{"id":3711,"date":"2024-03-25T19:47:47","date_gmt":"2024-03-26T00:47:47","guid":{"rendered":"https:\/\/patents.harnessip.com\/?p=3711"},"modified":"2024-04-06T15:24:34","modified_gmt":"2024-04-06T20:24:34","slug":"%c2%a7-271e1-pprovides-a-wide-berth-for-the-use-of-patented-inventions-in-activities-related-to-the-federal-regulatory-process","status":"publish","type":"post","link":"https:\/\/patents.harnessip.com\/?p=3711","title":{"rendered":"\u00a7 271(e)(1) Pprovides a Wide Berth for the Use of Patented Inventions in Activities Related to the Federal Regulatory Process"},"content":{"rendered":"\n<p>In Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.,<a href=\"https:\/\/cafc.uscourts.gov\/opinions-orders\/22-1877.OPINION.3-25-2024_2290338.pdf\"> [2022-1877] <\/a>(Fed. Cir. 2024), the Federal Circuit affirmed the district court&#8217;s summary judgment that Meril\u2019s act of importation of the two transcatheter heart valve systems fell within the safe harbor provision of 35 U.S.C. \u00a7 271(e)(1).<\/p>\n\n\n\n<p>The Federal Circuit concluded that the undisputed evidence showed Meril\u2019s importation of the two transcatheter heart valve systems was reasonably related to submitting information to the United States Food and Drug Administration, and affirmed the district court\u2019s<br>summary judgment of noninfringement.<\/p>\n\n\n\n<p>Section 271(e)(1) sets forth:<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .<\/p>\n<\/blockquote>\n\n\n\n<p>This safe harbor \u201cprovides a wide berth for the use of patented [inventions] in activities related to the federal regulatory process.\u201d  Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005). As the Supreme Court in Merck explained, \u201cit [is] apparent from the statutory text that \u00a7 271(e)(1)\u2019s exemption from infringement extends to all uses of patented<br>inventions that are reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act].\u201d  Moreover, the \u00a7 271(e)(1) exemption is not limited temporally. Mooring in the safe harbor is available to defendants irrespective of<br>the stage of research and even if the information is never ultimately submitted to the FDA.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd., [2022-1877] (Fed. Cir. 2024), the Federal Circuit affirmed the district court&#8217;s summary judgment that Meril\u2019s act of importation of the two transcatheter heart valve systems fell within the safe harbor &hellip; <a href=\"https:\/\/patents.harnessip.com\/?p=3711\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[112],"tags":[],"class_list":["post-3711","post","type-post","status-publish","format-standard","hentry","category-112"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3711"}],"version-history":[{"count":2,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3711\/revisions"}],"predecessor-version":[{"id":3713,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=\/wp\/v2\/posts\/3711\/revisions\/3713"}],"wp:attachment":[{"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/patents.harnessip.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}