{"id":738,"date":"2024-07-21T22:43:26","date_gmt":"2024-07-22T02:43:26","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/?p=738"},"modified":"2024-07-21T22:45:34","modified_gmt":"2024-07-22T02:45:34","slug":"%e5%bd%93%e7%bc%a9%e5%87%8f%e6%a0%87%e7%ad%be%e8%b6%b3%e5%a4%9f%e7%b2%be%e7%ae%80%e6%97%b6%ef%bc%8c%e7%be%8e%e5%9b%bd%e8%81%94%e9%82%a6%e5%b7%a1%e5%9b%9e%e6%b3%95%e9%99%a2%e4%bb%8d%e7%84%b6%e9%87%8d","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/2024\/07\/21\/%e5%bd%93%e7%bc%a9%e5%87%8f%e6%a0%87%e7%ad%be%e8%b6%b3%e5%a4%9f%e7%b2%be%e7%ae%80%e6%97%b6%ef%bc%8c%e7%be%8e%e5%9b%bd%e8%81%94%e9%82%a6%e5%b7%a1%e5%9b%9e%e6%b3%95%e9%99%a2%e4%bb%8d%e7%84%b6%e9%87%8d\/","title":{"rendered":"\u5f53\u7f29\u51cf\u6807\u7b7e\u8db3\u591f\u7cbe\u7b80\u65f6\uff0c\u7f8e\u56fd\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u4ecd\u7136\u91cd\u542f\u4e86\u5bf9\u4eff\u5236\u836f\u4f01\u4e1a\u7684\u8bf1\u5bfc\u4fb5\u6743\u8bc9\u8bbc"},"content":{"rendered":"<p><a href=\"http:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-large wp-image-740\" src=\"http:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22-1024x593.jpg\" alt=\"\" width=\"525\" height=\"304\" srcset=\"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22-1024x593.jpg 1024w, https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22-300x174.jpg 300w, https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22-768x445.jpg 768w, https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22-1536x889.jpg 1536w, https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2024\/07\/a7f5b502-51c0-44eb-af6f-3e955fae5d22.jpg 1900w\" sizes=\"auto, (max-width: 525px) 100vw, 525px\" \/><\/a><\/p>\n<p>\u8fd1\u65e5\uff0c\u5728Amarin Pharma\u8bc9Hikma Pharmaceuticals USA \u6848\uff08\u7f16\u53f72023-1169\uff09\u4e2d\uff0c\u7f8e\u56fd\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u63a8\u7ffb\u4e86\u7279\u62c9\u534e\u5dde\u5730\u533a\u6cd5\u9662\u7684\u88c1\u51b3\uff0c\u8ba4\u4e3aAmarin\u7684\u8bc9\u72b6\u5408\u7406\u5730\u58f0\u79f0Hikma\u79ef\u6781\u8bf1\u5bfc\u4e86\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u7684\u76f4\u63a5\u4fb5\u6743\uff0c\u4e0d\u8fc7\u540c\u65f6\u8fd8\u8868\u793a \u201c\u53ef\u80fd\u540c\u610f\u5730\u533a\u6cd5\u9662\uff08\u548cHikma\uff09\u201d\u8ba4\u4e3aHikma\u7684\u7f29\u51cf\u6807\u7b7e\u672c\u8eab\u5728\u6cd5\u5f8b\u4e0a\u5e76\u6ca1\u6709\u63a8\u8350\u3001\u9f13\u52b1\u6216\u63a8\u52a8\u4efb\u4f55\u4fb5\u6743\u4f7f\u7528\u3002<\/p>\n<p><!--more--><\/p>\n<p>\u6b64\u6848\u7f18\u8d77\u4e8eAmarin\u7684Vascepa icosapent ethyl\uff0c\u8be5\u836f\u7269\u83b7\u51c6\u7528\u4e8e\u6cbb\u7597\u8840\u6db2\u7518\u6cb9\u4e09\u916f\u81f3\u5c11\u4e3a500 mg\/dL\u7684\u91cd\u5ea6\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7\uff08SH\u9002\u5e94\u75c7\uff09\uff0c\u4ee5\u53ca\u7528\u4e8e\u964d\u4f4e\u8840\u6db2\u7518\u6cb9\u4e09\u916f\u81f3\u5c11\u4e3a150 mg\/dL\u65f6\u7684\u5fc3\u8840\u7ba1\u98ce\u9669\uff08CV\u9002\u5e94\u75c7\uff09\u3002Hikma\u5254\u9664\u4e86\u7531Amarin\u7684\u4e24\u9879\u4e13\u5229\u8986\u76d6\u7684CV\u9002\u5e94\u75c7\uff0c\u5e76\u83b7\u5f97FDA\u6279\u51c6\uff0c\u9500\u552e\u4ec5\u7528\u4e8eSH\u9002\u5e94\u75c7\u7684\u4eff\u5236\u836f\u3002Amarin\u8d77\u8bc9Hikma\u8bf1\u5bfc\u4fb5\u6743\uff0c\u8ba4\u4e3aHikma\u7684\u836f\u54c1\u6807\u7b7e\u548c\u516c\u5f00\u58f0\u660e\u6307\u5bfc\u533b\u751f\u5c06\u4eff\u5236\u836f\u7528\u4e8e\u4e13\u5229\u9002\u5e94\u75c7\u30022021\u5e74\uff0c\u5c3d\u7ba1\u884c\u653f\u6cd5\u5b98\u63d0\u51fa\u4e86\u76f8\u53cd\u7684\u5efa\u8bae\uff0c\u7279\u62c9\u534e\u5dde\u5730\u533a\u6cd5\u9662\u8fd8\u662f<a href=\"https:\/\/www.duanemorris.com\/alerts\/district_court_delaware_rules_generic_pharmas_use_skinny_label_permits_induced_0222.html\">\u9a73\u56de\u4e86Amarin\u5bf9Hikma\u7684\u8bc9\u8bbc<\/a>\u3002\u968f\u540e\uff0cAmarin\u63d0\u51fa\u4e0a\u8bc9\u3002<\/p>\n<p>\u6839\u636e\u7b2c\u4e09\u5de1\u56de\u6cd5\u9662\u91c7\u7528\u8bc9\u72b6\u7684\u6807\u51c6\uff0c\u5982\u679c\u6cd5\u9662\u63a5\u53d7\u6240\u6709\u5408\u7406\u9648\u8ff0\u7684\u4e8b\u5b9e\u6307\u63a7\u5e76\u4ece\u8fd9\u4e9b\u6307\u63a7\u4e2d\u5f97\u51fa\u6240\u6709\u5408\u7406\u63a8\u8bba\uff0c\u53ea\u6709\u8be5\u8bc9\u8bbc\u5177\u6709\u5408\u7406\u6027\uff0c\u624d\u80fd\u88ab\u7ee7\u7eed\u63a8\u8fdb\u3002\u6839\u636e\u4e13\u5229\u6cd5\uff0c\u8981\u63d0\u51fa\u8bf1\u5bfc\u4fb5\u6743\u8bc9\u8bbc\uff0c\u5fc5\u987b\u7533\u8fa9\uff081\uff09\u5b58\u5728\u7b2c\u4e09\u65b9\u7684\u76f4\u63a5\u4e13\u5229\u4fb5\u6743\u884c\u4e3a\uff1b\u548c\uff082\uff09\u88ab\u544a\u77e5\u9053\u5176\u884c\u4e3a\u6784\u6210\u4e13\u5229\u4fb5\u6743\uff0c\u4f46\u4ecd\u91c7\u53d6\u4e86\u8bf1\u5bfc\u4fb5\u6743\u7684\u79ef\u6781\u884c\u4e3a\u3002<\/p>\n<p>\u5728\u7a0b\u5e8f\u65b9\u9762\uff0c\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u6307\u51fa\uff0c\u8fd9\u8d77\u4e0a\u8bc9\u65e2\u4e0d\u662f\u56e0\u63d0\u4ea4\u7b80\u5316\u65b0\u836f\u7533\u8bf7\u800c\u5f15\u8d77\u7684\u4f20\u7edfHatch-Waxman\u6848\u4ef6\uff0c\u4e5f\u4e0d\u662f\u4ec5\u56e0\u7f29\u51cf\u6807\u7b7e\u800c\u5f15\u8d77\u7684\u8bf1\u5bfc\u4fb5\u6743\u6848\u4ef6\u3002Amarin\u662f\u5728\u6848\u4ef6\u88ab\u9a73\u56de\u540e\u624d\u63d0\u51fa\u4e0a\u8bc9\u7684\uff0c\u800c\u4e0d\u662f\u5728\u5ba1\u5224\u540e\u63d0\u51fa\u52a8\u8bae\u3002\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u63f4\u5f15\u5173\u4e8e\u7f29\u51cf\u6807\u7b7e\u7684<a href=\"https:\/\/www.duanemorris.com\/alerts\/federal_circuits_rehearing_decision_confirms_induced_infringement_even_when_skinny_label_0821.html\">GSK\u5148\u4f8b<\/a>\u6307\u51fa\uff0c\u6cd5\u9662\u9700\u8981\u5ba1\u67e5\u8bf1\u5bfc\u8bc9\u8bbc\u7684\u6574\u4f53\u60c5\u51b5\uff0c\u5c06\u6307\u63a7\u89c6\u4e3a\u771f\u5b9e\uff0c\u5e76\u786e\u5b9aAmarin\u662f\u5426\u5408\u7406\u5730\u6307\u63a7Hikma\u8bf1\u5bfc\u4e86\u4fb5\u6743\u884c\u4e3a\u3002<\/p>\n<p>\u5173\u4e8e\u5408\u7406\u6027\uff0c\u6cd5\u9662\u8868\u793a\u65e0\u53ef\u4e89\u8bae\u7684\u662fAmarin\u7684\u8bc9\u72b6\u5145\u5206\u8868\u660e\u4e86\uff08a\uff09\u533b\u751f\u5b58\u5728\u901a\u8fc7\u4e3aCV\u9002\u5e94\u75c7\u5f00\u51faHikma\u7684\u4eff\u5236\u836f\u800c\u4ea7\u751f\u76f4\u63a5\u4fb5\u6743\u884c\u4e3a\uff0c\u4ee5\u53ca\uff08b\uff09Hikma\u8bf1\u5bfc\u8be5\u4fb5\u6743\u884c\u4e3a\u7684\u610f\u56fe\u548c\u77e5\u60c5\u884c\u4e3a\uff0c\u6cd5\u9662\u4ec5\u5f15\u7528\u4e86\u5730\u533a\u6cd5\u9662\u7684\u58f0\u660e\uff0c\u5373\u201cHikma\u516c\u53f8\u7684\u65b0\u95fb\u7a3f\u53ef\u80fd\u4e0e\u8be5\u610f\u56fe\u6709\u5173\u3002\u201d\u56e0\u6b64\uff0c\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u5c06\u6ce8\u610f\u529b\u96c6\u4e2d\u5728Amarin\u7684\u8bc9\u72b6\u662f\u5426\u5408\u7406\u5730\u6307\u63a7\u4e86Hikma\u79ef\u6781\u8bf1\u5bfc\u2014\u2014\u5373\u9f13\u52b1\u3001\u63a8\u8350\u6216\u4fc3\u8fdb\u4e86\u533b\u751f\u7684\u4fb5\u6743\u884c\u4e3a\u3002<\/p>\n<p>\u5c31Hikma\u516c\u53f8\u7684\u836f\u54c1\u6807\u7b7e\uff0c\u5305\u62ec\u5bf9\u5fc3\u8840\u7ba1\u75be\u75c5\u60a3\u8005\u526f\u4f5c\u7528\u7684\u8bf4\u660e\u6765\u770b\uff0c\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u53ef\u80fd\u4f1a\u652f\u6301Hikma\u516c\u53f8\u548c\u5730\u533a\u6cd5\u9662\u7684\u89c2\u70b9\uff0c\u5373\u540c\u610fHikma\u516c\u53f8\u7684\u7f29\u51cf\u6807\u7b7e\u672c\u8eab\u5e76\u6ca1\u6709\u63a8\u8350\u3001\u9f13\u52b1\u6216\u4fc3\u8fdb\u4fb5\u6743\u884c\u4e3a\u3002\u968f\u540e\uff0c\u6cd5\u9662\u5c06\u6ce8\u610f\u529b\u8f6c\u5411\u4e86Hikma\u516c\u53f8\u7684\u516c\u5f00\u58f0\u660e\u548c\u5e02\u573a\u8425\u9500\u6750\u6599\u3002\u4f8b\u5982\uff0c\u5728\u83b7\u5f97FDA\u6279\u51c6\u540e\uff0cHikma\u516c\u53f8\u7684\u7f51\u7ad9\u5c06\u4eff\u5236\u836f\u54c1\u5ba3\u4f20\u4e3a \u201c\u9ad8\u7518\u6cb9\u4e09\u916f\u8840\u75c7 \u201d\u7c7b\u522b\u4e2d\u7684 \u201cAB\u7ea7\u201d\u4ea7\u54c1\uff0c\u6cd5\u9662\u8ba4\u4e3a\u8fd9\u8db3\u4ee5\u6db5\u76d6\u4fb5\u6743\u548c\u975e\u4fb5\u6743\u7528\u9014\u3002\u6cd5\u9662\u8fd8\u6307\u51fa\uff0c\u5728FDA\u6279\u51c6\u4e4b\u524d\uff0cHikma\u516c\u53f8\u66fe\u5728\u65b0\u95fb\u7a3f\u4e2d\u4f7f\u7528\u4e86 \u201c\u7b49\u540c\u4e8eVascepa\u00ae\u7684\u4eff\u5236\u836f\u201d\u3001\u201cVascepa\u00ae\u4eff\u5236\u836f\u201d\u3001\u201cHikma\u516c\u53f8\u7684Vascepa\u00ae\u4eff\u5236\u836f\u201d\u7b49\u5ba3\u4f20\u8bcd\u8bed\uff0c\u4f46\u5e76\u672a\u8bf4\u660e\u5176\u4ea7\u54c1\u4ec5\u5728SH\u9002\u5e94\u75c7\u4e2d\u88ab\u8bc4\u4e3aAB\u7ea7\u3002\u6cd5\u9662\u8fd8\u6307\u51fa\uff0c\u8bc9\u72b6\u6307\u63a7 Hikma \u516c\u53f8\u5439\u5618 Vascepa\u00ae 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Morris LLP)\u7684\u5f8b\u5e08<a href=\"https:\/\/www.duanemorris.com\/attorneys\/jasonluo.html\">\u7f57\u5bb6\u5fe0\u535a\u58eb(Jason Luo<\/a><a href=\"https:\/\/www.duanemorris.com\/attorneys\/jasonluo.html\">)<\/a>\u548c<a href=\"https:\/\/www.duanemorris.com\/attorneys\/frederickrball.html\">Frederick R. Ball<\/a>\uff0c\u6216\u201c\u751f\u547d\u79d1\u5b66\u53ca\u533b\u7597\u6280\u672f\u4e1a\u52a1\u7ec4\u201d\u6216\u201c\u77e5\u8bc6\u4ea7\u6743\u4e1a\u52a1\u7ec4\u201d\u7684\u5176\u4ed6\u5f8b\u5e08\u3002<\/p>\n<p><strong><em>\u5173\u4e8e\u5fb7\u8302\u6b23\u5f8b\u5e08\u4e8b\u52a1\u6240<\/em><\/strong><\/p>\n<p><em>\u5fb7\u8302\u6b23\u5f8b\u5e08\u4e8b\u52a1\u6240\u662f\u7531\u7f8e\u56fd\u5fb7\u8302\u5f8b\u5e08\u4e8b\u52a1\u6240(Duane Morris LLP)\u548c\u65b0\u52a0\u5761\u6b23\u6587\u5f8b\u5e08\u4e8b\u52a1\u6240(Selvam LLC)\u7ec4\u6210\u7684\u5408\u8d44\u5f8b\u5e08\u4e8b\u52a1\u6240\uff0c\u603b\u90e8\u4f4d\u4e8e\u65b0\u52a0\u5761\u3002\u5728\u5168\u7403\u6570\u5341\u4e2a\u529e\u516c\u5ba4\u4ee5\u53ca<\/em><em>900<\/em><em>\u591a\u540d\u5f8b\u5e08\u7ec4\u6210\u7684\u5de5\u4f5c\u7f51\u7edc\u652f\u6301\u4e0b\uff0c\u672c\u6240\u80fd\u4e3a\u5f53\u4eca\u4e0d\u65ad\u53d1\u5c55\u7684\u5168\u7403\u5e02\u573a\u6240\u9762\u4e34\u7684\u6cd5\u5f8b\u548c\u5546\u4e1a\u6311\u6218\u63d0\u4f9b\u521b\u65b0\u7684\u89e3\u51b3\u65b9\u6848\u3002\u672c\u6240\u7ecf\u5e38\u88ab\u300a\u94b1\u4f2f\u65af\u300b\u3001\u300a\u6cd5\u5f8b<\/em><em>500<\/em><em>\u5f3a\u300b\u548c\u300a\u56fd\u9645\u91d1\u878d\u6cd5\u5f8b\u8bc4\u8bba\u300b\u7b49\u77e5\u540d\u8bc4\u7ea7\u673a\u6784\u5217\u4e3a\u884c\u4e1a\u9886\u5148\u7684\u5f8b\u5e08\u4e8b\u52a1\u6240\u3002<\/em><\/p>\n<p><em>\u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u8d44\u8baf\u53c2\u8003\uff0c\u5e76\u4e0d\u5e94\u89e3\u91ca\u4e3a\u6cd5\u5f8b\u5efa\u8bae\u3002\u5982\u9700\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605\u6211\u53f8\u5b8c\u6574\u7684<\/em><a href=\"https:\/\/www.duanemorris.com\/site\/legal_notices.html\"><em>\u514d\u8d23\u58f0\u660e<\/em><\/a><em>\u3002<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8fd1\u65e5\uff0c\u5728Amarin Pharma\u8bc9Hikma Pharmaceuticals USA \u6848\uff08\u7f16\u53f72023-1169\uff09\u4e2d\uff0c\u7f8e\u56fd\u8054\u90a6\u5de1\u56de\u6cd5\u9662\u63a8\u7ffb\u4e86\u7279\u62c9\u534e\u5dde\u5730\u533a\u6cd5\u9662\u7684\u88c1\u51b3\uff0c\u8ba4\u4e3aAmarin\u7684\u8bc9\u72b6\u5408\u7406\u5730\u58f0\u79f0Hikma\u79ef\u6781\u8bf1\u5bfc\u4e86\u533b\u7597\u670d\u52a1\u63d0\u4f9b\u8005\u7684\u76f4\u63a5\u4fb5\u6743\uff0c\u4e0d\u8fc7\u540c\u65f6\u8fd8\u8868\u793a \u201c\u53ef\u80fd\u540c\u610f\u5730\u533a\u6cd5\u9662\uff08\u548cHikma\uff09\u201d\u8ba4\u4e3aHikma\u7684\u7f29\u51cf\u6807\u7b7e\u672c\u8eab\u5728\u6cd5\u5f8b\u4e0a\u5e76\u6ca1\u6709\u63a8\u8350\u3001\u9f13\u52b1\u6216\u63a8\u52a8\u4efb\u4f55\u4fb5\u6743\u4f7f\u7528\u3002<\/p>\n","protected":false},"author":435,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[66,168],"tags":[404,403,407,405,406,402],"ppma_author":[79],"class_list":["post-738","post","type-post","status-publish","format-standard","hentry","category-chinese","category-intellectual-property","tag-amarin-pharma","tag-generic-pharma","tag-hatch-waxman","tag-hikma-pharmaceuticals","tag-patent-infringement","tag-skinny-label"],"authors":[{"term_id":79,"user_id":435,"is_guest":0,"slug":"duanemorrisselvam","display_name":"Duane Morris and Selvam","avatar_url":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-content\/uploads\/sites\/51\/2020\/10\/dmlogo.jpg","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/posts\/738","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/users\/435"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/comments?post=738"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/posts\/738\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/media?parent=738"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/categories?post=738"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/tags?post=738"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/duanemorrisandselvam\/wp-json\/wp\/v2\/ppma_author?post=738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}