{"id":5808,"date":"2022-11-17T20:05:08","date_gmt":"2022-11-18T01:05:08","guid":{"rendered":"https:\/\/www.ktslaw.com.cn\/?p=5808"},"modified":"2023-03-07T20:25:23","modified_gmt":"2023-03-08T01:25:23","slug":"supreme-court-grants-amgens-petition-for-certiorari-to-reconsider-enablement-of-genus-claims","status":"publish","type":"post","link":"https:\/\/www.ktslaw.com.cn\/en\/supreme-court-grants-amgens-petition-for-certiorari-to-reconsider-enablement-of-genus-claims\/","title":{"rendered":"Supreme Court Grants Amgen\u2019s Petition for Certiorari to Reconsider Enablement of Genus Claims"},"content":{"rendered":"

By: Cindy Rothschild, PhD<\/strong><\/a>, Andrew T. Serafini, PhD<\/strong><\/a>, and Christopher Thomas<\/strong><\/a><\/p>\n

Last week, the Supreme Court granted Amgen\u2019s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with functional limitations. The Supreme Court declined to review Amgen\u2019s first question in the petition regarding whether enablement is a question of fact to be determined by the jury or a question of law determined by the court. Notably, the Supreme Court granted Amgen\u2019s petition for certiorari against the recommendation of the Solicitor General.<\/p>\n

As we reported late last year<\/a>, Amgen\u2019s petition for certiorari stems from the Federal Circuit\u2019s decision that patents covering Amgen\u2019s cholesterol medication Repatha\u00ae were not enabled because reaching their full scope would require undue experimentation. In its petition, Amgen argues that the Federal Circuit decision creates a new standard for enablement of genus claims that evaluates how much \u201ctime and effort\u201d is required to make
\nand test every embodiment so as \u201cto reach the full scope of claimed embodiments\u201d thereby requiring the Applicant to identify every embodiment meeting the claimed function. The full scope enablement of genus claims would require an Applicant to identify and make every embodiment that falls within the scope of the claims, which places a heavy burden on the Applicant to disclose and enable the entire genus that is claimed.<\/p>\n

The Supreme Court\u2019s decision to determine the standard for enabling genus claims and whether the \u201cfull scope of the claim\u201d standard is an improper heightened standard for enablement will be closely watched by biotechnology companies. At the heart of the issue is the balance between the scope of genus claims and their potentially preemptive effect and the disclosure requirements of a patent owner to properly enable one of ordinary skill in the art to make and use their invention. As the law currently stands, functional genus claims will be heavily scrutinized for enablement under the \u201cfull scope of the claim\u201d standard. Therefore, patentees drafting such claims should consider subgenus claims and species claims with sufficient evidence of enablement.<\/p>\n

Cynthia Rothschild, PhD<\/strong> is a partner in the Winston-Salem, NC office, Andrew T. Serafini, PhD<\/strong> is a partner in the Seattle, WA office, and Christopher Thomas<\/strong> is a senior associate in the Washington, DC office of Kilpatrick & Stockton LLP.<\/p>\n

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, 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","protected":false},"excerpt":{"rendered":"

By: Cindy Rothschild, PhD, Andrew T. Serafini, PhD, and Christopher Thomas Last week, the Supreme Court granted Amgen\u2019s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims […]<\/p>\n","protected":false},"author":23,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[105],"tags":[],"class_list":["post-5808","post","type-post","status-publish","format-standard","hentry","category-publication"],"acf":[],"yoast_head":"\nSupreme Court Grants Amgen\u2019s Petition for Certiorari to Reconsider Enablement of Genus Claims - Kilpatrick<\/title>\n<meta name=\"description\" content=\"Last week, the Supreme Court granted Amgen\u2019s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with functional limitations. The Supreme Court declined to review Amgen\u2019s first question in the petition regarding whether enablement is a question of fact to be determined by the jury or a question of law determined by the court. Notably, the Supreme Court granted Amgen\u2019s petition for certiorari against the recommendation of the Solicitor General.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ktslaw.com.cn\/en\/supreme-court-grants-amgens-petition-for-certiorari-to-reconsider-enablement-of-genus-claims\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Supreme Court Grants Amgen\u2019s Petition for Certiorari to Reconsider Enablement of Genus Claims - Kilpatrick\" \/>\n<meta property=\"og:description\" content=\"Last week, the Supreme Court granted Amgen\u2019s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. 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