{"id":5061,"date":"2025-02-01T10:27:36","date_gmt":"2025-02-01T02:27:36","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=5061"},"modified":"2025-02-05T10:32:32","modified_gmt":"2025-02-05T02:32:32","slug":"%e4%b8%ba%e4%ba%86%e7%94%b3%e8%af%b7%e5%8c%bb%e7%96%97%e5%99%a8%e6%9d%90%e4%b8%8a%e5%b8%82%e8%80%8c%e8%bf%9b%e5%8f%a3%e5%8f%af%e4%b8%bb%e5%bc%a0%e4%b8%93%e5%88%a9%e4%be%b5%e6%9d%83%e8%b1%81%e5%85%8d","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/5061\/","title":{"rendered":"\u4e3a\u4e86\u7533\u8bf7\u533b\u7597\u5668\u6750\u4e0a\u5e02\u800c\u8fdb\u53e3\u53ef\u4e3b\u5f20\u4e13\u5229\u4fb5\u6743\u8c41\u514d\uff1f 2024\u5e74\u8054\u90a6\u5de1\u56de\u4e0a\u8bc9\u6cd5\u9662Edwards Lifesciences v. Meril Life Sciences\u6848"},"content":{"rendered":"<blockquote><p>\u5370\u5ea6\u836f\u5382Meril\u4e3a\u4e86\u80fd\u5728\u836f\u7269\u6216\u533b\u7597\u5668\u6750\u4e13\u5229\u5230\u671f\u524d\uff0c\u83b7\u51c6\u5728\u7f8e\u56fd\u7533\u8bf7\u4e0a\u5e02\uff0c\u56e0\u6b64\u5fc5\u987b\u63d0\u524d\u5230\u7f8e\u56fd\u8fdb\u884c\u300c\u4e3a\u836f\u7269\u6216\u533b\u7597\u5668\u6750\u4e0a\u5e02\u7533\u8bf7\u51c6\u5907\u300d\u800c\u4ece\u4e8b\u7684\u4eba\u4f53\u5b9e\u9a8c\u6d3b\u52a8 \u2014 \u6b64\u79cd\u6d3b\u52a8\u6709\u53d7\u5230\u7f8e\u56fd\u4e13\u5229\u6cd5\u7b2c271\u6761(e)(1)\u7684\u5141\u8bb8\uff0c\u5e76\u8ba4\u5b9a\u4e0d\u6784\u6210\u4fb5\u6743\u3002\u4f46\u6761\u6587\u9650\u5236\u8fd9\u79cd\u6d3b\u52a8\u4ec5\u4ec5\u662f\u4e3a\u4e86\u300c\u7533\u8bf7\u4e0a\u5e02\u300d\u4e4b\u76ee\u7684\uff0c\u4e0d\u80fd\u8d85\u8fc7\u8be5\u76ee\u7684\u3002\u56e0\u6b64\uff0c\u8fd9\u9879\u9650\u5236\u5f15\u53d1\u4e862024\u5e74\u7f8e\u56fd\u8054\u90a6\u5de1\u56de\u6cd5\u9662\uff08CAFC\uff09Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.\u4e00\u6848<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/5061#1\">[1]<\/a>\u7684\u4e89\u8bae\u3002<\/p><\/blockquote>\n<figure id=\"attachment_2745\" aria-describedby=\"caption-attachment-2745\" style=\"width: 2560px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2745\" src=\"http:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/115333348_51M-scaled-e1736834727453.jpg\" alt=\"\" width=\"2560\" height=\"1707\" \/><figcaption id=\"caption-attachment-2745\" class=\"wp-caption-text\">\u56fe\u7247\u6765\u6e90 : shutterstock\u3001\u8fbe\u5fd7\u5f71\u50cf<\/figcaption><\/figure>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_69_1 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u9304<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 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title=\"\u7f8e\u56fdEdwards\u516c\u53f8\u544a\u5370\u5ea6Meril\u516c\u53f8\">\u7f8e\u56fdEdwards\u516c\u53f8\u544a\u5370\u5ea6Meril\u516c\u53f8<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/5061\/#%E5%85%B3%E9%94%AE%E8%AF%8D%E3%80%8Csolely%E3%80%8D%E7%9A%84%E4%BD%9C%E7%94%A8\" title=\"\u5173\u952e\u8bcd\u300csolely\u300d\u7684\u4f5c\u7528\">\u5173\u952e\u8bcd\u300csolely\u300d\u7684\u4f5c\u7528<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/5061\/#%E7%94%B3%E8%AF%B7%E5%85%A8%E9%99%A2%E5%AE%A1%E6%9F%A5%E5%92%8C%E6%9C%80%E9%AB%98%E6%B3%95%E9%99%A2%E5%AE%A1%E6%9F%A5%E5%9D%87%E8%A2%AB%E9%A9%B3%E5%9B%9E\" title=\"\u7533\u8bf7\u5168\u9662\u5ba1\u67e5\u548c\u6700\u9ad8\u6cd5\u9662\u5ba1\u67e5\u5747\u88ab\u9a73\u56de\">\u7533\u8bf7\u5168\u9662\u5ba1\u67e5\u548c\u6700\u9ad8\u6cd5\u9662\u5ba1\u67e5\u5747\u88ab\u9a73\u56de<\/a><\/li><\/ul><\/nav><\/div>\n<h1 class=\"Article_tittle_3_blue_bold\"><span class=\"ez-toc-section\" id=\"%E7%94%B3%E8%AF%B7%E4%B8%8A%E5%B8%82%E5%87%86%E5%A4%87%E4%B9%8B%E3%80%8C%E5%AE%89%E5%85%A8%E6%B8%AF%E3%80%8D%E6%9D%A1%E6%AC%BE\"><\/span><span style=\"color: #026292;\">\u7533\u8bf7\u4e0a\u5e02\u51c6\u5907\u4e4b\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>\u6839\u636e\u7f8e\u56fd\u4e13\u5229\u6cd535 U.S.C. \u00a7 271(e)(1)\u7684\u89c4\u5b9a\uff0c\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u662f\u300aHatch-Waxman\u6cd5\u300b\u7684\u7ec4\u6210\u90e8\u5206\uff0c\u5176\u76ee\u7684\u662f\u4fc3\u8fdb\u5b66\u540d\u836f\u53ca\u533b\u7597\u8bbe\u5907\u7684\u5f00\u53d1\u3002\u8be5\u6761\u6b3e\u8c41\u514d\u4e86\u67d0\u4e9b\u4e0e\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u4e0a\u5e02\u6838\u51c6\u76f8\u5173\u7684\u6d3b\u52a8\uff0c\u4f7f\u5176\u4e0d\u6784\u6210\u4e13\u5229\u4fb5\u6743\u3002\u8fd9\u4e9b\u6d3b\u52a8\u5fc5\u987b\u662f\u300c\u4ec5\u9650\u4e8e\uff08solely for\uff09\u4e0e\u83b7\u5f97FDA\u6838\u51c6\u4e4b\u5408\u7406\u76f8\u5173\u7684\u7528\u9014\u300d\uff08\u7b2c271\u6761(e)(1)\uff09\u3002\u8be5\u6761\u6b3e\u65e8\u5728\u5141\u8bb8\u4f01\u4e1a\u5bf9\u836f\u7269\u6216\u533b\u7597\u5668\u6750\u4ea7\u54c1\u4e0a\u5e02\u524d\u987b\u8fdb\u884c\u5fc5\u8981\u7684\u6d4b\u8bd5\u548c\u5f00\u53d1\uff0c\u800c\u65e0\u9700\u9762\u4e34\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\u7684\u98ce\u9669\uff1b\u53ea\u8981\u8fd9\u4e9b\u6d3b\u52a8\u662f\u4e3a\u4e86\u83b7\u5f97\u4e0a\u5e02\u6838\u51c6\u800c\u4ece\u4e8b\u7684\u3002<\/p>\n<h1 class=\"Article_tittle_3_blue_bold\"><span class=\"ez-toc-section\" id=\"%E7%BE%8E%E5%9B%BDEdwards%E5%85%AC%E5%8F%B8%E5%91%8A%E5%8D%B0%E5%BA%A6Meril%E5%85%AC%E5%8F%B8\"><\/span><span style=\"color: #026292;\">\u7f8e\u56fdEdwards\u516c\u53f8\u544a\u5370\u5ea6Meril\u516c\u53f8<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>Meril\u662f\u4e00\u5bb6\u4f4d\u4e8e\u5370\u5ea6\u7684\u533b\u7597\u8bbe\u5907\u516c\u53f8\uff0c\u5176\u5f00\u53d1\u7684\u300c\u7ecf\u5bfc\u7ba1\u5fc3\u810f\u74e3\u819c\u300d\u662fMyval\u7cfb\u7edf\u7684\u4e00\u90e8\u5206\uff0c\u7528\u4e8e\u6cbb\u7597\u5fc3\u810f\u75be\u75c5\u3002Meril\u4e8e2017\u5e746\u6708\u5728\u5370\u5ea6\u5f00\u59cb\u8fdb\u884cMyval\u7cfb\u7edf\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u4e8e2018\u5e7410\u6708\u83b7\u5f97\u5370\u5ea6\u7684\u4e0a\u5e02\u6838\u51c6\u540e\u5f00\u59cb\u5728\u5370\u5ea6\u5e02\u573a\u9500\u552e\u30022019\u5e744\u6708\uff0cMyval\u7cfb\u7edf\u66f4\u8fdb\u4e00\u6b65\u83b7\u5f97\u6b27\u76dfCE\u8ba4\u8bc1\u6807\u7ae0\uff0c\u56e0\u6b64\uff0cMeril\u88ab\u83b7\u51c6\u5728\u6b27\u6d32\u7ecf\u6d4e\u533a\uff08EEA\uff09\u5185\u9500\u552eMyval\u7cfb\u7edf<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/5061#1\">[2]<\/a>\u3002<\/p>\n<p>\u7136\u800c\u5728\u7f8e\u56fd\uff0cMyval\u7cfb\u7edf\u88ab\u89c6\u4e3a\u300cIII\u7c7b\u300d\u533b\u7597\u8bbe\u5907\uff0c\u56e0\u6b64\u9700\u9075\u5b88\u67d0\u4e9b\u76d1\u7ba1\u6807\u51c6<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/5061#1\">[3]<\/a>\u3002\u4e3a\u83b7\u5f97FDA\u7684\u4e0a\u5e02\u524d\u6838\u51c6\uff08Premarket Approval, PMA\uff09\uff0cMeril\u516c\u53f8\u5fc5\u987b\u5148\u7533\u8bf7\u5e76\u83b7\u5f97\u533b\u7597\u8bbe\u5907\u8bd5\u9a8c\u7684\u8c41\u514d\uff08Investigational Device Exemption, IDE\uff09\uff0c\u56e0\u6b64\u987b\u8ba9\u6267\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u4eba\u5458\u5c06Myval\u7cfb\u7edf\u690d\u5165\u53d7\u8bd5\u8005\u5e76\u6536\u96c6\u8fd9\u4e9b\u53d7\u8bd5\u8005\u7684\u6570\u636e\u540e\u5c06\u6570\u636e\u63d0\u4ea4\u7ed9FDA\u3002<\/p>\n<p>Meril\u516c\u53f8\u57282019\u5e749\u6708\u6d3e\u5458\u5de5\u53c2\u52a0\u4f4d\u4e8e\u7f8e\u56fd\u65e7\u91d1\u5c71\u4e3e\u884c\u7684\u7ecf\u5bfc\u7ba1\u5fc3\u8840\u7ba1\u6cbb\u7597\u4f1a\u8bae\uff08Transcatheter Cardiovascular Therapeutics Conference, TCTC\uff09\uff0c\u5e76\u6b32\u4e8e\u5728\u4f1a\u8bae\u4e0a\u5bfb\u627e\u80fd\u53c2\u4e0eFDA\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6f5c\u5728\u7814\u7a76\u8005\u3002Meril\u5411\u6d3e\u5f80\u53c2\u52a0TCTC\u768420\u540d\u5458\u5de5\u53e3\u5934\u4f20\u8fbe\u6307\u5bfc\u65b9\u9488\uff1a\u300c\u4e0d\u5f97\u5728\u4f1a\u8bae\u4e0a\u6216\u5728\u7f8e\u56fd\u5883\u5185\u9488\u5bf9\u7f8e\u56fd\u5e02\u573a\u8fdb\u884c\u4efb\u4f55\u9500\u552e\u6216\u9500\u552e\u8981\u7ea6\uff08offer for sale\uff09\uff0c\u4f46\u53ef\u4ee5\u9488\u5bf9\u5176\u4ed6\u56fd\u5bb6\u63d0\u51fa\u8981\u7ea6\u3002\u300dMeril\u5458\u5de5\u642d\u98de\u673a\u524d\u5f80\u65e7\u91d1\u5c71\u53c2\u52a0TCTC\u65f6\uff0c\u968f\u8eab\u643a\u5e26\u4e862\u5957Myval\u7cfb\u7edf\u6837\u54c1\u3002\u5e76\u5728\u5230\u8fbe\u65e7\u91d1\u5c71\u540e\uff0c\u5458\u5de5\u5c06\u88c5\u6709\u6837\u54c1\u7684\u888b\u5b50\u5e26\u5f80TCTC\uff0c\u5e76\u5c06\u5176\u5b58\u653e\u4e8eTCTC\u4f1a\u573a\u7684\u50a8\u85cf\u5ba4\u5185\u8fc7\u591c\u3002\u636e\u6089\uff0c\u8fd9\u4e9b\u6837\u54c1\u5728\u8fdb\u53e3\u5230\u7f8e\u56fd\u540e\u4ece\u672a\u88ab\u53d6\u51fa\u6216\u5411\u4efb\u4f55\u4eba\u5c55\u793a<a class=\"Article_content_15px\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/5061#1\">[4]<\/a>\u3002<\/p>\n<p>Edwards Lifesciences\uff08Edwards\u516c\u53f8\uff09\u662f\u540c\u6837\u4f9b\u5e94\u7528\u4e8e\u5fc3\u810f\u75be\u75c5\u6cbb\u7597\u8bbe\u5907\u7684\u533b\u7597\u8bbe\u5907\u516c\u53f8\uff0c\u5176\u4e3b\u8981\u4e3a\u4f9b\u5e94\u300c\u4eba\u5de5\u5fc3\u810f\u74e3\u819c\u7cfb\u7edf\u300d\uff0c\u5e76\u62e5\u6709\u672c\u6848\u7684\u5fc3\u810f\u74e3\u819c\u6280\u672f\u7684\u76f8\u5173\u4e13\u5229\u3002Edwards\u516c\u53f8\u4e8e2019\u5e7410\u6708\u5728\u7f8e\u56fd\u52a0\u5dde\u5317\u533a\u5730\u65b9\u6cd5\u9662\uff08N.D. Cal.\uff09\u8d77\u8bc9Meril\u516c\u53f8\uff0c\u6307\u63a7Meril\u516c\u53f8\u6d89\u53ca\u4ece\u4e8b\u5fc3\u810f\u74e3\u819c\u6280\u672f\u7684\u6d3b\u52a8\uff0c\u4fb5\u72af\u4e86\u5176\u4e13\u5229\u3002<\/p>\n<h1 class=\"Article_tittle_3_blue_bold\"><span class=\"ez-toc-section\" id=\"%E5%85%B3%E9%94%AE%E8%AF%8D%E3%80%8Csolely%E3%80%8D%E7%9A%84%E4%BD%9C%E7%94%A8\"><\/span><span style=\"color: #026292;\">\u5173\u952e\u8bcd\u300csolely\u300d\u7684\u4f5c\u7528<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>\u4f5c\u4e3a\u4fb5\u6743\u6297\u8fa9\uff0cMeril\u516c\u53f8\u4e3b\u5f20\u5176\u884c\u4e3a\u53d7\u7b2c271\u6761(e)(1)\u4e4b\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u4fdd\u62a4\uff0c\u56e0\u4e3a\u5176\u6d3b\u52a8\u7684\u76ee\u7684\u662f\u83b7\u5f97\u5305\u62ec\u5411\u76d1\u7ba1\u673a\u6784\u6838\u51c6\u63d0\u51fa\u7533\u8bf7\u6240\u505a\u7684\u51c6\u5907\u3002<\/p>\n<p>\u672c\u6848\u4e89\u8bae\u7684\u7126\u70b9\u5728\u4e8e\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u4e2d\u300csolely\u300d\uff08\u4ec5\u4ec5\uff09\u4e00\u8bcd\u7684\u8303\u56f4\u4ee5\u53ca\u54ea\u4e9b\u6d3b\u52a8\u53ef\u56e0\u6b64\u6761\u6b3e\u514d\u4e8e\u4e13\u5229\u4fb5\u6743\u8d23\u4efb\u3002\u56e0\u4e3aMeril\u516c\u53f8\u4e0d\u4ec5\u662f\u4e3a\u4e86\u62db\u52df\u7814\u53d1\u4eba\u5458\uff0c\u8fd8\u5305\u62ec\u5728\u5c55\u89c8\u4f1a\u4e0a\u5bf9\u7f8e\u56fd\u4ee5\u5916\u7684\u5e02\u573a\u505a\u9500\u552e\u62a5\u4ef7\u3002\u56e0\u6b64\uff0c\u5730\u533a\u6cd5\u9662\u5728\u7b80\u6613\u5224\u51b3\u4e2d\uff0c\u8ba4\u4e3aMeril\u8fdb\u53e3Myval\u7cfb\u7edf\u7684\u884c\u4e3a\u53d7\u5230\u7b2c271\u6761(e)(1)\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u7684\u4fdd\u62a4\u3002\u4e0a\u8bc9\u540e\uff0cCAFC\u8ba4\u4e3a\uff0c\u5176\u5728\u9075\u5faa\u6700\u9ad8\u6cd5\u9662\u5728Merck KGaA v. Integra Lifesciences\uff082005\uff09\u6848\u4e2d\u5bf9\u7b2c271\u6761(e)(1)\u89e3\u91ca\u7684\u5148\u4f8b\u4e2d\uff0c\u652f\u6301\u6b64\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u9002\u7528\u4e8e\u4e0eFDA\u6838\u51c6\u7528\u9014\u4e4b\u5408\u7406\u76f8\u5173\u7684\u884c\u4e3a\uff0c\u4f8b\u5982\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u62db\u52df\u7814\u7a76\u4eba\u5458\u3002<\/p>\n<p>CAFC\u8be6\u7ec6\u5ba1\u67e5Meril\u516c\u53f8\u7684\u6d3b\u52a8\u662f\u5426\u786e\u5b9e\u662f\u300c\u4ec5\u4ec5\u300d\u4e3a\u4e86\u7533\u8bf7\u4e0a\u5e02\u6838\u51c6\u4e4b\u76ee\u7684\u3002Meril\u516c\u53f8\u5c06\u5176\u5c1a\u672a\u6838\u51c6\u7684Myval\u7cfb\u7edf\u6837\u54c1\u5e26\u5230\u7f8e\u56fd\u53c2\u52a0TCTC\uff0c\u4f46\u5e76\u672a\u8fdb\u884c\u9500\u552e\u6216\u516c\u5f00\u5c55\u793a\uff0c\u800c\u662f\u5c06\u5176\u5b58\u653e\u5728\u5c45\u4f4f\u996d\u5e97\u7684\u58c1\u6a71\u548cTCTC\u4f1a\u573a\u7684\u50a8\u85cf\u5ba4\u4e2d\u3002\u6b64\u5916\uff0cMeril\u516c\u53f8\u7684\u6d3b\u52a8\u8fd8\u5305\u62ec\u4e3a\u5411\u76d1\u7ba1\u673a\u6784\u63d0\u4ea4\u800c\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u548c\u6570\u636e\u6536\u96c6\u3002CAFC\u8ba4\u4e3a\uff0c\u8fd9\u4e9b\u6d3b\u52a8\u4e0e\u4e3a\u83b7\u5f97\u7f8e\u56fdFDA\u4e0a\u5e02\u6838\u51c6\u4ece\u4e8b\u7684\u51c6\u5907\u5408\u7406\u76f8\u5173\uff0c\u5c5e\u4e8e\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u7684\u4fdd\u62a4\u8303\u56f4\u5185\u3002CAFC\u6307\u51fa\uff0c\u5373\u4f7f\u8fd9\u4e9b\u6d3b\u52a8\u5177\u6709\u591a\u91cd\u76ee\u7684\uff0c\u53ea\u8981\u5176\u4e2d\u4e00\u4e2a\u76ee\u7684\u662f\u83b7\u5f97FDA\u6838\u51c6\uff0c\u300c\u5b89\u5168\u6e2f\u300d\u6761\u6b3e\u4f9d\u7136\u9002\u7528\u3002\u4e5f\u5c31\u662f\u8bf4\uff0cCAFC\u8ba4\u4e3a\u300csolely\u300d\uff08\u4ec5\u4ec5\uff09\u5e76\u975e\u300conly\u300d\uff08\u53ea\u80fd\u6709\uff09\u3002<\/p>\n<p>\u4e0d\u8fc7\uff0cCAFC\u7684\u6cd5\u5b98\u827e\u4f26\u00b7\u6d1b\u91cc\uff08Alan Lourie\uff09\u63d0\u51fa\u53cd\u5bf9\u610f\u89c1\uff0c\u8ba4\u4e3a\u591a\u6570\u610f\u89c1\u5728\u89e3\u8bfb\u7b2c271\u6761(e)(1)\u65f6\u51fa\u9519\uff0c\u672a\u8003\u8651Meril\u516c\u53f8\u5c06Myval\u7cfb\u7edf\u8fdb\u53e3\u81f3\u7f8e\u56fd\u53c2\u52a0\u533b\u5b66\u4f1a\u8bae\u7684\u5176\u4ed6\u5546\u4e1a\u76ee\u7684\u3002<\/p>\n<h1 class=\"Article_tittle_3_blue_bold\"><span class=\"ez-toc-section\" id=\"%E7%94%B3%E8%AF%B7%E5%85%A8%E9%99%A2%E5%AE%A1%E6%9F%A5%E5%92%8C%E6%9C%80%E9%AB%98%E6%B3%95%E9%99%A2%E5%AE%A1%E6%9F%A5%E5%9D%87%E8%A2%AB%E9%A9%B3%E5%9B%9E\"><\/span><span style=\"color: #026292;\">\u7533\u8bf7\u5168\u9662\u5ba1\u67e5\u548c\u6700\u9ad8\u6cd5\u9662\u5ba1\u67e5\u5747\u88ab\u9a73\u56de<\/span><span class=\"ez-toc-section-end\"><\/span><\/h1>\n<p>\u7531\u4e8eCAFC\u6709\u6cd5\u5b98\u91c7\u4e0d\u540c\u610f\u89c1\uff0c\u6545Edwards\u516c\u53f8\u5c31\u8be5\u5224\u51b3\u5411CAFC\u63d0\u51fa\u5168\u4f53\u6cd5\u5b98\u590d\u5ba1\u8bf7\u6c42\uff0c\u8d28\u7591CAFC\u5bf9\u300csolely\u300d\u4e00\u8bcd\u7684\u89e3\u91ca\u3002\u7136\u800c\uff0cCAFC\u9a73\u56de\u4e86\u8fd9\u4e00\u8bf7\u6c42\uff0c\u7ef4\u6301\u4e86\u539f\u5224\u3002<\/p>\n<p>2024\u5e7410\u6708\uff0cEdwards\u516c\u53f8\u518d\u5411\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u63d0\u4ea4\u4e00\u4efd\u79fb\u5ba1\u8bf7\u613f\u4e66\uff0c\u8bf7\u6c42\u63a8\u7ffbCAFC\u5bf9271\u6761(e)(1)\u7684\u89e3\u8bfb\u3002\u7136\u800c\uff0c\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u4e8e2025\u5e741\u6708\u9a73\u56de\u8be5\u8bf7\u613f\uff0c\u7ef4\u6301CAFC\u7684\u5224\u51b3\u3002<\/p>\n<p><a id=\"1\" name=\"1\"><\/a>\u5907\u6ce8\uff1a<\/p>\n<div>\n<ol>\n<li class=\"Article_footer_note\">Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024).<\/li>\n<li class=\"Article_footer_note\">Id, at 1349.<\/li>\n<li class=\"Article_footer_note\">Id, at 1349.<\/li>\n<li class=\"Article_footer_note\">Id, at 1349-1350.<\/li>\n<\/ol>\n<\/div>\n<p class=\"Article_content_15px\"><strong>\u8d23\u4efb\u7f16\u8f91\uff1a\u5362\u9880<\/strong><\/p>\n<p class=\"Article_content_15px\"><strong>\u3010\u672c\u6587\u4ec5\u53cd\u6620\u4e13\u5bb6\u4f5c\u8005\u610f\u89c1\uff0c\u4e0d\u4ee3\u8868\u672c\u62a5\u7acb\u573a\u3002\u3011<\/strong><\/p>\n<table border=\"0\" width=\"94%\" cellspacing=\"1\" cellpadding=\"8\">\n<tbody>\n<tr>\n<td bgcolor=\"#EFEFF8\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\" width=\"162\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-2013\" src=\"http:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/I2.jpg\" alt=\"\" width=\"162\" height=\"207\" \/><\/td>\n<td width=\"20\"><\/td>\n<td valign=\"top\" width=\"475\">\n<table border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"3\">\n<tbody>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\" width=\"13%\"><strong>\u4f5c\u8005\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\" width=\"87%\"><strong>\u6768\u667a\u6770<\/strong><\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\"><strong>\u73b0\u4efb\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\">\u4e91\u6797\u79d1\u6280\u5927\u5b66\u79d1\u6280\u6cd5\u5f8b\u6240 \u6559\u6388<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u7ecf\u5386\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\">\u4e91\u6797\u79d1\u6280\u5927\u5b66\u79d1\u6280\u6cd5\u5f8b\u6240 \u526f\u6559\u6388<br \/>\n\u771f\u7406\u5927\u5b66\u6cd5\u5f8b\u7cfb\u52a9\u7406\u6559\u6388<br \/>\n\u771f\u7406\u5927\u5b66\u6cd5\u5f8b\u7cfb\u526f\u6559\u6388<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\"><strong>\u5b66\u5386\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\">\u53f0\u6e7e\u5927\u5b66\u6cd5\u5f8b\u7cfb<br \/>\n\u4e2d\u592e\u5927\u5b66\u4ea7\u4e1a\u7ecf\u6d4e\u6240\u7855\u58eb<br \/>\n\u53f0\u6e7e\u5927\u5b66\u6cd5\u5b66\u535a\u58eb<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u4e13\u957f\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\">\u77e5\u8bc6\u4ea7\u6743\u3001\u7f8e\u56fd\u4e13\u5229\u6cd5\u3001\u7f8e\u56fd\u8457\u4f5c\u6743\u6cd5\u3001\u5baa\u6cd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>\u5370\u5ea6\u836f\u5382Meril\u4e3a\u4e86\u80fd\u5728\u836f\u7269\u6216\u533b\u7597\u5668\u6750\u4e13\u5229\u5230\u671f\u524d\uff0c\u83b7\u51c6\u5728\u7f8e\u56fd\u7533\u8bf7\u4e0a\u5e02\uff0c\u56e0\u6b64\u5fc5\u987b\u63d0\u524d\u5230\u7f8e\u56fd\u8fdb\u884c\u300c\u4e3a\u836f\u7269\u6216\u533b\u7597\u5668 [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":2745,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,254,277,256],"tags":[],"author_name1":[310],"class_list":{"0":"post-5061","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-283","8":"category-254","9":"category-277","10":"category-256","11":"author_name1--zh-hans"},"_links":{"self":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5061","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=5061"}],"version-history":[{"count":0,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/5061\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media\/2745"}],"wp:attachment":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=5061"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=5061"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=5061"},{"taxonomy":"author_name1","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/author_name1?post=5061"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}