{"id":57942,"date":"2023-06-28T10:00:29","date_gmt":"2023-06-28T04:30:29","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=57942"},"modified":"2023-06-07T18:49:50","modified_gmt":"2023-06-07T13:19:50","slug":"biotechnology-patent-and-the-problem-of-non-obviousness","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/biotechnology-patent-and-the-problem-of-non-obviousness\/","title":{"rendered":"Biotechnology Patents and the Problem of Non-Obviousness"},"content":{"rendered":"\n<p>A biotechnology patent involves\nusing biology to create new products and solve problems. This includes genetic\nengineering to produce therapeutic proteins and drugs and working with living\nand non-living organisms like plants, animals, seeds, and enzymes.\nBiotechnology research has seen significant growth, especially in DNA\nrecombinant engineering, leading to advancements in cloning, pharmaceuticals,\nand other areas. Biotech has been instrumental in developing medicine and\nagriculture, but with rapid growth comes a need to protect inventions to ensure\ncontinued progress. Unfortunately, conflicts have arisen between patent laws\nand biotechnological inventions.<\/p>\n\n\n\n<p>Determining whether an invention in biotechnology is eligible for a <strong><a href=\"https:\/\/corpbiz.io\/patent-registration\">patent<\/a><\/strong> can be challenging because of novelty and non-obviousness. This is particularly true in biotech, which is rapidly evolving, complex, and relatively young. What may seem new and innovative today may become ordinary and evident in just a few years.<\/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\/biotechnology-patent-and-the-problem-of-non-obviousness\/#Biotechnology\" >Biotechnology<\/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\/biotechnology-patent-and-the-problem-of-non-obviousness\/#Biotechnology_and_Patent_Laws_Linkage\" >Biotechnology and Patent Laws Linkage<\/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\/biotechnology-patent-and-the-problem-of-non-obviousness\/#The_Drawbacks_of_an_Undefined_Non-Obviousness_Standard_in_Patent_Law\" >The Drawbacks of an Undefined Non-Obviousness Standard in Patent Law<\/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\/biotechnology-patent-and-the-problem-of-non-obviousness\/#Patentability_of_Biotechnology_Inventions_The_Emerging_Issues_and_Challenges\" >Patentability of Biotechnology Inventions: The Emerging Issues and\nChallenges<\/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\/biotechnology-patent-and-the-problem-of-non-obviousness\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Biotechnology\"><\/span>Biotechnology<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The concept of patenting\nbiotechnology inventions is controversial due to the nature of the subject\nmatter. To be patentable, an invention must be new and non-obvious. However,\nbiotechnology inventions often deal with living organisms and genetic material\nalready in nature. This poses challenges in identifying the novelty and non-obviousness\nof such inventions.<\/p>\n\n\n\n<p>Moreover, patenting naturally\noccurring subject matter is considered unethical and against the public\ninterest. The test of obviousness in patent law adds to the difficulty of\nobtaining patents for biotechnology inventions. The patentability criteria,\nsuch as novelty, utility, and non-obviousness, have presented new challenges in\nbiotechnology. Novelty is difficult to identify in living organisms, and\nobviousness is challenging in gene sequencing due to similar techniques.<\/p>\n\n\n\n<p>The complexity of genetically\nengineered inventions makes it hard to decide whether they are patentable. The\ncurrent patent framework may not provide sufficient protection for\nbiotechnology inventions, and there is a risk of granting patents to\nundeserving patentees. The complexities involved in creating biotech\ninnovations allow for the issuance of patents for gene fragments, genetic\ntests, and proteins, even if the precise details of their functionality are not\nfully understood.<\/p>\n\n\n\n<p>The unique features of biotechnology\ninventions, such as living organisms and genetic material, pose significant\nchallenges to the patent system. While biotechnology inventions are considered\nfrom the same perspective as other inventions as far as patent law is\nconcerned, adaptations may be necessary to consider the nature of the subject\nmatter.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Biotechnology_and_Patent_Laws_Linkage\"><\/span>Biotechnology and Patent Laws Linkage<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India, patent laws are applicable to new and valuable inventions. This includes articles or substances a manufacturer produces and the manufacturing process itself. However, in the case of medicine, drugs, and certain types of chemicals, a patent can only be obtained for the manufacturing process and not for the product or article itself. Biotech inventions primarily involve products containing &#8220;biological material&#8221; or processes for producing such material, which essentially refers to genetic material that can reproduce or be reproduced in a biological system for <strong><a href=\"https:\/\/corpbiz.io\/learning\/biotechnology-patents-in-india\/\">biotechnology patent<\/a><\/strong>. Indian law requires the deposition of the biological material used under Section 10(4) and Rule 13(8) of<strong> <\/strong>the Patent Act. Despite ongoing debates about whether biotech inventions should be patentable, they are now considered alongside other innovations. However, given that biotech research often involves living organisms, it is crucial to exercise due care. Biotechnology falls under the &#8220;Utility Patent&#8221; category, available for developing or innovating a new sound machine, industrial technique, material composition, or technology. The challenge in determining the patentability of biotech inventions arises from the concepts of novelty and non-obviousness in a rapidly growing and complex field. It is imperative to develop clear guidelines to protect the interests of inventors. Additionally, patenting life forms is still an area under exploration in India.<\/p>\n\n\n\n<p>The patent laws in India allow for\npatents to be granted for new and useful inventions, including the\nmanufacturing process of an article. In the case of biotech inventions, patents\nare typically granted for products containing &#8220;Biological Material&#8221;\nor processes for producing such material. Although there is still some debate\nabout whether biotech inventions should be eligible for patents, they fall\nunder the category of &#8220;Utility Patent&#8221; for novel and sound machines,\ntechniques, materials, or technologies. However, determining the patentability\nof biotech inventions can be challenging due to the concepts of novelty and\nnon-obviousness. Nonetheless, established practices allow for patents on\nnatural substances that have been isolated and possess increased activity or\npurity compared to their natural form. Biotech inventions must still meet the\nfour hurdles of patentability: novelty, non-obviousness, inventive step, and\nusefulness.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Novelty: <\/h3>\n\n\n\n<p>Under patent law, an\ninvention must be new to be eligible for a patent, which grants the owner a\nlegally enforceable monopoly over their invention. This is intended to prevent\ngranting patents for previously known inventions. The substance doesn&#8217;t need to\nbe absent from nature, but it must not have been made public before filing the\npatent application. Therefore, the argument that biotechnology cannot be\npatented because the substance already exists in nature is invalid. In the case\nof Bishwanath Prasad Radhe Shyam v. Hindustan Metal Industries, the court\nemphasized that a patent must be granted only for a new and useful invention,\nwhich is the inventor&#8217;s discovery, not simply a confirmation of what was\nalready known before the patent&#8217;s filing date.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2.&nbsp;Non-Obviousness: <\/h3>\n\n\n\n<p>Non-obviousness is a\nterm used to describe an innovation that is not just a minor improvement or\nrearrangement of an existing invention but includes a new addition. The concept\nof non-obviousness is closely related to inventive steps, as it seeks to avoid\ngranting patents for inventions that are simply ordinary product designs or\ndevelopment, in the case of M\/s. Bishwanath Prasad Radhey Shyam Appellant v.\nM\/s. Hindustan Metal Industries, the court emphasized that an improvement or\ncombination of known elements must be more than a simple workshop improvement\nto be patentable. It must independently meet the criteria for an invention or\nan &#8220;inventive step.&#8221; The combination must produce a new result or a\nbetter, cheaper article than before and must not be a mere collocation of old known\nelements. An expert in the field evaluates non-obviousness but also from the\nperspective of a person with common skills in art.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_Drawbacks_of_an_Undefined_Non-Obviousness_Standard_in_Patent_Law\"><\/span>The Drawbacks of an Undefined Non-Obviousness Standard in Patent Law<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ensuring that the non-obviousness\nstandard is appropriately applied is crucial to the functioning of patent law.\nIf the standard is too high, it can reduce the incentives for inventors to\ncreate and reveal their inventions. Conversely, the standard is set too low. In\nthat case, excessive patenting may occur, resulting in inefficient patent\nthickets, anti-commons, minefields, hold-ups, and other issues, which can also\ndiminish inventors&#8217; incentives to invent. Thus, setting a non-obviousness\nstandard that is either too restrictive or too lax can impede technological progress\nand have social and economic consequences.<\/p>\n\n\n\n<p>However, since the non-obviousness\nstandard is not well-defined, decision-makers cannot apply the standard\nconsistently. Simply using the term &#8220;non-obvious&#8221; as a standard is\ninsufficient, as it is nothing more than a bare legal conclusion. The\nnon-obviousness standard was only intended to establish the basis for\ndeveloping criteria for evaluating obviousness. Since this development has not\noccurred, the non-obviousness standard has become an empty legal conclusion\nwithout standards to guide decision-making, leading to indeterminate\nconsequences. As a result, non-obviousness determinations are unpredictable and\ninconsistent.<\/p>\n\n\n\n<p>Given this, the recent widespread\ncriticism of the judicial system and Patent Office for wrongly applying a low\nnon-obviousness standard appears partly misguided. Since an indeterminate\nstandard cannot be consistently or accurately applied, criticism of the failure\nto define the non-obviousness standard may be warranted. Still, criticism for failing\nto apply it correctly may not be justified.<\/p>\n\n\n\n<p>The prevailing viewpoint in patent\nlaw is that the non-obviousness requirement is too lenient, leading to patents\non insignificant inventions that ultimately impede technological innovation.\nHowever, the problem with the non-obviousness standard is not only that it is\ntoo low but also that it is indeterminate. This indeterminacy has three leading\ncauses: the lack of clarity regarding the degree of innovation needed to\nsatisfy the standard, the absence of a defined baseline level of skill to\nmeasure innovation, and the challenge of expecting a technologically\nunsophisticated decision maker to assess an innovation from the viewpoint of an\nexpert in the field. The unpredictability resulting from indeterminacy leads to\nseveral unintended consequences, such as excessive patent grants on obvious\ninventions, too many patent applications for prominent innovations and not\nenough for non-obvious ones, increased patent litigation, and inefficient\nincentives for innovation. These outcomes may occur even when the\nnon-obviousness standard is correctly applied, indicating that the patent\nsystem&#8217;s ills may stem from indeterminacy rather than a too-low non-obviousness\nstandard. As a result, calls for adjusting the non-obviousness threshold may be\nirrelevant until the standard becomes more specific.<\/p>\n\n\n\n<p>To obtain biotechnology patent, an\ninventor must create something that is not obvious at the time of invention and\nis a significant advancement over existing technology. The non-obviousness\nrequirement serves to protect society by preventing undeserving patents and\nmonopolies. Inefficient application of this standard can lead to reduced\ninnovation and the creation of trivial advances that result in patent thickets\nand other inefficiencies. Patent litigation commonly focuses on the\nnon-obviousness requirement, which is critical to innovation policy and the\ntechnology economy in the United States.<\/p>\n\n\n\n<p>The non-obviousness prerequisite in\npatent law, as stated in Section-103 of <strong>the Patent Act<\/strong><sup><a href=\"https:\/\/ipindia.gov.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf\"><strong>[1]<\/strong><\/a><\/sup>, specifies that a patent cannot be\nawarded if the idea being patented would have been apparent to someone with\naverage expertise in the relevant field. To meet this legal standard, certain\nfactors must be evaluated, such as the existing knowledge of an average skilled\nperson, the degree of innovation required to satisfy the non-obviousness\nrequirement, and the extent to which the invention improves upon existing\ntechnologies. Combining these three elements can determine whether the\ninventor\u2019s advance over the baseline exceeds the required quantum in meeting\nthe Section-103 standards. the non-obviousness requirement is a crucial aspect\nof obtaining a patent that ensures deserving inventions receive protection\nwhile preventing the granting of undeserving monopolies. It requires assessing\nwhat was previously known in the field, the level of innovation necessary to\nmeet the non-obviousness requirement, and the advancement provided by the\ninvention over prior art.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patentability_of_Biotechnology_Inventions_The_Emerging_Issues_and_Challenges\"><\/span>Patentability of Biotechnology Inventions: The Emerging Issues and\nChallenges<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A biotechnology patent invention\nposes unique challenges due to the fact that the core subject matter of these\ninventions already exists in nature. Patent law requires an invention to be\nnovel and non-obvious, identifying novelty in living beings is complex, and\nobviousness is a tricky characteristic in biotechnology due to similar\ntechniques for isolating gene sequences. Additionally, the utility standard has\nbeen viewed as de minimis in most technologies but has been raised for\ninnovations in biotechnology, making it challenging to obtain patents for some\ninventions. Patents for the human genome are also complicated because human\ngenes occur naturally and are discovered, not invented. The unique features of\nbiotechnology innovations and genetically modified organisms can lead to\ndifficult questions of interpretation and understanding of patent law as the\ndifference between invention and discovery becomes blurred. Furthermore, the\ncomplex nature of genetically engineered inventions can make it difficult to\naccurately and precisely describe them, potentially leading to undeserving\npatentees being granted patents on gene fragments, genetic tests, and proteins\nwhere the real work is not entirely known. These factors make obtaining biotechnology\npatent inventions a challenging and contentious issue.<\/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 patent system poses a challenge for biotechnology to receive equal protection for biotechnology patent. Almost every patent law principle in biotechnology must be reevaluated, particularly the unclear patentability requirement of non-obviousness. Due to the complexities of determining non-obviousness, it is difficult to judge. The question has always been whether biotech patents fulfil the criteria for innovation, usefulness, inventive step, and non-obviousness in some instances. As seen, the courts have established exceptions to patentable subjects. Biotechnology patent enforcement activities are increasing in India, and in the future, more precise tests for determining the existence of innovative steps in inventions are anticipated. Companies should exercise caution when making strategic decisions about patent filings and be aware of the risks associated with non-obviousness evaluation.<\/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\/patent-process-all-you-need-to-know\/\">Patent Process: All You Need To Know<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A biotechnology patent involves using biology to create new products and solve problems. This includes genetic engineering to produce therapeutic proteins and drugs and working with living and non-living organisms like plants, animals, seeds, and enzymes. Biotechnology research has seen significant growth, especially in DNA recombinant engineering, leading to advancements in cloning, pharmaceuticals, and other [&hellip;]<\/p>\n","protected":false},"author":74,"featured_media":57962,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[282],"tags":[3759],"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":2243,"readingTime":7,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/57942"}],"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=57942"}],"version-history":[{"count":5,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/57942\/revisions"}],"predecessor-version":[{"id":57963,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/57942\/revisions\/57963"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/57962"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=57942"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=57942"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=57942"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}