{"id":40813,"date":"2026-02-16T00:00:46","date_gmt":"2026-02-15T16:00:46","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=40813"},"modified":"2026-02-25T10:45:20","modified_gmt":"2026-02-25T02:45:20","slug":"2025%e5%b9%b4%e7%be%8e%e5%9b%bd%e8%8d%af%e5%93%81%e4%b8%93%e5%88%a9%e5%ae%9e%e5%8a%a1%e4%b8%8e%e5%85%b3%e9%94%ae%e5%88%a4%e5%86%b3%e5%9b%9e%e9%a1%be-1","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/40813\/","title":{"rendered":"2025\u5e74\u7f8e\u56fd\u836f\u54c1\u4e13\u5229\u5b9e\u52a1\u4e0e\u5173\u952e\u5224\u51b3\u56de\u987e-1"},"content":{"rendered":"<p><strong>\u6797\u675c<\/strong><strong> \/ <\/strong><strong>\u6c38\u4fe1\u836f\u54c1\u6cd5\u89c4\u5904\u4e13\u5458<\/strong><\/p>\n<blockquote><p>\u7b14\u8005\u957f\u671f\u5173\u6ce8\u8054\u90a6\u5de1\u56de\u4e0a\u8bc9\u6cd5\u9662\uff08CAFC\uff09\u5728\u4e13\u5229\u8303\u56f4\u89e3\u91ca\u4e0e\u6709\u6548\u6027\u5224\u65ad\u4e0a\u7684\u6700\u65b0\u53d1\u5c55\u30022025\u5e74\u7684\u591a\u9879\u88c1\u5b9a\uff0c\u5982 <em>Alnylam<\/em><a href=\"#_ftn1\"><strong><em>[1]<\/em><\/strong><\/a>\u3001<em>Azurity<\/em><a href=\"#_ftn2\"><strong><em>[2]<\/em><\/strong><\/a> \u53ca <em>Xencor<\/em><a href=\"#_ftn3\"><strong><em>[3]<\/em><\/strong><\/a> \u7b49\u6848\uff0c\u518d\u6b21\u5f3a\u8c03\u4e86\u5185\u5728\u8bc1\u636e\uff08Intrinsic Evidence\uff09 \u2014 \u5305\u542b\u8bf4\u660e\u4e66\u4e0e\u5ba1\u67e5\u5386\u53f2\u7eaa\u5f55 \u2014 \u5728\u51b3\u5b9a\u4e13\u5229\u6743\u8fb9\u754c\u65f6\u7684\u81f3\u9ad8\u5730\u4f4d\u3002\u4e13\u5229\u6743\u4eba\u4e0d\u4ec5\u8981\u9762\u5bf9\u6743\u5229\u9879\u6587\u5b57\u7684\u5b57\u9762\u675f\u7f1a\uff0c\u66f4\u5fc5\u987b\u4e3a\u5176\u5728\u5ba1\u67e5\u8fc7\u7a0b\u4e2d\u6240\u4f5c\u7684\u6bcf\u4e00\u9879\u58f0\u660e\u4e0e\u4fee\u6b63\u8d1f\u8d23\u3002\u65e0\u8bba\u662f\u62c5\u4efb\u300c\u8bcd\u5178\u7f16\u7e82\u8005\u300d\u91cd\u65b0\u5b9a\u4e49\u672f\u8bed\uff0c\u6216\u662f\u5728\u9762\u5bf9\u5148\u524d\u6280\u672f\u65f6\u4f5c\u51fa\u7684\u8303\u56f4\u653e\u5f03\uff0c\u8fd9\u4e9b\u884c\u4e3a\u90fd\u5c06\u6210\u4e3a\u8bc9\u8bbc\u4e2d\u4e0d\u53ef\u56de\u907f\u7684\u6cd5\u5f8b\u7ea6\u675f\u3002\u300a2025\u5e74\u7f8e\u56fd\u836f\u54c1\u4e13\u5229\u5b9e\u52a1\u4e0e\u5173\u952e\u5224\u51b3\u56de\u987e\u300b\u5c06\u52062\u520a\u671f\uff0c\u6574\u5408\u8fd1\u671f\u91cd\u8981\u5224\u4f8b\uff0c\u4ece\u672f\u8bed\u5b9a\u4e49\u3001\u8fde\u63a5\u8bcd\u6cd5\u5f8b\u6548\u679c\u5230\u6709\u6548\u6027\u8981\u4ef6\uff0c\u4e3a\u4e13\u5229\u5b9e\u52a1\u63d0\u4f9b\u6df1\u5ea6\u89e3\u6790\u4e0e\u6d1e\u89c1\u3002<span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">\u672c\u520a\u671f(200\u671f)\u4e3a\u7b2c\u4e00\u90e8\u5206\uff0c\u805a\u7126\u300c\u672f\u8bed\u5b9a\u4e49\u300d\u53ca\u300c\u8fde\u63a5\u8bcd\u6cd5\u5f8b\u6548\u679c\u300d\uff1b\u800c\u300c\u6709\u6548\u6027\u8981\u4ef6\u300d\u5219\u4f1a\u5728201\u671f\u63a2\u8ba8\uff0c\u5e76\u540c\u65f6\u5f52\u7eb3\u7ed3\u8bba\u53ca\u63d0\u51fa\u5efa\u8bae\u3002<\/span><\/p><\/blockquote>\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 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/40813\/#%E8%AF%8D%E5%85%B8%E7%BC%96%E7%BA%82%E8%80%85%E8%A7%92%E8%89%B2%E4%B8%8E%E5%AE%A1%E6%9F%A5%E5%8E%86%E5%8F%B2%E5%AE%9A%E4%B9%89%E7%9A%84%E8%BD%AC%E5%8C%96\" title=\"\u8bcd\u5178\u7f16\u7e82\u8005\u89d2\u8272\u4e0e\u5ba1\u67e5\u5386\u53f2\u5b9a\u4e49\u7684\u8f6c\u5316\">\u8bcd\u5178\u7f16\u7e82\u8005\u89d2\u8272\u4e0e\u5ba1\u67e5\u5386\u53f2\u5b9a\u4e49\u7684\u8f6c\u5316<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/40813\/#%E8%BF%9E%E6%8E%A5%E8%AF%8D%E7%9A%84%E9%97%AD%E9%94%81%E6%95%88%E6%9E%9C%E4%B8%8E%E5%8A%9F%E8%83%BD%E4%B8%8A%E6%97%A0%E5%85%B3%E7%9A%84%E9%99%90%E5%88%B6\" title=\"\u8fde\u63a5\u8bcd\u7684\u95ed\u9501\u6548\u679c\u4e0e\u529f\u80fd\u4e0a\u65e0\u5173\u7684\u9650\u5236\">\u8fde\u63a5\u8bcd\u7684\u95ed\u9501\u6548\u679c\u4e0e\u529f\u80fd\u4e0a\u65e0\u5173\u7684\u9650\u5236<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"%E8%AF%8D%E5%85%B8%E7%BC%96%E7%BA%82%E8%80%85%E8%A7%92%E8%89%B2%E4%B8%8E%E5%AE%A1%E6%9F%A5%E5%8E%86%E5%8F%B2%E5%AE%9A%E4%B9%89%E7%9A%84%E8%BD%AC%E5%8C%96\"><\/span><strong>\u8bcd\u5178\u7f16\u7e82\u8005\u89d2\u8272\u4e0e\u5ba1\u67e5\u5386\u53f2\u5b9a\u4e49\u7684\u8f6c\u5316<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u7f8e\u56fd\u4e13\u5229\u6cd5\u4e2d\uff0c\u4e13\u5229\u6743\u4eba\u53ef\u4ee5\u9009\u62e9\u81ea\u5df1\u62c5\u4efb<strong>\u8bcd\u5178\u7f16\u7e82\u8005\uff08<\/strong><strong>Lexicographer<\/strong><strong>\uff09<\/strong>\uff0c\u4ee5\u4e0d\u540c\u4e8e\u901a\u5e38\u542b\u4e49\u7684\u65b9\u5f0f\u4f7f\u7528\u672f\u8bed\uff0c\u53ea\u8981\u5728\u8bf4\u660e\u4e66\u6216\u5ba1\u67e5\u5386\u53f2\u4e2d\u660e\u786e\u9648\u8ff0\u5373\u53ef\u3002<a href=\"#_ftn4\">[4]<\/a>\u5728 <em>Alnylam v. Moderna<\/em> \u6848\u4e2d\uff0c\u4e89\u70b9\u5728\u4e8e\u300c\u652f\u94fe\u70f7\u57fa\u300d\uff08branched alkyl\uff09\u662f\u5426\u5305\u542b\u4e8c\u7ea7\u78b3\u3002\u867d\u7136\u8be5\u8bcd\u7684\u901a\u5e38\u542b\u4e49\u5305\u542b\u4e8c\u7ea7\u3001\u4e09\u7ea7\u548c\u56db\u7ea7\u78b3\uff0c\u4f46\u6cd5\u9662\u8ba4\u5b9a Alnylam \u516c\u53f8\u5728\u8bf4\u660e\u4e66\u6807\u9898\u4e3a\u300c\u5b9a\u4e49\u300d\u7684\u7ae0\u8282\u4e0b\uff0c\u660e\u786e\u5b9a\u4e49\u300c\u652f\u94fe\u70f7\u57fa\u300d\u662f\u6307\u4e00\u4e2a\u78b3\u539f\u5b50\u4e0e\u81f3\u5c11\u4e09\u4e2a\u5176\u4ed6\u78b3\u539f\u5b50\u76f8\u8fde\uff0c\u56e0\u6b64\u4e0d\u5305\u542b\u4e8c\u7ea7\u78b3\u3002\u6cd5\u9662\u5f3a\u8c03\uff0c\u5f53\u4e13\u5229\u6743\u4eba\u4f7f\u7528\u300crefer to\u300d\u5e76\u5c06\u672f\u8bed\u6807\u793a\u4e8e\u5f15\u53f7\u5185\u65f6\uff0c\u5373\u5c55\u73b0\u4e86\u660e\u786e\u7684\u5b9a\u4e49\u610f\u56fe\u3002\u5373\u4f7f Alnylam \u516c\u53f8\u8fa9\u79f0\u5b9a\u4e49\u4e2d\u5305\u542b\u300c\u9664\u975e\u53e6\u6709\u89c4\u5b9a\u300d\uff08unless otherwise specified\uff09\u7684\u5f39\u6027\uff0c\u6cd5\u9662\u4ecd\u8ba4\u4e3a\u5fc5\u987b\u5177\u5907\u660e\u786e\u4e14\u65e0\u53ef\u7f6e\u7591\u7684\u8bc1\u636e\u624d\u80fd\u504f\u79bb\u8be5\u5b9a\u4e49\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u5ba1\u67e5\u5386\u53f2\u4e5f\u80fd\u5c06\u539f\u672c\u5177\u5907\u5178\u578b\u542b\u4e49\u7684\u8fde\u63a5\u8bcd\u8f6c\u5316\u4e3a\u975e\u5178\u578b\u610f\u4e49\u3002\u5728 <em>Eye Therapies v. Slayback Pharma<\/em> \u6848<a href=\"#_ftn5\">[5]<\/a>\u4e2d\uff0c\u4e89\u8bae\u5728\u4e8e\u300c\u57fa\u672c\u4e0a\u7531\u2026\u2026\u7ec4\u6210\u300d\uff08consisting essentially of\uff09\u662f\u5426\u6392\u9664\u5176\u4ed6\u6d3b\u6027\u6210\u5206\u3002\u4e00\u822c\u800c\u8a00\uff0c\u8be5\u8fde\u63a5\u8bcd\u5141\u8bb8\u5305\u542b\u4e0d\u5b9e\u8d28\u5f71\u54cd\u53d1\u660e\u7279\u6027\u7684\u672a\u5217\u6210\u5206\u3002\u7136\u800c\uff0c\u8be5\u6848\u7533\u8bf7\u4eba\u5728\u5ba1\u67e5\u8fc7\u7a0b\u4e2d\u4e3a\u4e86\u533a\u522b\u5148\u524d\u6280\u672f Dean \u4e13\u5229<a href=\"#_ftn6\">[6]<\/a>\uff08\u8be5\u4e13\u5229\u7ed3\u5408\u4e24\u79cd\u6d3b\u6027\u6210\u5206\uff09\uff0c\u660e\u786e\u4e3b\u5f20\u5176\u53d1\u660e\u7684\u57fa\u672c\u7279\u6027\u662f\u300c\u4e0d\u5305\u542b\u65bd\u7528\u5176\u4ed6\u6d3b\u6027\u6210\u5206\u7684\u65b9\u6cd5\u300d\u5e76\u4f7f\u7528\u300c\u5373\uff08i.e.\uff09\u300d\u6765\u5b9a\u4e49\u5176\u8bf7\u6c42\u9879\u3002<\/p>\n<p>\u6cd5\u9662\u6700\u7ec8\u8ba4\u5b9a\uff0c\u8fd9\u79cd\u5728\u5ba1\u67e5\u5386\u53f2\u4e2d\u7684\u9650\u5236\u6027\u9648\u8ff0\u5177\u6709\u62d8\u675f\u529b\uff0c\u5373\u4f7f\u8be5\u89e3\u91ca\u4f1a\u5bfc\u81f4\u90e8\u5206\u8bf4\u660e\u4e66\u5b9e\u65bd\u4f8b\u65e0\u6cd5\u88ab\u6743\u5229\u8303\u56f4\u6db5\u76d6\uff0c\u4e13\u5229\u6743\u4eba\u4ecd\u5fc5\u987b\u4e3a\u5176\u5728\u4e89\u53d6\u4e13\u5229\u6838\u51c6\u65f6\u6240\u4f5c\u7684\u660e\u786e\u9650\u5b9a\u627f\u62c5\u540e\u679c\u3002\u8fd9\u518d\u6b21\u8bc1\u660e\uff0c\u4e13\u5229\u6743\u4eba\u5728\u5ba1\u67e5\u9636\u6bb5\u7684\u8bf4\u660e\u4e0e\u4fee\u6b63\u662f\u5b9a\u4e49\u8bf7\u6c42\u9879\u542b\u4e49\u7684\u5173\u952e\u4f9d\u636e\uff0c\u5176\u6cd5\u5f8b\u6548\u679c\u8db3\u4ee5\u6539\u53d8\u957f\u671f\u516c\u8ba4\u7684\u672f\u8bed\u60ef\u4f8b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E8%BF%9E%E6%8E%A5%E8%AF%8D%E7%9A%84%E9%97%AD%E9%94%81%E6%95%88%E6%9E%9C%E4%B8%8E%E5%8A%9F%E8%83%BD%E4%B8%8A%E6%97%A0%E5%85%B3%E7%9A%84%E9%99%90%E5%88%B6\"><\/span><strong>\u8fde\u63a5\u8bcd\u7684\u95ed\u9501\u6548\u679c\u4e0e\u529f\u80fd\u4e0a\u65e0\u5173\u7684\u9650\u5236<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u8fde\u63a5\u8bcd\u7684\u9009\u62e9\u76f4\u63a5\u51b3\u5b9a\u4e86\u8bf7\u6c42\u9879\u7684\u5f00\u653e\u6216\u5c01\u95ed\u7a0b\u5ea6\uff0c\u5176\u4e2d\u300c\u7531\u2026\u2026\u6240\u7ec4\u6210\u300d\uff08consisting of\uff09\u5177\u6709\u4e25\u683c\u7684\u5c01\u95ed\u6027\u3002\u5728 <em>Azurity Pharms. v.<a name=\"_ftnref7\"><\/a> Alkem Lab&#8217;ys<\/em> \u6848\u4e2d\uff0cAzurity \u516c\u53f8\u4e3a\u4e86\u514b\u670d\u5148\u524d\u6280\u672f Palepu<a href=\"#_ftn7\">[7]<\/a> \u6240\u63ed\u9732\u542b\u4e19\u4e8c\u9187\uff08PG\uff09\u7684\u914d\u65b9\uff0c\u5c06\u8bf7\u6c42\u9879\u7531\u300ccomprising\u300d\u6539\u4e3a\u300cconsisting of\u300d\u5e76\u660e\u786e\u58f0\u660e\u5176\u53d1\u660e\u4e0d\u542b\u4e19\u4e8c\u9187\u3002\u5c3d\u7ba1\u5728\u4fb5\u6743\u8bc9\u8bbc\u4e2d\uff0c\u88ab\u63a7\u4fb5\u6743\u4ea7\u54c1\u4ec5\u542b\u6709\u5fae\u91cf\u4e19\u4e8c\u9187\u4e14\u4f5c\u4e3a\u8c03\u5473\u5242\u7684\u4e00\u90e8\u5206\uff0c\u6cd5\u9662\u4ecd\u8ba4\u5b9a Azurity \u516c\u53f8\u5df2\u5728\u5ba1\u67e5\u5386\u53f2\u4e2d\u4f5c\u51fa\u660e\u786e\u4e14\u6beb\u65e0\u7591\u4e49\u7684\u653e\u5f03\u3002<a name=\"_ftnref8\"><\/a>\u8fd9\u79cd\u5168\u9762\u6027\u7684\u653e\u5f03\uff08Disclaimer\uff09\u4e0d\u4ec5\u9002\u7528\u4e8e\u300c\u8f7d\u4f53\u300d\uff0c\u4e5f\u5ef6\u4f38\u81f3\u300c\u8c03\u5473\u5242\u300d\uff0c\u4f7f Azurity \u516c\u53f8\u65e0\u6cd5\u5bf9\u4efb\u4f55\u542b\u6709\u4e19\u4e8c\u9187\u7684\u4ea7\u54c1\u4e3b\u5f20\u6743\u5229\u3002<a href=\"#_ftn8\">[8]<\/a><\/p>\n<p>\u53e6\u4e00\u65b9\u9762\uff0c\u5bf9\u4e8e\u8bf7\u6c42\u9879\u4e2d\u52a0\u5165\u7684\u63cf\u8ff0\u6027\u8bed\u53e5\uff0c\u6cd5\u9662\u4f1a\u8bc4\u4f30\u5176\u662f\u5426\u5177\u5907\u300c\u529f\u80fd\u6027\u5173\u7cfb\u300d\u3002\u5728 <em>Bayer Pharma v. Mylan Pharms.<\/em><a name=\"_ftnref9\"><\/a> \u6848<a href=\"#_ftn9\">[9]<\/a>\u4e2d\uff0c\u8bf7\u6c42\u9879\u52a0\u5165\u4e86\u300c\u5728\u4e34\u5e8a\u4e0a\u5df2\u88ab\u8bc1\u5b9e\u6709\u6548\u300d\uff08clinically proven effective\uff09\u7684\u9650\u5236\u3002\u6cd5\u9662\u5224\u5b9a\u8be5\u8bed\u53e5\u5c5e\u4e8e<strong>\u529f\u80fd\u4e0a\u65e0\u5173\u7684\u9650\u5236\uff08<\/strong><strong>Functionally Unrelated Limitation<\/strong><strong>\uff09<\/strong>\u3002\u5176\u7406\u7531\u4f9d\u636e\u5728\u4e8e\uff1a<a name=\"_ftnref10\"><\/a>\u65e0\u8bba\u6cbb\u7597\u65b9\u6848\u662f\u5426\u7ecf\u8fc7\u4e34\u5e8a\u8bc1\u5b9e\uff0c\u5b9e\u9645\u65bd\u7528\u836f\u7269\u7684\u8fc7\u7a0b\uff08\u5242\u91cf\u4e0e\u9891\u7387\uff09\u5b8c\u5168\u76f8\u540c\u3002<a href=\"#_ftn10\">[10]<\/a>\u4f9d\u636e <em>King Pharms.<\/em><a name=\"_ftnref11\"><\/a> \u6848<a href=\"#_ftn11\">[11]<\/a>\u7684\u539f\u5219\uff0c\u8fd9\u79cd\u9650\u5236\u65e0\u6cd5\u4f7f\u5df2\u88ab\u9884\u89c1\u7684\u6cbb\u7597\u65b9\u6cd5\u5177\u5907\u53ef\u4e13\u5229\u6027\uff0c\u56e0\u4e3a\u5b83\u5e76\u672a\u6539\u53d8\u5df2\u77e5\u7684\u7269\u7406\u6b65\u9aa4\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u5173\u4e8e\u4ea7\u54c1\u7ed3\u6784\u7684\u89e3\u91ca\u4e5f\u5fc5\u987b\u5fe0\u4e8e\u5b57\u9762\u6548\u529b\u3002\u5728 <em>Bayer<\/em> \u6848\u4e2d\uff0c\u6cd5\u9662\u63a8\u7ffb\u4e86\u4e13\u5229\u5ba1\u5224\u4e0e\u4e0a\u8bc9\u59d4\u5458\u4f1a\u5c06\u300c\u7b2c\u4e00\u4ea7\u54c1\u5305\u542b rivaroxaban \u4e0e aspirin\u300d\u89e3\u91ca\u4e3a\u6db5\u76d6\u5206\u5f00\u5242\u578b\u7684\u89c1\u89e3\u3002\u6cd5\u9662\u8ba4\u4e3a\u300c\u7b2c\u4e00\u4ea7\u54c1\u300d\u7684\u5b57\u9762\u8bed\u8a00\u8981\u6c42\u5355\u4e00\u5242\u578b\uff0c\u5c06\u5176\u89c6\u4e3a\u53ef\u5206\u5f00\u7ed9\u836f\u4f1a\u4f7f\u8be5\u9650\u5236\u8bed\u5931\u53bb\u610f\u4e49\u3002<a name=\"_ftnref12\"><\/a>\u7ed3\u5408\u8fd9\u4e24\u6848\u53ef\u4ee5\u770b\u51fa\uff0c\u6cd5\u9662\u5728\u5ba1\u7406\u4fb5\u6743\u4e0e\u6709\u6548\u6027\u65f6\uff0c\u6781\u5ea6\u91cd\u89c6\u8bed\u6cd5\u7ed3\u6784\u7684\u4e25\u8c28\u6027\uff0c\u4efb\u4f55\u8bd5\u56fe\u900f\u8fc7\u6df7\u6dc6\u6982\u5ff5\uff08\u5982 Azurity \u516c\u53f8\u7684\u6df7\u642d\u7406\u8bba<a href=\"#_ftn12\">[12]<\/a>\uff09\u6216\u52a0\u5165\u65e0\u5173\u7684\u529f\u80fd\u63cf\u8ff0\uff08\u5982 Bayer \u516c\u53f8\u7684\u4e34\u5e8a\u8bc1\u660e\uff09\u6765\u6269\u5927\u6216\u7ef4\u6301\u8303\u56f4\u7684\u505a\u6cd5\uff0c\u5728\u4e25\u683c\u7684\u6cd5\u5f8b\u68c0\u9a8c\u4e0b\u5747\u96be\u4ee5\u594f\u6548\u3002<\/p>\n<p><span style=\"color: #0000ff;\"><strong>\u5907\u6ce8\uff1a<\/strong><\/span><\/p>\n<p><a href=\"#_ftnref1\">[1]<\/a> <em>Alnylam Pharmaceuticals, Inc. v. Moderna Inc.<\/em>, No. 23-2357 (Fed. Cir. Jun. 4, 2025)<br \/>\n<a href=\"#_ftnref2\">[2]<\/a> <em>Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.<\/em>, No. 23-1977 (Fed. Cir. Apr. 8, 2025)<br \/>\n<a href=\"#_ftnref3\">[3]<\/a> <em>In Re: Xencor, Inc., <\/em>No. 24-1870 (Fed. Cir. Mar. 13, 2025)<br \/>\n<a href=\"#_ftnref4\">[4]<\/a> \u4e13\u5229\u6743\u4eba\u300c\u53ef\u4ee5\u9009\u62e9\u81ea\u5df1\u62c5\u4efb\u8bcd\u5178\u7f16\u7e82\u8005\uff08lexicographer\uff09\uff0c\u5e76\u4ee5\u4e0d\u540c\u4e8e\u5176\u901a\u5e38\u542b\u4e49\uff08ordinary meaning\uff09\u7684\u65b9\u5f0f\u4f7f\u7528\u672f\u8bed\uff0c\u53ea\u8981\u8be5\u672f\u8bed\u7684\u7279\u6b8a\u5b9a\u4e49\u5728\u4e13\u5229\u8bf4\u660e\u4e66\u6216\u6587\u4ef6\u5386\u53f2\u8bb0\u5f55\u4e2d\u660e\u786e\u8bf4\u660e\u5373\u53ef\u3002\u300d\u300c\u5185\u90e8\u8bc1\u636e\u5fc5\u987b\u300e\u660e\u786e\u9648\u8ff0\u300f\u6216\u300e\u660e\u786e\u91cd\u65b0\u5b9a\u4e49\u300f\u67d0\u4e2a\u8bf7\u6c42\u9879\u7528\u8bed\uff0c\u4ee5\u4f7f\u672c\u9886\u57df\u5408\u7406\u6280\u672f\u4eba\u5458\u80fd\u591f\u5bdf\u89c9\u4e13\u5229\u6743\u4eba\u6709\u610f\u5982\u6b64\u91cd\u65b0\u5b9a\u4e49\u8be5\u7528\u8bed\u3002\u300d<br \/>\n\u5728\u6cd5\u5b9a\u5b9a\u4e49\u7684\u8bed\u5883\u4e2d\uff0c\u4f17\u6240\u7686\u77e5\u7684\u6cd5\u5f8b\u539f\u5219\u662f\uff1a\u300c\u6cd5\u5b9a\u5b9a\u4e49\u5728\u4e00\u822c\u60c5\u51b5\u4e0b\u63a7\u5236\u6cd5\u5b9a\u7528\u8bed\u7684\u610f\u4e49\u3002\u300d\u4e13\u5229\u60c5\u5883\u4e2d\u7684\u5b9a\u4e49\u7406\u5e94\u5177\u6709\u540c\u7b49\u6548\u529b\uff0c\u539f\u56e0\u4e0d\u8a00\u800c\u55bb\uff1a\u516c\u5f00\u901a\u77e5\u662f\u4e00\u9879\u6838\u5fc3\u653f\u7b56\uff0c\u516c\u4f17\u4fe1\u8d56\u662f\u4f17\u6240\u5468\u77e5\u7684\u73b0\u5b9e\uff0c\u7cbe\u786e\u6027\u81f3\u5173\u91cd\u8981\uff0c\u800c\u4e14\u7533\u8bf7\u4eba\u5bf9\u5b9a\u4e49\u7684\u63d0\u4f9b\u62e5\u6709\u5145\u5206\u7684\u63a7\u5236\u6743\uff0c\u56e0\u6b64\uff0c\u5f53\u660e\u786e\u9648\u8ff0\u4e00\u4e2a\u5b9a\u4e49\u65f6\uff0c\u516c\u4f17\u901a\u5e38\u6709\u6743\u671f\u671b\u83b7\u5f97\u5173\u4e8e\u4f8b\u5916\u60c5\u51b5\u7684\u660e\u786e\u901a\u77e5\u3002<br \/>\n<a href=\"#_ftnref5\">[5]<\/a> <em>Eye Therapies, LLC. v. Slayback Pharma, LLC.,<\/em> No. 23-2173 (Fed. Cir. Jun. 30, 2025)<br \/>\n<a href=\"#_ftnref6\">[6]<\/a> \u7f8e\u56fd\u4e13\u5229\u7b2c 6,242,442 \u53f7<br \/>\n<a href=\"#_ftnref7\">[7]<\/a> \u7f8e\u56fd\u4e13\u5229\u7533\u8bf7\u516c\u5f00\u53f72016\/0101147<br \/>\n<a href=\"#_ftnref8\">[8]<\/a> <a href=\"https:\/\/naipnews.naipo.com\/38381\/\" target=\"_blank\" rel=\"noopener\">\u3010\u5317\u7f8e\u667a\u6743\u62a5 396\u671f\u3011\u4ece Azurity v. Alkem (Fed. Cir. 2025) \u6848\u770b \u300cconsisting of \u300d\u7684\u4e13\u5229\u8303\u56f4\u89e3\u91ca<\/a><br \/>\n<a href=\"#_ftnref9\">[9]<\/a> <em>Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc.,<\/em> No. 23-2434 (Fed. Cir. Sep. 23, 2025)<br \/>\n<a href=\"#_ftnref10\">[10]<\/a> \u300c\u65e0\u8bba\u5df2\u88ab\u9884\u89c1\u7684\u6cbb\u7597\u65b9\u6848\u662f\u5426\u88ab\u8bc1\u5b9e\u5728\u4e34\u5e8a\u6709\u6548\uff0c\u5b9e\u9645\u7684\u65b9\u6cd5\u4ecd\u7136\u662f\u76f8\u540c\u7684\u3002\u300d\u7531\u4e8e \u2019310 \u4e13\u5229\u7684\u8bf7\u6c42\u9879\u5df2\u660e\u786e\u89c4\u5b9a\u987b\u7ed9\u4e88\u75c5\u4eba\u670d\u7528\u7684 rivaroxaban \u4e0e aspirin \u7684\u786e\u5207\u5242\u91cf\uff0c\u56e0\u6b64\u989d\u5916\u52a0\u5165\u300c\u5728\u4e34\u5e8a\u4e0a\u5df2\u88ab\u8bc1\u5b9e\u6709\u6548\u300d\u7684\u9650\u5236\uff0c\u5e76\u4e0d\u8fdb\u4e00\u6b65\u754c\u5b9a\u6240\u65bd\u7528\u7684\u5242\u91cf\u3002\u300c\u5728\u4e34\u5e8a\u4e0a\u5df2\u88ab\u8bc1\u5b9e\u6709\u6548\u300d\u2014\u2014\u5373\u4f7f\u5177\u6709\u9650\u5236\u6027\u2014\u2014\u4e5f\u65e0\u6cd5\u8d4b\u4e88\u6240\u4e89\u8bae\u7684\u8bf7\u6c42\u9879\u4e13\u5229\u6027\uff0c\u56e0\u4e3a\u5b83\u662f\u4e00\u9879\u5728\u529f\u80fd\u4e0a\u65e0\u5173\u7684\u9650\u5236\u6761\u4ef6\u3002<br \/>\n<a href=\"#_ftnref11\">[11]<\/a> <em>King Pharmaceuticals, Inc. v. Eon Labs, Inc.<\/em>, 616 F.3d 1267 (Fed. Cir. 2010)\u3002\u6cd5\u9662\u88c1\u5b9a\uff1a\u4e00\u9879\u5df2\u88ab\u9884\u89c1\u7684\u6cbb\u7597\u65b9\u6cd5\uff0c\u4ec5\u4ec5\u56e0\u4e3a\u52a0\u5165\u4e86\u300c\u544a\u77e5\u75c5\u4eba\u300d\u8be5\u65b9\u6cd5\u7684\u76ca\u5904\u8fd9\u4e00\u9650\u5236\uff0c\u5e76\u4e0d\u8db3\u4ee5\u4f7f\u5176\u6210\u4e3a\u53ef\u4e13\u5229\u7684\u53d1\u660e\u3002\u300c\u76f8\u5173\u7684\u5ba1\u67e5\u91cd\u70b9\u5728\u4e8e\uff0c\u8be5\u989d\u5916\u7684\u6307\u5bfc\u6027\u9650\u5236\u662f\u5426\u4e0e\u5df2\u77e5\u7684\u6cbb\u7597\u65b9\u6cd5\u5177\u6709\u300e\u65b0\u9896\u4e14\u975e\u663e\u800c\u6613\u89c1\u7684\u529f\u80fd\u6027\u5173\u7cfb\u300f\u3002\u300d\u6b64\u9879\u5ba1\u67e5\u80cc\u540e\u7684\u539f\u5219\u662f\u300c\u9632\u6b62\u900f\u8fc7\u52a0\u5165\u65b0\u9896\u4f46\u5728\u529f\u80fd\u4e0a\u65e0\u5173\u7684\u9650\u5236\u6761\u4ef6\uff0c\u5bf9\u5df2\u77e5\u4ea7\u54c1\u4e0e\u65b9\u6cd5\u8fdb\u884c\u65e0\u9650\u671f\u7684\u4e13\u5229\u4fdd\u62a4\u3002\u300d<br \/>\n<a href=\"#_ftnref12\">[12]<\/a> \u867d\u7136Alkem \u516c\u53f8\u7684 ANDA \u5c06\u5305\u542b\u6bcf\u6beb\u5347\u989d\u59161\u6beb\u514b\u7684\u4e19\u4e8c\u9187\u63cf\u8ff0\u4e3a\u300c\u7528\u4e8e\u6eb6\u89e3\u9632\u8150\u5242\u7684\u52a9\u6eb6\u5242\u300d\uff0c\u4f46 Azurity \u516c\u53f8\u4e3b\u5f20\u4e19\u4e8c\u9187\u4e0e\u8461\u8404\u9999\u6599\u5171\u540c\u6784\u6210\u4e00\u79cd\u8c03\u5473\u5242\uff0c\u5e76\u89e3\u91ca\u8bf4\u300c\u52a9\u6eb6\u5242\u300d\u4e19\u4e8c\u9187\u4f1a\u4ee5\u4e0b\u5217\u65b9\u5f0f\u5bf9\u836f\u7269\u7684\u98ce\u5473\u4ea7\u751f\u4f5c\u7528\uff1a\u5b83\u6709\u52a9\u4e8e\u4fdd\u6301\u8461\u8404\u9999\u6599\u5316\u5b66\u7269\u8d28\u7684\u6eb6\u89e3\uff1b\u5b83\u4f1a\u63d0\u9ad8\u836f\u7269\u98ce\u5473\u7684\u4e00\u81f4\u6027\uff1b\u5e76\u4e14\u5b83\u80fd\u300c\u63a9\u76d6\u4ee4\u4eba\u4e0d\u5feb\u7684\u5473\u9053\u300d\u3002<\/p>\n<p><strong>\u8d23\u4efb\u7f16\u8f91\uff1a\u674e\u6dd1\u83b2<\/strong><br \/>\n<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=\"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>\u6797\u675c<\/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\">\u53f0\u6e7e<span style=\"font-family: inherit; font-size: inherit;\">\u6c38\u4fe1\u836f\u54c1\u5de5\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\/\u4ea7\u54c1\u6cd5\u89c4\u5904\u4e13\u5458<\/span><\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u5b66\u5386\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\">\u53f0\u6e7e<span style=\"font-family: inherit; font-size: inherit; background-color: initial;\">\u9759\u5b9c\u5927\u5b66\u5e94\u7528\u5316\u5b66\u7cfb<\/span><\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\"><strong>\u4e13\u957f\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\">\u533b\u836f\u4e13\u5229\u3001\u4e13\u5229\u6cd5\u89c4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>\u6797\u675c \/ \u6c38\u4fe1\u836f\u54c1\u6cd5\u89c4\u5904\u4e13\u5458 \u7b14\u8005\u957f\u671f\u5173\u6ce8\u8054\u90a6\u5de1\u56de\u4e0a\u8bc9\u6cd5\u9662\uff08CAFC\uff09\u5728\u4e13\u5229\u8303\u56f4\u89e3\u91ca\u4e0e\u6709\u6548\u6027\u5224\u65ad\u4e0a\u7684\u6700\u65b0\u53d1\u5c55\u3002 [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":2323,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,254,285,277,256],"tags":[],"author_name1":[2671],"class_list":{"0":"post-40813","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-283","8":"category-254","9":"category-285","10":"category-277","11":"category-256","12":"author_name1-2671"},"_links":{"self":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/40813","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=40813"}],"version-history":[{"count":5,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/40813\/revisions"}],"predecessor-version":[{"id":41024,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/posts\/40813\/revisions\/41024"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media\/2323"}],"wp:attachment":[{"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=40813"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=40813"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=40813"},{"taxonomy":"author_name1","embeddable":true,"href":"https:\/\/naipnews.naipo.com\/zh-hans\/wp-json\/wp\/v2\/author_name1?post=40813"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}