{"id":71507,"date":"2023-06-21T14:07:27","date_gmt":"2023-06-21T06:07:27","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=71507"},"modified":"2026-09-10T14:31:32","modified_gmt":"2026-09-10T06:31:32","slug":"%e6%8a%97%e4%bd%93%e4%b8%93%e5%88%a9%e8%af%b4%e6%98%8e%e4%b9%a6%e4%b8%8d%e7%ac%a6%e5%90%88%e5%8f%af%e6%8d%ae%e4%bb%a5%e5%ae%9e%e6%96%bd%e8%a6%81%e4%bb%b6%ef%bc%9f%e6%9c%80%e9%ab%98%e6%b3%95%e9%99%a220","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/71507\/","title":{"rendered":"\u6297\u4f53\u4e13\u5229\u8bf4\u660e\u4e66\u4e0d\u7b26\u5408\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\uff1f\u6700\u9ad8\u6cd5\u96622023\u5e74Amgen Inc. v. Sanofi\u6848"},"content":{"rendered":"
\"\"
\u56fe\u7247\u6765\u6e90 : shutterstock\u3001\u8fbe\u5fd7\u5f71\u50cf<\/figcaption><\/figure>\n

\u5317\u7f8e\u667a\u6743\u62a5\u5148\u524d\u66fe\u9488\u5bf9\u6297\u4f53\u4e13\u5229\u7684\u5145\u5206\u63ed\u9732\u8981\u4ef6\u8fdb\u884c\u76f8\u5173\u62a5\u5bfc[1]<\/a>\uff0c\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u4e8e2023\u5e745\u670818\u65e5\u505a\u51faAmgen v. Sanofi\u6848\u5224\u51b3\uff0c\u8be5\u6848\u6d89\u53ca\u751f\u533b\u6297\u4f53\u4e13\u5229\u8bf4\u660e\u4e66\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\u7684\u8981\u6c42\u3002\u539f\u544aAmgen\u6240\u8bf7\u6c42\u7684\u6297\u4f53\u4e13\u5229\uff0c\u4e43\u4ee5\u4e8c\u79cd\u529f\u80fd\u754c\u5b9a\uff0c\u5728\u8bf4\u660e\u4e66\u4e2d\u63d0\u4f9b\u4e8626\u4e2a\u5b9e\u65bd\u4f8b\uff0c\u4ee5\u53ca\u4e8c\u79cd\u627e\u51fa\u5176\u4ed6\u6297\u4f53\u7684\u8bd5\u9a8c\u65b9\u6cd5\u3002\u88ab\u544aSanofi\u4e3b\u5f20\uff0c\u5177\u6709\u8fd9\u4e8c\u79cd\u529f\u80fd\u7684\u6297\u4f53\u53ef\u80fd\u8fbe\u6570\u767e\u4e07\u79cd\uff0c\u4f46\u8bf4\u660e\u4e66\u53ea\u63d0\u4f9b26\u4e2a\u5b9e\u65bd\u4f8b\u548c\u4e8c\u79cd\u5b9e\u9a8c\u65b9\u6cd5\uff0c\u4e0d\u7b26\u5408\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\u3002\u6700\u9ad8\u6cd5\u9662\u6700\u540e\u652f\u6301\u88ab\u544a\u4e3b\u5f20\uff0c\u8ba4\u4e3a\u8bf4\u660e\u4e66\u4e0d\u7b26\u5408\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\uff0c\u6545\u4e13\u5229\u65e0\u6548\u3002<\/p><\/blockquote>\n

\u7ed3\u5408PCSK9\u7279\u5b9a\u533a\u57df\u4e4b\u6297\u4f53<\/span><\/p>\n

\u672c\u6848\u6d89\u53ca\u6709\u52a9\u4e8e\u964d\u4f4e\u4f4e\u5bc6\u5ea6\u8102\u86cb\u767d\u80c6\u56fa\u9187\uff08low-density lipoprotein cholesterol\uff09\u6c34\u5e73\u7684\u6297\u4f53\u3002\u4f4e\u5bc6\u5ea6\u8102\u86cb\u767d\u80c6\u56fa\u9187\u6709\u65f6\u88ab\u79f0\u4e3aLDL\u80c6\u56fa\u9187\u6216\u574f\u80c6\u56fa\u9187\uff08\u56e0\u4e3a\u5b83\u4f1a\u5bfc\u81f4\u5fc3\u8840\u7ba1\u75be\u75c5\u3001\u5fc3\u810f\u75c5\u548c\u4e2d\u98ce\uff09[2]<\/a>\u3002<\/p>\n

\u4eba\u4f53\u4f1a\u4ea7\u751fLDL\u53d7\u4f53\uff08receptors\uff09\uff0c\u800c\u6267\u884c\u4ece\u8840\u6db2\u4e2d\u79fb\u9664LDL\u80c6\u56fa\u9187\u7684\u529f\u80fd\u3002\u800cPCSK9\u662f\u4e00\u79cd\u5929\u7136\u5b58\u5728\u7684\u86cb\u767d\u8d28\uff0c\u53ef\u7ed3\u5408\u5e76\u964d\u89e3LDL\u53d7\u4f53\u3002\u79d1\u5b66\u5bb6\u7814\u7a76\u4f55\u4f7f\u7528\u6297\u4f53\u6765\u6291\u5236PCSK9\u7ed3\u5408\u548c\u964d\u89e3LDL\u53d7\u4f53\uff0c\u4ee5\u6b64\u4f5c\u4e3a\u6cbb\u7597\u9ad8LDL\u80c6\u56fa\u9187\u60a3\u8005\u7684\u4e00\u79cd\u65b9\u6cd5[3]<\/a>\u3002<\/p>\n

2000\u5e74\u4ee3\u4e2d\u671f\uff0c\u8bb8\u591a\u5236\u836f\u516c\u53f8\u5f00\u59cb\u7814\u7a76\u5236\u9020\u9488\u5bf9PCSK9\u7684\u6297\u4f53\u7684\u53ef\u80fd\u6027\u3002\u4ed6\u4eec\u8bd5\u56fe\u521b\u9020\u53ef\u4ee5\u7ed3\u5408PCSK9\u7279\u5b9a\u533a\u57df\uff08\u79f0\u4e3a\u300c\u6700\u4f73\u70b9\u300d\uff09\u7684\u6297\u4f53\u3002\u6700\u4f73\u70b9\u662fPCSK9\u7684692\u4e2a\u603b\u6c28\u57fa\u9178\u4e2d\u768415\u4e2a\u6c28\u57fa\u9178\u5e8f\u5217\u3002\u79d1\u5b66\u5bb6\u53d1\u73b0\uff0c\u900f\u8fc7\u7ed3\u5408\u6700\u4f73\u70b9\uff0c\u6297\u4f53\u53ef\u4ee5\u9632\u6b62PCSK9\u7ed3\u5408\u5e76\u964d\u89e3LDL\u53d7\u4f53[4]<\/a>\u3002<\/p>\n

Amgen\u5bf9PCSK9\u6291\u5236\u6297\u4f53\u7684\u4e13\u5229<\/span><\/p>\n

\u6700\u7ec8\uff0c\u539f\u544aAmgen\u5f00\u53d1\u4e86\u4e00\u79cdPCSK9\u6291\u5236\u836f\u7269\uff0c\u5e76\u4ee5Repatha\u4e3a\u540d\u4e0a\u5e02\u9500\u552e\u3002\u88ab\u544aSanofi\u4e5f\u751f\u4ea7\u4e86\u4e00\u79cd\u5b83\u547d\u540d\u4e3aPraluent\u7684\u836f\u7269\u3002\u6bcf\u79cd\u836f\u7269\u90fd\u4f7f\u7528\u5177\u6709\u5176\u72ec\u7279\u6c28\u57fa\u9178\u5e8f\u5217\u7684\u4e0d\u540c\u6297\u4f53[5]<\/a>\u3002<\/p>\n

2011\u5e74\uff0cAmgen\u83b7\u5f97\u4e86Repatha\u4e2d\u4f7f\u7528\u7684\u6297\u4f53\u4e13\u5229\uff0cSanofi\u83b7\u5f97\u4e86\u4e00\u9879\u6db5\u76d6 Praluent\u4e2d\u4f7f\u7528\u7684\u6297\u4f53\u7684\u4e13\u5229\u3002\u6bcf\u9879\u4e13\u5229\u90fd\u900f\u8fc7\u5176\u6c28\u57fa\u9178\u5e8f\u5217\u63cf\u8ff0\u4e86\u76f8\u5173\u6297\u4f53\u3002\u5728\u672c\u6848\u4e2d\uff0c\u8fd9\u4e24\u9879\u4e13\u5229\u5747\u4e0d\u5b58\u5728\u4e89\u8bae[6]<\/a>\u3002<\/p>\n

\u672c\u6848\u7684\u4e89\u8bae\uff0c\u96c6\u4e2d\u5728Amgen\u57282014\u5e74\u83b7\u5f97\u7684\u53e6\u5916\u4e24\u9879\u4e13\u5229\uff0c\u8fd9\u4e24\u9879\u4e13\u5229\u4e0e\u8be5\u516c\u53f82011\u5e74\u7684\u4e13\u5229\u6709\u5173\u3002\u5176\u5206\u522b\u662f\u7f8e\u56fd\u4e13\u5229\u53f7 8,829,165\uff082014\u5e749\u67089\u65e5\uff09\u3001\u7f8e\u56fd\u4e13\u5229\u53f7 8,859,741\uff082014\u5e7410\u670814\u65e5\uff09\uff0c\u7b80\u79f0\u4e3a\u2019165 \u548c\u2019741 \u4e13\u5229\u3002\u672c\u6848\u6d89\u53ca’165\u4e13\u5229\u7684\u8bf7\u6c42\u987919\u548c29\uff0c\u4ee5\u53ca’741\u4e13\u5229\u7684\u8bf7\u6c42\u98797\u3002<\/p>\n

\u8bf4\u660e\u4e66\u63d0\u4f9b26\u4e2a\u5b9e\u65bd\u4f8b\u4e0e\u5b9e\u9a8c\u65b9\u6cd5<\/span><\/p>\n

\u5728\u8fd9\u4e9b\u8bf7\u6c42\u9879\u4e2d\uff0cAmgen\u5e76\u672a\u4e3b\u5f20\u5bf9\u6c28\u57fa\u9178\u5e8f\u5217\u63cf\u8ff0\u7684\u4efb\u4f55\u7279\u5b9a\u6297\u4f53\u7684\u4fdd\u62a4\u3002\u53cd\u4e4b\uff0cAmgen\u58f0\u79f0\u4e3b\u5f20\u81ea\u5df1\u62e5\u6709\u6297\u4f53\u7684\u300c\u6574\u4e2a\u5c5e\u300d\uff0c\u53ea\u8981\u8fd9\u4e9b\u6297\u4f53\u5177\u6709\u4e0b\u8ff0\u4e8c\u529f\u80fd\uff1a(1)\u300c\u4e0e PCSK9\u4e0a\u7684\u7279\u5b9a\u6c28\u57fa\u9178\u6b8b\u57fa\u7ed3\u5408\u300d\uff1b\u4ee5\u53ca(2)\u300c\u963b\u65adPCSK9\u4e0eLDL\u53d7\u4f53\u7ed3\u5408\u300d[7]<\/a>\u3002<\/p>\n

\u5728\u63d0\u4ea4\u7ed9\u7f8e\u56fd\u4e13\u5229\u5c40\u7684\u8bf4\u660e\u4e66\u4e2d\uff0cAmgen\u660e\u786e\u8bc6\u522b\u6267\u884c\u8fd9\u4e24\u79cd\u529f\u80fd\u768426\u79cd\u6297\u4f53\u7684\u6c28\u57fa\u9178\u5e8f\u5217\uff0c\u5e76\u63cf\u8ff0\u4e86\u8fd926\u79cd\u6297\u4f53\u4e2d\u4e24\u79cd\u6297\u4f53\u7684\u4e09\u7ef4\u7ed3\u6784\u3002\u4f46\u9664\u6b64\u4e4b\u5916\uff0cAmgen\u4ec5\u5411\u79d1\u5b66\u5bb6\u63d0\u4f9b\u4e86\u4e24\u79cd\u65b9\u6cd5\u6765\u5236\u9020\u5176\u4ed6\u6297\u4f53\uff0c\u8fd9\u4e9b\u6297\u4f53\u53ef\u6267\u884c\u5176\u63cf\u8ff0\u7684\u7ed3\u5408\u548c\u963b\u65ad\u529f\u80fd\u3002<\/p>\n

\u7b2c\u4e00\u79cd\u65b9\u6cd5\u662fAmgen\u6240\u8bf4\u7684\u300c\u8def\u7ebf\u56fe\u300d\u3002\u8def\u7ebf\u56fe\u6307\u5bfc\u79d1\u5b66\u5bb6\uff1a(1)\u5728\u5b9e\u9a8c\u5ba4\u4e2d\u4ea7\u751f\u4e00\u7cfb\u5217\u6297\u4f53\uff1b(2)\u6d4b\u8bd5\u8fd9\u4e9b\u6297\u4f53\u4ee5\u786e\u5b9a\u662f\u5426\u6709\u4efb\u4f55\u6297\u4f53\u4e0ePCSK9\u7ed3\u5408\uff1b(3)\u6d4b\u8bd5\u90a3\u4e9b\u4e0ePCSK9\u7ed3\u5408\u7684\u6297\u4f53\uff0c\u4ee5\u786e\u5b9a\u662f\u5426\u6709\u7ed3\u5408\u8bf7\u6c42\u9879\u4e2d\u6240\u8ff0\u7684\u6700\u4f73\u7ed3\u5408\u70b9\uff1b(4)\u6d4b\u8bd5\u90a3\u4e9b\u4e0e\u8bf7\u6c42\u9879\u4e2d\u63cf\u8ff0\u7684\u6700\u4f73\u70b9\u7ed3\u5408\u7684\u6297\u4f53\uff0c\u4ee5\u786e\u5b9a\u662f\u5426\u6709\u4efb\u4f55\u6297\u4f53\u963b\u65adPCSK9\u4e0eLDL\u53d7\u4f53\u7684\u7ed3\u5408\u3002<\/p>\n

\u7b2c\u4e8c\u79cd\u65b9\u6cd5\u662f Amgen \u6240\u8bf4\u7684\u300c\u4fdd\u5b88\u66ff\u4ee3\u300d\u3002\u8fd9\u9879\u6280\u672f\u8981\u6c42\u79d1\u5b66\u5bb6\uff1a(1)\u4ece\u5df2\u77e5\u6267\u884c\u6240\u8ff0\u529f\u80fd\u7684\u6297\u4f53\u5f00\u59cb\uff1b(2)\u7528\u5df2\u77e5\u5177\u6709\u76f8\u4f3c\u7279\u6027\u7684\u5176\u4ed6\u6c28\u57fa\u9178\u66ff\u6362\u6297\u4f53\u4e2d\u9009\u5b9a\u7684\u6c28\u57fa\u9178\uff1b(3)\u6d4b\u8bd5\u4ea7\u751f\u7684\u6297\u4f53\uff0c\u770b\u5b83\u662f\u5426\u4e5f\u6267\u884c\u6240\u63cf\u8ff0\u7684\u529f\u80fd[8]<\/a>\u3002<\/p>\n

\u63a7\u544aSanofi\u4fb5\u6743\uff0cSanofi\u4e3b\u5f20\u4e0d\u7b26\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6<\/span><\/p>\n

\u5728\u83b7\u5f97\u8fd9\u4e8c\u9879\u4e13\u5229\u4e0d\u4e45\u540e\uff0cAmgen\u516c\u53f8\u8d77\u8bc9\u88ab\u544aSanofi\u4fb5\u6743[9]<\/a>\u3002<\/p>\n

Sanofi\u63d0\u51fa\u6297\u8fa9\uff0c\u4e3b\u5f20\u7cfb\u4e89\u4e13\u5229\u4e0d\u7b26\u5408\u4e13\u5229\u6cd5\u7b2c112\u6761\u4e4b\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\uff0c\u7cfb\u4e89\u4e13\u5229\u65e0\u6548\u3002<\/p>\n

\u7f8e\u56fd\u4e13\u5229\u6cd5\u7b2c112\u6761(a)\u89c4\u5b9a\uff1a\u300c\u8bf4\u660e\u4e66\u5e94\u5bf9\u53d1\u660e\u3001\u521b\u4f5c\u4e0e\u4f7f\u7528\u8be5\u53d1\u660e\u7684\u65b9\u5f0f\u548c\u5de5\u827a\u8fc7\u7a0b\uff0c\u4ee5\u5b8c\u6574\u3001\u6e05\u6670\u3001\u7b80\u6d01\u800c\u7cbe\u786e\u7684\u8bcd\u53e5\u8fdb\u884c\u4e66\u9762\u63cf\u8ff0\uff0c\u4f7f\u4efb\u4f55\u719f\u6089\u8be5\u53d1\u660e\u6240\u5c5e\u6280\u672f\u9886\u57df\u6216\u4e0e\u8be5\u53d1\u660e\u6700\u5bc6\u5207\u76f8\u5173\u7684\u6280\u672f\u9886\u57df\u7684\u4eba\uff0c\u90fd\u80fd\u5236\u9020\u53ca\u4f7f\u7528\u8be5\u53d1\u660e\u3002\u8bf4\u660e\u4e66\u8fd8\u5e94\u8be5\u63d0\u51fa\u53d1\u660e\u4eba\u6216\u5171\u540c\u53d1\u660e\u4eba\u6240\u601d\u53ca\u7684\u5b9e\u65bd\u53d1\u660e\u7684\u6700\u4f73\u5b9e\u65bd\u4f8b\u3002[10]<\/a>\u300d<\/p>\n

Sanofi\u8fa9\u79f0\uff0c\u867d\u7136\u5176\u8bf4\u660e\u4e66\u4e2d\u63ed\u9732\u4e8626\u79cd\u6b64\u79cd\u6297\u4f53\u7684\u6c28\u57fa\u9178\u5e8f\u5217\uff0c\u56e0\u4e3a\u5176\u4e13\u5229\u8bf7\u6c42\u9879\u6db5\u76d6\u7684\u8303\u56f4\uff0c\u53ef\u80fd\u9ad8\u8fbe\u6570\u767e\u4e07\u79cd\u6297\u4f53\u3002\u800c\u4e14\uff0cAmgen\u6240\u6307\u51fa\u7684\u4e8c\u79cd\u627e\u51fa\u5176\u4ed6\u6297\u4f53\u7684\u65b9\u6cd5\uff0c\u5e76\u65e0\u6cd5\u8ba9\u6240\u5c5e\u6280\u672f\u9886\u57df\u4e2d\u5177\u6709\u901a\u5e38\u77e5\u8bc6\u8005\u771f\u7684\u627e\u51fa\u6240\u6709\u5177\u6709\u6b64\u4e8c\u529f\u80fd\u7684\u6297\u4f53\u3002\u53cd\u4e4b\uff0c\u8fd9\u4e9b\u65b9\u6cd5\u9700\u8981\u79d1\u5b66\u5bb6\u53c2\u4e0e\u4e00\u4e2a\u53cd\u590d\u8bd5\u9519\u8bd5\u9a8c\uff08trial-and-error\uff09\u7684\u53d1\u73b0\u8fc7\u7a0b[11]<\/a>\u3002<\/p>\n

\u6700\u9ad8\u6cd5\u9662\u5224\u51b3\u652f\u6301\u4e00\u5ba1\u3001\u4e8c\u5ba1\u5224\u51b3<\/span><\/p>\n

\u5730\u65b9\u6cd5\u9662\u548c\u8054\u90a6\u5de1\u56de\u4e0a\u8bc9\u6cd5\u9662\u5224\u51b3\u90fd\u652f\u6301Sanofi\u3002\u4e0a\u8bc9\u6cd5\u9662\u6307\u51fa\uff0c\u6ca1\u6709\u5408\u7406\u7684\u4e8b\u5b9e\u8c03\u67e5\u8005\u53ef\u4ee5\u5f97\u51fa\u7ed3\u8bba\uff0cAmgen\u9664\u4e86\u5728\u5176\u6839\u636e\u5176\u6c28\u57fa\u9178\u5e8f\u5217\u786e\u8ba4\u768426\u4e2a\u6297\u4f53\u5b9e\u65bd\u4f8b\u7684\u72ed\u7a84\u8303\u56f4\u4e4b\u5916\uff0c\u5df2\u7ecf\u63d0\u4f9b\u4e86\u5236\u9020\u548c\u4f7f\u7528\u6240\u8bf7\u6c42\u4fdd\u62a4\u4e4b\u6297\u4f53\u7684\u300c\u9002\u5f53\u6307\u5bfc\u300d\uff08adequate guidance\uff09[12]<\/a>\u3002<\/p>\n

\u6b64\u6848\u4e0a\u8bc9\u5230\u6700\u9ad8\u6cd5\u9662\uff0c\u6700\u9ad8\u6cd5\u9662\u4e8e2023\u5e745\u670818\u65e5\uff0c\u5168\u4f53\u4e00\u81f4\u540c\u610f\u505a\u51fa\u5224\u51b3\uff0c\u7ef4\u6301\u4e0a\u8bc9\u6cd5\u9662\u5224\u51b3\uff0c\u8ba4\u4e3a\u7cfb\u4e89\u4e13\u5229\u8bf4\u660e\u4e66\u4e0d\u7b26\u5408\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\uff0c\u6545\u7cfb\u4e89\u4e13\u5229\u8bf7\u6c42\u9879\u65e0\u6548\u3002<\/p>\n

\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\u4e0e\u5408\u7406\u6570\u91cf\u7684\u8bd5\u9a8c<\/span><\/p>\n

\u6700\u9ad8\u6cd5\u9662\u8fc7\u53bb\u591a\u6b21\u5f3a\u8c03\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\uff08enablement\uff09\u4e4b\u8981\u6c42\u3002\u5176\u5f3a\u8c03\uff0c\u5982\u679c\u4e00\u9879\u4e13\u5229\u8bf7\u6c42\u4fdd\u62a4\u65b9\u6cd5\u3001\u673a\u5668\u3001\u5236\u9020\u6216\u7269\u8d28\u6210\u5206\u7684\u6574\u4e2a\u7c7b\u522b\uff08entire class\uff09\uff0c\u5219\u8be5\u4e13\u5229\u7684\u8bf4\u660e\u4e66\u5fc5\u987b\u4f7f\u672c\u9886\u57df\u6280\u672f\u4eba\u5458\u80fd\u591f\u5236\u9020\u548c\u4f7f\u7528\u6574\u4e2a\u7c7b\u522b[13]<\/a>\u3002<\/p>\n

\u4e0d\u8fc7\uff0c\u8fc7\u53bb\u7684\u5224\u51b3\u5e76\u4e0d\u603b\u662f\u8981\u6c42\u8bf4\u660e\u4e66\u5fc5\u987b\u8be6\u7ec6\u63cf\u8ff0\u5982\u4f55\u5236\u4f5c\u548c\u4f7f\u7528\u6240\u8bf7\u6c42\u7c7b\u522b\u4e2d\u7684\u6bcf\u4e2a\u5355\u72ec\u7684\u5b9e\u65bd\u4f8b\u3002\u5982\u679c\u8bf4\u660e\u8fd8\u516c\u5f00\u4e86\u300c\u4e00\u4e9b\u901a\u7528\u8d28\u91cf\u2026\u2026\u8d2f\u7a7f\u300d\u6574\u4e2a\u7c7b\u522b\uff0c\u8d4b\u4e88\u5176\u300c\u5bf9\u7279\u5b9a\u76ee\u7684\u7684\u7279\u6b8a\u9002\u7528\u6027\u300d\uff0c\u90a3\u4e48\u63d0\u51fa\u4e00\u4e2a\u5b9e\u65bd\u4f8b\u5c31\u8db3\u591f[14]<\/a>\u3002\u8bf4\u660e\u4e66\u8ba9\u6240\u5c5e\u6280\u672f\u9886\u57df\u4e2d\u5177\u6709\u901a\u5e38\u77e5\u8bc6\u8005\u4ece\u4e8b\u67d0\u79cd\u7a0b\u5ea6\u7684\u6539\u7f16\u6216\u6d4b\u8bd5\uff0c\u4e5f\u672a\u5fc5\u4f1a\u5bfc\u81f4\u8bf4\u660e\u4e66\u4e0d\u5145\u5206[15]<\/a>\u3002\u8bf4\u660e\u4e66\u53ef\u80fd\u8981\u6c42\u8fdb\u884c\u5408\u7406\u6570\u91cf\u7684\u5b9e\u9a8c\uff0c\u6765\u5236\u9020\u548c\u4f7f\u7528\u6240\u8bf7\u6c42\u4fdd\u62a4\u53d1\u660e\uff0c\u81f3\u4e8e\u662f\u5426\u5408\u7406\uff0c\u53d6\u51b3\u4e8e\u53d1\u660e\u7684\u6027\u8d28\u548c\u57fa\u7840\u6280\u672f[16]<\/a>\u3002<\/p>\n

Amgen\u5728\u8bf4\u660e\u4e66\u4e2d\u63d0\u4f9b\u7684\u4e8c\u79cd\u7814\u7a76\u65b9\u6cd5\u9700\u8981\u8fc7\u5ea6\u5b9e\u9a8c<\/span><\/p>\n

\u56de\u5230\u672c\u6848\u4e2d\u7684\u7cfb\u4e89\u4e13\u5229\u8bf7\u6c42\u9879\u3002Amgen\u7684\u8bf7\u6c42\u9879\u8303\u56f4\u6bd4\u5b83\u6839\u636e\u6c28\u57fa\u9178\u5e8f\u5217\u786e\u5b9a\u768426\u79cd\u5b9e\u65bd\u4f8b\u7684\u6297\u4f53\u8981\u5e7f\u6cdb\u5f97\u591a\u3002Amgen\u672a\u80fd\u8ba9\u5176\u6240\u8bf7\u6c42\u7684\u8303\u56f4\u90fd\u80fd\u88ab\u636e\u4ee5\u5b9e\u65bd\uff0c\u5373\u4fbf\u5141\u8bb8\u8fdb\u884c\u5408\u7406\u7a0b\u5ea6\u7684\u5b9e\u9a8c\u3002\u867d\u7136Amgen\u8bd5\u56fe\u5784\u65ad\u4e00\u6574\u7c7b\u7531\u5176\u529f\u80fd\u5b9a\u4e49\u7684\u4e1c\u897f\u2014\u2014\u6bcf\u4e00\u79cd\u6297\u4f53\u90fd\u7ed3\u5408\u5230PCSK9\u6700\u4f73\u70b9\u7684\u7279\u5b9a\u533a\u57df\u5e76\u963b\u6b62PCSK9\u4e0eLDL\u53d7\u4f53\u7ed3\u5408\uff0c\u4f46\u8bb0\u5f55\u663e\u793a\uff0c\u8fd9\u7c7b\u6297\u4f53\u4e0d\u4ec5\u4ec5\u5305\u62ecAmgen\u5df2\u900f\u8fc7\u5176\u6c28\u57fa\u9178\u5e8f\u5217\u63cf\u8ff0\u768426\u79cd\u6297\u4f53\uff0c\u8fd8\u542b\u5305\u62ec\u6ca1\u6709\u63cf\u8ff0\u7684\u5927\u91cf\u5176\u4ed6\u6297\u4f53[17]<\/a>\u3002<\/p>\n

Amgen\u575a\u79f0\u5176\u8bf7\u6c42\u9879\u4ecd\u7136\u6709\u6548\uff0c\u56e0\u4e3a\u79d1\u5b66\u5bb6\u53ea\u8981\u9075\u5faa\u300c\u8def\u7ebf\u56fe\u300d\u6216\u300c\u4fdd\u5b88\u66ff\u4ee3\u300d\u65b9\u6cd5\uff0c\u5c31\u53ef\u4ee5\u5236\u9020\u548c\u4f7f\u7528\u6bcf\u79cd\u529f\u80fd\u6027\u6297\u4f53\u3002\u7136\u800c\uff0c\u8fd9\u4e24\u79cd\u65b9\u6cd5\u53ea\u4e0d\u8fc7\u662f\u4e24\u9879\u7814\u7a76\u4efb\u52a1\u3002\u300c\u8def\u7ebf\u56fe\u300d\u65b9\u6cd5\u4ec5\u63cf\u8ff0\u4e86Amgen\u81ea\u5df1\u5bfb\u627e\u529f\u80fd\u6027\u6297\u4f53\u7684\u8bd5\u9519\u6cd5\u7684\u5206\u6b65\u8bf4\u660e\u3002\u800c\u300c\u4fdd\u5b88\u66ff\u6362\u300d\u65b9\u6cd5\u4e5f\u4e00\u6837\uff0c\u5176\u8981\u6c42\u79d1\u5b66\u5bb6\u5bf9\u5df2\u77e5\u6709\u6548\u7684\u6297\u4f53\u7684\u6c28\u57fa\u9178\u5e8f\u5217\u8fdb\u884c\u66ff\u6362\uff0c\u7136\u540e\u6d4b\u8bd5\u751f\u6210\u7684\u6297\u4f53\uff0c\u770b\u5b83\u4eec\u662f\u5426\u4e5f\u6709\u6548[18]<\/a>\u3002<\/p>\n

\u9a73\u56deAmgen\u7684\u5176\u4ed6\u8bba\u70b9<\/span><\/p>\n

Amgen\u53e6\u6307\u51fa\uff0c\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u9519\u8bef\u5730\u5c06\u53d1\u660e\u662f\u5426\u53ef\u636e\u4ee5\u5b9e\u65bd\u7684\u95ee\u9898\uff0c\u4e0e\u6240\u5c5e\u9886\u57df\u6280\u672f\u4eba\u5458\u5728\u5e7f\u6cdb\u7684\u8bf7\u6c42\u9879\u4e2d\u505a\u51fa\u6bcf\u4e2a\u5b9e\u65bd\u4f8b\u53ef\u80fd\u9700\u8981\u591a\u957f\u65f6\u95f4\uff0c\u4e24\u8005\u6df7\u4e3a\u4e00\u8c08\u3002\u4f46\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u660e\u786e\u8868\u793a\uff0c\u5b83\u5e76\u672a\u5c06\u5236\u9020\u6574\u7c7b\u6297\u4f53\u6240\u9700\u7684\u7d2f\u79ef\u65f6\u95f4\u548c\u52aa\u529b\u89c6\u4e3a\u51b3\u5b9a\u6027\u56e0\u7d20[19]<\/a>\u3002<\/p>\n

Amgen\u8fdb\u800c\u4e89\u8fa9\uff0c\u4e13\u5229\u6cd5\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5355\u4e00\u7684\u3001\u901a\u7528\u7684\u53ef\u636e\u4ee5\u5b9e\u65bd\u6807\u51c6\uff0c\u800c\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u5bf9Amgen\u7684\u6b64\u79cd\u8bf7\u6c42\u9879\uff08\u4ea6\u5373\u7531\u5176\u529f\u80fd\u5b9a\u4e49\u7684\u4e00\u6574\u7c7b\u5b9e\u65bd\u4f8b\uff09\uff0c\u5e94\u7528\u4e86\u66f4\u9ad8\u7684\u6807\u51c6\u3002\u6700\u9ad8\u6cd5\u9662\u539f\u5219\u4e0a\u540c\u610f\u5b58\u5728\u4e00\u4e2a\u6cd5\u5f8b\u7684\u7edf\u4e00\u6807\u51c6\uff0c\u4f46\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u5728\u672c\u6848\u4e2d\u7684\u5904\u7406\u65b9\u5f0f\u5b8c\u5168\u7b26\u5408\u7f8e\u56fd\u56fd\u4f1a\u7684\u6307\u4ee4\u548c\u6700\u9ad8\u6cd5\u9662\u7684\u5148\u4f8b[20]<\/a>\u3002<\/p>\n

\u6700\u540e\uff0c\u867d\u7136Amgen\u8b66\u544a\u8bf4\uff0c\u6b64\u89c1\u89e3\u53ef\u80fd\u4f1a\u7834\u574f\u4e86\u4e13\u5229\u6cd5\u5bf9\u7a81\u7834\u6027\u53d1\u660e\u7684\u6fc0\u52b1\u63aa\u65bd\u3002\u6cd5\u9662\u8ba4\u4e3a\uff0c\u81ea1790\u5e74\u4ee5\u6765\uff0c\u56fd\u4f1a\u5728\u4e13\u5229\u6cd5\u4e2d\u8bbe\u8ba1\u4e86\u8bb8\u591a\u5236\u5ea6\uff0c\u5305\u62ec\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6\uff0c\u5c31\u662f\u8981\u5728\u300c\u6fc0\u52b1\u53d1\u660e\u4eba\u300d\u4e0e\u300c\u786e\u4fdd\u516c\u4f17\u83b7\u5f97\u521b\u65b0\u7684\u597d\u5904\u300d\u4e4b\u95f4\u8fbe\u6210\u5e73\u8861\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u6cd5\u9662\u7684\u804c\u8d23\u662f\u6839\u636e\u4e13\u5229\u6cd5\u7684\u8981\u6c42\u6267\u884c\u53ef\u636e\u4ee5\u5b9e\u65bd\u8981\u4ef6[21]<\/a>\u3002<\/p>\n

<\/a>\u5907\u6ce8\uff1a<\/p>\n

\n
    \n
  1. \u5317\u7f8e\u667a\u6743\u62a5124\u671f\uff1a\u300c2022\u5e74\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u5bf9\u4e13\u5229\u300c\u5145\u5206\u63ed\u9732\u8981\u4ef6\u300d\u7684\u6700\u65b0\u8fdb\u5c55<\/a>\u00a0\u300d\u3002<\/li>\n
  2. Amgen Inc. v. Sanofi, 2023 WL 3511533, at 3 (May 18, 2023).<\/li>\n
  3. Id. at 4.<\/li>\n
  4. Id. at 4.<\/li>\n
  5. Id. at 5.<\/li>\n
  6. Id. at 5.<\/li>\n
  7. Id. at 5.<\/li>\n
  8. Id. at 5.<\/li>\n
  9. Id. at 3.<\/li>\n
  10. 35 U.S.C. \u00a7 112(a).<\/li>\n
  11. Amgen Inc. v. Sanofi, 2023 WL 3511533, at 5.<\/li>\n
  12. Id. at 3.<\/li>\n
  13. Id. at 7.<\/li>\n
  14. Id. at 9.\u5176\u5f15\u8ff0Incandescent Lamp, 159 U.S., at 475, 16 S.Ct. 75.<\/li>\n
  15. Id. at 9. \u5176\u5f15\u8ff0Wood v. Underhill, 5 How. 1, 4\u20135.<\/li>\n
  16. Id. at 10. \u5176\u5f15\u8ff0See Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 270\u2013271.<\/li>\n
  17. Id. at 10.<\/li>\n
  18. Id. at 10.<\/li>\n
  19. Id. at 11.<\/li>\n
  20. Id. at 11.<\/li>\n
  21. Id. at 11.<\/li>\n<\/ol>\n<\/div>\n\n\n\n
    \n\n\n\n
    \n

    \u597d\u6d88\u606f\uff5e\u5317\u7f8e\u667a\u6743\u62a5\u6709\u5fae\u4fe1\u516c\u4f17\u53f7\u4e86\uff01<\/strong><\/span><\/p>\n

    \u300a\u5317\u7f8e\u667a\u6743\u62a5\u300b\u5185\u5bb9\u6db5\u76d6\u4e16\u754c\u5404\u56fd\u7684\u77e5\u8bc6\u4ea7\u6743\u65b0\u95fb\u3001\u91cd\u8981\u7684\u4fb5\u6743\u8bc9\u8bbc\u6848\u4f8b\u5206\u6790\u3001\u6cd5\u89c4\u89e3\u6790\uff0c\u4ee5\u53ca\u4ea7\u4e1a\u4e0e\u6280\u672f\u65b0\u77e5\u7b49\u7b49\u3002<\/p>\n

    \u7acb\u5373\u5173\u6ce8\u5317\u7f8e\u667a\u6743\u5fae\u4fe1\u516c\u4f17\u53f7\u2192 NAIP_IPServices<\/strong><\/p>\n

    \uff5e\u6b22\u8fce\u8bfb\u8005\u5206\u4eab\u4e0e\u8f6c\u53d1\uff5e<\/p>\n<\/td>\n

    		\"\"<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

     <\/p>\n

    \u3010\u672c\u6587\u53ea\u53cd\u6620\u4e13\u5bb6\u4f5c\u8005\u610f\u89c1\uff0c\u4e0d\u4ee3\u8868\u672c\u62a5\u7acb\u573a\u3002\u3011<\/strong><\/p>\n\n\n\n
    \n\n\n\n
    \"\"<\/td>\n<\/td>\n\n\n\n\n\n\n\n\n
    \u4f5c\u8005\uff1a<\/strong><\/td>\n\u6768\u667a\u6770<\/strong><\/td>\n<\/tr>\n
    \u73b0\u4efb\uff1a<\/strong><\/td>\n\u4e91\u6797\u79d1\u6280\u5927\u5b66\u79d1\u6280\u6cd5\u5f8b\u6240 \u6559\u6388<\/td>\n<\/tr>\n
    \u7ecf\u5386\uff1a<\/strong><\/td>\n\u4e91\u6797\u79d1\u6280\u5927\u5b66\u79d1\u6280\u6cd5\u5f8b\u6240 \u526f\u6559\u6388
    \n\u771f\u7406\u5927\u5b66\u6cd5\u5f8b\u7cfb\u52a9\u7406\u6559\u6388
    \n\u771f\u7406\u5927\u5b66\u6cd5\u5f8b\u7cfb\u526f\u6559\u6388<\/td>\n<\/tr>\n
    \u5b66\u5386\uff1a<\/strong><\/td>\n\u53f0\u6e7e\u5927\u5b66\u6cd5\u5f8b\u7cfb
    \n\u4e2d\u592e\u5927\u5b66\u4ea7\u4e1a\u7ecf\u6d4e\u6240\u7855\u58eb
    \n\u53f0\u6e7e\u5927\u5b66\u6cd5\u5b66\u535a\u58eb<\/td>\n<\/tr>\n
    \u4e13\u957f\uff1a<\/strong><\/td>\n\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":"

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