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data-event-name="pinnable-header.vector-toc.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-toc.unpin">hide</button> </div> <ul class="vector-toc-contents" id="mw-panel-toc-list"> <li id="toc-mw-content-text" class="vector-toc-list-item vector-toc-level-1"> <a href="#" class="vector-toc-link"> <div class="vector-toc-text">(Top)</div> </a> </li> <li id="toc-Biological_patents_in_different_jurisdictions" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Biological_patents_in_different_jurisdictions"> <div class="vector-toc-text"> <span class="vector-toc-numb">1</span> <span>Biological patents in different jurisdictions</span> </div> </a> <button aria-controls="toc-Biological_patents_in_different_jurisdictions-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Biological patents in different jurisdictions subsection</span> </button> <ul id="toc-Biological_patents_in_different_jurisdictions-sublist" class="vector-toc-list"> <li id="toc-Australia" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Australia"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.1</span> <span>Australia</span> </div> </a> <ul id="toc-Australia-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Canada" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Canada"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.2</span> <span>Canada</span> </div> </a> <ul id="toc-Canada-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Europe" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Europe"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.3</span> <span>Europe</span> </div> </a> <ul id="toc-Europe-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Japan" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Japan"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.4</span> <span>Japan</span> </div> </a> <ul id="toc-Japan-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-United_States" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#United_States"> <div class="vector-toc-text"> <span class="vector-toc-numb">1.5</span> <span>United States</span> </div> </a> <ul id="toc-United_States-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Ethics" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Ethics"> <div class="vector-toc-text"> <span class="vector-toc-numb">2</span> <span>Ethics</span> </div> </a> <button aria-controls="toc-Ethics-sublist" class="cdx-button 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3.3em}@media(max-width:640px){body.mediawiki .mw-parser-output .sidebar{width:100%!important;clear:both;float:none!important;margin-left:0!important;margin-right:0!important}}body.skin--responsive .mw-parser-output .sidebar a>img{max-width:none!important}@media screen{html.skin-theme-clientpref-night .mw-parser-output .sidebar:not(.notheme) .sidebar-list-title,html.skin-theme-clientpref-night .mw-parser-output .sidebar:not(.notheme) .sidebar-title-with-pretitle{background:transparent!important}html.skin-theme-clientpref-night .mw-parser-output .sidebar:not(.notheme) .sidebar-title-with-pretitle a{color:var(--color-progressive)!important}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .sidebar:not(.notheme) .sidebar-list-title,html.skin-theme-clientpref-os .mw-parser-output .sidebar:not(.notheme) .sidebar-title-with-pretitle{background:transparent!important}html.skin-theme-clientpref-os .mw-parser-output .sidebar:not(.notheme) .sidebar-title-with-pretitle a{color:var(--color-progressive)!important}}@media print{body.ns-0 .mw-parser-output .sidebar{display:none!important}}</style><style data-mw-deduplicate="TemplateStyles:r1202158006">.mw-parser-output .law-sidebar .sidebar-heading{background:#aaddff;color:#000}.mw-parser-output .law-sidebar .sidebar-above{font-weight:normal}.mw-parser-output .law-sidebar .sidebar-below{padding:0.4em;border-top:1px #aaa solid;font-weight:normal;font-size:smaller}</style><table class="sidebar nomobile nowraplinks hlist law-sidebar"><tbody><tr><th class="sidebar-title">Patent law</th></tr><tr><th class="sidebar-heading"> Overviews</th></tr><tr><td class="sidebar-content"> <ul><li><a href="/wiki/Patent" title="Patent">Patent</a></li> <li><a href="/wiki/Patent_claim" title="Patent claim">Patent claim</a></li> <li><a href="/wiki/History_of_patent_law" title="History of patent law">History</a></li> <li><a href="/wiki/Economics_and_patents" title="Economics and patents">Economics</a></li> <li><a href="/wiki/Criticism_of_patents" title="Criticism of patents">Criticism</a></li></ul></td> </tr><tr><th class="sidebar-heading"> Procedural concepts</th></tr><tr><td class="sidebar-content"> <ul><li><a href="/wiki/Patent_application" title="Patent application">Application</a></li> <li><a href="/wiki/Patent_prosecution" title="Patent prosecution">Prosecution</a></li> <li><a href="/wiki/Patent_opposition_proceedings" title="Patent opposition proceedings">Opposition</a></li> <li><a href="/wiki/Patent_valuation" title="Patent valuation">Valuation</a></li> <li><a href="/wiki/License#Intellectual_property" title="License">Licensing</a></li> <li><a href="/wiki/Patent_infringement" title="Patent infringement">Infringement</a></li></ul></td> </tr><tr><th class="sidebar-heading"> Patentability requirements and related concepts</th></tr><tr><td class="sidebar-content"> <ul><li><a href="/wiki/Patentable_subject_matter" title="Patentable subject matter">Patentable subject matter</a></li> <li><a href="/wiki/Inventor_(patent)" title="Inventor (patent)">Inventorship</a></li> <li><a href="/wiki/Novelty_(patent)" title="Novelty (patent)">Novelty</a></li> <li><a href="/wiki/Inventive_step_and_non-obviousness" title="Inventive step and non-obviousness">Inventive step and non-obviousness</a></li> <li><a href="/wiki/Industrial_applicability" title="Industrial applicability">Industrial applicability</a></li> <li><a href="/wiki/Utility_(patentability_requirement)" title="Utility (patentability requirement)">Utility</a></li> <li><a href="/wiki/Person_having_ordinary_skill_in_the_art" title="Person having ordinary skill in the art">Person skilled in the art</a></li> <li><a href="/wiki/Prior_art" title="Prior art">Prior art</a></li></ul></td> </tr><tr><th class="sidebar-heading"> Other legal requirements</th></tr><tr><td class="sidebar-content"> <ul><li><a href="/wiki/Sufficiency_of_disclosure" title="Sufficiency of disclosure">Sufficiency of disclosure</a></li> <li><a href="/wiki/Unity_of_invention" title="Unity of invention">Unity of invention</a></li></ul></td> </tr><tr><th class="sidebar-heading"> By region / country</th></tr><tr><td class="sidebar-content"> <ul><li><a href="/wiki/Patent_Cooperation_Treaty" title="Patent Cooperation Treaty">Patent Cooperation Treaty</a> (PCT)</li> <li><a href="/wiki/Australian_patent_law" title="Australian patent law">Australia</a></li> <li><a href="/wiki/Canadian_patent_law" title="Canadian patent law">Canada</a></li> <li><a href="/wiki/Patent_law_of_China" title="Patent law of China">China</a></li> <li><a href="/wiki/European_patent_law" title="European patent law">Europe</a></li> <li><a href="/wiki/German_patent_law" title="German patent law">Germany</a></li> <li><a href="/wiki/Japanese_patent_law" title="Japanese patent law">Japan</a></li> <li><a href="/wiki/Patent_law_in_the_Netherlands" title="Patent law in the Netherlands">Netherlands</a></li> <li><a href="/wiki/United_States_patent_law" title="United States patent law">United States</a></li></ul></td> </tr><tr><th class="sidebar-heading"> By specific subject matter</th></tr><tr><td class="sidebar-content"> <ul><li><a class="mw-selflink selflink">Biological</a></li> <li><a href="/wiki/Business_method_patent" title="Business method patent">Business method</a></li> <li><a href="/wiki/Chemical_patent" title="Chemical patent">Chemical</a></li> <li><a href="/wiki/Insurance_patent" title="Insurance patent">Insurance</a></li> <li><a href="/wiki/Software_patent" title="Software patent">Software</a></li> <li><a href="/wiki/Tax_patent" title="Tax patent">Tax</a></li></ul></td> </tr><tr><th class="sidebar-heading"> See also</th></tr><tr><td class="sidebar-content"> <ul><li><a href="/wiki/Patent_analysis" title="Patent analysis">Patent analysis</a></li> <li><a href="/wiki/Pirate_Party" title="Pirate Party">Pirate Party</a></li> <li><a href="/wiki/Category:Patent_law" title="Category:Patent law">Category</a></li> <li><a href="/wiki/Glossary_of_patent_law_terms" title="Glossary of patent law terms">Glossary</a></li></ul></td> </tr><tr><td class="sidebar-navbar"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><style data-mw-deduplicate="TemplateStyles:r1239400231">.mw-parser-output .navbar{display:inline;font-size:88%;font-weight:normal}.mw-parser-output .navbar-collapse{float:left;text-align:left}.mw-parser-output .navbar-boxtext{word-spacing:0}.mw-parser-output .navbar ul{display:inline-block;white-space:nowrap;line-height:inherit}.mw-parser-output .navbar-brackets::before{margin-right:-0.125em;content:"[ "}.mw-parser-output .navbar-brackets::after{margin-left:-0.125em;content:" ]"}.mw-parser-output .navbar li{word-spacing:-0.125em}.mw-parser-output .navbar a>span,.mw-parser-output .navbar a>abbr{text-decoration:inherit}.mw-parser-output .navbar-mini abbr{font-variant:small-caps;border-bottom:none;text-decoration:none;cursor:inherit}.mw-parser-output .navbar-ct-full{font-size:114%;margin:0 7em}.mw-parser-output .navbar-ct-mini{font-size:114%;margin:0 4em}html.skin-theme-clientpref-night .mw-parser-output .navbar li a abbr{color:var(--color-base)!important}@media(prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .navbar li a abbr{color:var(--color-base)!important}}@media print{.mw-parser-output .navbar{display:none!important}}</style><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Patent_law" title="Template:Patent law"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Patent_law" title="Template talk:Patent law"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Patent_law" title="Special:EditPage/Template:Patent law"><abbr title="Edit this template">e</abbr></a></li></ul></div></td></tr></tbody></table> <p>A <b>biological patent</b> is a <a href="/wiki/Patent" title="Patent">patent</a> on an <a href="/wiki/Invention" title="Invention">invention</a> in the field of <a href="/wiki/Biology" title="Biology">biology</a> that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for <a href="/wiki/Term_of_patent" title="Term of patent">a limited period of time</a>. The scope and reach of biological patents vary among jurisdictions,<sup id="cite_ref-GEN_1-0" class="reference"><a href="#cite_note-GEN-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> and may include biological technology and products, <a href="/wiki/Genetically_modified_organisms" class="mw-redirect" title="Genetically modified organisms">genetically modified organisms</a> and <a href="/wiki/Genetic_material" class="mw-redirect" title="Genetic material">genetic material</a>. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.<sup id="cite_ref-GEN_1-1" class="reference"><a href="#cite_note-GEN-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Biological_patents_in_different_jurisdictions">Biological patents in different jurisdictions</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=1" title="Edit section: Biological patents in different jurisdictions"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Australia">Australia</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=2" title="Edit section: Australia"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In February 2013, Judge Justice <a href="/wiki/John_Nicholas_(judge)" title="John Nicholas (judge)">John Nicholas</a> ruled in the <a href="/wiki/Federal_Court_of_Australia" title="Federal Court of Australia">Federal Court of Australia</a> in favour of a <a href="/wiki/Myriad_Genetics" title="Myriad Genetics">Myriad Genetics</a> patent on the <a href="/wiki/BRCA1" title="BRCA1">BRCA1</a> gene.<sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> This was a landmark ruling, affirming the validity of patents on naturally occurring <a href="/wiki/DNA" title="DNA">DNA</a> sequences. However, the <a href="/wiki/U.S._Supreme_Court" class="mw-redirect" title="U.S. Supreme Court">U.S. Supreme Court</a> came to the opposite conclusion only a few months later. The Australian ruling has been appealed to the Full Bench of the Federal Court; submissions in the case include consideration of the U.S. Supreme Court ruling.<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> This decision was decided in 2014, affirming Nicholas J's decision in favor of Myriad, confirming that isolated genetic material (<a href="/wiki/Gene" title="Gene">genes</a>) are valid subjects of patents.<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> In October 2015, the <a href="/wiki/High_Court_of_Australia" title="High Court of Australia">High Court of Australia</a> ruled that naturally occurring genes cannot be patented.<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Canada">Canada</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=3" title="Edit section: Canada"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Per Canada's <i>Patent Act</i>, patents are granted by the Canadian Intellectual Property Office (CIPO). Patents will only be granted for “any new and useful art, process, machine, manufacture or composition of matter”, and improvements thereon.<sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Patents will not be granted for “mere scientific principle or abstract theorem.”<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> In the case of pharmaceuticals, along with obtaining a patent, applicants must also seek approval from <a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a>. This process is governed by the <i>Patented Medicines (Notice of Compliance) Regulations</i>.<sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup> </p><p>In <i><a href="/wiki/Harvard_College_v_Canada_(Commissioner_of_Patents)" title="Harvard College v Canada (Commissioner of Patents)">Harvard College v Canada (Commissioner of Patents)</a>,</i> also referred to as the <a href="/wiki/Oncomouse" title="Oncomouse">oncomouse</a> case, the <a href="/wiki/Supreme_Court_of_Canada" title="Supreme Court of Canada">Supreme Court of Canada</a> ruled that higher life forms were not patentable subject matter. The OncoMouse was one of the first <a href="/wiki/Genetically_modified_mouse" title="Genetically modified mouse">transgenic mice</a> developed for use in cancer research, and the first mammal to be the subject of a patent application. Writing for the majority, Bastarache J. asserted that it was the role of Parliament to address whether higher life forms should be patentable.<sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> In contrast, the <a href="/wiki/United_States_Patent_and_Trademark_Office" title="United States Patent and Trademark Office">United States Patent & Trademark Office</a> issued the patents covering methods for providing a cell culture from a transgenic non-human anima to <a href="/wiki/Harvard_College" title="Harvard College">Harvard College</a>. The patent was also allowed in Europe before eventually being revoked in 2006 for a failure to pay fees and file translations.<sup id="cite_ref-wipo.int_12-0" class="reference"><a href="#cite_note-wipo.int-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> Although animals cannot be patented, Canada allows for the patent of antibodies obtained through immunizing animals.<sup id="cite_ref-:0_13-0" class="reference"><a href="#cite_note-:0-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> </p><p>Methods of medical treatment cannot be patented in Canada, however, medical use claims such as the use of an <a href="/wiki/Antibody" title="Antibody">antibody</a> for the treatment of a particular disease is patentable. Further, <a href="/wiki/Antigen" title="Antigen">antigens</a> which have not been previously characterized are also patentable.<sup id="cite_ref-:0_13-1" class="reference"><a href="#cite_note-:0-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> </p><p>Gene patents confer a property right to the patent holder. While CIPO will grant patents for isolated <a href="/wiki/Genomic_DNA" title="Genomic DNA">gDNA</a> and <a href="/wiki/Complementary_DNA" title="Complementary DNA">cDNA</a>, the <a href="/wiki/Supreme_Court_of_Canada" title="Supreme Court of Canada">Supreme Court of Canada</a> has not yet ruled on gene patentability. However, in 2016 the Children's Hospital of Eastern Ontario (CHEO) sought to invalidate five Canadian patents held by Transgenomic. The gene patents covered the genes associated with, and <a href="/wiki/Genetic_testing" title="Genetic testing">genetic testing</a> for <a href="/wiki/Long_QT_syndrome" title="Long QT syndrome">Long QT syndrome</a>. The parties reached a settlement. The patent was not invalidated, but, Transgenomic provided Canadian health institutions the right to test Canadians for the disease on a non-profit basis.<sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-15" class="reference"><a href="#cite_note-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> In <a href="/wiki/Association_for_Molecular_Pathology_v._Myriad_Genetics,_Inc." title="Association for Molecular Pathology v. Myriad Genetics, Inc."><i>Association for</i> <i>Molecular Pathology v Myriad</i></a>, the <a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">United States Supreme Court</a> determined that genes were unpatentable products of nature and that no intellectual property existed as nothing was invented.<sup id="cite_ref-16" class="reference"><a href="#cite_note-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> Given this decision, the majority of Canadian Long QT syndrome tests were previously outsourced to the United States. After the settlement, domestic testing levels increased in Canada. The terms of the settlement could set a precedent for the repatriation of further genetic testing.<sup id="cite_ref-17" class="reference"><a href="#cite_note-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Europe">Europe</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=4" title="Edit section: Europe"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p><a href="/wiki/European_Union" title="European Union">European Union</a> directive <a href="/wiki/Directive_98/44/EC" class="mw-redirect" title="Directive 98/44/EC">98/44/EC</a> (the <i>Biotech Directive</i>) reconciled the legislation of biological patents among certain countries under the jurisdiction of the <a href="/wiki/European_Patent_Organisation" title="European Patent Organisation">European Patent Organisation</a>.<sup id="cite_ref-GEN_1-2" class="reference"><a href="#cite_note-GEN-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> It allows for the patenting of natural biological products, including <a href="/wiki/DNA_sequencing" title="DNA sequencing">gene sequences</a>, as long as they are "isolated from [their] natural environment or produced by means of a technical process."<sup id="cite_ref-GEN_1-3" class="reference"><a href="#cite_note-GEN-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> </p><p>The <a href="/wiki/European_Patent_Office" title="European Patent Office">European Patent Office</a> has <a href="/wiki/G_2/06" title="G 2/06">ruled</a> that European patents cannot be granted for processes that involve the destruction of human <a href="/wiki/Embryo" title="Embryo">embryos</a>.<sup id="cite_ref-18" class="reference"><a href="#cite_note-18"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup> </p><p>In the case of the <a href="/wiki/Oncomouse" title="Oncomouse">oncomouse</a>, the <a href="/wiki/European_Patent_Office" title="European Patent Office">European Patent Office</a> (EPO) allowed for the patent. The EPO's patent standards prohibits patents for inventions contrary to <i><a href="/wiki/Public_policy_doctrine" title="Public policy doctrine">ordre public</a></i> and morality. Patents also could not be issued for “animal varieties or essentially biological processes for the production of…animals”. The EPO undertook a utilitarian balancing test to make their determination on the <i>ordre public</i> and morality exceptions. They found that the likelihood of advancing cancer research and medical benefits outweighed potential suffering of the animal. The EPO also determined that the oncomouse was not an animal variety, and thus not excluded. An amended patent with claims limited to mice was issued.<sup id="cite_ref-wipo.int_12-1" class="reference"><a href="#cite_note-wipo.int-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Japan">Japan</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=5" title="Edit section: Japan"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Under the umbrella of <a href="/wiki/Biotechnology" title="Biotechnology">biotechnology</a>, applications for patents on biological inventions are examined according to general guidelines for patents. In response to requests for additional clarity, the <a href="/wiki/Japan_Patent_Office" title="Japan Patent Office">Japan Patent Office</a> (JPO) set forth specific guidelines for biology-related inventions. Over the years, the JPO has continued to amend these guidelines to clarify their application to new technologies. These amendments have broadened the scope of patents within the biotechnology industry. The <a href="/w/index.php?title=Japanese_Patent_Act&action=edit&redlink=1" class="new" title="Japanese Patent Act (page does not exist)">Japanese Patent Act</a> requires that patented inventions be “industrially applicable”, i.e. they must have market or commercial potential. The JPO explicitly lists “medical activities” among inventions that fall outside the scope of industrially applicable inventions, meaning that methods of surgery, therapy, and the diagnosis of human diseases cannot be patented.<sup id="cite_ref-19" class="reference"><a href="#cite_note-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="United_States">United States</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=6" title="Edit section: United States"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1236090951">.mw-parser-output .hatnote{font-style:italic}.mw-parser-output div.hatnote{padding-left:1.6em;margin-bottom:0.5em}.mw-parser-output .hatnote i{font-style:normal}.mw-parser-output .hatnote+link+.hatnote{margin-top:-0.5em}@media print{body.ns-0 .mw-parser-output .hatnote{display:none!important}}</style><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Biological_patents_in_the_United_States" title="Biological patents in the United States">Biological patents in the United States</a></div> <p>In the United States, up until 2013 natural biological substances themselves could have been patented (apart from any associated process or usage) if they were sufficiently "isolated" from their naturally occurring states. Prominent historical examples of such patents include those on <a href="/wiki/Adrenaline" title="Adrenaline">adrenaline</a>,<sup id="cite_ref-20" class="reference"><a href="#cite_note-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Insulin" title="Insulin">insulin</a>,<sup id="cite_ref-21" class="reference"><a href="#cite_note-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Vitamin_B12" title="Vitamin B12">vitamin B<sub>12</sub></a>,<sup id="cite_ref-22" class="reference"><a href="#cite_note-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> and various genes.<sup id="cite_ref-23" class="reference"><a href="#cite_note-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> A <a href="/wiki/Association_for_Molecular_Pathology_v._Myriad_Genetics" class="mw-redirect" title="Association for Molecular Pathology v. Myriad Genetics">landmark ruling</a> by the <a href="/wiki/U.S._Supreme_Court" class="mw-redirect" title="U.S. Supreme Court">U.S. Supreme Court</a> in June 2013 declared naturally occurring DNA sequences ineligible for patents.<sup id="cite_ref-24" class="reference"><a href="#cite_note-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Ethics">Ethics</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=7" title="Edit section: Ethics"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Patenting_genes">Patenting genes</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=8" title="Edit section: Patenting genes"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Gene patents are a form of intellectual property which provide the patent holder with the exclusive right to exclude others from making, using, selling, or importing the invention for a specified period of time, typically twenty years.<sup id="cite_ref-25" class="reference"><a href="#cite_note-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> </p><p>The patenting of <a href="/wiki/Genes" class="mw-redirect" title="Genes">genes</a> is a controversial issue in terms of <a href="/wiki/Bioethics" title="Bioethics">bioethics</a>. Some believe it is unethical to patent genetic material because it treats life as a <a href="/wiki/Commodity" title="Commodity">commodity</a>, or that it undermines the dignity of people and animals by allowing ownership of genes.<sup id="cite_ref-two_26-0" class="reference"><a href="#cite_note-two-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> Some say that living materials occur naturally, and therefore cannot be patented.<sup id="cite_ref-one_27-0" class="reference"><a href="#cite_note-one-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> Along with concerns about the commodification of human life, the medical community has also warned that gene patents can inhibit the practice of medicine and progress of science.<sup id="cite_ref-five_28-0" class="reference"><a href="#cite_note-five-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> For example, the <a href="/wiki/American_Medical_Association" title="American Medical Association">American Medical Association</a>'s stance is that gene patents inhibit access to genetic testing for patients and hinder research on genetic disease.<sup id="cite_ref-29" class="reference"><a href="#cite_note-29"><span class="cite-bracket">[</span>29<span class="cite-bracket">]</span></a></sup> A contrary position is that forbidding patents on biotechnological innovations would also be unethical. Supporters of this idea suggest that patents allow the public, as well as <a href="/wiki/Policy-makers" class="mw-redirect" title="Policy-makers">policy makers</a>, to hold the owner of the patent(s) accountable. They favour biological patents because they require disclosure of information to the public.<sup id="cite_ref-three_30-0" class="reference"><a href="#cite_note-three-30"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup> </p><p>Agreements such as the <a href="/wiki/Agreement_on_Trade-related_Aspects_of_Intellectual_Property_Rights" class="mw-redirect" title="Agreement on Trade-related Aspects of Intellectual Property Rights">Agreement on Trade-related Aspects of Intellectual Property Rights</a> (TRIPS) require members of the <a href="/wiki/World_Trade_Organization" title="World Trade Organization">World Trade Organization</a> (WTO) to have intellectual property protection laws in place for most biological innovation. The cost of research and development for innovations such as biologics is extremely high. Such protection regimes help to protect innovators from free-riders.<sup id="cite_ref-31" class="reference"><a href="#cite_note-31"><span class="cite-bracket">[</span>31<span class="cite-bracket">]</span></a></sup> Based on these provisions, it is unlikely that many countries will prohibit patents on genes altogether.<sup id="cite_ref-one_27-1" class="reference"><a href="#cite_note-one-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> </p><p>Another area of controversy in genetic patenting is how gene samples are obtained. Prior consent is required to collect genetic samples, and collection of samples from people requires consent at the national and community levels as well as the individual level. Conflicts have resulted when consent is not obtained at all three levels. The question of benefit sharing also arises when obtaining genetic samples, specifically the potential responsibility of the collector to share any benefits or profits of the discoveries with the population or person from whom the sample came.<sup id="cite_ref-one_27-2" class="reference"><a href="#cite_note-one-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> </p><p>The last major ethical issue involving gene patents is how the patents are used post-issuance. The use of patented materials and processes will be very expensive or even prohibited to some degree by conditions the patent owner sets.<sup id="cite_ref-five_28-1" class="reference"><a href="#cite_note-five-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> Limiting access like this would directly impact agricultural institutes and university researchers, among others. There is potential that holders of biotechnology patents will exploit their rights in order to make larger profits, at the potential expense of farmers, healthcare patients, and other users of patented technologies. The ethics of using patents to increase profits are also debated. A typical argument in favour of biotech patents is that they enable companies to earn money that the companies in turn invest in further research. Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.<sup id="cite_ref-one_27-3" class="reference"><a href="#cite_note-one-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Patents_relating_to_the_diagnosis,_treatment_and_prevention_of_COVID-19"><span id="Patents_relating_to_the_diagnosis.2C_treatment_and_prevention_of_COVID-19"></span>Patents relating to the diagnosis, treatment and prevention of COVID-19</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=9" title="Edit section: Patents relating to the diagnosis, treatment and prevention of COVID-19"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In light of the <a href="/wiki/COVID-19_pandemic" title="COVID-19 pandemic">COVID-19 pandemic</a>, several companies around the world raced to develop testing, vaccines, and cures for COVID-19. This required a substantial investment of time and money, and <a href="/wiki/Patent" title="Patent">patents</a> were used to protect this innovation. Patent holders are able to refuse licensing for third-parties to manufacture the patented medicine, creating a monopoly for the patent holder and lower supply levels. Furthermore, patent-holders control pricing for licensing and access. This patent-regime has the potential to limit access to life-saving vaccines and cures, especially for those in poor countries.<sup id="cite_ref-32" class="reference"><a href="#cite_note-32"><span class="cite-bracket">[</span>32<span class="cite-bracket">]</span></a></sup> Pharmaceutical industry executives diminished the idea of sharing intellectual property, arguing that companies would have no incentive to innovate if their patents were considered worthless during a pandemic. However, health advocates argue that taxpayers substantially contributed to the development of the vaccines and they should thus be regarded as global public goods.<sup id="cite_ref-Christian_Science_Monitor_33-0" class="reference"><a href="#cite_note-Christian_Science_Monitor-33"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> </p><p>A lack of access to medication and vaccines is especially problematic during a global pandemic. In April 2020, the Director General of the <a href="/wiki/World_Health_Organization" title="World Health Organization">World Health Organization</a> supported a proposal by <a href="/wiki/Carlos_Alvarado_Quesada" title="Carlos Alvarado Quesada">Carlos Alvarado</a>, to create a pool of rights for testing medicine and vaccine with free access or affordable licensing terms for all countries. He asked all companies, countries, and research institutions to support “open data, open science, and open collaboration.” He warned that poorer countries would be the hardest hit by the pandemic and failure to assist could prolong the pandemic.<sup id="cite_ref-34" class="reference"><a href="#cite_note-34"><span class="cite-bracket">[</span>34<span class="cite-bracket">]</span></a></sup> </p><p>Instead, patent-holders have undertaken case-by-case negotiations to form exclusive licensing contracts. This approach is criticized by the global health community as being too slow, especially where variants are concerned. Further, some poor countries such as <a href="/wiki/South_Africa" title="South Africa">South Africa</a> paid more per dose for vaccines than rich countries and the <a href="/wiki/European_Union" title="European Union">European Union</a>.<sup id="cite_ref-Christian_Science_Monitor_33-1" class="reference"><a href="#cite_note-Christian_Science_Monitor-33"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> </p><p>One potential remedy is for States to implement <a href="/wiki/Compulsory_license" title="Compulsory license">compulsory patent licenses</a>. These licenses give the State power to grant permission to third parties to formulate <a href="/wiki/Generic_drug" title="Generic drug">generic versions</a> of the medicine for use in that state. This is beneficial to states with lesser buying power. However, such initiatives are not popular with industry.<sup id="cite_ref-Zohny_35-0" class="reference"><a href="#cite_note-Zohny-35"><span class="cite-bracket">[</span>35<span class="cite-bracket">]</span></a></sup> In March 2020, <a href="/wiki/Israel" title="Israel">Israel</a> became the first country to issue a COVID-19 related compulsory license under Section 104 of the <i>Patent Statute</i>. This provision allowed Israel to undermine the patent regime for national defence purposes. No consultation with the patent-holder is required and there is no right for <a href="/wiki/Judicial_review" title="Judicial review">judicial review</a>. The permit allowed Israel to import a generic version of <a href="/wiki/Lopinavir/ritonavir" title="Lopinavir/ritonavir">Kaletra</a> from India to treat COVID patients.<sup id="cite_ref-:1_36-0" class="reference"><a href="#cite_note-:1-36"><span class="cite-bracket">[</span>36<span class="cite-bracket">]</span></a></sup> <a href="/wiki/Canada" title="Canada">Canada's</a> Bill C-13, which came into force in March 2020, allows the Commissioner of Patents to allow the country to produce, sell, and use a patented invention if the <a href="/wiki/Minister_of_Health_(Canada)" title="Minister of Health (Canada)">Federal Minister of Health</a> deems there to be a public health emergency. Although no consultation with patent-holders is required, the country will compensate them with an amount “the Commissioner considers to be adequate remuneration in the circumstances.”<sup id="cite_ref-:1_36-1" class="reference"><a href="#cite_note-:1-36"><span class="cite-bracket">[</span>36<span class="cite-bracket">]</span></a></sup> Germany also has allowed its Federal Health Minister to take executive action to make medicines available in return for adequate compensation. France amended their patent law to preclude the need for amicable negotiations with patent-holders where urgency exists.<sup id="cite_ref-37" class="reference"><a href="#cite_note-37"><span class="cite-bracket">[</span>37<span class="cite-bracket">]</span></a></sup> </p><p>These issues may also be addressed through use of voluntary licensing proposals. Alternatively, public pressure on patent holders may play a significant role. For example, Labrador Diagnostics LLC, which purchased patents from the defunct <a href="/wiki/Theranos" title="Theranos">Theranos</a>, brought an action, and sought an injunction against BioFire Diagnostics for making COVID-19 diagnostic tests. The action was abandoned after public backlash.<sup id="cite_ref-Zohny_35-1" class="reference"><a href="#cite_note-Zohny-35"><span class="cite-bracket">[</span>35<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=10" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/Bioprospecting" title="Bioprospecting">Bioprospecting and biopiracy</a></li> <li><a href="/wiki/Budapest_Treaty" title="Budapest Treaty">Budapest Treaty</a></li> <li><a href="/wiki/Human_Genome_Project" title="Human Genome Project">Human Genome Project</a></li> <li><a href="/wiki/The_Lens" title="The Lens">The Lens</a></li></ul> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=11" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist reflist-columns references-column-width" style="column-width: 30em;"> <ol class="references"> <li id="cite_note-GEN-1"><span class="mw-cite-backlink">^ <a href="#cite_ref-GEN_1-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-GEN_1-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-GEN_1-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-GEN_1-3"><sup><i><b>d</b></i></sup></a></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite id="CITEREFSharples,_Andrew2011" class="citation web cs1">Sharples, Andrew (2011-03-23). <a rel="nofollow" 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Retrieved <span class="nowrap">2013-06-13</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Genetic+Engineering+and+Biotechnology+News&rft.atitle=Gene+Patents+in+Europe+Relatively+Stable+Despite+Uncertainty+in+the+U.S.&rft.date=2011-03-23&rft.au=Sharples%2C+Andrew&rft_id=http%3A%2F%2Fwww.genengnews.com%2Finsight-and-intelligenceand153%2Fgene-patents-in-europe-relatively-stable-despite-uncertainty-in-the-u-s%2F77899385%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABiological+patent" class="Z3988"></span></span> </li> <li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFCorderoy2013" class="citation news cs1">Corderoy, Amy (February 15, 2013). <a rel="nofollow" class="external text" href="http://www.smh.com.au/national/health/landmark-patent-ruling-over-breast-cancer-gene-brca1-20130215-2egsq.html">"Landmark patent ruling over breast cancer gene BRCA1"</a>. <i><a href="/wiki/Sydney_Morning_Herald" class="mw-redirect" title="Sydney Morning Herald">Sydney Morning Herald</a></i><span class="reference-accessdate">. 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Retrieved <span class="nowrap">2021-04-17</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.iam-media.com&rft.atitle=The+key+covid-19+compulsory+licensing+developments+so+far+%7C+IAM&rft_id=https%3A%2F%2Fwww.iam-media.com%2Fcoronavirus%2Fthe-key-covid-19-compulsory-licensing-developments-so-far&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABiological+patent" class="Z3988"></span></span> </li> <li id="cite_note-37"><span class="mw-cite-backlink"><b><a href="#cite_ref-37">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://blogs.lse.ac.uk/politicsandpolicy/vaccines-and-patents/">"Vaccines and patents: how self-interest and artificial scarcity weaken human solidarity"</a>. <i>British Politics and Policy at LSE</i>. 2021-02-09<span class="reference-accessdate">. Retrieved <span class="nowrap">2021-04-17</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=British+Politics+and+Policy+at+LSE&rft.atitle=Vaccines+and+patents%3A+how+self-interest+and+artificial+scarcity+weaken+human+solidarity&rft.date=2021-02-09&rft_id=https%3A%2F%2Fblogs.lse.ac.uk%2Fpoliticsandpolicy%2Fvaccines-and-patents%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3ABiological+patent" class="Z3988"></span></span> </li> </ol></div> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Biological_patent&action=edit&section=12" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>Relevant legal provisions of the European Patent Convention: <ul><li><a rel="nofollow" class="external text" href="https://new.epo.org/en/legal/epc/2020/a53.html">Article 53(a)</a> <a href="/wiki/European_Patent_Convention" title="European Patent Convention">EPC</a>: "Exceptions to patentability" (formerly <a rel="nofollow" class="external text" href="https://new.epo.org/en/legal/epc-1973/2006/a53a.html">Article 53a</a> <a href="/wiki/European_Patent_Convention" title="European Patent Convention">EPC 1973</a>)</li> <li><a rel="nofollow" class="external text" href="https://new.epo.org/en/legal/epc/2020/r28.html">Rule 28</a> <a href="/wiki/European_Patent_Convention" title="European Patent Convention">EPC</a>: "Exceptions to patentability" (formerly <a rel="nofollow" class="external text" href="https://new.epo.org/en/legal/epc-1973/2006/r23c.html">Rule 23c</a> <a href="/wiki/European_Patent_Convention" title="European Patent Convention">EPC 1973</a>), barring the patentability of, notably, "processes for cloning human beings" (Rule 28(a) EPC); "processes for modifying the germ line genetic identity of human beings" (Rule 28(b) EPC); and "uses of human embryos for industrial or commercial purposes" (Rule 28(c) EPC)</li></ul></li></ul> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><style data-mw-deduplicate="TemplateStyles:r1236075235">.mw-parser-output .navbox{box-sizing:border-box;border:1px solid #a2a9b1;width:100%;clear:both;font-size:88%;text-align:center;padding:1px;margin:1em auto 0}.mw-parser-output .navbox .navbox{margin-top:0}.mw-parser-output .navbox+.navbox,.mw-parser-output .navbox+.navbox-styles+.navbox{margin-top:-1px}.mw-parser-output .navbox-inner,.mw-parser-output .navbox-subgroup{width:100%}.mw-parser-output .navbox-group,.mw-parser-output .navbox-title,.mw-parser-output .navbox-abovebelow{padding:0.25em 1em;line-height:1.5em;text-align:center}.mw-parser-output .navbox-group{white-space:nowrap;text-align:right}.mw-parser-output .navbox,.mw-parser-output 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