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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">2015 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">Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</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 October 15, 2014<br />Decided January 20, 2015</th></tr><tr><th scope="row" class="infobox-label">Full case name</th><td class="infobox-data"><i>Teva Pharmaceuticals USA, Inc. v. Sandoz, 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/13-854.htm">13-854</a></td></tr><tr><th scope="row" class="infobox-label">Citations</th><td class="infobox-data">574 <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> 318 (<i><a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_574" title="List of United States Supreme Court cases, volume 574">more</a></i>)<div>135 S. Ct. 831; 190 <a href="/wiki/L._Ed._2d" class="mw-redirect" title="L. Ed. 2d">L. Ed. 2d</a> 719; 2014 <a href="/wiki/U.S._LEXIS" class="mw-redirect" title="U.S. LEXIS">U.S. LEXIS</a> 4897; 83 U.S.L.W. 4055; 113 <a href="/wiki/U.S.P.Q.2d" class="mw-redirect" title="U.S.P.Q.2d">U.S.P.Q.2d</a> 1269</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">810 <a href="/wiki/F._Supp._2d" class="mw-redirect" title="F. Supp. 2d">F. Supp. 2d</a> <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infdco20110831a36">578</a> (<a href="/wiki/S.D.N.Y." class="mw-redirect" title="S.D.N.Y.">S.D.N.Y.</a> 2011); 876 <a href="/wiki/F._Supp._2d" class="mw-redirect" title="F. Supp. 2d">F. Supp. 2d</a> <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/inadvfdco130305000062">295</a> (S.D.N.Y. 2012); affirmed in part, reversed in part, and remanded, 723 <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/infco20130726110">1363</a> (<a href="/wiki/Fed._Cir." class="mw-redirect" title="Fed. Cir.">Fed. Cir.</a> 2013); stay denied, 572 U.S. 1301 (2014); <a href="/wiki/Certiorari" title="Certiorari">cert.</a> granted, 572 U.S. 1033 (2014)</td></tr><tr><th scope="row" class="infobox-label">Subsequent</th><td class="infobox-data">On remand, 789 <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/infco20150618145">1335</a> (Fed. Cir. 2015)</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">When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a "clear error," not a de novo, standard of review.</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 opinions</th></tr><tr><th scope="row" class="infobox-label">Majority</th><td class="infobox-data">Breyer, joined by Roberts, Scalia, Kennedy, Ginsburg, Sotomayor, Kagan</td></tr><tr><th scope="row" class="infobox-label">Dissent</th><td class="infobox-data">Thomas, joined by Alito</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">F.R.C.P. 52(a)(6)</td></tr></tbody></table> <p><i><b>Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</b></i>, 574 U.S. 318 (2015),<sup id="cite_ref-opinion_1-0" class="reference"><a href="#cite_note-opinion-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> is a <a href="/wiki/Patent" title="Patent">patent</a> case of the <a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">Supreme Court of the United States</a> regarding the <a href="/wiki/Copaxone" class="mw-redirect" title="Copaxone">Copaxone</a> patent.<sup id="cite_ref-SCOTUSBlog1_2-0" class="reference"><a href="#cite_note-SCOTUSBlog1-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-SCOTUSBlog2_3-0" class="reference"><a href="#cite_note-SCOTUSBlog2-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> The Court held that, when <a href="/wiki/Appeal" title="Appeal">reviewing</a> a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent <a href="/wiki/Claim_(patent)" class="mw-redirect" title="Claim (patent)">claim</a>, the Federal Circuit must apply a "<a href="/wiki/Standard_of_review#Clearly_erroneous" title="Standard of review">clear error</a>," not a <a href="/wiki/Standard_of_review#De_novo" title="Standard of review">de novo</a>, <a href="/wiki/Standard_of_review" title="Standard of review">standard of review</a>.<sup id="cite_ref-SCOTUSBlog1_2-1" class="reference"><a href="#cite_note-SCOTUSBlog1-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-SCOTUSBlog2_3-1" class="reference"><a href="#cite_note-SCOTUSBlog2-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-opinion_1-1" class="reference"><a href="#cite_note-opinion-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Facts_and_procedural_history">Facts and procedural history</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Teva_Pharmaceuticals_USA,_Inc._v._Sandoz,_Inc.&action=edit&section=1" title="Edit section: Facts and procedural history"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The case originated in the <a href="/wiki/Southern_District_of_New_York" title="Southern District of New York">Southern District of New York</a>, where <a href="/wiki/Novartis" title="Novartis">Sandoz</a> sued to invalidate <a href="/wiki/Teva_Pharmaceutical_Industries" class="mw-redirect" title="Teva Pharmaceutical Industries">Teva</a>'s patent on a drug for the treatment of <a href="/wiki/Multiple_sclerosis" title="Multiple sclerosis">multiple sclerosis</a>. In the <a href="/wiki/Markman_hearing" title="Markman hearing">Markman hearing</a>, Sandoz argued that a <a href="/wiki/Claim_(patent)" class="mw-redirect" title="Claim (patent)">claim</a> was fatally <a href="/w/index.php?title=Indefiniteness_(U.S._patent_law)&action=edit&redlink=1" class="new" title="Indefiniteness (U.S. patent law) (page does not exist)">indefinite</a> for failing to identify which of three possible meanings a particular claim term, related to the <a href="/wiki/Molecular_weight" class="mw-redirect" title="Molecular weight">molecular weight</a> of a component of the drug, should be interpreted to have. The district court judge held that the claim term was definite, and that a "person of ordinary skill in the art" would interpret the term "molecular weight" to mean the "peak average molecular weight", that is, the weight of the molecule most prevalent in the mixture.<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> In doing so, the judge relied in part on <a href="/wiki/Expert_witness" title="Expert witness">expert witness</a> testimony. </p><p>Sandoz appealed to the Federal Circuit, which reviewed the claim under a 'de novo' standard, decided that the claim term was fatally indefinite, and hence that the patent was invalid.<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><p>Teva appealed to the US Supreme Court and won. </p> <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=Teva_Pharmaceuticals_USA,_Inc._v._Sandoz,_Inc.&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-opinion-1"><span class="mw-cite-backlink">^ <a href="#cite_ref-opinion_1-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-opinion_1-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><i>Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</i>, No. <a rel="nofollow" class="external text" href="https://supreme.justia.com/cases/federal/us/574/13-854/">13-854</a>, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_574" title="List of United States Supreme Court cases, volume 574">574</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/574/318/">318</a> (2015).</span> </li> <li id="cite_note-SCOTUSBlog1-2"><span class="mw-cite-backlink">^ <a href="#cite_ref-SCOTUSBlog1_2-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-SCOTUSBlog1_2-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1176897979">.mw-parser-output .bluebook-title{font-style:italic}.mw-parser-output .bluebook-title i{font-style:normal}.mw-parser-output .bluebook-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 .bluebook-lock-limited a,.mw-parser-output .bluebook-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 .bluebook-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-hidden-error{display:none;color:#d33}.mw-parser-output .cs1-visible-error{color:#d33}.mw-parser-output .cs1-maint{display:none;color:#3a3;margin-left:0.3em}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}</style><cite id="CITEREF"><span class="bluebook-title bluebook-lock-none" title=""><a rel="nofollow" class="external text" href="http://www.scotusblog.com/case-files/cases/teva-pharmaceuticals-usa-inc-v-sandoz-inc/">Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</a></span>, SCOTUSblog (last visited July 4, 2018).</cite></span> </li> <li id="cite_note-SCOTUSBlog2-3"><span class="mw-cite-backlink">^ <a href="#cite_ref-SCOTUSBlog2_3-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-SCOTUSBlog2_3-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1176897979"><cite id="CITEREFDenniston2015">Lyle Denniston, <span class="bluebook-title bluebook-lock-none" title=""><a rel="nofollow" class="external text" href="http://www.scotusblog.com/2015/01/new-dispute-over-copaxone-patent/">New dispute over Copaxone patent</a></span>, SCOTUSblog (January 26, 2015).</cite></span> </li> <li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</a></b></span> <span class="reference-text"><cite><i>Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</i></cite>, <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infdco20110831a36">810 F. Supp. 2d 578</a> (<a href="/wiki/S.D.N.Y." class="mw-redirect" title="S.D.N.Y.">S.D.N.Y.</a> 2011).</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"><cite><i>Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</i></cite>, <a rel="nofollow" class="external text" href="https://www.leagle.com/decision/infco20130726110">723 F.3d 1363</a> (<a href="/wiki/Fed._Cir." class="mw-redirect" title="Fed. Cir.">Fed. Cir.</a> 2013).</span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Teva_Pharmaceuticals_USA,_Inc._v._Sandoz,_Inc.&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>Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.</i>, <a href="/wiki/List_of_United_States_Supreme_Court_cases,_volume_574" title="List of United States Supreme Court cases, volume 574">574</a> <a href="/wiki/United_States_Reports" title="United States Reports">U.S.</a> 318 (2015) is available from: <a rel="nofollow" class="external text" href="https://www.courtlistener.com/opinion/2771248/teva-pharmaceuticals-usa-inc-v-sandoz-inc/">CourtListener</a>  <a rel="nofollow" class="external text" href="https://scholar.google.com/scholar_case?case=745501008375680315">Google Scholar</a>  <a rel="nofollow" class="external text" href="https://supreme.justia.com/cases/federal/us/574/318/">Justia</a>  <a rel="nofollow" class="external text" href="https://www.oyez.org/cases/2014/13-854">Oyez (oral argument audio)</a>  <a rel="nofollow" class="external text" href="https://web.archive.org/web/0/https://www.supremecourt.gov/opinions/14pdf/13-854_o7jp.pdf">Supreme Court (slip opinion) (archived)</a> </li></ul>    </div><noscript><img src="https://login.wikimedia.org/wiki/Special:CentralAutoLogin/start?type=1x1" 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=Teva_Pharmaceuticals_USA,_Inc._v._Sandoz,_Inc.&oldid=1174675987">https://en.wikipedia.org/w/index.php?title=Teva_Pharmaceuticals_USA,_Inc._v._Sandoz,_Inc.&oldid=1174675987</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:Multiple_sclerosis" title="Category:Multiple sclerosis">Multiple sclerosis</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: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_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><li><a href="/wiki/Category:2015_in_United_States_case_law" title="Category:2015 in United States case law">2015 in United States case law</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:Use_mdy_dates_from_March_2021" title="Category:Use mdy dates from March 2021">Use mdy dates from March 2021</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 10 September 2023, at 00:45<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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