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<a class="vector-toc-link" href="#First_Federal_Circuit_decision"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</span> <span>First Federal Circuit decision</span> </div> </a> <ul id="toc-First_Federal_Circuit_decision-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Remand_and_second_Federal_Circuit_decision" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Remand_and_second_Federal_Circuit_decision"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>Remand and second Federal Circuit decision</span> </div> </a> <ul id="toc-Remand_and_second_Federal_Circuit_decision-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Supreme_Court_decision" class="vector-toc-list-item vector-toc-level-1 vector-toc-list-item-expanded"> <a class="vector-toc-link" href="#Supreme_Court_decision"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>Supreme Court 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</div> </div> <div id="bodyContent" class="vector-body" aria-labelledby="firstHeading" data-mw-ve-target-container> <div class="vector-body-before-content"> <div class="mw-indicators"> </div> <div id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><p class="mw-empty-elt"> </p> <div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">2012 United States Supreme Court case</div><style data-mw-deduplicate="TemplateStyles:r1257001546">.mw-parser-output .infobox-subbox{padding:0;border:none;margin:-3px;width:auto;min-width:100%;font-size:100%;clear:none;float:none;background-color:transparent}.mw-parser-output .infobox-3cols-child{margin:auto}.mw-parser-output .infobox .navbar{font-size:100%}@media screen{html.skin-theme-clientpref-night .mw-parser-output .infobox-full-data:not(.notheme)>div:not(.notheme)[style]{background:#1f1f23!important;color:#f8f9fa}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .infobox-full-data:not(.notheme) div:not(.notheme){background:#1f1f23!important;color:#f8f9fa}}@media(min-width:640px){body.skin--responsive .mw-parser-output .infobox-table{display:table!important}body.skin--responsive .mw-parser-output .infobox-table>caption{display:table-caption!important}body.skin--responsive .mw-parser-output .infobox-table>tbody{display:table-row-group}body.skin--responsive .mw-parser-output .infobox-table tr{display:table-row!important}body.skin--responsive .mw-parser-output .infobox-table th,body.skin--responsive .mw-parser-output .infobox-table td{padding-left:inherit;padding-right:inherit}}</style><table class="infobox scotus" style="line-height: 1.4em"><tbody><tr><th colspan="2" class="infobox-above fn" style="background-color: #99c0ff; padding: 0.2em; line-height: 1.4em; font-size:125%; font-style: italic">Mayo v. Prometheus</th></tr><tr><td colspan="2" class="infobox-image"><span typeof="mw:File"><span title="Seal of the United States Supreme Court"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/f/f3/Seal_of_the_United_States_Supreme_Court.svg/100px-Seal_of_the_United_States_Supreme_Court.svg.png" decoding="async" width="100" height="100" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/f/f3/Seal_of_the_United_States_Supreme_Court.svg/150px-Seal_of_the_United_States_Supreme_Court.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/f/f3/Seal_of_the_United_States_Supreme_Court.svg/200px-Seal_of_the_United_States_Supreme_Court.svg.png 2x" data-file-width="720" data-file-height="720" /></span></span><div class="infobox-caption" style="padding-top: 0.5em; font-weight: bold"><a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">Supreme Court of the United States</a></div></td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #99c0ff; white-space:nowrap">Argued December 7, 2011<br />Decided March 20, 2012</th></tr><tr><th scope="row" class="infobox-label">Full case name</th><td class="infobox-data"><i>Mayo Collaborative Services, <a href="/wiki/Doing_business_as" class="mw-redirect" title="Doing business as">DBA</a> Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc.</i></td></tr><tr><th scope="row" class="infobox-label">Docket no.</th><td class="infobox-data"><a rel="nofollow" class="external text" href="https://www.supremecourt.gov/docketfiles/10-1150.htm">10-1150</a></td></tr><tr><th scope="row" class="infobox-label">Citations</th><td class="infobox-data">566 <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> 66 (<i><a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_566" title="List of United States Supreme Court cases, volume 566">more</a></i>)<div>132 S. Ct. 1289; 182 <a href="/wiki/L._Ed._2d" class="mw-redirect" title="L. Ed. 2d">L. Ed. 2d</a> 321; 2012 <a href="/wiki/U.S._LEXIS" class="mw-redirect" title="U.S. LEXIS">U.S. LEXIS</a> 2316</div></td></tr><tr><th scope="row" class="infobox-label">Argument</th><td class="infobox-data"><a rel="nofollow" class="external text" href="https://www.oyez.org/cases/2010-2019/2011/2011_10_1150">Oral argument</a></td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #99c0ff; white-space:nowrap">Case history</th></tr><tr><th scope="row" class="infobox-label">Prior</th><td class="infobox-data">Patent held invalid, 2008 WL 878910 (<a href="/wiki/S.D._Cal." class="mw-redirect" title="S.D. Cal.">S.D. Cal.</a>); reversed, 581 <a href="/wiki/F.3d" class="mw-redirect" title="F.3d">F.3d</a> <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infco20090916133">1336</a> (<a href="/wiki/Fed._Cir." class="mw-redirect" title="Fed. Cir.">Fed. Cir.</a> 2009); vacated and remanded in light of <i><a href="/wiki/Bilski_v._Kappos" title="Bilski v. Kappos">Bilski v. Kappos</a></i>, 130 S.Ct. 3543 (2010); reversed anew, 628 <a href="/wiki/F.3d" class="mw-redirect" title="F.3d">F.3d</a> <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infco20101217141">1347</a> (Fed. Cir. 2010); certiorari granted, 131 S.Ct. 3027 (2011)</td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #99c0ff; white-space:nowrap">Holding</th></tr><tr><td colspan="2" class="infobox-full-data">Patent claims directed to a diagnostic method, that is based on a newly discovered natural correlation and utilizes well-known routine methods of analysis, were not patent eligible subject matter, because such method did not add an "inventive concept to application of the natural laws".<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup></td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #99c0ff; white-space:nowrap">Court membership</th></tr><tr><td colspan="2" class="infobox-full-data"><dl style="margin:0; padding:0.1em 0.5em; text-align:center; line-height:1.3em;"> <dt style="margin:0;">Chief Justice</dt> <dd style="margin:0 0 0.3em;"><a href="/wiki/John_Roberts" title="John Roberts">John Roberts</a> </dd> <dt style="margin:0;">Associate Justices</dt> <dd style="margin:0;"><a href="/wiki/Antonin_Scalia" title="Antonin Scalia">Antonin Scalia</a> <b>·</b>  <a href="/wiki/Anthony_Kennedy" title="Anthony Kennedy">Anthony Kennedy</a><br /><a href="/wiki/Clarence_Thomas" title="Clarence Thomas">Clarence Thomas</a> <b>·</b>  <a href="/wiki/Ruth_Bader_Ginsburg" title="Ruth Bader Ginsburg">Ruth Bader Ginsburg</a><br /><a href="/wiki/Stephen_Breyer" title="Stephen Breyer">Stephen Breyer</a> <b>·</b>  <a href="/wiki/Samuel_Alito" title="Samuel Alito">Samuel Alito</a><br /><a href="/wiki/Sonia_Sotomayor" title="Sonia Sotomayor">Sonia Sotomayor</a> <b>·</b>  <a href="/wiki/Elena_Kagan" title="Elena Kagan">Elena Kagan</a> </dd></dl></td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #99c0ff; white-space:nowrap">Case opinion</th></tr><tr><th scope="row" class="infobox-label">Majority</th><td class="infobox-data">Breyer, joined by <i>unanimous</i></td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #99c0ff; white-space:nowrap">Laws applied</th></tr><tr><td colspan="2" class="infobox-full-data"><a href="/wiki/Title_35_of_the_United_States_Code" title="Title 35 of the United States Code">35 U.S.C.</a> <a rel="nofollow" class="external text" href="https://www.law.cornell.edu/uscode/text/35/101">§ 101</a></td></tr></tbody></table> <p><i><b>Mayo v. Prometheus</b></i>, 566 U.S. 66 (2012), was a case decided by the <a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">Supreme Court of the United States</a> that unanimously held that claims directed to a method of giving a drug to a patient, measuring <a href="/wiki/Metabolite" title="Metabolite">metabolites</a> of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not <a href="/wiki/Patent-eligible_subject_matter" class="mw-redirect" title="Patent-eligible subject matter">patent-eligible subject matter</a>.<sup id="cite_ref-SCOTUS_Decision_2-0" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p><p>The basic idea behind the court's decision in <i>Mayo</i> is as follows: although a discovery of a new natural phenomenon (or a law of Nature) would satisfy the <a href="/wiki/Non-obviousness" class="mw-redirect" title="Non-obviousness">non-obviousness</a> requirement, patent claims, that either wholly pre-empt the natural phenomenon or add no additional "inventive concept" to this discovery, do not meet <a href="/wiki/Subject_matter_eligibility" class="mw-redirect" title="Subject matter eligibility">patent-eligible subject matter</a> criterion.<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> </p><p>The decision was controversial, with proponents claiming it frees <a href="/wiki/Clinical_pathology" title="Clinical pathology">clinical pathologists</a> to practice their medical discipline, and critics claiming that it destabilizes <a href="/wiki/United_States_patent_law" title="United States patent law">patent law</a> and will stunt investment in the field of <a href="/wiki/Personalized_medicine" title="Personalized medicine">personalized medicine</a>, preventing new products and services from emerging in that field.<sup id="cite_ref-C&ENews_4-0" class="reference"><a href="#cite_note-C&ENews-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> A 2017 study concluded, that the decision in Mayo promoted biotech businesses and non-profit institutions to "increase use of trade secrecy" rather than the more traditional patenting, with substantial detriment to the society.<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> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Parties_to_the_case">Parties to the case</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=1" title="Edit section: Parties to the case"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The case arose in a dispute between Mayo Collaborative Services and Prometheus Laboratories concerning a diagnostic test. Mayo Collaborative Services is a for-profit<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> <a href="/wiki/Medical_laboratory" title="Medical laboratory">diagnostic testing lab</a> offering diagnostic services that operates as a subsidiary of Mayo Foundation for Medical Education and Research,<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> which is a nonprofit corporation<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> affiliated with the <a href="/wiki/Mayo_Clinic" title="Mayo Clinic">Mayo Clinic</a>. Mayo Collaborative Services does business as "Mayo Medical Laboratories", has 3,200 employees working in 58 laboratories and offers services worldwide.<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> </p><p>Prometheus is a <a href="/w/index.php?title=Specialty_pharmaceutical&action=edit&redlink=1" class="new" title="Specialty pharmaceutical (page does not exist)">specialty pharmaceutical</a> and diagnostics company in the fields of gastroenterology and cancer; it was bought by <a href="/wiki/Nestl%C3%A9" title="Nestlé">Nestlé</a> in 2011.<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> Prometheus sells diagnostic kits and also offers diagnostic services as a <a href="/wiki/Medical_laboratory" title="Medical laboratory">diagnostic testing lab</a>. </p> <div class="mw-heading mw-heading2"><h2 id="Patents_at_issue">Patents at issue</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=2" title="Edit section: Patents at issue"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The two US patents in the case are 6,355,623<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> and 6,680,302,<sup id="cite_ref-12" class="reference"><a href="#cite_note-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> which are owned by <a href="/wiki/Centre_hospitalier_universitaire_Sainte-Justine" title="Centre hospitalier universitaire Sainte-Justine">Hospital Sainte-Justine</a> in Montreal. The patents concern the use of <a href="/wiki/Thiopurine" title="Thiopurine">thiopurine</a> drugs in the treatment of <a href="/wiki/Autoimmune_disease" title="Autoimmune disease">autoimmune diseases</a>, such as <a href="/wiki/Crohn%27s_disease" title="Crohn's disease">Crohn's disease</a> and <a href="/wiki/Ulcerative_colitis" title="Ulcerative colitis">ulcerative colitis</a>.<sup id="cite_ref-SCOTUS_Decision_2-1" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> Different people <a href="/wiki/Metabolism" title="Metabolism">metabolize</a> these drugs differently, so doctors have to work with patients to find the right dose. If the dose is too high there are too many side effects, while if the dose is too low the drug does not work. When the patents were filed, the metabolites of these drugs were known, most importantly, <a href="/wiki/6-Thioguanine" class="mw-redirect" title="6-Thioguanine">6-thioguanine</a>, but the "right" level of these metabolites was not known. The scientists at Hospital Sainte-Justine identified the threshold level for effectiveness,<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> and filed for patent protection on methods to use that threshold level to determine dosage. </p><p>The Supreme Court took claim 1 of the '623 patent as exemplary: </p> <blockquote><p>A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: </p><ul><li>(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and</li> <li>(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,</li></ul><p> wherein the level of 6-thioguanine less than about 230 pmol per 8x10<sup>8</sup> red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10<sup>8</sup> red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.</p></blockquote> <div class="mw-heading mw-heading2"><h2 id="The_dispute">The dispute</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=3" title="Edit section: The dispute"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Prometheus is the exclusive licensee of these patents and sells diagnostic kits based on them.<sup id="cite_ref-SCOTUS_Decision_2-2" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> Mayo bought and used these kits until 2004, when it decided to offer its own diagnostic tests to its clients at Mayo and worldwide, without buying the kit from Prometheus.<sup id="cite_ref-SCOTUS_Decision_2-3" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> In June 2004 Prometheus sued Mayo for infringement in the <a href="/wiki/United_States_District_Court_for_the_Southern_District_of_California" title="United States District Court for the Southern District of California">Southern District Court of California</a>, and in March 2008 the district court held the patents invalid under <a href="/wiki/Title_35_of_the_United_States_Code#Section_101" title="Title 35 of the United States Code">§101</a> (the section of US law governing <a href="/wiki/Patentable_subject_matter" title="Patentable subject matter">patentable subject matter</a>.)<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> </p><p>The debate between the two companies is based on a certain diagnostic test, specifically concerning the use of thiopurine drugs, which are used to treat autoimmune diseases. The problem with thiopurine drugs is that different patients metabolize them differently, which causes difficulty in determining whether a patient's dosage is too high or too low. While too low of a dosage is simply ineffective, too high of a dosage can cause various toxic effects including pancreatitis, hepatotoxicity, and myelosuppression (reduction in the ability to produce blood cells). Prometheus had a patent on how to properly treat patients using thiopurine drugs that included an administering step in which a doctor would administer the drug to the patient, a determining step in which the doctor measures the metabolite levels in the patient's blood, and a step to either increase or decrease the dosage based on the results. According to the patent, if the level of thiopurine metabolite is less than about 230 picomoles (pmol) per 8x10^8 red blood cells, then the dosage needs to be increased, whereas if the level of thiopurine metabolite is greater than about 400 pmol per 8x10^8 red blood cells, then the dosage needs to be decreased. Prometheus sold diagnostic tests based on the patent, and Mayo bought and used those diagnostic tests. However, in 2004, Mayo announced it would begin to use and sell their own test. This caused Prometheus to sue Mayo for patent infringement. </p> <div class="mw-heading mw-heading2"><h2 id="District_Court_ruling">District Court ruling</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=4" title="Edit section: District Court ruling"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The District Court characterized the claims as having three steps: (1) administering the drug to a subject, (2) determining metabolite levels, and (3) being warned that an adjustment in dosage may be required. All parties acknowledged that the first two steps, by themselves, were already known, and that the third step contained the novel matter that drove the patent filing. Mayo argued that only the third step mattered, and that the claims covered unpatentable subject matter. Prometheus argued that all the steps in the claims had to be considered, and that the whole process was new and was patentable subject matter. </p><p>The court found that the first two steps were just "data-gathering", leaving the third step as merely an unpatentable mental step, comprising the correlation, because no step required a change in administered dose.<sup id="cite_ref-PatentDocs2ndFedCirc_15-0" class="reference"><a href="#cite_note-PatentDocs2ndFedCirc-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> Further, the court found that the inventors of the patents did not invent the correlation, because the metabolites detected according to the patent claims "are products of the natural metabolizing of thiopurine drug, and the inventors merely observed the relationship between these naturally-produced metabolites and therapeutic efficacy and toxicity." Having determined that the claims encompass the correlations themselves, the District Court held that the claims "wholly preempt" the correlations.<sup id="cite_ref-PatentDocs1stFedCirc_16-0" class="reference"><a href="#cite_note-PatentDocs1stFedCirc-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p><p>These two findings—that the claims cover only natural phenomena, and that the claims cover any application of the natural phenomena—led squarely to a rejection under <a href="/wiki/Title_35_of_the_United_States_Code#Section_101" title="Title 35 of the United States Code">§101</a>, just as if someone tried to claim Einstein's equation "E=mc<sup>2</sup>" as opposed to, for example, an innovative machine that made use of that law of nature. </p> <div class="mw-heading mw-heading2"><h2 id="First_Federal_Circuit_decision">First Federal Circuit decision</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=5" title="Edit section: First Federal Circuit decision"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Prometheus <a href="/wiki/Appeal" title="Appeal">appealed</a>, and in September 2009 the Federal Circuit reversed the District Court, finding that the claims were patentable.<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><sup id="cite_ref-PatentDocs1stFedCirc_16-1" class="reference"><a href="#cite_note-PatentDocs1stFedCirc-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup><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> The Federal Circuit found that the District Court erred in its analysis of the first two steps. The Federal Circuit found that these steps were not just "data gathering", but rather that they called for two physical transformations—first administering the drug to the patient, which transforms the patient, and secondly measuring the metabolites, which involves several concrete, transformative steps. The Federal Circuit relied on its own decision <i><a href="/wiki/In_re_Bilski" title="In re Bilski">In re Bilski</a></i> in this analysis; in that decision, the court stated that if a method requires a specific machine for its implementation, or involves a physical transformation, it is patentable. </p><p> The Federal Circuit also found that the District Court erred in not treating each claim as a whole. The decision said: </p><blockquote><p>[I]t is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter. After all, even though a fundamental principle itself is not patent-eligible, processes incorporating a fundamental principle may be patent-eligible. Thus, it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable under § 101.<sup id="cite_ref-PatentDocs1stFedCirc_16-2" class="reference"><a href="#cite_note-PatentDocs1stFedCirc-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup></p></blockquote><p>Finally, the Federal Circuit found that because the claims are directed to an entire process, and not just the correlation itself, the claims do not preempt all applications of the correlation.<sup id="cite_ref-PatentDocs1stFedCirc_16-3" class="reference"><a href="#cite_note-PatentDocs1stFedCirc-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p><div class="mw-heading mw-heading2"><h2 id="Remand_and_second_Federal_Circuit_decision">Remand and second Federal Circuit decision</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=6" title="Edit section: Remand and second Federal Circuit decision"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Mayo appealed to the <a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">Supreme Court</a>,<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> and in June 2010 the Supreme Court granted <a href="/wiki/Certiorari" title="Certiorari">certiorari</a> and immediately vacated the Federal Circuit decision and remanded the case back to the Federal Circuit for further consideration in light of the <a href="/wiki/Bilski_v._Kappos" title="Bilski v. Kappos">Supreme Court's ruling on the <i>Bilski</i> case</a> (in other words, it issued a <a href="/wiki/GVR_Order" class="mw-redirect" title="GVR Order">GVR Order</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> The Supreme Court's <i>Bilski</i> decision made the <a href="/wiki/Machine-or-transformation_test" title="Machine-or-transformation test">machine-or-transformation test</a> less absolute, calling it only an "important clue" to patentability. </p><p> In December 2010, the Federal Circuit issued its new ruling on the case.<sup id="cite_ref-FedCircuitDecision_21-0" class="reference"><a href="#cite_note-FedCircuitDecision-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> The Federal Circuit essentially re-iterated the arguments it had made the first time.<sup id="cite_ref-PatentDocs2ndFedCirc_15-1" class="reference"><a href="#cite_note-PatentDocs2ndFedCirc-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup><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> Its decision acknowledged the Supreme Court's <i>Bilski</i> decision, but still found the first two steps were transformative and that the claim as a whole was patentable. The Federal Circuit went into more depth on the third step, the "mental step", noting that:</p><blockquote><p>a subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus's claimed methods as a whole.<sup id="cite_ref-FedCircuitDecision_21-1" class="reference"><a href="#cite_note-FedCircuitDecision-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup></p></blockquote> <div class="mw-heading mw-heading2"><h2 id="Supreme_Court_decision">Supreme Court decision</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=7" title="Edit section: Supreme Court decision"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Mayo again appealed to the Supreme Court, which agreed to take the case. It was argued on December 7, 2011 and the court handed down a unanimous decision on March 20, 2012.<sup id="cite_ref-SCOTUS_Decision_2-4" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> The Supreme Court reversed the Federal Circuit and basically reiterated the findings of the District Court.<sup id="cite_ref-Patently-O_SCOTUS_decision_23-0" class="reference"><a href="#cite_note-Patently-O_SCOTUS_decision-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Patent_Docs_on_SCOTUS_decision_24-0" class="reference"><a href="#cite_note-Patent_Docs_on_SCOTUS_decision-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> </p><p>The court called the correlation between the naturally-produced metabolites and therapeutic efficacy and toxicity to be an unpatentable "natural law" and found the first two steps to be not "genuine applications of those laws[, but] rather ... drafting efforts designed to monopolize the correlations."<sup id="cite_ref-SCOTUS_Decision_2-5" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> The court said, "Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law."<sup id="cite_ref-SCOTUS_Decision_2-6" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> A commentator on the ruling wrote: "The conclusion here is that (1) a newly discovered law of nature is itself unpatentable and (2) the application of that newly discovered law is also normally unpatentable if the application merely relies upon elements already known in the art."<sup id="cite_ref-Patently-O_SCOTUS_decision_23-1" class="reference"><a href="#cite_note-Patently-O_SCOTUS_decision-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p> The court seemed to be aware of the impact its decision would have on the diagnostics industry,<sup id="cite_ref-Patent_Docs_on_SCOTUS_decision_24-1" class="reference"><a href="#cite_note-Patent_Docs_on_SCOTUS_decision-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> as it ended its decision by writing: </p><blockquote><p>In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another. And we must recognize the role of Congress in crafting more finely tailored rules where necessary.... We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.<sup id="cite_ref-SCOTUS_Decision_2-7" class="reference"><a href="#cite_note-SCOTUS_Decision-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup></p></blockquote> <div class="mw-heading mw-heading2"><h2 id="Reactions_and_aftermath">Reactions and aftermath</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=8" title="Edit section: Reactions and aftermath"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Opinions_critical_of_the_decision">Opinions critical of the decision</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=9" title="Edit section: Opinions critical of the decision"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The decision was controversial. Those opposed to it found the reasoning poor, considered the decision to be destabilizing of patent law, and expressed concern about long-term effects on medicine. </p><p>Gene Quinn, a well-known pro-patent spokesman, blogging in <i>IP Watchdog</i>, stated one view of the decision: "The sky is falling! Those who feel the Supreme Court's decision in <i>Mayo</i> is terrible are right." He added: </p> <blockquote><p>Those in the biotech, medical diagnostics and pharmaceutical industries have just been taken out behind the woodshed and summarily executed by the Supreme Court this morning. An enormous number of patents will now have no enforceable claims. Hundreds of billions of dollars in corporate value has been erased.</p></blockquote> <p>Quinn then called for the Federal Circuit to overrule <i>Mayo</i>, as he asserted it had done with other erroneous precedents and predicted that it would do so with <i>Mayo</i>: </p> <blockquote><p>How long will it take the Federal Circuit to overrule this inexplicable nonsense? . . . Those well acquainted with the industry know that the Supreme Court is not the final word on patentability, and while the claims at issue in this particular case are unfortunately lost, the Federal Circuit will work to moderate (and eventually overturn) this embarrassing display by the Supreme Court. This will eventually be accomplished the same as it was after the Supreme Court definitively ruled software is not patentable in <i>Gottschalk v. Benson</i>, and the same as the ruling in <i>KSR v. Teleflex</i> will be overruled. . . . [T]here is still a lot of work left to be done by the Federal Circuit to finally overrule the Supreme Court's <i>KSR</i> decision. It took almost 10 years to overrule <i>Gottschalk v. Benson</i>, so we are likely in for a decade of work to moderate the nonsense [<i>Mayo</i>] thrust upon the industry this morning.<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></blockquote> <p>Kevin Noonan, a <a href="/wiki/Biotechnology" title="Biotechnology">biotech</a> patent lawyer and editor of the <i>Patent Docs</i> blog, criticized this decision and the Supreme Court broadly, for undermining precedent and the stability of patent law, thus broadly undermining the biotech industry. Noonan wrote: </p> <blockquote><p>It is also clear that the Court has little time for the specifics of patent law generally, not surprising from a Court who characterized <a href="/wiki/Inventive_step_and_non-obviousness" title="Inventive step and non-obviousness">obviousness law</a> as "gobbledygook" not so many years ago. . . . [T]he Court also signaled its willingness to credit their theories of what drives and sustains innovation against the arguments, based on actual experience, from groups and individuals who have created companies and been involved in innovation in the biotechnology industry. And the Court seems equally ready to be influenced by the consumers of innovation, such as <i>amicus</i> the American Medical Association, who understandably wish to have the maximum freedom to have their patients benefit from new technology (and the minimum interference from patent holders who would reduce their opportunities to profit therefrom).<sup id="cite_ref-26" class="reference"><a href="#cite_note-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup></p></blockquote> <p>Robert R. Sachs, a patent lawyer and co-founder of The Bilski Blog, wrote: </p> <blockquote><p>The Court's analysis creates a framework for patent eligibility in which almost any method claim can be invalidated. . . . Reading the Court's treatment of Prometheus' claim, one would think that claims are some type of qualitative instruction manual, a recipe that speaks to "audiences" such as doctors, about which things are "relevant to their decision making." Claims are no such thing: they are definitions that articulate a specific combination of steps or structures. They are objective in form and design, not subjective or advisory. The notion that the claims here "trust" doctors to "use those laws" is at best silly, and at worst badly misguided. Reducing the claim to this "instruction manual" allows the Court to analogize the claim to Einstein "telling linear accelerator operators about his basic law"—a low point in modern legal reasoning.<sup id="cite_ref-27" class="reference"><a href="#cite_note-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup></p></blockquote> <p>Hans Sauer, an attorney for the biotech industry trade group, <a href="/wiki/Biotechnology_Industry_Organization" class="mw-redirect" title="Biotechnology Industry Organization">BIO</a>, said, "We are troubled that the Court's opinion fails to appropriately recognize the importance of personalized medicine, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases."<sup id="cite_ref-28" class="reference"><a href="#cite_note-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> </p><p>Kendrew H. Colton, a Chicago patent attorney, said that, because the ruling applies to the thousands of diagnostic patents that have already issued and puts them at risk of being invalidated, investors in personalized medicine "may revisit the value proposition for investments already made and may curtail or redirect future investments in new projects."<sup id="cite_ref-C&ENews_4-1" class="reference"><a href="#cite_note-C&ENews-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Opinions_supportive_of_the_decision">Opinions supportive of the decision</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=10" title="Edit section: Opinions supportive of the decision"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>On the other hand, those in favor of the decision found it "a very high quality piece of legal craftsmanship" that "may well be the Supreme Court's finest work in the patent-eligibility field."<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> Dr. Robert Wah, Chairman for the <a href="/wiki/American_Medical_Association" title="American Medical Association">American Medical Association</a>, said that the Supreme Court had "prevented irreparable harm to patient care with today's unanimous decision to invalidate two patents that gave Prometheus Laboratories exclusive rights over the body's natural responses to illness and medical treatment", and said that the decision was "a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research."<sup id="cite_ref-30" class="reference"><a href="#cite_note-30"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup> </p><p>Another commentator, Professor <a href="/wiki/Richard_H._Stern" title="Richard H. Stern">Richard H. Stern</a>, who teaches computer law at <a href="/wiki/The_George_Washington_University_Law_School" class="mw-redirect" title="The George Washington University Law School">The George Washington University Law School</a>, praised the decision because in it "the court for the first time agreed upon a full harmonisation of its prior and at times seemingly inconsistent judgments on patent-eligibility and how to determine it."<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> In the same vein, this commentator praised the decision for reaffirming earlier precedents such as <i><a href="/wiki/O%27Reilly_v._Morse" title="O'Reilly v. Morse">O'Reilly v. Morse</a></i> and <i><a href="/wiki/Neilson_v._Harford" class="mw-redirect" title="Neilson v. Harford">Neilson v. Harford</a></i>, which the lower court in the <i>Mayo</i> case had ignored or seemingly misunderstood. </p><p>A business-oriented commentator viewed the decision as seeking to strike a balance between competing policy considerations: </p> <blockquote><p>While the collective groans of patent professionals the world over are hard to ignore after the decision in <i>Prometheus</i>, it was a necessary evil to safeguard against the likely potential for financial posturing of companies with exclusive rights over processes of the human body. Ultimately, the conclusion in <i>Prometheus</i> is premised upon the public policy consideration that certain types of medical and diagnostic findings should not be afforded patent protection, as the need for unencumbered access to critical scientific data and study in the medical community overwhelms any alleged monetary disincentive suffered by the patent applicant. The Court recognized that patent protection should not serve as a stumbling block for continued scientific innovation and improvement in medical treatment methodologies.<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></p></blockquote> <div class="mw-heading mw-heading3"><h3 id="Response_by_the_US_Patent_and_Trademark_Office">Response by the US Patent and Trademark Office</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=11" title="Edit section: Response by the US Patent and Trademark Office"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Prior to the Mayo v Prometeus decision the <a href="/wiki/USPTO" class="mw-redirect" title="USPTO">USPTO</a> practice of patent eligibility of chemical diagnostic method was governed by the 2006 <a href="/wiki/United_States_Court_of_Appeals_for_the_Federal_Circuit" title="United States Court of Appeals for the Federal Circuit">CAFC</a> decision in <i><a href="/wiki/LabCorp_v._Metabolite,_Inc." title="LabCorp v. Metabolite, Inc.">LabCorp v. Metabolite, Inc.</a></i>, which held such claims patent-ineligible based on <a href="/w/index.php?title=Machine-or-transformation&action=edit&redlink=1" class="new" title="Machine-or-transformation (page does not exist)">machine-or-transformation</a> test. The <a href="/wiki/US_Supreme_Court" class="mw-redirect" title="US Supreme Court">US Supreme Court</a> dismissed its own <a href="/wiki/Writ_of_certiorari" class="mw-redirect" title="Writ of certiorari">writ of certiorari</a> for <i>LabCorp v. Metabolite, Inc.</i> as improperly granted, but the minority opinion in that case suggested a test, which was eventually adopted in Mayo v. Prometeus. </p><p>The Mayo decision made medical diagnostics methods a <a href="/wiki/Patentable_subject_matter" title="Patentable subject matter">patentable subject matter</a>. <a href="/wiki/US_Patent_and_Trademark_Office" class="mw-redirect" title="US Patent and Trademark Office">US Patent and Trademark Office</a> released preliminary guidelines for patent examiners in light of this case on March 21, 2012.<sup id="cite_ref-33" class="reference"><a href="#cite_note-33"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> On July 3, 2012, it issued a more substantial set of "interim guidelines" for "process claims in which a law of nature, natural phenomenon, or naturally occurring relation or correlation is a limiting element or step"<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> that replaced the preliminary guidelines.<sup id="cite_ref-35" class="reference"><a href="#cite_note-35"><span class="cite-bracket">[</span>35<span class="cite-bracket">]</span></a></sup> </p><p>Soon after "Mayo" (in 2014) the Supreme Court decided another patentable subject matter case in <i><a href="/wiki/Alice_Corp._v._CLS_Bank_International" title="Alice Corp. v. CLS Bank International">Alice Corp. v. CLS Bank International</a></i>. In June 2020 the Office issued new guidelines on subject matter eligibility, which implement Mayo/Alice decisions and were incorporated into the <a href="/wiki/Manual_of_Patent_Examining_Procedure" title="Manual of Patent Examining Procedure">MPEP</a>, particularly in Sections 2103 through 2106.07(c).<sup id="cite_ref-36" class="reference"><a href="#cite_note-36"><span class="cite-bracket">[</span>36<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=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=12" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_566" title="List of United States Supreme Court cases, volume 566">List of United States Supreme Court cases, volume 566</a></li> <li><i><a href="/wiki/Alice_Corp._v._CLS_Bank_International" title="Alice Corp. v. CLS Bank International">Alice Corp. v. CLS Bank International</a></i></li> <li><i><a href="/wiki/DDR_Holdings,_LLC_v._Hotels.com" class="mw-redirect" title="DDR Holdings, LLC v. Hotels.com">DDR Holdings, LLC v. Hotels.com</a></i></li> <li><i><a href="/wiki/Funk_Bros._Seed_Co._v._Kalo_Inoculant_Co." title="Funk Bros. Seed Co. v. Kalo Inoculant Co.">Funk Bros. Seed Co. v. Kalo Inoculant Co.</a></i></li> <li><i><a href="/wiki/Parker_v._Flook" title="Parker v. Flook">Parker v. Flook</a></i></li> <li><i><a href="/wiki/Association_for_Molecular_Pathology_v._Myriad_Genetics,_Inc." title="Association for Molecular Pathology v. Myriad Genetics, Inc.">Association for Molecular Pathology v. Myriad Genetics, Inc.</a></i></li> <li><i><a href="/wiki/DDR_Holdings,_LLC_v._Hotels.com" class="mw-redirect" title="DDR Holdings, LLC v. Hotels.com">DDR Holdings, LLC v. Hotels.com</a></i></li> <li><i><a href="/wiki/Ariosa_v._Sequenom" title="Ariosa v. Sequenom">Ariosa v. Sequenom</a></i></li> <li><i><a href="/w/index.php?title=Genetic_Technologies_v._Merial&action=edit&redlink=1" class="new" title="Genetic Technologies v. Merial (page does not exist)">Genetic Technologies v. Merial</a></i></li> <li><i><a href="/wiki/Patentable_subject_matter#The_algorithm_exception_and_the_patent-eligibility_trilogy" title="Patentable subject matter">patent-eligibility trilogy</a></i></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=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=13" 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-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></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 class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.lexisnexis.com/community/casebrief/p/casebrief-mayo-collaborative-servs-v-prometheus-labs-inc-834664167#:~:text=Conclusion%3A,%C2%A7%20101">"Mayo Collaborative Servs. V. Prometheus Labs., Inc. | Case Brief for Law School | LexisNexis"</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Mayo+Collaborative+Servs.+V.+Prometheus+Labs.%2C+Inc.+%26%23124%3B+Case+Brief+for+Law+School+%26%23124%3B+LexisNexis&rft_id=https%3A%2F%2Fwww.lexisnexis.com%2Fcommunity%2Fcasebrief%2Fp%2Fcasebrief-mayo-collaborative-servs-v-prometheus-labs-inc-834664167%23%3A~%3Atext%3DConclusion%253A%2C%25C2%25A7%2520101&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-SCOTUS_Decision-2"><span class="mw-cite-backlink">^ <a href="#cite_ref-SCOTUS_Decision_2-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-3"><sup><i><b>d</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-4"><sup><i><b>e</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-5"><sup><i><b>f</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-6"><sup><i><b>g</b></i></sup></a> <a href="#cite_ref-SCOTUS_Decision_2-7"><sup><i><b>h</b></i></sup></a></span> <span class="reference-text"><i>Mayo Collaborative Servs. v. Prometheus Labs., Inc.</i>, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_566" title="List of United States Supreme Court cases, volume 566">566</a> <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> <a rel="nofollow" class="external text" href="https://supreme.justia.com/cases/federal/us/566/66/">66</a> (2012).</span> </li> <li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222" /><cite id="CITEREFCubert2020" class="citation journal cs1">Cubert, Jeremy A. (January 2020). "Has the Sun Set for Life Science Patents?: Mayo, Myriad and the Patent Eligibility Divide". <i>ACS Symposium Series</i>. <b>1363</b>: <span class="nowrap">61–</span>71. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1021%2Fbk-2020-1363.ch004">10.1021/bk-2020-1363.ch004</a>. <a href="/wiki/S2CID_(identifier)" class="mw-redirect" title="S2CID (identifier)">S2CID</a> <a rel="nofollow" class="external text" href="https://api.semanticscholar.org/CorpusID:229259955">229259955</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=ACS+Symposium+Series&rft.atitle=Has+the+Sun+Set+for+Life+Science+Patents%3F%3A+Mayo%2C+Myriad+and+the+Patent+Eligibility+Divide&rft.volume=1363&rft.pages=%3Cspan+class%3D%22nowrap%22%3E61-%3C%2Fspan%3E71&rft.date=2020-01&rft_id=info%3Adoi%2F10.1021%2Fbk-2020-1363.ch004&rft_id=https%3A%2F%2Fapi.semanticscholar.org%2FCorpusID%3A229259955%23id-name%3DS2CID&rft.aulast=Cubert&rft.aufirst=Jeremy+A.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-C&ENews-4"><span class="mw-cite-backlink">^ <a href="#cite_ref-C&ENews_4-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-C&ENews_4-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text">C&E News on SCOTUS Prometheus ruling: <i><a rel="nofollow" class="external text" href="http://cen.acs.org/articles/90/i14/Patent-Ruling-Dismays-Biotech.html?h=-1802238606">Patent Ruling Dismays Biotech</a></i></span> </li> <li id="cite_note-5"><span class="mw-cite-backlink"><b><a href="#cite_ref-5">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222" /><cite id="CITEREFGuerriniMcGuireMajumderBollinger2017" class="citation journal cs1">Guerrini, Christi J; McGuire, Amy L; Majumder, Mary A; Bollinger, Juli M; Rowan, Paul J (December 1, 2017). <a rel="nofollow" class="external text" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965503">"Constraints on gene patent protection fuel secrecy concerns: a qualitative study"</a>. <i>Journal of Law and the Biosciences</i>. <b>4</b> (3): <span class="nowrap">542–</span>564. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1093%2Fjlb%2Flsx034">10.1093/jlb/lsx034</a>. <a href="/wiki/PMC_(identifier)" class="mw-redirect" title="PMC (identifier)">PMC</a> <span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965503">5965503</a></span>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a> <a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/29868184">29868184</a>.</cite><span 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Mayo Collaborative Services (Fed. 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Mayo Collaborative Services (Fed. Cir. 2009)"</a>. <i>Patent Docs</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Patent+Docs&rft.atitle=Prometheus+Laboratories%2C+Inc.+v.+Mayo+Collaborative+Services+%28Fed.+Cir.+2009%29&rft_id=https%3A%2F%2Fwww.patentdocs.org%2F2009%2F09%2Fprometheus-laboratories-inc-v-mayo-collaborative-services-fed-cir-2009.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-17"><span class="mw-cite-backlink"><b><a href="#cite_ref-17">^</a></b></span> <span class="reference-text"><cite><i>Prometheus Laboratories, Inc. v. Mayo Collaborative Services</i></cite>, <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infco20090916133">581 F.3d 1336</a> (<a href="/wiki/Fed._Cir." class="mw-redirect" title="Fed. Cir.">Fed. 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September 16, 2009.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Patently-O&rft.atitle=Patentable+Subject+Matter%3A+Federal+Circuit+Upholds+Patentability+of+Drug+Dosage+Method+Claim&rft.date=2009-09-16&rft_id=https%3A%2F%2Fpatentlyo.com%2Fpatent%2F2009%2F09%2Fpatentable-subject-matter-federal-circuit-upholds-patentability-of-drug-dosage-method-claim.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-19"><span class="mw-cite-backlink"><b><a href="#cite_ref-19">^</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://www.supremecourt.gov/Search.aspx?FileName=/docketfiles/09-490.htm">"Search - Supreme Court of the United States"</a>. <i>www.supremecourt.gov</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.supremecourt.gov&rft.atitle=Search+-+Supreme+Court+of+the+United+States&rft_id=https%3A%2F%2Fwww.supremecourt.gov%2FSearch.aspx%3FFileName%3D%2Fdocketfiles%2F09-490.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-20"><span class="mw-cite-backlink"><b><a href="#cite_ref-20">^</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://www.supremecourt.gov/orders/courtorders/062910zr.pdf">"Supreme Court Order granting Certiorari"</a> <span class="cs1-format">(PDF)</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Supreme+Court+Order+granting+Certiorari&rft_id=https%3A%2F%2Fwww.supremecourt.gov%2Forders%2Fcourtorders%2F062910zr.pdf&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-FedCircuitDecision-21"><span class="mw-cite-backlink">^ <a href="#cite_ref-FedCircuitDecision_21-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-FedCircuitDecision_21-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><cite><i>Prometheus Laboratories, Inc. v. Mayo Collaborative Services</i></cite>, <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infco20101217141">628 F.3d 1347</a> (Fed. Cir. 2010).</span> </li> <li id="cite_note-22"><span class="mw-cite-backlink"><b><a href="#cite_ref-22">^</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://patentlyo.com/patent/2010/12/prometheus-laboratories-v-mayo-the-broad-scope-of-statutory-subject-matter.html">"Prometheus Laboratories v. Mayo: The Broad Scope of Statutory Subject Matter"</a>. <i>Patently-O</i>. 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March 20, 2012.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Patently-O&rft.atitle=Mayo+v.+Prometheus%3A+Natural+Process+%2B+Known+Elements+%3D+Normally+No+Patent&rft.date=2012-03-20&rft_id=https%3A%2F%2Fpatentlyo.com%2Fpatent%2F2012%2F03%2Fmayo-v-prometheus-natural-process-known-elements-normally-no-patent.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-Patent_Docs_on_SCOTUS_decision-24"><span class="mw-cite-backlink">^ <a href="#cite_ref-Patent_Docs_on_SCOTUS_decision_24-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Patent_Docs_on_SCOTUS_decision_24-1"><sup><i><b>b</b></i></sup></a></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://www.patentdocs.org/2012/03/mayo-collaborative-services-v-prometheus-laboratories-inc-what-the-supreme-court-said.html">"Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said"</a>. <i>Patent Docs</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Patent+Docs&rft.atitle=Mayo+Collaborative+Services+v.+Prometheus+Laboratories+--+What+the+Supreme+Court+Said&rft_id=https%3A%2F%2Fwww.patentdocs.org%2F2012%2F03%2Fmayo-collaborative-services-v-prometheus-laboratories-inc-what-the-supreme-court-said.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-25"><span class="mw-cite-backlink"><b><a href="#cite_ref-25">^</a></b></span> <span class="reference-text">Gene Quinn, <a rel="nofollow" class="external text" href="https://ipwatchdog.com/2012/03/20/supreme-court-mayo-v-prometheus/id=22920/#:~:text=Those%20in%20the%20biotech%2C%20medical,corporate%20value%20has%20been%20erased"><i>Killing Industry: The Supreme Court Blows Mayo v. Prometheus</i></a></span> </li> <li id="cite_note-26"><span class="mw-cite-backlink"><b><a href="#cite_ref-26">^</a></b></span> <span class="reference-text">Kevin Noonan, <a rel="nofollow" class="external text" href="http://www.patentdocs.org/2012/03/mayo-collaborative-services-v-prometheus-laboratories-what-the-courts-decision-means.html"><i>Mayo Collaborative Services v. Prometheus Laboratories—What the Court's Decision Means</i></a>, <style data-mw-deduplicate="TemplateStyles:r920966791">.mw-parser-output span.smallcaps{font-variant:small-caps}.mw-parser-output span.smallcaps-smaller{font-size:85%}</style><span class="smallcaps">Patent Docs</span> (March 22, 2012).</span> </li> <li id="cite_note-27"><span class="mw-cite-backlink"><b><a href="#cite_ref-27">^</a></b></span> <span class="reference-text">Robert R. Sachs, <a rel="nofollow" class="external text" href="http://www.patentlyo.com/patent/2012/03/punishing-prometheus-part-ii-what-is-a-claim.html"><i>Punishing Prometheus: The Supreme Court’s Blunders in Mayo v. Prometheus</i></a>, <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r920966791" /><span class="smallcaps">Patently-O</span> (March 26, 2012).</span> </li> <li id="cite_note-28"><span class="mw-cite-backlink"><b><a href="#cite_ref-28">^</a></b></span> <span class="reference-text">Hans Sauer, quoted in <a rel="nofollow" class="external text" href="http://www.patentdocs.org/2012/03/early-reaction-to-supreme-court-decision-in-mayo-v-prometheus.htm"><i>Early Reaction to Supreme Court Decision in Mayo v. Prometheus</i></a>, <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r920966791" /><span class="smallcaps">Patent Docs</span> (March 20, 2012).</span> </li> <li id="cite_note-29"><span class="mw-cite-backlink"><b><a href="#cite_ref-29">^</a></b></span> <span class="reference-text">See Richard H. Stern, <i>Mayo v Prometheus: No Patents on Conventional Implementations of Natural Principles and Fundamental Truths</i>, [2012] Eur. Intell. Prop. Rev. 502, available at <a rel="nofollow" class="external text" href="http://docs.law.gwu.edu/facweb/claw/MayoPro.pdf">GW Law</a> <a rel="nofollow" class="external text" href="https://web.archive.org/web/20160222050756/http://docs.law.gwu.edu/facweb/claw/MayoPro.pdf">Archived</a> February 22, 2016, at the <a href="/wiki/Wayback_Machine" title="Wayback Machine">Wayback Machine</a>.</span> </li> <li id="cite_note-30"><span class="mw-cite-backlink"><b><a href="#cite_ref-30">^</a></b></span> <span class="reference-text">Robert Wah, quoted in <a rel="nofollow" class="external text" href="http://www.patentdocs.org/2012/03/early-reaction-to-supreme-court-decision-in-mayo-v-prometheus.htm"><i>Early Reaction to Supreme Court Decision in Mayo v. Prometheus</i></a>, <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r920966791" /><span class="smallcaps">Patent Docs</span> (March 20, 2012).</span> </li> <li id="cite_note-31"><span class="mw-cite-backlink"><b><a href="#cite_ref-31">^</a></b></span> <span class="reference-text">See Richard H. Stern, <i>Mayo v. Prometheus: No Patents on Conventional Implementations of Natural Principles and Fundamental Truths</i>, [2012] Eur. Intell. Prop. Rev. 502, available at <a rel="nofollow" class="external text" href="http://docs.law.gwu.edu/facweb/claw/MayoPro.pdf">GW Law</a> <a rel="nofollow" class="external text" href="https://web.archive.org/web/20160222050756/http://docs.law.gwu.edu/facweb/claw/MayoPro.pdf">Archived</a> February 22, 2016, at the <a href="/wiki/Wayback_Machine" title="Wayback Machine">Wayback Machine</a>.</span> </li> <li id="cite_note-32"><span class="mw-cite-backlink"><b><a href="#cite_ref-32">^</a></b></span> <span class="reference-text">William J. Manolis, <a rel="nofollow" class="external text" href="http://heinonline.org/HOL/Page?handle=hein.journals/duqbuslr15&div=9&collection=journals&set_as_cursor=9&men_tab=srchresults"><i>A Struggle for Clairvoyance Section 101 of the Patent Act as a Gatekeeper to Patent Eligibility: Mayo Collaborative Serv. v. Prometheus Laboratories, Inc.</i></a>, 15 <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r920966791" /><span class="smallcaps">Duq. Bus.</span> L.J. 113, 136 (2013).</span> </li> <li id="cite_note-33"><span class="mw-cite-backlink"><b><a href="#cite_ref-33">^</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="http://www.uspto.gov/patents/law/exam/mayo_prelim_guidance.pdf">"Patent Office's Preliminary Guidelines"</a> <span class="cs1-format">(PDF)</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Patent+Office%27s+Preliminary+Guidelines&rft_id=http%3A%2F%2Fwww.uspto.gov%2Fpatents%2Flaw%2Fexam%2Fmayo_prelim_guidance.pdf&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-34"><span class="mw-cite-backlink"><b><a href="#cite_ref-34">^</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://www.uspto.gov/blog/director/">"Director's Blog: the latest from USPTO leadership"</a>. <i>www.uspto.gov</i>. December 18, 2024.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.uspto.gov&rft.atitle=Director%27s+Blog%3A+the+latest+from+USPTO+leadership&rft.date=2024-12-18&rft_id=https%3A%2F%2Fwww.uspto.gov%2Fblog%2Fdirector%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-35"><span class="mw-cite-backlink"><b><a href="#cite_ref-35">^</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="http://www.uspto.gov/patents/law/exam/2012_interim_guidance.pdf">"Patent Office's Interim Guidelines"</a> <span class="cs1-format">(PDF)</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Patent+Office%27s+Interim+Guidelines&rft_id=http%3A%2F%2Fwww.uspto.gov%2Fpatents%2Flaw%2Fexam%2F2012_interim_guidance.pdf&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> <li id="cite_note-36"><span class="mw-cite-backlink"><b><a href="#cite_ref-36">^</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://www.uspto.gov/web/offices/pac/mpep/s2106.html">"MPEP"</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=MPEP&rft_id=https%3A%2F%2Fwww.uspto.gov%2Fweb%2Foffices%2Fpac%2Fmpep%2Fs2106.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></span> </li> </ol></div> <div class="mw-heading mw-heading2"><h2 id="Further_reading">Further reading</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=14" title="Edit section: Further reading"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222" /><cite id="CITEREFHolman2012" class="citation journal cs1">Holman, Christopher M. (2012). "Preliminary Thoughts on <i>Mayo v. Prometheus</i>: The Implications for Biotechnology". <i>Biotechnology Law Report</i>. <b>31</b> (2): <span class="nowrap">111–</span>113. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1089%2Fblr.2012.9923">10.1089/blr.2012.9923</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Biotechnology+Law+Report&rft.atitle=Preliminary+Thoughts+on+Mayo+v.+Prometheus%3A+The+Implications+for+Biotechnology&rft.volume=31&rft.issue=2&rft.pages=%3Cspan+class%3D%22nowrap%22%3E111-%3C%2Fspan%3E113&rft.date=2012&rft_id=info%3Adoi%2F10.1089%2Fblr.2012.9923&rft.aulast=Holman&rft.aufirst=Christopher+M.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222" /><cite id="CITEREFWarrenFredrich2012" class="citation journal cs1">Warren, William L.; Fredrich, Stacy D. (2012). "Law of Nature or Patentable Discovery? : Supreme Court's <i>Mayo v. Prometheus</i> Decision Raises More Questions for Personalized Medicine". <i>Genetic Engineering & Biotechnology News</i>. <b>32</b> (9): <span class="nowrap">10–</span>11. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1089%2Fgen.32.9.02">10.1089/gen.32.9.02</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Genetic+Engineering+%26+Biotechnology+News&rft.atitle=Law+of+Nature+or+Patentable+Discovery%3F+%3A+Supreme+Court%27s+Mayo+v.+Prometheus+Decision+Raises+More+Questions+for+Personalized+Medicine&rft.volume=32&rft.issue=9&rft.pages=%3Cspan+class%3D%22nowrap%22%3E10-%3C%2Fspan%3E11&rft.date=2012&rft_id=info%3Adoi%2F10.1089%2Fgen.32.9.02&rft.aulast=Warren&rft.aufirst=William+L.&rft.au=Fredrich%2C+Stacy+D.&rfr_id=info%3Asid%2Fen.wikipedia.org%3AMayo+Collaborative+Services+v.+Prometheus+Laboratories%2C+Inc." class="Z3988"></span></li></ul> <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=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&action=edit&section=15" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>Text of <i>Mayo Collaborative Services v. Prometheus Laboratories, Inc.</i>, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_566" title="List of United States Supreme Court cases, volume 566">566</a> <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> 66 (2012) is available from: <a rel="nofollow" class="external text" href="https://www.law.cornell.edu/supremecourt/text/10-1150">Cornell</a>  <a rel="nofollow" class="external text" href="https://www.courtlistener.com/opinion/625710/mayo-collaborative-services-v-prometheus-laboratories-inc/">CourtListener</a>  <a rel="nofollow" class="external text" href="https://scholar.google.com/scholar_case?case=16025237560214135711">Google Scholar</a>  <a rel="nofollow" class="external text" href="https://supreme.justia.com/cases/federal/us/566/66/">Justia</a>  <a rel="nofollow" class="external text" href="https://www.oyez.org/cases/2011/10-1150">Oyez (oral argument audio)</a>  <a rel="nofollow" class="external text" href="https://web.archive.org/web/0/https://www.supremecourt.gov/opinions/11pdf/10-1150.pdf">Supreme Court (slip opinion) (archived)</a> </li> <li><a rel="nofollow" class="external text" href="http://www.scotusblog.com/case-files/cases/mayo-collaborative-services-v-prometheus-laboratories-inc/">Coverage of the case on SCOTUSblog</a></li> <li><a rel="nofollow" class="external text" href="https://www.supremecourt.gov/oral_arguments/argument_transcripts/10-1150.pdf">Transcript of oral arguments of <i>Mayo v. Prometheus</i></a></li> <li><a rel="nofollow" class="external text" href="https://opencrs.com/document/R42815/">Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine</a> <a href="/wiki/Congressional_Research_Service" title="Congressional Research Service">Congressional Research Service</a></li></ul>    </div><noscript><img src="https://login.wikimedia.org/wiki/Special:CentralAutoLogin/start?useformat=desktop&type=1x1&usesul3=0" alt="" width="1" height="1" style="border: none; position: absolute;"></noscript> <div class="printfooter" data-nosnippet="">Retrieved from "<a dir="ltr" href="https://en.wikipedia.org/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&oldid=1267218467">https://en.wikipedia.org/w/index.php?title=Mayo_Collaborative_Services_v._Prometheus_Laboratories,_Inc.&oldid=1267218467</a>"</div></div> <div id="catlinks" class="catlinks" data-mw="interface"><div id="mw-normal-catlinks" class="mw-normal-catlinks"><a href="/wiki/Help:Category" title="Help:Category">Categories</a>: <ul><li><a href="/wiki/Category:United_States_Supreme_Court_cases" title="Category:United States Supreme Court cases">United States Supreme Court cases</a></li><li><a href="/wiki/Category:United_States_patent_case_law" title="Category:United States patent case law">United States patent case law</a></li><li><a href="/wiki/Category:2012_in_United_States_case_law" title="Category:2012 in United States case law">2012 in United States case law</a></li><li><a href="/wiki/Category:Mayo_Clinic" title="Category:Mayo Clinic">Mayo Clinic</a></li><li><a href="/wiki/Category:United_States_Supreme_Court_cases_of_the_Roberts_Court" title="Category:United States Supreme Court cases of the Roberts Court">United States Supreme Court cases of the Roberts Court</a></li></ul></div><div id="mw-hidden-catlinks" class="mw-hidden-catlinks mw-hidden-cats-hidden">Hidden categories: <ul><li><a href="/wiki/Category:Webarchive_template_wayback_links" title="Category:Webarchive template wayback links">Webarchive template wayback links</a></li><li><a href="/wiki/Category:Use_mdy_dates_from_September_2023" title="Category:Use mdy dates from September 2023">Use mdy dates from September 2023</a></li><li><a href="/wiki/Category:Articles_with_short_description" title="Category:Articles with short description">Articles with short description</a></li><li><a href="/wiki/Category:Short_description_is_different_from_Wikidata" title="Category:Short description is different from Wikidata">Short description is different from Wikidata</a></li></ul></div></div> </div> </main> </div> <div class="mw-footer-container"> <footer id="footer" class="mw-footer" > <ul id="footer-info"> <li id="footer-info-lastmod"> This page was last edited on 4 January 2025, at 03:46<span class="anonymous-show"> (UTC)</span>.</li> <li id="footer-info-copyright">Text is available under the <a href="/wiki/Wikipedia:Text_of_the_Creative_Commons_Attribution-ShareAlike_4.0_International_License" title="Wikipedia:Text of the Creative Commons Attribution-ShareAlike 4.0 International License">Creative Commons Attribution-ShareAlike 4.0 License</a>; additional terms may apply. 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