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<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">2005 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">Merck KGaA v. Integra Lifesciences I, Ltd.</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 April 20, 2005<br />Decided June 13, 2005</th></tr><tr><th scope="row" class="infobox-label">Full case name</th><td class="infobox-data"><i>Merck KGaA, Petitioner v. Integra Lifesciences I, Ltd., et al.</i></td></tr><tr><th scope="row" class="infobox-label">Citations</th><td class="infobox-data">545 <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> <a rel="nofollow" class="external text" href="https://supreme.justia.com/us/545/193/case.html">193</a> (<i><a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_545" title="List of United States Supreme Court cases, volume 545">more</a></i>)<div>125 S. Ct. 2372; 162 <a href="/wiki/L._Ed._2d" class="mw-redirect" title="L. Ed. 2d">L. Ed. 2d</a> 160; 2005 <a href="/wiki/U.S._LEXIS" class="mw-redirect" title="U.S. LEXIS">U.S. LEXIS</a> 4840; 73 U.S.L.W. 4468; 74 <a href="/wiki/U.S.P.Q.2d" class="mw-redirect" title="U.S.P.Q.2d">U.S.P.Q.2d</a> (<a href="/wiki/Bloomberg_BNA" class="mw-redirect" title="Bloomberg BNA">BNA</a>) 1801; 18 Fla. L. Weekly Fed. S 394</div></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"><i>Integra Lifesciences I, Ltd. v. Merck KGaA</i>, 331 <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/20031191331f3d86011108">860</a> (<a href="/wiki/United_States_Court_of_Appeals_for_the_Federal_Circuit" title="United States Court of Appeals for the Federal Circuit">Fed. Cir.</a> 2003); <a href="/wiki/Certiorari" title="Certiorari">cert.</a> granted, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_543" title="List of United States Supreme Court cases, volume 543">543</a> <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> 1041 (2005).</td></tr><tr><th scope="row" class="infobox-label">Subsequent</th><td class="infobox-data">On remand at <i>Integra Lifesciences I, LTD. v. Merck KGaA</i>, 496 F.3d <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/20071830496f3d133411830">1334</a> (Fed. Cir. 2005).</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">The Court held that the use of patented compounds in preclinical studies is protected under § 271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA.</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/William_Rehnquist" title="William Rehnquist">William Rehnquist</a> </dd> <dt style="margin:0;">Associate Justices</dt> <dd style="margin:0;"><a href="/wiki/John_Paul_Stevens" title="John Paul Stevens">John P. Stevens</a> <b>·</b>  <a href="/wiki/Sandra_Day_O%27Connor" title="Sandra Day O'Connor">Sandra Day O'Connor</a><br /><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/David_Souter" title="David Souter">David Souter</a> <b>·</b>  <a href="/wiki/Clarence_Thomas" title="Clarence Thomas">Clarence Thomas</a><br /><a href="/wiki/Ruth_Bader_Ginsburg" title="Ruth Bader Ginsburg">Ruth Bader Ginsburg</a> <b>·</b>  <a href="/wiki/Stephen_Breyer" title="Stephen Breyer">Stephen Breyer</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">Scalia, 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/United_States_Constitution" class="mw-redirect" title="United States Constitution">U.S. Const.</a>; <span class="plainlinksneverexpand"><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/35/271#e_1">§ 271(e)(1)</a></span></td></tr></tbody></table> <p><i><b>Merck KGaA v. Integra Lifesciences I, Ltd.</b></i>, 545 U.S. 193 (2005), is a <a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">United States Supreme Court</a> case with ramifications for <a href="/wiki/Patent" title="Patent">patent law</a>.<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> The dispute dates to approximately 1996 and centers on a federal law known as the "<a href="/wiki/Research_exemption" title="Research exemption">FDA safe harbor</a>" (§ 271(e)(1)).<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> </p><p>While the Court refused to "quibble" with the <a href="/wiki/United_States_Court_of_Appeals_for_the_Federal_Circuit" title="United States Court of Appeals for the Federal Circuit">Court of Appeals</a> over its conclusion that the exemption “does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process,” the Court held that: </p> <dl><dd>Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not “reasonably related to the development and submission of information” to the FDA. It does not follow from this, however, that §271(e)(1)’s exemption from infringement categorically excludes either (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA. Under certain conditions, we think the exemption is sufficiently broad to protect the use of patented compounds in both situations.<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></dd></dl> <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=Merck_KGaA_v._Integra_Lifesciences_I,_Ltd.&action=edit&section=1" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a href="/wiki/United_States_patent_law" title="United States patent law">United States patent law</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=Merck_KGaA_v._Integra_Lifesciences_I,_Ltd.&action=edit&section=2" 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"> <div class="mw-references-wrap"><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"><i>Merck KGaA v. Integra Lifesciences I, Ltd.</i>, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_545" title="List of United States Supreme Court cases, volume 545">545</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/545/193/">193</a> (2005). <span typeof="mw:File"><span><img alt="Public domain" src="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/15px-PD-icon.svg.png" decoding="async" width="15" height="15" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/23px-PD-icon.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/30px-PD-icon.svg.png 2x" data-file-width="196" data-file-height="196" /></span></span> <i>This article incorporates <a href="/wiki/Copyright_status_of_works_by_the_federal_government_of_the_United_States" title="Copyright status of works by the federal government of the United States">public domain material from this U.S government document</a>.</i></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"><span class="plainlinksneverexpand"><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/35/271#e_1">§ 271(e)(1)</a></span>.</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"><i>Merck KGaA</i>, 545 U.S. at 205-06.</span> </li> </ol></div></div> <ul><li>Kintisch, E. (2005, April 8). <i>Case probes what's fair game in the search for new drugs</i>. In <i>Science, 308</i>, 174.</li> <li>Mamudi, Sam, <i>Supreme Court broadens research exemption</i>, Managing Intellectual Property, June 14, 2005</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=Merck_KGaA_v._Integra_Lifesciences_I,_Ltd.&action=edit&section=3" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>Text of <i>Merck KGaA v. Integra Lifesciences I, Ltd.</i>, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_545" title="List of United States Supreme Court cases, volume 545">545</a> <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> 193 (2005) is available from: <a rel="nofollow" class="external text" href="https://www.law.cornell.edu/supct/html/03-1237.ZS.html">Cornell</a>  <a rel="nofollow" class="external text" href="https://www.courtlistener.com/opinion/799974/merck-kgaa-v-integra-lifesciences-i-ltd/">CourtListener</a>  <a rel="nofollow" class="external text" href="https://scholar.google.com/scholar_case?case=1273608188103605897">Google Scholar</a>  <a rel="nofollow" class="external text" href="https://supreme.justia.com/us/545/193/case.html">Justia</a>  <a rel="nofollow" class="external text" href="https://www.oyez.org/cases/2004/03-1237">Oyez (oral argument audio)</a> </li> <li><a rel="nofollow" class="external text" href="http://www.nature.com/bioent/2006/060401/full/bioent907.html"><i>Trendspotting: a shift in intellectual property focus</i>. 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