776,"date":"2022-03-21T07:17:50","date_gmt":"2022-03-21T07:17:50","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=10776"},"modified":"2022-03-21T07:17:52","modified_gmt":"2022-03-21T07:17:52","slug":"patenting-stem-cell-related-inventions-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/patenting-stem-cell-related-inventions-in-india\/","title":{"rendered":"Patenting Stem Cell Related Inventions in India &#8211; An Overview"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Stem\ncells are cells that can distinguish or develop into various types of cells.\nThis distinctive characteristic grants them great medical significance as they\ncan unravel many secrets regarding living organisms, mortality, and diseases\nand may even be able to treat them. In this blog, we will discuss patenting\nstem cell-related inventions in India.<\/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-6a2ae8bac425a\" 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-6a2ae8bac425a\"  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\/patenting-stem-cell-related-inventions-in-india\/#Types_of_Stem_Cells\" title=\"Types of Stem\nCells\">Types of Stem\nCells<\/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\/patenting-stem-cell-related-inventions-in-india\/#Patenting_Stem_Cell_Embryos_Cell_in_India\" title=\"Patenting Stem\nCell (Embryos Cell) in India\">Patenting Stem\nCell (Embryos Cell) 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\/patenting-stem-cell-related-inventions-in-india\/#Applying_for_Patenting_Stem_Cell_bases_Inventions\" title=\"Applying for\nPatenting Stem Cell bases Inventions\">Applying for\nPatenting Stem Cell bases Inventions<\/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\/patenting-stem-cell-related-inventions-in-india\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Stem_Cells\"><\/span>Types of Stem\nCells<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There\nare 2 primary types of stem cells are:<\/p>\n\n\n\n<ol><li><strong><em>SSCs or Somatic Stem Cells<\/em><\/strong>:\nSomatic Stem Cells are undifferentiated cells found throughout our bodies. They\nreplace dying cells &amp; regenerate or repair damaged tissues. Somatic Stem\nCells are multipotent, i.e., they can distinguish into specialised cells in a\nspecific lineage. For instance, hematopoietic stem cells can distinguish into\ntypes of blood cells. <\/li><li><strong><em>ESCs or Embryonic Stem Cells<\/em><\/strong>:\nThese cells are derived from embryos and they are usually isolated from the\nembryo 3 to 5 days after fertilisation. Embryonic Stem Cells are pluripotent\ni.e., they can distinguish into most types of cells. There are other\nsources\/types of stem cells also. For instance, stem cells can be attained from\nthe umbilical cord or via artificially activating an unfertilised egg to behave\nlike an embryo, etc.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patenting_Stem_Cell_Embryos_Cell_in_India\"><\/span>Patenting Stem\nCell (Embryos Cell) in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According\nto the <strong><em>Patents Act, 1970<\/em><\/strong>, patenting stem cell is not possible for now\ndue to exclusions under <strong><em>Section 3 (c)<\/em><\/strong> (finding of any living\nthing or non-living substances occurring in nature) and <strong><em>Section 3(j) <\/em><\/strong>(plants\n&amp; animals in whole or any part thereof other than micro-organisms). Under <strong><em>Section\n3(i),<\/em><\/strong> patenting stem cell-based therapies is not possible in India,\nwhich excludes processes for the medical or related treatment of animals or\nhuman beings.<\/p>\n\n\n\n<p>Some\ninventions concerning stem cells, like unique and inventive synergetic\ncompositions, and methods of processing, differentiating, preparing, attaining\nstem cells, maybe patentable given they don&#8217;t fall under <strong><em>Section 3(b)<\/em><\/strong>. This\nprovision eliminates from patentability inventions whose use or commercial\nexploitation could be contrary to public order\/morality\/cause prejudice to the\nhealth of the environment or living organisms. Section 3(b) is originated from\nArticle 27(2) of the Agreement on TRIPS. TRIPS adds a caution that such\nexclusion from patentability should not be mere because the misuse of the\ninvention is prohibited by law.<\/p>\n\n\n\n<p>The stem cells source are of primary concern in stem cell-based inventions. Moral &amp; ethical problems emerge due to ESCs being attained from the destruction of embryos. The issues become more difficult when commercial exploitation is added into the mix. The IPO or Indian Patent Office has had different run-ins with <a href=\"https:\/\/swaritadvisors.com\/patent-registration\" class=\"text-primary\"><strong>Patent registration<\/strong><\/a> applications for stem cell-based inventions.<\/p>\n\n\n\n<p>When\na Patent application in India <strong><em>1492\/DELNP\/2007<\/em><\/strong> was objected to\nunder Section 3(b), the applicant or candidate argued that the stem cells were\ncollected from the umbilical cord, otherwise generally discarded after birth,\nwhich was collected with the approval of the mother. The specification also\ndeliberated the cord collection, and the application was allowed.<\/p>\n\n\n\n<p>Indian\nPatent application <strong><em>4551\/CHENP\/2008<\/em><\/strong> initially claimed a method for selecting\ncardiomyocytes from a cell mixture containing cardiomyocytes &amp; non- cardiomyocytes\nderived from embryonic stem cells or cells having identical characteristics. To\nconquer the objection under <strong><em>Section 3(b)<\/em><\/strong>, a disclaimer was added\nto the claim that no cells originating from human embryonic stem cells were\nengaged. An identical disclaimer was added to the claims of Indian Patent\napplication <strong><em>6526\/CHENP\/2008<\/em><\/strong>. The specifications in both these instances\ntaught that the disclosed inventions could work with stem cells attained\nwithout the destruction of human embryos.<\/p>\n\n\n\n<p>The\nIndian Patent Office required clarification of IPA 3649\/DELNP\/2008. Whose claim\nwas directed to a method for producing pluripotent human stem cells, which\ninvolved parthenogenetically activating an unfertilised human egg. The\napplicant submitted that a parthenote was dissimilar from an embryo as it was\nincompetent of developing into a feasible fetus and the application was permitted.\nHere, the European Court of Justice\u2019s decision in <strong><em>C-364\/13<\/em><\/strong> on parthenotes was\ndependent, where it was held in order to be categorised as a human embryo, a\nnon-fertilised human ovum must mandatorily have the inherent capacity of\ndeveloping into a human. The CJEU also said that unfertilised human ova whose\ndivision &amp; further development have been encouraged by parthenogenesis is\nnot comprised in the term &#8220;human embryos&#8221; as long as they are not\ncapable of developing into a human and have not been genetically operated to\nget such a capacity.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Applying_for_Patenting_Stem_Cell_bases_Inventions\"><\/span>Applying for\nPatenting Stem Cell bases Inventions<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nlaw is clear that patenting stem cell and stem cell-based therapies are not possible.\nThe other types of stem cell-based prosecution, practice, and inventions\nsuggest that inventions involving the use of human ESCs attained by the\ndestruction of human embryos are not patentable in India. The time at which\nsuch destruction takes place is unrelated. Hence, even if an inventor has used\nestablished cell lines derived from human embryos, the claims are likely to be\nrejected.<\/p>\n\n\n\n<p>If\nthe application is filed for a human ESC-related invention, the Patent\ndescription should contain at least some embodiments\/examples showing that, at\nthe filing date of application, the invention could be worked without\ndestroying human embryos. Documented scientific outcomes accompanied by an\naffidavit would help demonstrate this. If required to do so, it\u2019s recommendable\nto change claims to add a disclaimer that human ESCs attained from human\nembryos were not used. The Indian Patent Office may also insist on requiring\nthe deletion of paragraphs concerning human ESCs attained by finishing human\nembryos from the specification.<\/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>It&#8217;s nothing wrong to say that stem cell research is a very auspicious field and can prove to be a boon for the biotechnology sector of the country. Research in this field must be encouraged by providing appropriate <strong>IPR (Intellectual Property Rights<\/strong><sup><a href=\"https:\/\/www.wipo.int\/about-ip\/en\/\" class=\"text-primary\"><strong>[1]<\/strong><\/a><\/sup><strong>)<\/strong> to such inventions.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stem cells are cells that can distinguish or develop into various types of cells. This distinctive characteristic grants them great medical significance as they can unravel many secrets regarding living organisms, mortality, and diseases and may even be able to treat them. In this blog, we will discuss patenting stem cell-related inventions in India. Types [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":10784,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[55],"tags":[1001],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/10776"}],"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=10776"}],"version-history":[{"count":13,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/10776\/revisions"}],"predecessor-version":[{"id":10790,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/10776\/revisions\/10790"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/10784"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=10776"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=10776"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=10776"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}