{"id":56749,"date":"2023-05-19T12:25:50","date_gmt":"2023-05-19T06:55:50","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=56749"},"modified":"2023-05-20T11:44:22","modified_gmt":"2023-05-20T06:14:22","slug":"conceptual-issues-in-patenting-of-life-forms","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/conceptual-issues-in-patenting-of-life-forms\/","title":{"rendered":"Conceptual issues in patenting of life forms"},"content":{"rendered":"\n<p>Intellectual property pertains to the creations of the human mind, and if they possess commercial value, they can be considered assets. It includes inventions, industrial designs, literary and artistic works, symbols, and more. The term &#8220;patent&#8221; has its roots in the Latin word &#8220;patent-em,&#8221; which means open, although this apparent contradiction requires clarification. The optimal dissemination of new knowledge plays a crucial role in achieving the highest level of economic efficiency. We discuss Conceptual issues in patenting of life forms.<\/p>\n\n\n\n<p>A patent is a form of <strong><a href=\"https:\/\/corpbiz.io\/trademark-registration\">intellectual property right <\/a><\/strong>granted to an individual, providing them with exclusive control over their invention while necessitating its complete disclosure. The invention can be a product or a process, but it must be applicable in an industrial context.<\/p>\n\n\n\n<p>The\nconcept of patentability for life forms and its associated challenges emerged\nduring the late 1900s with the rapid advancement of gene technology and\nbiotechnology research. Researchers in these fields began manipulating\nnaturally occurring life forms to benefit society on a larger scale, introducing\nconcepts like bio-patenting or patenting life forms.<\/p>\n\n\n\n<p>Presently, this concept encounters diverse legal and ethical dilemmas due to its commercial utilization and the absence of well-defined regulations. Furthermore, specific terminologies related to bio-patenting still need to be clarified within the framework of <strong>the Patent Act of 1970<\/strong><sup><a href=\"https:\/\/ipindia.gov.in\/\"><strong>[1]<\/strong><\/a><\/sup>. These complexities highlight the need for comprehensive and precise laws to govern the patenting of life forms and related practices.<\/p>\n\n\n\n<p>Overall,\nintellectual property rights, including patents, play a crucial role in\nincentivizing innovation, fostering economic growth, and safeguarding\ninventors&#8217; rights while balancing commercial interests and ethical\nconsiderations.<\/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\/conceptual-issues-in-patenting-of-life-forms\/#Why_should_life_forms_be_patented\" >Why should life forms be patented?<\/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\/conceptual-issues-in-patenting-of-life-forms\/#Position_in_India\" >Position 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\/conceptual-issues-in-patenting-of-life-forms\/#Patents_in_microorganisms\" >Patents in microorganisms<\/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\/conceptual-issues-in-patenting-of-life-forms\/#Conceptual_Issues_of_Patenting_Life_Forms\" >Conceptual Issues of Patenting Life Forms<\/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\/conceptual-issues-in-patenting-of-life-forms\/#GMO_Patent_Laws_in_India\" >GMO Patent Laws in India<\/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\/conceptual-issues-in-patenting-of-life-forms\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Why_should_life_forms_be_patented\"><\/span>Why should life forms be patented? <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The famous case of Diamond v. Chakrabarty (1980) acknowledged that genetically modified organisms (GMOs) are living entities but are not naturally occurring in nature. In this case, the U.S. Supreme Court ruled that a genetically modified bacterium capable of breaking down crude oil components could be granted a patent. The court justified this decision by highlighting that the modified bacterium did not exist naturally, nor did any naturally occurring bacteria exhibit its specific capabilities. <\/p>\n\n\n\n<p>Furthermore, the court recognized that the modified bacterium met the essential criteria for patentability, being a product of human intellect with its distinct name, characteristics, and specific application. This verdict significantly impacted the field of genetic engineering, leading to a surge in patent activities. Numerous patent applications were put on hold pending the case&#8217;s resolution, but they have since been processed. Currently, the National Centre for Biotechnology Information (NCBI) reports approximately 500 pending <strong><a href=\"https:\/\/corpbiz.io\/patent-registration\">patent applications<\/a><\/strong> related to genetic engineering, with more expected in the near future. As a result, the rate of patent activity in the field of genetic engineering is growing at approximately twice the speed of similar technologies.<\/p>\n\n\n\n<p>It\nis essential to consider that genetic modification is a costly and\ntime-consuming process. Suppose the creators of genetically modified products\nare not granted the benefits of their creations. In that case, they will need\nmore motivation and financial support to continue their research, potentially\nresulting in stagnation within the field. Allowing these creators to benefit\nfrom their work incentivizes further innovation and ensures the progression of\ngenetic engineering, enabling ongoing discoveries and advancements.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Position_in_India\"><\/span>Position in India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A\nsignificant case regarding the patentability of life forms was Dimminaco A.G,\nwhich established that manufacturing involves a specific procedure, often\nincorporating vaccines containing living organisms. The application of Article\n27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights\n(TRIPS) resulted in notable changes to the definition of invention within the\nPatent Act of 1970.<\/p>\n\n\n\n<p>However,\nthe Act lacks explicit definitions related to life forms, leading to ambiguity\nand arbitrariness in interpreting the provisions. Standard terms like\n&#8220;microorganism&#8221; and similar terminology are left to the discretion of\nthe interpreter, occasionally referencing the TRIPS Agreement.<\/p>\n\n\n\n<p>The\npatenting of life forms in India faces several challenges due to the need to\nconsider multiple factors when interpreting the Act. Apart from meeting\ncriteria such as novelty, inventive step, and industrial applicability, other\nfactors present obstacles to granting patents for inventions involving life\nforms. These include provisions in the Patent Act&#8217;s sections 3(a) to 3(p),\nencompassing considerations like &#8220;against public order or morality,&#8221;\n&#8220;discovery of a living substance,&#8221; and &#8220;inventions directed to\nmethods of agriculture,&#8221; among others.<\/p>\n\n\n\n<p>In\nmany instances, inventions involving life forms are categorized as preexisting\nnatural matter and are therefore deemed ineligible for patent protection.\nAdditionally, utilizing such naturally occurring matter in an industrial\ncontext raises various legal and ethical concerns, often conflicting with the\npublic interest. Thus, it is essential to carefully analyze the conceptual\nissues surrounding the patenting of life forms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patents_in_microorganisms\"><\/span>Patents in microorganisms <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before\n1980, the answer to the question of whether microorganisms could be patented\nwas a clear &#8220;no.&#8221; Microorganisms were considered natural products and\nthus ineligible for patent protection. However, the advent of DNA manipulation\nbetween organisms changed this perception.<\/p>\n\n\n\n<p>According\nto the Mashelkar committee report, microorganisms are now recognized as\npatentable subject matter in India. Unlike many developed countries, India\nallowed product patents for inventions involving microorganisms and other\nbiological materials. From May 20, 2003, India began granting patents for\nmicroorganism-related inventions, although it was not obligated to introduce\nlaws for patenting microorganisms before December 31, 2004. <\/p>\n\n\n\n<p>Patenting microorganisms are classified as a product patents offering a protection period of either five years from the grant date or seven years from the date of application filing.<\/p>\n\n\n\n<p>&nbsp;Currently, patents for microbiological\ninventions are granted for 20 years from the filing date.<\/p>\n\n\n\n<p>The\nprimary difference in legal practices between India and developed nations is\nthat India prohibits patenting microorganisms that already occur naturally.<\/p>\n\n\n\n<p>Such\ncases are considered discoveries and fall under section 3(d) provisions, making\nthem ineligible for patents. However, genetically modified versions of these\nmicroorganisms, which enhance their known efficacies, can be patented.<\/p>\n\n\n\n<p>The\ngranting of patents for microorganisms in India depends on regulations related\nto the deposition of microorganisms under the Budapest Treaty, of which India\nis a member. Accessibility of the microorganism from the depositories is also a\ncrucial factor. As per proviso (ii) of section 10(d), if a microorganism is not\nentirely and specifically described and is not available to the public, it must\nbe deposited with the International Depositary Authority under the Budapest\nTreaty.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conceptual_Issues_of_Patenting_Life_Forms\"><\/span>Conceptual Issues of Patenting Life Forms<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1.The Legal Issues \u2013<\/h3>\n\n\n\n<p>According\nto the Patent Act of 1970, a product or process can only be eligible for a\npatent if it involves innovation and complete disclosure. However, when considering\ninnovations in the biotechnology field, it becomes evident that they may be\nperceived as naturally occurring subject matter, falling within the exclusion\nclauses of Section 3 of the Act.<strong><\/strong><\/p>\n\n\n\n<p>Furthermore,\nusing a substance that is naturally available but excluding it from the general\npublic may be considered against the public interest, thereby excluding it from\npatentability. Some cases describe this as the transformation of\n&#8220;naturally occurring material created by a higher power&#8221; into private\nobjects using technology.<\/p>\n\n\n\n<p>An\nillustrative case highlighting this is <strong>Funk\nBros. v. Inoculant Co<\/strong>., which involved culturing Rhizobia to immunize\nleguminous plants. The court ruled that the inherent characteristics of\nbacteria were merely a &#8220;work of nature&#8221; and, therefore, not\npatentable.<\/p>\n\n\n\n<p>However,\nthe case of Diamond v. Chakrabarty presents a contrasting perspective. In this\ncase, the U.S. Supreme Court adopted a liberal approach and granted a patent\nfor a genetically improved bacterial species. The court focused on the\ninventive step taken to harness the bacteria&#8217;s unique capability. It emphasized\nthat the term &#8220;manufacture&#8221; encompassed all man-made creations.<\/p>\n\n\n\n<p>Following\nthis landmark decision, several patents were granted with little regard for\nmoral considerations. The need for more clarity regarding when an invention\nshould be examined from the standpoint of public morality raises the question\nof when human intervention alone is sufficient to deem an invention patentable,\nparticularly in the context of Genetically Modified Organisms (GMOs).\nFurthermore, inconsistent court rulings need to establish clear guidelines\nconcerning patentable life forms.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2.The Moral and Ethical Issues-<\/h3>\n\n\n\n<p>The\ninclusion of <strong>genetically modified\norganisms <\/strong>(GMOs) in the realm of patentable inventions has sparked ethical\nand moral debates, questioning whether these actions amount to assuming the\nrole of a higher power and degrading the sanctity of life in pursuit of private\ninterests.<\/p>\n\n\n\n<p>A\ncritical case to consider is Relaxin, where the court differentiated between\npatenting a single gene and patenting human life itself. The court reasoned\nthat since cloning technology had not advanced to the stage where an entire\nhuman could be cloned from a single gene, the two could not be equated.\nAdditionally, particular inventions hold significant societal importance,\nmaking their patentability apparent. In the case of isolating Relaxin for\ngenetic coding, it was considered more than a mere discovery.<\/p>\n\n\n\n<p>In\nanother case before the European Courts, the patentability of a genetically\nmodified plant faced opposition based on moral grounds. During this case, the\nBoard explained the terms &#8220;morality&#8221; and &#8220;public order.&#8221;\nHowever, these concepts vary among nations, as the criteria for determining\nwhat is moral or disruptive to public order largely depend on the collective\nconscience of different segments of society.<\/p>\n\n\n\n<p>For\nmany, patenting life forms is often deemed immoral, as manipulating genes can\npresent a perspective where life is reduced to a mere commodity, exploited for\nprofit by private entities or individuals.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Ownership Issues-<\/h3>\n\n\n\n<p>The\nissue of ownership rights over modified life forms has been a subject of\ndiscussion in various instances. For instance, consider the case of the\nT-Lymphocyte, where a patent was granted based on an invention derived from a\ncancer patient&#8217;s spleen without their consent or knowledge. This action led to\nlegal disputes and raised questions about whether researchers should obtain explicit\nconsent to claim ownership rights over genetically modified materials.\nAdditionally, what benefits should be provided to contributors involved in the\nresearch?<\/p>\n\n\n\n<p>Despite\nthese concerns, it is crucial to recognize that the primary objective of\npatenting life forms is to benefit humanity as a whole. The commercial aspect\nshould be seen in collaboration rather than in the context of promoting the\npublic interest. It is essential to acknowledge that research can only be\nincentivized if a fair reward exists. Granting patents encourages efforts\ntowards advancing society, particularly in areas that aim to improve quality of\nlife or revolutionize healthcare. Temporary monopolization is seen as a minor\ntrade-off for the greater goal.<\/p>\n\n\n\n<p>However,\nother aspects can lead to discontents, such as the potential advantages\ndeveloped countries have over developing ones and their involvement in the\nappropriation of biological materials from various communities. It is evident\nin the pharmaceutical industry, where affluent nations derive financial\nbenefits from others by requiring periodic payments for the use of patented\ninventions deemed essential for survival.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"GMO_Patent_Laws_in_India\"><\/span>GMO Patent Laws in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>GMO (Genetically\nModified Organism)<\/strong> patent laws encompass\nthe legal framework governing the protection and ownership of genetically\nmodified organisms. Before the 2002 amendment to India&#8217;s patent law of 1970,\nthere was limited or no significant patent safeguard for inventions related to\nlife forms and genetically modified organisms within the country. However, the\nDimminaco A.G v. Controller of Patent and Design ruling changed this. The\nCalcutta High Court determined that a process for producing vaccines containing\nlive viruses is eligible for patent protection. The court reasoned that the\nterm &#8220;manufacture&#8221; encompasses non-living entities and living\norganisms. Even if the final product includes a live virus, the process\ninvolved in its creation can be considered an invention.<\/p>\n\n\n\n<p>The\nlandmark case of Monsanto Technology LLC v. Nuziveedu Seeds Ltd further\nsupported the case for patenting G.M. and living organisms. In this particular\ncase, the renowned Supreme Court of India made a ruling stating that\ngenetically modified cotton seeds could be patented, thereby granting\npermission to the U.S. company Monsanto to proceed with their patent claims.<\/p>\n\n\n\n<p>These\nlegal decisions have contributed to shaping the landscape of G.M. and living\norganism patents in India, clarifying the scope of patentability and\nrecognizing the innovative aspects involved in developing and commercializing\ngenetically modified organisms.<\/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>Patents on life forms have negative consequences for research, indigenous economies, and genetic diversity. They create monopolies and drive-up prices, making essential products unaffordable for many. Patents also hinder the exchange of information and impede cooperative scientific efforts. Taxpayer-funded research is exploited by corporations profiting from patented products, making citizens pay twice for medicines and other goods. Patents can lead to unsustainable and inequitable agricultural practices and a decline in genetic diversity. The patenting of genetically modified organisms makes it easier for corporations to maintain control while promising benefits that often fail to materialize. Patents on genetic resources from developing countries allow the wealthy industrial nations to accumulate more wealth at the expense of the South. Additionally, patenting life forms raises significant religious and ethical concerns. While the biotechnology revolution presents opportunities, it is essential to prioritize societal well-being over conflicting ideologies when making regulatory decisions.<\/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\/biotechnology-patents-in-india\/\">Biotechnology Patents In India: A Complete Outlook<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Intellectual property pertains to the creations of the human mind, and if they possess commercial value, they can be considered assets. It includes inventions, industrial designs, literary and artistic works, symbols, and more. The term &#8220;patent&#8221; has its roots in the Latin word &#8220;patent-em,&#8221; which means open, although this apparent contradiction requires clarification. The optimal [&hellip;]<\/p>\n","protected":false},"author":74,"featured_media":56846,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[322],"tags":[3632],"acf":{"service_id":"20"},"authorName":"Maithli Jha","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2023\/05\/MicrosoftTeams-image-1-22.jpg","authorDescription":"Maithli is a final-year law student at Guru Gobind Singh Indraprastha University (GGSIPU) with a keen interest in emerging legal fields. She is committed to constantly learning and utilizing her theoretical knowledge in practical ways within the field of law.","postViews":2218,"readingTime":8,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/56749"}],"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\/74"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=56749"}],"version-history":[{"count":6,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/56749\/revisions"}],"predecessor-version":[{"id":56850,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/56749\/revisions\/56850"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/56846"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=56749"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=56749"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=56749"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}