{"id":6539,"date":"2026-06-15T07:00:12","date_gmt":"2026-06-14T22:00:12","guid":{"rendered":"https:\/\/www.itohpat.co.jp\/?post_type=ip&#038;p=6539"},"modified":"2026-06-15T07:55:58","modified_gmt":"2026-06-14T22:55:58","slug":"6539","status":"publish","type":"ip","link":"https:\/\/www.itohpat.co.jp\/zh-CN\/ip\/6539\/","title":{"rendered":"\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u5173\u4e8e\u8bf1\u5bfc\u4fb5\u6743\u7684\u5224\u51b3 Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (Supreme Court, June 4, 2026)"},"content":{"rendered":"<p>\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e3a\u201c<span>\u6700\u9ad8\u6cd5\u9662<\/span>\u201d<span>\uff09\u5728<\/span>2026<span>\u5e74<\/span>6<span>\u6708<\/span>4<span>\u65e5\u7684\u5224\u51b3\u4e2d\uff0c\u5bf9\u8bf1\u5bfc\u4fb5\u6743\uff08<\/span>Induced Infringement<span>\uff09\u7684\u5224\u5b9a\u53d1\u8868\u4e86\u88c1\u51b3\u3002\u6839\u636e\u7f8e\u56fd\u4e13\u5229\u6cd5\u7b2c<\/span>271<span>\u6761<\/span>(b)<span>\u6b3e<\/span><a href=\"#_edn1\" name=\"_ednref1\"><span>[i]<\/span><\/a><span>\uff0c\u6784\u6210\u8bf1\u5bfc\u4fb5\u6743\u9700\u6ee1\u8db3\u4ee5\u4e0b\u4e09\u9879\u8981\u4ef6\uff1a<\/span><\/p>\r\n<p>(i)<span>\u5b58\u5728\u7531\u7b2c\u4e09\u65b9\u5b9e\u65bd\u7684\u76f4\u63a5\u4fb5\u6743\u884c\u4e3a\uff1b<\/span><\/p>\r\n<p>(ii)<span>\u8bf1\u5bfc\u8005\u77e5\u6089\u5176\u6240\u8bf1\u5bfc\u7684\u884c\u4e3a\u5c5e\u4e8e\u4e13\u5229\u4fb5\u6743\uff1b<\/span><\/p>\r\n<p>(iii)<span>\u8bf1\u5bfc\u8005\u91c7\u53d6\u4e86\u79ef\u6781\u884c\u4e3a\u4ee5\u4fc3\u8fdb\u76f4\u63a5\u4fb5\u6743\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u5728\u672c\u6b21\u7684\u5224\u51b3\u4e2d\uff0c\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u4e00\u81f4\u9a73\u56de\u4e86\u5982\u4e0b\u4e3b\u5f20\uff1a\u4eff\u5236\u836f\u751f\u4ea7\u5546\u901a\u8fc7\u542b\u84c4\u5730\u4fc3\u4f7f\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u5c06\u836f\u54c1\u5904\u65b9\u7528\u4e8e\u4e13\u5229\u4fdd\u62a4\u7684\u7528\u9014\u5373\u53ef\u6ee1\u8db3\u4e0a\u8ff0\u7b2c\uff08iii<span>\uff09\u9879\u8981\u4ef6\u3002\u5177\u4f53\u5730\uff0c\u6700\u9ad8\u6cd5\u9662\u6307\u51fa\uff0c\u8ba4\u5b9a\u79ef\u6781\u8bf1\u5bfc\uff08<\/span>active inducement<span>\uff09\u5fc5\u987b\u5b58\u5728\u5bfc\u81f4\u4fb5\u6743\u53d1\u751f\u7684\u660e\u786e\u4e14\u79ef\u6781\u7684\u63aa\u65bd\uff0c\u800c\u4e0d\u80fd\u4ee5\u6807\u51c6\u7684\u884c\u4e1a\u60ef\u4f8b\u3001\u5355\u7eaf\u7684\u4e0d\u4f5c\u4e3a\u3001\u6216\u4f9d\u8d56\u63a8\u6d4b\u7684\u6a21\u7cca\u8868\u8ff0\u4f5c\u4e3a\u4f9d\u636e\u3002\u73b0\u5c06\u672c\u5224\u51b3\u7684\u5185\u5bb9\u62a5\u544a\u5982\u4e0b\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\uff1c\u80cc\u666f\uff1e<\/p>\r\n<p>Amarin Pharma<span>\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e3a<\/span>\u201cAmarin<span>\u516c\u53f8<\/span>\u201d<span>\uff09\u9500\u552e\u4e00\u79cd\u4ee5<\/span>\u201cVascepa\u201d<span>\u4e3a\u5546\u54c1\u540d\u7684\u4e8c\u5341\u78b3\u4e94\u70ef\u9178\u4e59\u916f\uff08<\/span>Icosapent Ethyl<span>\uff09\uff0c\u5176\u4e3a\u9c7c\u6cb9\u4e2d\u5e38\u89c1\u7684<\/span>\u03c9-3<span>\u8102\u80aa\u9178\u4e59\u916f\u3002<\/span>Amarin<span>\u516c\u53f8\u662f\u7f8e\u56fd\u4e13\u5229\u7b2c<\/span>9,700,537<span>\u53f7\u548c\u7b2c<\/span>10,568,861<span>\u53f7\u7684\u4e13\u5229\u6743\u4eba\uff0c\u8be5\u4e24\u9879\u4e13\u5229\u4e0e\u7528\u4e8e\u964d\u4f4e\u6b63\u5728\u670d\u7528\u4ed6\u6c40\u7c7b\u836f\u7269\uff08<\/span>statin<span>\uff09<\/span><a href=\"#_edn2\" name=\"_ednref2\"><span>[ii]<\/span><\/a><span>\u7684\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7\u60a3\u8005\u7684\u5fc3\u8840\u7ba1\u98ce\u9669\u7684<\/span>Vascepa<span>\u7684\u7528\u9014\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e3a<\/span>\u201cCV<span>\u9002\u5e94\u75c7<\/span>\u201d<span>\uff09\u76f8\u5173\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>Vascepa<span>\u4ea6\u83b7\u6279\u4f5c\u4e3a\u6cbb\u7597\u60a3\u8005\u8840\u6db2\u4e2d\u7518\u6cb9\u4e09\u916f\u6c34\u5e73\u8fbe\u5230<\/span>500mg\/dL<span>\u4ee5\u4e0a\u7684\u91cd\u5ea6\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7\uff08\u4ee5\u4e0b\u7b80\u79f0<\/span>\u201cSH<span>\u9002\u5e94\u75c7<\/span>\u201d<span>\uff09\u7684\u836f\u7269\u3002\u4e0e<\/span>CV<span>\u9002\u5e94\u75c7\u4e0d\u540c\uff0c<\/span>Amarin<span>\u516c\u53f8\u5e76\u4e0d\u62e5\u6709<\/span>Vascepa<span>\u7528\u4e8e<\/span>SH<span>\u9002\u5e94\u75c7\u7684\u4e13\u5229\u6743\u3002<\/span>Hikma Pharmaceuticals<span>\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e3a<\/span>\u201cHikma<span>\u516c\u53f8<\/span>\u201d<span>\uff09\u4ece\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08<\/span>FDA<span>\uff09\u83b7\u5f97\u4e86\u4e0e<\/span>\u201c<span>\u7626\u6807\u7b7e\uff08<\/span>skinny label<span>\uff09<\/span>\u201d<span>\u76f8\u5173\u7684\u4eff\u5236\u836f\u7684\u6279\u51c6\uff0c\u6240\u8c13<\/span>\u201c<span>\u7626\u6807\u7b7e\uff08<\/span>skinny label<span>\uff09<\/span>\u201d<span>\u662f\u6307\u4ec5\u5305\u542b\u672a\u53d7\u4e13\u5229\u4fdd\u62a4\u7684<\/span>SH<span>\u9002\u5e94\u75c7\uff0c\u800c\u4e0d\u5305\u542b\u53d7\u4e13\u5229\u4fdd\u62a4\u7684<\/span>CV<span>\u9002\u5e94\u75c7<\/span><a href=\"#_edn3\" name=\"_ednref3\"><span>[iii]<\/span><\/a><span>\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u5728Hikma<span>\u516c\u53f8\u7684\u4e8c\u5341\u78b3\u4e94\u70ef\u9178\u4e59\u916f\u7684\u4eff\u5236\u836f\u4e0a\u5e02\u540e\u4e0d\u4e45\uff0c<\/span>Amarin<span>\u516c\u53f8\u5411\u7f8e\u56fd\u7279\u62c9\u534e\u8054\u90a6\u5730\u533a\u6cd5\u9662\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e3a<\/span>\u201c<span>\u5730\u533a\u6cd5\u9662<\/span>\u201d<span>\uff09\u63d0\u8d77\u8bc9\u8bbc\uff0c\u4e3b\u5f20<\/span>Hikma<span>\u516c\u53f8\u6784\u6210<\/span>35 U.S.C. \u00a7271(b)<span>\u89c4\u5b9a\u7684\u8bf1\u5bfc\u4fb5\u6743\u3002<\/span>Amarin<span>\u516c\u53f8\u4e3b\u5f20\uff0c\u7efc\u5408<\/span>Hikma<span>\u516c\u53f8\u5728\u591a\u4e2a\u6587\u4ef6\u4e2d\u7684\u8868\u8ff0\u6765\u770b\uff0c<\/span>Hikma<span>\u516c\u53f8\u79ef\u6781\u8bf1\u5bfc\u4e86\u4ed6\u4eba\u4fb5\u72af<\/span>Amarin<span>\u516c\u53f8\u7684<\/span>CV<span>\u9002\u5e94\u75c7\u7684\u4e13\u5229\u3002\u7279\u522b\u662f\uff0c<\/span>Amarin<span>\u516c\u53f8\u4e3b\u5f20\uff1a\u4ee5\u4e0b\u7684\u4e8b\u5b9e\u6784\u6210\u4e86<\/span>\u201c<span>\u4e00\u6761\u5408\u7406\u7684\u56e0\u679c\u94fe\u6761\uff0c\u5373\uff0c\u80fd\u591f\u5bfc\u81f4\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u4e3a\u4e86\u964d\u4f4e\u60a3\u8005\u7684\u5fc3\u8840\u7ba1\u98ce\u9669\u800c\u5f00\u5177\u6216\u8c03\u914d<\/span>Hikma<span>\u516c\u53f8\u7684\u836f\u7269<\/span>\u201d<span>\u3002<\/span><\/p>\r\n<p>\uff081<span>\uff09<\/span>Hikma<span>\u516c\u53f8\u7684\u4ea7\u54c1\u6807\u7b7e\u867d\u7136\u7701\u7565\u4e86\u5173\u4e8e\u836f\u7269\u5bf9\u5fc3\u8840\u7ba1\u6b7b\u4ea1\u7387\u7684\u5f71\u54cd\u5c1a\u672a\u786e\u5b9a\u7684\u8bf4\u660e\uff08\u4e0e<\/span>CV<span>\u9002\u5e94\u75c7\u76f8\u5173\u7684\u4f7f\u7528\u9650\u5236\uff09\uff0c\u4f46\u4ecd\u4fdd\u7559\u4e86\u90e8\u5206\u60a3\u8005\u670d\u7528\u4ed6\u6c40\u7c7b\u836f\u7269\u540e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4fe1\u606f\u3002<\/span><\/p>\r\n<p>\uff082<span>\uff09\u968f\u9644\u4e8e\u6807\u7b7e\u7684\u60a3\u8005\u7528\u836f\u4fe1\u606f\u624b\u518c\u4e2d\u8bb0\u8f7d\u4e86\u9488\u5bf9\u60a3\u6709\u5fc3\u810f\u75be\u75c5\uff08\u5fc3\u8840\u7ba1\u75be\u75c5\uff09\u7684\u60a3\u8005\u53ef\u80fd\u51fa\u73b0\u526f\u4f5c\u7528\u7684\u8b66\u544a\uff0c\u5e76\u63d0\u53ca\u836f\u7269\u53ef\u80fd\u88ab\u7528\u4e8e\u60a3\u8005\u7528\u836f\u4fe1\u606f\u624b\u518c\u4e2d\u6240\u8bb0\u8f7d\u7684\u7528\u9014\u4e4b\u5916\u7684\u76ee\u7684\u3002<\/span><\/p>\r\n<p>\uff083<span>\uff09<\/span>Hikma<span>\u516c\u53f8\u7684\u7f51\u9875\u4e0a\u5c06\u8be5\u516c\u53f8\u7684\u4eff\u5236\u836f\u6807\u6ce8\u4e3a<\/span>\u201cAB<span>\u7b49\u7ea7<\/span>\u201d<a href=\"#_edn4\" name=\"_ednref4\"><span>[iv]<\/span><\/a><span>\uff0c\u5e76\u5c06\u5176\u6cbb\u7597\u5927\u7c7b\u5f52\u7c7b\u4e3a\u6db5\u76d6<\/span>SH<span>\u9002\u5e94\u75c7\u4f46\u5728\u6982\u5ff5\u4e0a\u66f4\u5bbd\u6cdb\u7684<\/span>\u201c<span>\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7<\/span>\u201d<span>\u3002<\/span><\/p>\r\n<p>\uff084<span>\uff09<\/span>Hikma<span>\u516c\u53f8\u53d1\u5e03\u4e86\u4e00\u7cfb\u5217\u5c06\u5176\u4ea7\u54c1\u79f0\u4e3a<\/span>\u201c<span>\u4eff\u5236\u7248<\/span>Vascepa\u201d<span>\u7684\u65b0\u95fb\u7a3f\u3002\u8fd9\u4e9b\u65b0\u95fb\u7a3f\u672a\u63d0\u53ca\u83b7\u6279\u7528\u9014\u4ec5\u9650\u4e8e<\/span>SH<span>\u9002\u5e94\u75c7\uff0c\u53cd\u800c\u5927\u8086\u5ba3\u4f20\u4e86\u7531<\/span>SH<span>\u9002\u5e94\u75c7\u548c<\/span>CV<span>\u9002\u5e94\u75c7\u4e24\u8005\u5171\u540c\u8d21\u732e\u7684<\/span>Vascepa<span>\u5728\u7f8e\u56fd\u56fd\u5185\u7684\u9500\u552e\u989d\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u5730\u533a\u6cd5\u9662\u9a73\u56de\u4e86Amarin<span>\u516c\u53f8\u7684\u8d77\u8bc9\uff0c\u8ba4\u4e3a<\/span>Hikma<span>\u516c\u53f8\u7684\u4efb\u4f55\u9648\u8ff0\u5747\u4e0d\u6784\u6210\u4fc3\u8fdb\u4fb5\u72af<\/span>Amarin<span>\u516c\u53f8<\/span>CV<span>\u9002\u5e94\u75c7\u7528\u9014\u4e13\u5229\u7684\u79ef\u6781\u884c\u4e3a\u3002\u4e0e\u6b64\u76f8\u53cd\uff0c\u7f8e\u56fd\u8054\u90a6\u5de1\u56de\u4e0a\u8bc9\u6cd5\u9662\uff08<\/span>CAFC<span>\uff09\u63a8\u7ffb\u4e86\u5730\u533a\u6cd5\u9662\u7684\u88c1\u5b9a\uff0c\u968f\u540e<\/span>Hikma<span>\u516c\u53f8\u5411\u6700\u9ad8\u6cd5\u9662\u63d0\u8d77\u4e0a\u8bc9\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\uff1c\u6700\u9ad8\u6cd5\u9662\u5224\u51b3\uff1e<\/p>\r\n<p>\u6700\u9ad8\u6cd5\u9662\u540c\u610f\u5730\u533a\u6cd5\u9662\u7684\u7ed3\u8bba\uff0c\u5373\u8ba4\u5b9aAmarin<span>\u516c\u53f8\u672a\u80fd\u5c31\u8fdd\u53cd<\/span>35 U.S.C. \u00a7 271(b)<span>\u6240\u89c4\u5b9a\u7684\u79ef\u6781\u8bf1\u5bfc\u884c\u4e3a\u4e3b\u5f20\u5408\u7406\u7684\u8bc9\u8bbc\u8bf7\u6c42\u3002<\/span><\/p>\r\n<p>\u5728\u672c\u6848\u4e2d\uff0c\u6700\u9ad8\u6cd5\u9662\u6307\u51fa\u4ee5\u4e0b\u56db\u70b9\uff1a<\/p>\r\n<p>\uff08i<span>\uff09\u8bf1\u5bfc\u4fb5\u6743\u5fc5\u987b\u4f34\u968f\u7740\u65e8\u5728\u5bfc\u81f4\u4ea7\u751f\u4e13\u5229\u4fb5\u6743\u8fd9\u4e00\u7ed3\u679c\u7684\u79ef\u6781\u7684\uff08\u800c\u975e\u6d88\u6781\u7684\uff09\u884c\u4e3a\uff1b<\/span><\/p>\r\n<p>\uff08ii<span>\uff09\u4ece\u907f\u514d\u4e0d\u5f53\u59a8\u788d\u6b63\u5e38\u5546\u4e1a\u6d3b\u52a8\u7684\u89d2\u5ea6\u51fa\u53d1\uff0c\u901a\u5e38\u4f34\u968f\u4ea7\u54c1\u6b63\u5e38\u6d41\u901a\u7684\u884c\u4e3a\u4e0d\u8db3\u4ee5\u786e\u7acb\uff08\u8bfe\u4ee5\uff09\u4fb5\u6743\u8d23\u4efb\uff1b<\/span><\/p>\r\n<p>\uff08iii<span>\uff09\u4ec5\u51ed\u6a21\u7cca\u7684\u8868\u8ff0\u5e76\u7ed3\u5408\u5bf9\u4ed6\u4eba\u884c\u4e3a\u7684\u63a8\u6d4b\uff0c\u4e0d\u80fd\u6784\u6210\u8bf1\u5bfc\u4fb5\u6743\u7684\u4f9d\u636e\uff1b<\/span><\/p>\r\n<p>\uff08iv<span>\uff09\u6240\u8981\u6c42\u7684\u8bf1\u5bfc\u884c\u4e3a\uff0c\u65e0\u8bba\u662f\u660e\u793a\u8fd8\u662f\u6697\u793a\uff0c\u5bf9\u4e8e\u4fe1\u606f\u63a5\u53d7\u65b9\u5747\u5fc5\u987b\u662f<\/span>\u201c<span>\u660e\u786e\u7684\uff08<\/span>clear<span>\uff09<\/span>\u201d<span>\u4e14<\/span>\u201c<span>\u79ef\u6781\u7684\uff08<\/span>affirmative<span>\uff09<\/span>\u201d<span>\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u9488\u5bf9Amarin<span>\u516c\u53f8\u4e3a\u4e86\u652f\u6301\u8bf1\u5bfc\u7684\u4e3b\u5f20\u800c\u63d0\u51fa\u7684\u5177\u4f53\u4e8b\u5b9e\uff0c\u6700\u9ad8\u6cd5\u9662\u5f3a\u8c03\u5982\u4e0b\u3002\u5373\uff0c\u7531\u4e8e\u6cd5\u5f8b\u89c4\u5b9a<\/span>Hikma<span>\u516c\u53f8\u7684\u6807\u7b7e\u5fc5\u987b\u4e0e<\/span>Amarin<span>\u516c\u53f8\u7684\u6807\u7b7e\u4fdd\u6301\u4e00\u81f4\uff0c\u56e0\u6b64\uff0c<\/span>Hikma<span>\u516c\u53f8\u7701\u7565<\/span>\u201c<span>\u4e0e<\/span>CV<span>\u9002\u5e94\u75c7\u76f8\u5173\u7684\u4f7f\u7528\u9650\u5236<\/span>\u201d<a href=\"#_edn5\" name=\"_ednref5\"><span>[v]<\/span><\/a><span>\u5e76\u4fdd\u7559\u4e34\u5e8a\u8bd5\u9a8c\u4fe1\u606f\u7684\u884c\u4e3a\uff0c\u5c5e\u4e8e\u5c65\u884c\u6cd5\u5b9a\u4e49\u52a1\u7684\u884c\u4e3a\u3002\u6b64\u5916\uff0c\u57fa\u4e8e\u5ba2\u89c2\u4e8b\u5b9e\u8bb0\u8f7d\u4eff\u5236\u836f\u4e0e\u539f\u7814\u836f\u5177\u6709\u540c\u7b49\u7597\u6548\u5c5e\u4e8e\u884c\u4e1a\u5185\u7684\u5e38\u89c4\u60ef\u4f8b\uff0c\u6cd5\u9662\u6307\u51fa\uff0c\u4e0d\u80fd\u5c06\u9075\u5b88\u6cd5\u5f8b\u6cd5\u89c4\u6216\u7b26\u5408\u884c\u4e1a\u5e38\u89c4\u60ef\u4f8b\u7684\u884c\u4e3a\u4f5c\u4e3a\u4fb5\u6743\u884c\u4e3a\u7684\u6784\u6210\u8981\u7d20\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u6700\u9ad8\u6cd5\u9662\u8fdb\u4e00\u6b65\u6307\u51fa\uff0cAmarin<span>\u516c\u53f8\u4e0d\u80fd\u4ec5\u4f9d\u8d56\u4e8e\u5355\u7eaf\u7684\u7701\u7565\u3001\u4e0d\u4f5c\u4e3a\u6216\u672a\u5c65\u884c\u884c\u4e3a\u6765\u4e3b\u5f20\u79ef\u6781\u7684\u8bf1\u5bfc\u884c\u4e3a\u3002\u5728\u672c\u6848\u4e2d\uff0c\u6700\u9ad8\u6cd5\u9662\u5224\u51b3\uff0c\u867d\u7136\u53d1\u6325\u60f3\u8c61\u529b\u53ef\u4ee5\u8ba4\u4e3a\u4e00\u90e8\u5206\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u4f1a\u9605\u8bfb\u5b57\u91cc\u884c\u95f4\u7684\u542b\u4e49\uff0c\u57fa\u4e8e\u7626\u6807\u7b7e\u4e2d\u7701\u7565\u4e86<\/span>\u201c<span>\u4e0e<\/span>CV<span>\u9002\u5e94\u75c7\u76f8\u5173\u7684\u4f7f\u7528\u9650\u5236<\/span>\u201d<span>\u3001\u6216\u8005\u65b0\u95fb\u7a3f\u4e2d\u672a\u8bf4\u660e<\/span>Hikma<span>\u516c\u53f8\u83b7\u6279\u7684\u7528\u9014\u4ec5\u9650\u4e8e<\/span>SH<span>\u9002\u5e94\u75c7\uff0c\u4ece\u800c\u6709\u53ef\u80fd\u63a8\u5bfc\u51fa\u4e0d\u6070\u5f53\u7684\u7ed3\u8bba\uff0c\u7136\u800c\uff0c\u8bf1\u5bfc\u884c\u4e3a\u7684\u6210\u7acb\u5fc5\u987b\u8981\u5b58\u5728\u79ef\u6781\u7684\u9648\u8ff0\u6216\u884c\u4e3a\u3002\u5426\u5219\uff0c\u666e\u901a\u7684\u7ecf\u8425\u8005\u65e0\u8bba\u5176\u5546\u54c1\u6216\u670d\u52a1\u5982\u4f55\u88ab\u4ed6\u4eba\u8bef\u7528\uff0c\u4e5f\u65e0\u8bba\u5176\u4e0e\u4e0d\u6cd5\u884c\u4e3a\u8005\u4e4b\u95f4\u7684\u8054\u7cfb\u591a\u4e48\u8584\u5f31\uff0c\u90fd\u53ef\u80fd\u88ab\u8feb\u627f\u62c5\u8d23\u4efb\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u53e6\u5916\uff0c\u5bf9\u4e8e\u60a3\u8005\u7528\u836f\u4fe1\u606f\u624b\u518c\u4e2d\u6709\u5173\u5fc3\u810f\u75be\u75c5\u60a3\u8005\u53ef\u80fd\u51fa\u73b0\u526f\u4f5c\u7528\u7684\u8b66\u544a\u5185\u5bb9\u7684\u8bb0\u8f7d\uff0c\u6700\u9ad8\u6cd5\u9662\u5224\u5b9a\uff0c\u5c06\u5176\u89e3\u91ca\u4e3a\u8bf1\u5bfc\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u5b9e\u65bd\u4fb5\u6743\u7684\u624b\u6bb5\u8fc7\u4e8e\u8fc2\u56de\u4e14\u4e0d\u5408\u5e38\u7406\u3002\u6700\u9ad8\u6cd5\u9662\u6307\u51fa\uff0c\u82e5\u5c06\u6b64\u7c7b\u8b66\u544a\u8ba4\u5b9a\u4e3a\u8bf1\u5bfc\u4fb5\u6743\uff0c\u5219\u4e0e\u672a\u53d7\u4e13\u5229\u4fdd\u62a4\u7684\u7528\u9014\u65e0\u5173\u7684\u4efb\u4f55\u63cf\u8ff0\uff0c\u5373\u4fbf\u5176\u662f\u9488\u5bf9\u4e13\u5229\u7528\u9014\u5185\u7684\u4f7f\u7528\u7684\u8b66\u544a\uff0c\u4e5f\u53ef\u80fd\u88ab\u8ba4\u5b9a\u4e3a\u79ef\u6781\u9f13\u52b1\u4fb5\u6743\u3002<\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u5bf9\u4e8eHikma<span>\u516c\u53f8\u7684\u7f51\u9875\u4e0a\u7684\u8bb0\u8f7d\uff0c\u6700\u9ad8\u6cd5\u9662\u540c\u6837\u8ba4\u4e3a\u7f3a\u4e4f\u8bf4\u670d\u529b\u3002\u6700\u9ad8\u6cd5\u9662\u89e3\u91ca\u79f0\uff0c\u5c06\u672c\u516c\u53f8\u7684\u836f\u54c1\u7684\u6cbb\u7597\u7c7b\u522b\u8bb0\u8f7d\u4e3a<\/span>\u201c<span>\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7<\/span>\u201d<span>\uff0c\u5c31\u5982\u540c\u5c06\u67d0\u79cd\u7279\u5b9a\u7684\u767d\u8840\u75c5\u6cbb\u7597\u836f\u4e0d\u8868\u8ff0\u4e3a<\/span>\u201c<span>\u767d\u8840\u75c5\u6cbb\u7597\u836f<\/span>\u201d<span>\u800c\u8868\u8ff0\u4e3a<\/span>\u201c<span>\u6297\u764c\u836f<\/span>\u201d<span>\u4e00\u6837\u3002\u5e76\u4e14\uff0c<\/span>\u201c<span>\u6297\u764c\u836f<\/span>\u201d<span>\u8fd9\u4e00\u8868\u8ff0\u4ec5\u4ee3\u8868\u4e00\u4e2a\u5bbd\u6cdb\u7684\u6cbb\u7597\u7c7b\u522b\uff0c\u5e76\u4e0d\u7b49\u540c\u4e8e\u6307\u793a\u9488\u5bf9\u67d0\u79cd\u7279\u5b9a\u7c7b\u578b\u7684\u764c\u75c7\u5f00\u5177\u53d7\u4e13\u5229\u4fdd\u62a4\u7684\u7528\u9014\u5185\u7684\u5904\u65b9\u3002\u6b64\u5916\uff0c<\/span>Hikma<span>\u516c\u53f8\u7684\u7f51\u9875\u4e0a\u5df2\u7ecf\u660e\u786e\u8bf4\u660e<\/span>Hikma<span>\u516c\u53f8\u7684\u4eff\u5236\u836f\u4ec5\u9002\u7528\u4e8e<\/span>Vascepa<span>\u83b7\u6279\u9002\u5e94\u75c7\u4e2d\u7684\u4e00\u90e8\u5206\u800c\u975e\u5168\u90e8\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>\u6700\u540e\uff0c\u9488\u5bf9\u5173\u4e8eSH<span>\u9002\u5e94\u75c7\u548c<\/span>CV<span>\u9002\u5e94\u75c7\u4e24\u8005\u5171\u540c\u8d21\u732e\u7684\u7f8e\u56fd\u56fd\u5185\u9500\u552e\u989d\u7684\u8bb0\u8f7d\uff0c\u6700\u9ad8\u6cd5\u9662\u6307\u51fa\uff0c\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u82e5\u8981\u57fa\u4e8e\u8be5\u8bb0\u8f7d\u5b9e\u65bd\u4fb5\u6743\u884c\u4e3a\uff0c\u9700\u8981\u6ee1\u8db3\u4ee5\u4e0b\u4e00\u7cfb\u5217\u7684\u903b\u8f91\u63a8\u7406\uff1a <\/span><\/p>\r\n<p>(i)<span>\u7279\u610f\u67e5\u627e\u5e76\u9605\u8bfb\u4e3b\u8981\u9762\u5411\u6295\u8d44\u8005\u800c\u975e\u533b\u751f\u53d1\u5e03\u7684\u65b0\u95fb\u7a3f\uff1b<\/span><\/p>\r\n<p>(ii)<span>\u5177\u5907\u8db3\u591f\u7684\u836f\u54c1\u9500\u552e\u77e5\u8bc6\uff0c\u4ee5\u80fd\u591f\u7406\u89e3\u6240\u5f15\u7528\u7684\u9500\u552e\u989d\u662f\u6765\u6e90\u4e8e<\/span>SH<span>\u9002\u5e94\u75c7\u548c<\/span>CV<span>\u9002\u5e94\u75c7\u8fd9\u4e24\u4e2a\u7528\u9014\u7684\uff1b<\/span><\/p>\r\n<p>(iii)<span>\u4ece\u8be5\u4e8b\u5b9e\u89e3\u8bfb\u51fa\u5e94\u5f53\u5f00\u59cb\u5411\u5df2\u7ecf\u670d\u7528\u4ed6\u6c40\u7c7b\u836f\u7269\u7684\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7\u60a3\u8005\u5f00\u5177<\/span>Hikma<span>\u516c\u53f8\u7684\u4eff\u5236\u836f\u5904\u65b9\u8fd9\u4e00\u9690\u6666\u7684\u6697\u793a\u3002<\/span><\/p>\r\n<p>\u6700\u9ad8\u6cd5\u9662\u5224\u5b9a\uff0c\u5728\u6ca1\u6709\u5176\u4ed6\u8bc1\u636e\u7684\u60c5\u51b5\u4e0b\uff0c\u6b64\u7c7b\u63a8\u7406\u4e0d\u6784\u6210\u4f9d\u636e\u7f8e\u56fd\u4e13\u5229\u6cd5\u7b2c271<span>\u6761<\/span>(b)<span>\u6b3e\u4ea7\u751f\u8d23\u4efb\u7684\u79ef\u6781\u8bf1\u5bfc\u7684\u5408\u7406\u60c5\u5f62\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p>&lt;<span>\u5b9e\u52a1\u4e0a\u7684\u542f\u793a<\/span>&gt;<\/p>\r\n<p>Amarin<span>\u516c\u53f8\u7684\u4e3b\u5f20\u53cd\u6620\u4e86<\/span>CAFC<span>\u5728<\/span>GlaxoSmithKline LLC<span>\u8bc9<\/span>Teva Pharmaceuticals USA, Inc. 7 F.4th 1320 (2021)<span>\u4e00\u6848\u4e2d\u786e\u7acb\u7684\u601d\u8def\u3002\u8be5\u6cd5\u9662\uff08<\/span>CAFC<span>\uff09\u6b64\u524d\u4e3b\u8981\u5173\u6ce8\u7684\u7126\u70b9\u662f\u6d89\u6848\u8868\u8ff0\u662f\u5426\u4f1a\u88ab\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u89e3\u8bfb\u4e3a\u4fc3\u4f7f\u4fb5\u6743\u7684\u6307\u793a\u3002<\/span><\/p>\r\n<p>\u4e0e\u6b64\u76f8\u53cd\uff0cHikma<span>\u6848\u7684\u5224\u51b3\u6452\u5f03\u4e86\u4e0a\u8ff0\u601d\u8def\uff0c\u5e76\u5f3a\u8c03\uff1a\u5173\u952e\u4e0d\u5728\u4e8e\u88ab\u544a\u7684\u53d1\u8a00\u5355\u7eaf\u5730\u80fd\u88ab\u4ed6\u4eba\u5982\u4f55\u7406\u89e3\uff0c\u800c\u5728\u4e8e\u88ab\u544a\u662f\u5426\u901a\u8fc7\u5176\u8a00\u8bba\u79ef\u6781\u5730\u4fc3\u6210\u4e86\u4fb5\u6743\u884c\u4e3a\u3002<\/span><\/p>\r\n<p>\u672c\u5224\u51b3\u5bf9\u4eff\u5236\u836f\u751f\u4ea7\u5546\u800c\u8a00\u662f\u4e00\u573a\u80dc\u5229\uff0c\u6709\u671b\u964d\u4f4e\u4f34\u968f\u4eff\u5236\u836f\u4e0a\u5e02\u5e26\u6765\u7684\u98ce\u9669\uff0c\u5e76\u7ed9\u4e88\u5176\u5728\u9500\u552e\u5ba3\u4f20\u8d44\u6599\u4e2d\u65e0\u987b\u660e\u786e\u5426\u8ba4\u4e13\u5229\u5bf9\u8c61\u6240\u6db5\u76d6\u7684\u7528\u9014\u8fd9\u4e00\u66f4\u5e7f\u6cdb\u7684\u6d3b\u52a8\u7a7a\u95f4\u3002<\/p>\r\n<p>\u76f8\u5bf9\u800c\u8a00\uff0c\u5bf9\u4e8e\u539f\u7814\u836f\u4f01\u4e1a\u800c\u8a00\uff0c\u53ef\u80fd\u4f1a\u66f4\u52a0\u91cd\u89c6\u53d6\u5f97\u90a3\u4e9b\u5373\u4f7f\u5229\u7528\u201c<span>\u7626\u6807\u7b7e<\/span>\u201d<span>\u89c4\u5b9a\u4e5f\u65e0\u6cd5\u89c4\u907f\u4fb5\u6743\u8d23\u4efb\u7684\u7269\u8d28\u6210\u5206\u4e13\u5229\uff08<\/span>composition-of-matter patent<span>\uff09\u3002<\/span><\/p>\r\n<p>&nbsp;<\/p>\r\n<p><strong><u>\u53c2\u8003\u94fe\u63a5<\/u><\/strong><\/p>\r\n<p>\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\u7684\u5224\u51b3\u4e66\u5168\u6587\u53ef\u901a\u8fc7\u4ee5\u4e0b\u94fe\u63a5\u67e5\u9605\uff1a<\/p>\r\n<p><span style=\"text-decoration: underline;\">https:\/\/www.supremecourt.gov\/opinions\/25pdf\/24-889_5i36.pdf<\/span><\/p>\r\n<p><a href=\"#_ednref1\" name=\"_edn1\"><span>[i]<\/span><\/a>\u7f8e\u56fd\u4e13\u5229\u6cd5\u7b2c271<span>\u6761<\/span>(b)<span>\u6b3e<\/span>\u89c4\u5b9a\uff1a\u201c\u79ef\u6781\u8bf1\u5bfc\u4ed6\u4eba\u5b9e\u65bd\u4e13\u5229\u4fb5\u6743\u884c\u4e3a\u8005\uff0c\u5e94\u627f\u62c5\u4f5c\u4e3a\u4fb5\u6743\u8005\u7684\u8d23\u4efb\u3002\u201d<\/p>\r\n<p><a href=\"#_ednref2\" name=\"_edn2\"><span>[ii]<\/span><\/a> \u4ed6\u6c40\u7c7b\u836f\u7269\u662f\u7528\u4e8e\u9884\u9632\u5fc3\u8840\u7ba1\u75be\u75c5\u7684\u836f\u7269\u3002<\/p>\r\n<p><a href=\"#_ednref3\" name=\"_edn3\"><span>[iii]<\/span><\/a> \u5728\u7f8e\u56fd\uff0c\u6839\u636e\u300aHatch-Waxman<span>\u6cd5\u300b\u6240\u89c4\u5b9a\u7684<\/span>\u201c<span>\u7626\u6807\u7b7e\uff08<\/span>skinny label<span>\uff09<\/span>\u201d<span>\u5236\u5ea6\uff0c\u4eff\u5236\u836f\u751f\u4ea7\u4f01\u4e1a\u53ef\u4ee5\u5c31\u539f\u7814\u836f\u7528\u9014\u4e2d\u7684\u672a\u53d7\u4e13\u5229\u4fdd\u62a4\u7684\u7528\u9014\u53d6\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08<\/span>FDA<span>\uff09\u7684\u4e0a\u5e02\u6279\u51c6\u3002\u6839\u636e\u8be5\u5236\u5ea6\uff0c\u8981\u6c42\u9664\u5220\u9664\u6d89\u53ca\u4e0e\u4e13\u5229\u4fdd\u62a4\u5bf9\u8c61\u7684\u7528\u9014\u76f8\u5173\u7684\u4e34\u5e8a\u6307\u793a\u3001\u4e0e\u7528\u91cf\u76f8\u5173\u7684\u6307\u5357\u3001\u4e0e\u7597\u6548\u76f8\u5173\u7684\u8bf4\u660e\u7b49\u5185\u5bb9\u4e4b\u5916\uff0c\u4eff\u5236\u836f\u7684\u6807\u7b7e\u4e0e\u539f\u7814\u836f\u7684\u6807\u7b7e\u4fdd\u6301\u4e00\u81f4\u3002<\/span><\/p>\r\n<p><a href=\"#_ednref4\" name=\"_edn4\"><span>[iv]<\/span><\/a> \u201cAB<span>\u7b49\u7ea7<\/span>\u201d<span>\u662f\u6307\u8be5\u4ea7\u54c1\u4ec5\u5728\u4eff\u5236\u836f\u7684\u6807\u7b7e\u6240\u8bb0\u8f7d\u7684\u6761\u4ef6\u7684\u8303\u56f4\u5185\uff0c\u624d\u88ab\u8ba4\u5b9a\u4e3a\u4e0e\u54c1\u724c\u539f\u7814\u836f\u5177\u6709\u540c\u7b49\u7597\u6548\uff0c\u800c\u8be5\u8303\u56f4\u5e76\u4e0d\u5305\u542b\u5c1a\u672a\u83b7\u5f97\u6279\u51c6\u4e14\u53d7\u4e13\u5229\u4fdd\u62a4\u7684\u4f7f\u7528\u65b9\u6cd5\u3002<\/span><\/p>\r\n<p><a href=\"#_ednref5\" name=\"_edn5\"><span>[v]<\/span><\/a> \u5728Vascepa<span>\u6700\u521d\u7684\u6807\u7b7e\u4e2d\uff0c\u7531\u4e8e\u5176\u5c1a\u672a\u53d6\u5f97\u964d\u4f4e\u5fc3\u8840\u7ba1\u98ce\u9669\u9002\u5e94\u75c7\u7684\u6279\u51c6\uff0c\u56e0\u6b64\u5176\u836f\u54c1\u6807\u7b7e\u4e2d\u5305\u542b\u6709<\/span>\u201c<span>\u5173\u4e8e<\/span>CV<span>\u9002\u5e94\u75c7\u7684\u4f7f\u7528\u9650\u5236<\/span>\u201d<span>\u3002\u6b64\u540e\uff0c\u5728\u53d6\u5f97\u8be5\u9002\u5e94\u75c7\u7684\u6279\u51c6\u540e\uff0c<\/span>Amarin<span>\u516c\u53f8\u4ece<\/span>Vascepa<span>\u7684\u6807\u7b7e\u4e2d\u5220\u9664\u4e86\u8be5<\/span>CV<span>\u9002\u5e94\u75c7\u7684\u4f7f\u7528\u9650\u5236\uff08<\/span>CV Limitation of Use<span>\uff09\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"\u7f8e\u56fd\u6700\u9ad8\u6cd5\u9662\uff08\u4ee5\u4e0b\u7b80\u79f0\u4e3a\u201c\u6700\u9ad8\u6cd5\u9662\u201d\uff09\u57282026\u5e746\u67084\u65e5\u7684\u5224\u51b3\u4e2d\uff0c\u5bf9\u8bf1\u5bfc\u4fb5\u6743\uff08Induced Infring","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false,"footnotes":""},"ip_cat":[27,4],"class_list":["post-6539","ip","type-ip","status-publish","hentry","ip_cat-ip","zh-CN"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/ip\/6539","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/ip"}],"about":[{"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/types\/ip"}],"version-history":[{"count":1,"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/ip\/6539\/revisions"}],"predecessor-version":[{"id":6541,"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/ip\/6539\/revisions\/6541"}],"wp:attachment":[{"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/media?parent=6539"}],"wp:term":[{"taxonomy":"ip_cat","embeddable":true,"href":"https:\/\/www.itohpat.co.jp\/wp-json\/wp\/v2\/ip_cat?post=6539"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}