{"id":184,"date":"2019-07-22T08:13:23","date_gmt":"2019-07-22T08:13:23","guid":{"rendered":"https:\/\/videaimip.com\/blog\/?p=184"},"modified":"2024-07-23T06:12:25","modified_gmt":"2024-07-23T06:12:25","slug":"can-genes-be-patented","status":"publish","type":"post","link":"https:\/\/videaimip.com\/blog\/can-genes-be-patented\/","title":{"rendered":"Gene Patent : Expressing the Truth"},"content":{"rendered":"\n<figure class=\"wp-block-image is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/videaimip.com\/blog\/wp-content\/uploads\/2019\/07\/dna-1811955_1280-1024x512.jpg\" alt=\"\" class=\"wp-image-185\" width=\"512\" height=\"256\" title=\"Gene Patent\" srcset=\"https:\/\/videaimip.com\/blog\/wp-content\/uploads\/2019\/07\/dna-1811955_1280-1024x512.jpg 1024w, https:\/\/videaimip.com\/blog\/wp-content\/uploads\/2019\/07\/dna-1811955_1280-300x150.jpg 300w, https:\/\/videaimip.com\/blog\/wp-content\/uploads\/2019\/07\/dna-1811955_1280-768x384.jpg 768w, https:\/\/videaimip.com\/blog\/wp-content\/uploads\/2019\/07\/dna-1811955_1280-1200x600.jpg 1200w, https:\/\/videaimip.com\/blog\/wp-content\/uploads\/2019\/07\/dna-1811955_1280.jpg 1280w\" sizes=\"auto, (max-width: 512px) 85vw, 512px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>WHAT DOES A PATENT OVER A GENE MEAN?<\/strong><\/h2>\n\n\n\n<p>A <a href=\"http:\/\/videaimip.com\/patent_service.html\">patent <\/a>for a gene or gene patent means ownership and exclusive rights for a specific DNA\/RNA sequence by an individual, organization, or corporation, who claims to have originally isolated a natural gene sequence and altered through gene engineering technologies to obtain a known function. This means ownership of the specific nucleotide composition of the gene, its nucleotide sequence, the process for obtaining or using, or a combination of such claims<a href=\"https:\/\/imxplayerpc.com\/\">.<\/a><\/p>\n\n\n\n<p>It means exclusive rights of the owner of the patent to dictate terms for use or commercial exploitation of the gene for 20 years. This also implies that patent owner (founder individual or institutes or companies) has sole ownership of genetic testing for patented genes. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ARE NATURALLY OCCURING GENES PATENTABLE?<\/strong><\/h2>\n\n\n\n<p>Until recently, in Untied States of America, a naturally\noccurring biological substance was patentable (falling under the category of\nutility patents) if they were sufficiently &#8220;isolated&#8221; from their\nnaturally occurring states. The first human product to be patented was purified\nform of adrenaline in 1906. Then started the Cohen-Boyer patenting and\nlicensing era in 1970s where patents for recombinant DNA and method for\nproducing the same were given. These patents covered inventions for splicing\ngenes to make recombinant proteins that are foundational to the biotechnology\nindustry.<\/p>\n\n\n\n<p>A landmark case in the field of biotechnology pertaining\nto organisms as a whole was made with the Diamond v. Chakrabarty case in 1980,\nwherein, it was upheld that a newly created living organism, a bacterium for\ndigesting crude oil in oil spills, was patentable and the first patent for an\norganism as a whole was provided because the DNA of Chakrabarty&#8217;s organism was\nmodified, and truly man-made. This started the era of patenting of genetically\nmodified genes and organisms.<\/p>\n\n\n\n<p>This was followed by several other patents in the field\nof monoclonal antibodies, transgenic mice, isolation of cancer-related genes\nand their usage and many more.<\/p>\n\n\n\n<p>However, the 2013 case of Association for Molecular\nPathology v. Myriad Genetics challenged the validity of gene patents in United States\nof America. Prior to the case, the U.S. Patent Office accepted patents on\nisolated DNA sequences as a composition of matter. It was on 13<sup>th<\/sup>\nJune, 2013 that the Supreme Court of the United States ruled that human genes\ncannot be patented in the U.S. because DNA is a &#8220;product of nature.&#8221;\nPrior to this ruling, more than 4,300 human genes were patented. The Supreme\nCourt&#8217;s decision invalidated those gene patents, making the genes accessible\nfor research and for commercial genetic testing.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>WHAT IS PATENTABLE? WHICH GENES ARE PATENTABLE?<\/strong><\/h3>\n\n\n\n<p>The 2013 Association for Molecular Pathology v. Myriad\nGenetics case clearly stated that human genes cannot be patented in the U.S.\nbecause DNA is a &#8220;product of nature&#8221;i.e. any naturally occurring gene\nis not patentable. However, any gene\/nucleotide sequence which has been\nmanipulated in the lab can be still patented, because this brings the\nsufficient human intervention factor into the gene\/nucleotide sequence. Hence, synthetically\nmutated or genetically modified genes which do not occur naturally in nature and\ntheir products are patentable, example:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gene sequence \/ Amino Acid sequence (Polynucleotides) (product)<\/li>\n\n\n\n<li>A method of expressing Gene sequence \/ Amino Acid sequence (Polynucleotides) (process)<\/li>\n\n\n\n<li>Vectors (e.g., plasmids) (product and\/or process)<\/li>\n\n\n\n<li>Gene constructs or cassettes and gene libraries<\/li>\n\n\n\n<li>An antibody against that protein \/ sequence<\/li>\n\n\n\n<li>A kit made from the antibody \/ sequence.<\/li>\n<\/ul>\n\n\n\n<p>When a genetically modified Gene sequence\/ Amino Acid sequence\nare novel, involve an inventive step and have industrial application, the\nfollowing can be claimed.<\/p>\n\n\n\n<p>Gene patents cover three distinct types of invention:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li> diagnostics; <\/li>\n\n\n\n<li> composition of matter; and<\/li>\n\n\n\n<li> functional use. <\/li>\n<\/ul>\n\n\n\n<p> Diagnostics: When an invention involves recognition of alteration in genetic makeup in disease associated locus for diagnosis and prognosis which generates statistical observation of genetic and phenotypic difference, then such a genetic makeup can be patented, e.g. breast and ovarian cancers (BRCA1 and BRCA2), colon cancers (HNPCC, FAP), cystic fibrosis (CFTR), hemochromatosis (HFE), spinocerebellar ataxia (SCA1\u201312) etc. This kind of recognition involves a detailed research over several years. <\/p>\n\n\n\n<p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nComposition of matter:This relates to chemicals\nand materials, including the isolated and purified gene (cDNA) and all\nderivative products (e.g., recombinant proteins or drugs, viral vectors and\ngene transfer \u2018therapies\u2019, transfected cells, cell lines and higher order\nanimal models in which the patented gene has been inserted or knocked out).\n\n\n\n<\/p>\n\n\n\n<p> Functional use:This relates to patenting a role that a gene(s) plays in disease or other bodily and cellular functions or pathways, and claim methods and compositions of matter (typically called \u2018small molecule\u2019 drugs) used to up- or down regulate the gene. For e.g. in the Viagra patent case, the patent claims any selective PDE5 inhibitor used to treat impotence. <\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>PATENTABILITY OF GENES: INDIAN SCENARIO<\/strong><\/h4>\n\n\n\n<p>Indian Patent Act 1970 specifies the following sections\nfor Patentability of Genes:<\/p>\n\n\n\n<p>Section 2 (1) (j): Novelty, inventive step &amp;\nindustrial applicability of products or processes,<\/p>\n\n\n\n<p>Section 3 (b): Inventions contrary to morality or which\ncause serious prejudice to human, animal or plant life or health or\nenvironment,<\/p>\n\n\n\n<p>Section 3(c): The mere discovery of scientific principle\nor the formulation of an abstract theory, discovery of any living thing or\nnon-living substance occurring in nature would not patentable,<\/p>\n\n\n\n<p>Section 3(j): Plants or animals in whole or any part\nthereof, other than microorganisms but including seeds varieties and species\nand essentially biological processes for production and propagation of plants\nand animals cannot be patented.<\/p>\n\n\n\n<p>Section 10 (4): Sufficiency of disclosure and the best\nmethod of performing the invention, and <\/p>\n\n\n\n<p>Section 10 (5): Unity of invention and clarity,\nsuccinctness and support of the claims.<\/p>\n\n\n\n<p>A gene is product which naturally occurs and hence under\nSection 3(c) of Indian Patent Act, a gene is not patentable. Thus, merely\nisolated naturally occurring genes are considered a discovery and not an\ninvention and are therefore deemed to be not patentable as per sub-Section\n3(c).<\/p>\n\n\n\n<p>The Indian Patent practice shows an approach which is\nbroad and assimilating in nature. Moreover, the draft manual 2005 and\n&#8220;Guidelines for Examination of Biotechnology Applications for Patent&#8221;\nhad an annexure specifically dedicated to invention related to biotechnology\nand pharmaceutics. This gave a clearer picture of kind of gene related\ninventions which are and are not patentable. It clarified that though natural\norigin plants, animals, their varieties and species are not patentable but\nrecombinant DNA and plasmids are patentable if there is substantial human\nintervention.<\/p>\n\n\n\n<p>Therefore to sum up the findings a gene is patentable in India only when it is recombinant with sufficient human intervention and has an industrial application. For example, a patent can be granted for the isolated DNA sequence corresponding to the coding region of a gene only if the sequence is new and was isolated by a method that would be considered non-obvious by a skilled person, and if it presents unexpected, surprising properties. Hence, the sequence function must be disclosed in the patent application and should meet the industrial applicability requirements.<\/p>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>WHAT DOES A PATENT OVER A GENE MEAN? A patent for a gene or gene patent means ownership and exclusive rights for a specific DNA\/RNA sequence by an individual, organization, or corporation, who claims to have originally isolated a natural gene sequence and altered through gene engineering technologies to obtain a known function. This means &hellip; <a href=\"https:\/\/videaimip.com\/blog\/can-genes-be-patented\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Gene Patent : Expressing the Truth&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[20,16,17,19,8,18],"class_list":["post-184","post","type-post","status-publish","format-standard","hentry","category-patent","tag-cells","tag-dna","tag-genes","tag-medical","tag-patent","tag-science"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gene Patent : Expressing the Truth | VIDEAIM IP - LEADING IPR FIRM IN BANGALORE\/GURGAON<\/title>\n<meta name=\"description\" content=\"A gene patent means exclusive rights for a specific DNA sequence by an inventor or applicant, who altered an originally isolated a natural gene sequence to obtain a known function.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/videaimip.com\/blog\/can-genes-be-patented\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gene Patent : Expressing the Truth | VIDEAIM IP - 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