{"id":6261,"date":"2023-02-28T00:00:08","date_gmt":"2023-02-28T05:00:08","guid":{"rendered":"https:\/\/kilpatricktownsend.jp\/?p=6261"},"modified":"2023-04-06T04:33:27","modified_gmt":"2023-04-06T08:33:27","slug":"amgen-v-sanofi-supreme-court-to-hear-patent-enablement-arguments-on-march-27","status":"publish","type":"post","link":"https:\/\/kilpatricktownsend.jp\/en\/amgen-v-sanofi-supreme-court-to-hear-patent-enablement-arguments-on-march-27\/","title":{"rendered":"Amgen v. Sanofi: Supreme Court to Hear Patent Enablement Arguments on March 27"},"content":{"rendered":"<p>February 28, 2023<\/p>\n<p>by\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/People\/I\/IsaacsonAprilAbele\">April Abele Isaacson<\/a>\u00a0,\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/People\/M\/McKeonTinaWilliams\">Tina Williams McKeon<\/a><\/p>\n<p>We previously reported on the ongoing dispute between Amgen and Sanofi regarding enablement of genus claims\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/en\/Blog\/MEMO\/2021\/1\/Will-the-Federal-Circuit-Continue-to-Invalidate-Genus-Claims\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>,\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/en\/Blog\/MEMO\/2021\/3\/The-Federal-Circuit-Continues-to-Invalidate-Genus-Claims-Defined-by-Function\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>,\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/Blog\/memo\/2021\/4\/amgen%20petitions%20for%20en%20banc%20rehearing%20for%20federal%20circuit%20to%20reconsider%20enablement%20of%20genus%20claims\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>,\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/Blog\/MEMO\/2021\/12\/Amgen-Petitions-for-Certiorari-to-Reconsider-Enablement-of-Genus-Claims\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>, and\u00a0<a href=\"https:\/\/kilpatricktownsend.com\/Blog\/memo\/2022\/11\/supreme%20court%20grants%20amgens%20petition%20for%20certiorari%20to%20reconsider%20enablement%20of%20genus%20claims\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.\u00a0 But, the case is nearing a final decision. On January 31, the Supreme Court set arguments to\u00a0<a href=\"https:\/\/www.supremecourt.gov\/docket\/docketfiles\/html\/public\/21-757.html\" target=\"_blank\" rel=\"noopener noreferrer\">address Question 2 presented by the petition for cert<\/a>: Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to \u201cmake and use\u201d the claimed invention, 35 U.S.C. \u00a7 112, or whether it must instead enable those skilled in the art \u201c<em>to reach the full scope<\/em>\u00a0of claimed embodiments\u201d without undue experimentation-i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial \u201c\u2019time and effort.\u2019\u201d\u00a0 In other words, can the requirement of \u201cenablement to the full scope\u201d continue to render genus claims to biotechnology inventions invalid?<\/p>\n<p>More than 30 amicus briefs were filed by numerous entities, including the Intellectual Property Owners Association, the New York Intellectual Property Law Association, the Intellectual Property Law Association of Chicago, intellectual property professors, and various biopharma companies.\u00a0 The briefs were roughly split in their support of Amgen versus Sanofi.\u00a0 For example, fourteen professors jointly argued that the Federal Circuit\u2019s recent approach to enablement of genus claims exceeds the statutory requirement and is unnecessarily harsh in the analysis of chemical and biotechnology fields, whereas Eli Lilly argued that the Supreme Court should decide that claims with only functional limitations should be invalid.<\/p>\n<p>In April 2022, the Court invited the Solicitor General to file a brief in the case expressing the views of the United States, but the Solicitor General recommended the Court decline to hear the case.\u00a0 Despite the government\u2019s recommendation, in November 2022, the Court granted cert on Question 2 of Amgen\u2019s petition.\u00a0 On February 10, the\u00a0<a href=\"https:\/\/www.supremecourt.gov\/docket\/docketfiles\/html\/public\/21-757.html\" target=\"_blank\" rel=\"noopener noreferrer\">United States filed an amicus brief<\/a>, and\u00a0<a href=\"https:\/\/www.supremecourt.gov\/docket\/docketfiles\/html\/public\/21-757.html\" target=\"_blank\" rel=\"noopener noreferrer\">moved to participate in the oral argument<\/a>.\u00a0 On February 21, the\u00a0<a href=\"https:\/\/www.supremecourt.gov\/docket\/docketfiles\/html\/public\/21-757.html\" target=\"_blank\" rel=\"noopener noreferrer\">Court granted the Solicitor General\u2019s motion<\/a>\u00a0for leave to participate in oral argument as amicus curiae, for divided argument, and for enlargement of time for oral argument.\u00a0 The Court, however, denied leave for the Chemistry and the Law Division of the American Chemical Society to participate in the oral argument.<\/p>\n<p>At the March 27 oral argument, Amgen will have 35 minutes to present its argument, Sanofi will have 20 minutes, and the United States will have 15 minutes.\u00a0 The\u00a0<a href=\"https:\/\/www.supremecourt.gov\/oral_arguments\/argument_audio\/2022\" target=\"_blank\" rel=\"noopener noreferrer\">audio recordings will be posted on the Court\u2019s website<\/a>\u00a0later that day.\u00a0 Because the stakes could not be higher to biopharma companies and industry stakeholders, it will be fascinating to determine what can be gleaned from the Court\u2019s questions and comments during oral argument.\u00a0 A decision is expected to be handed down before the Court recesses for the summer.\u00a0 We will undoubtedly provide more posts as the case proceeds as the Supreme Court decision will have substantial ramifications regarding genus claims and functional terms.<\/p>\n<p><em><a href=\"https:\/\/www.kilpatricktownsend.com\/en\/People\/I\/IsaacsonAprilAbele\" target=\"_blank\" rel=\"noopener noreferrer\">April Abele Isaacson<\/a><\/em>\u00a0is a partner in the San Francisco, CA office and\u00a0<em><a href=\"https:\/\/kilpatricktownsend.com\/en\/People\/M\/McKeonTinaWilliams\" target=\"_blank\" rel=\"noopener noreferrer\">Tina Williams McKeon<\/a><\/em>\u00a0is a partner in the Atlanta, GA office of Kilpatrick Townsend &amp; Stockton, LLP.<\/p>\n<p><em>The opinions expressed are those of the author(s) and do not necessarily reflect the views of Kilpatrick Townsend, its clients, or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.<\/em><\/p>\n<p>Click here for <a href=\"https:\/\/kilpatricktownsend.jp\/\u7c73\u9023\u90a6\u6700\u9ad8\u88c1\u5224\u6240amgen-v-sanofi\/\"><u>Japanese<\/u><\/a> version.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>February 28, 2023 by\u00a0April Abele Isaacson\u00a0,\u00a0Tina Williams McKeon We previously reported on the ongoing dispute between Amgen and Sanofi regarding enablement of genus claims\u00a0here,\u00a0here,\u00a0here,\u00a0here, and\u00a0here.\u00a0 But, the case is nearing a final decision. On January 31, the Supreme Court set arguments to\u00a0address Question 2 presented by the petition for cert: Whether enablement is governed by [&hellip;]<\/p>\n","protected":false},"author":26,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[105],"tags":[],"class_list":["post-6261","post","type-post","status-publish","format-standard","hentry","category-publication"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Amgen v. 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