{"id":189917,"date":"2026-08-12T09:50:16","date_gmt":"2026-08-12T01:50:16","guid":{"rendered":"https:\/\/henrygoh.com\/?p=189917"},"modified":"2026-09-02T13:43:29","modified_gmt":"2026-09-02T05:43:29","slug":"malaysia-pharmaceutical-patent-linkage","status":"publish","type":"post","link":"https:\/\/henrygoh.com\/zh\/malaysia-pharmaceutical-patent-linkage\/","title":{"rendered":"\u9a6c\u6765\u897f\u4e9a\u62df\u5b9e\u65bd\u836f\u54c1\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\uff1a\u4e13\u5229\u4ece\u4e1a\u8005\u4e0e\u5236\u836f\u4f01\u4e1a\u5ba2\u6237\u987b\u77e5"},"content":{"rendered":"<div class=\"wp-block-stackable-image stk-block-image has-text-align-center stk-block stk-97216b9\" data-block-id=\"97216b9\"><figure><span class=\"stk-img-wrapper stk-image--shape-stretch\"><img loading=\"lazy\" decoding=\"async\" class=\"stk-img wp-image-190206\" src=\"https:\/\/henrygoh.com\/wp-content\/uploads\/2026\/08\/malaysia-pharmaceutical-patent-linkage.webp\" width=\"890\" height=\"500\" alt=\"top 8 tips before starting cosmetic product business in malaysia\" srcset=\"https:\/\/henrygoh.com\/wp-content\/uploads\/2026\/08\/malaysia-pharmaceutical-patent-linkage.webp 890w, https:\/\/henrygoh.com\/wp-content\/uploads\/2026\/08\/malaysia-pharmaceutical-patent-linkage-300x169.webp 300w, https:\/\/henrygoh.com\/wp-content\/uploads\/2026\/08\/malaysia-pharmaceutical-patent-linkage-768x431.webp 768w, https:\/\/henrygoh.com\/wp-content\/uploads\/2026\/08\/malaysia-pharmaceutical-patent-linkage-18x10.webp 18w\" sizes=\"auto, (max-width: 890px) 100vw, 890px\" \/><\/span><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\u9a6c\u6765\u897f\u4e9a\u536b\u751f\u90e8\u65d7\u4e0b\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u673a\u6784 (National Pharmaceutical Regulatory Agency, NPRA) \u62df\u9488\u5bf9\u836f\u54c1\u5b9e\u65bd\u6b63\u5f0f\u7684\u4e13\u5229\u94fe\u63a5 (Patent Linkage) \u5236\u5ea6\u3002\u8be5\u884c\u653f\u673a\u5236\u6e90\u4e8e\u9a6c\u6765\u897f\u4e9a\u6839\u636e\u300a\u5168\u9762\u4e0e\u8fdb\u6b65\u8de8\u592a\u5e73\u6d0b\u4f19\u4f34\u5173\u7cfb\u534f\u5b9a\u300b(Comprehensive and Progressive Agreement for Trans-Pacific Partnership, CPTPP) \u7b2c18.53\u6761\u6240\u627f\u62c5\u7684\u4e49\u52a1\uff0c\u5c06\u4eff\u5236\u836f\u7684\u4e0a\u5e02\u8bb8\u53ef\u4e0e\u76f8\u5e94\u65b0\u836f\u4ea7\u54c1 (New Drug Product, NDP) \u7684\u4e13\u5229\u72b6\u6001\u6b63\u5f0f\u5173\u8054\u8d77\u6765\u3002\u62df\u8bae\u7684\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u65e8\u5728\u5728\u76d1\u7ba1\u6548\u7387\u4e0e\u77e5\u8bc6\u4ea7\u6743\u4fdd\u62a4\u4e4b\u95f4\u53d6\u5f97\u5e73\u8861\uff0c\u540c\u65f6\u786e\u4fdd\u836f\u7269\u53ef\u53ca\u6027\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u4e13\u5229\u4ece\u4e1a\u8005\u4ee5\u53ca\u5236\u836f\u4f01\u4e1a\u5ba2\u6237\u800c\u8a00\uff0c\u65e0\u8bba\u662f\u5bfb\u6c42\u786e\u4fdd\u5e02\u573a\u72ec\u5360\u6743\u7684\u672c\u5730\u6216\u5916\u56fd\u539f\u7814\u836f\u4f01\uff0c\u8fd8\u662f\u8ba1\u5212\u8fdb\u5165\u9a6c\u6765\u897f\u4e9a\u5e02\u573a\u7684\u4eff\u5236\u836f\u5236\u9020\u5546\uff0c\u4e86\u89e3\u8fd9\u4e00\u5236\u5ea6\u5bf9\u4e8e\u5e94\u5bf9\u9a6c\u6765\u897f\u4e9a\u7684\u76d1\u7ba1\u73af\u5883\u81f3\u5173\u91cd\u8981\u3002&nbsp;<\/p>\n\n\n\n<h2 id=\"key-takeaways\" class=\"wp-block-heading has-medium-font-size\"><strong>\u6838\u5fc3\u8981\u70b9<\/strong>&nbsp;<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9a6c\u6765\u897f\u4e9a\u62df\u4e8e2027\u5e745\u67081\u65e5\u8d77\u5b9e\u65bd\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u3002&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u73b0\u6709\u5df2\u6ce8\u518c\u65b0\u836f\u4ea7\u54c1\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba (Product Registration Holders, PRH) \u987b\u5728\u8fc7\u6e21\u671f, \u53732026\u5e747\u67081\u65e5\u81f32027\u5e744\u670830\u65e5\u5185, \u5411 NPRA \u66f4\u65b0\u5176\u4e13\u5229\u4fe1\u606f\u3002&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4ec5\u7b2c4\u7c7b (Category 4) \u7533\u8bf7\u4f1a\u542f\u52a8\u4e13\u5229\u94fe\u63a5\u673a\u5236\uff0c\u5373\u7531\u4eff\u5236\u836f\u7533\u8bf7\u4eba(\u975e\u4e13\u5229\u6743\u4eba\/\u88ab\u8bb8\u53ef\u4eba) \u63d0\u4ea4\u7533\u8bf7\uff0c\u5e76\u4e3b\u5f20\u76f8\u5173\u4e13\u5229\u65e0\u6548\u3001\u4e0d\u6784\u6210\u4fb5\u6743\uff0c\u6216\u62df\u5728\u4e13\u5229\u5230\u671f\u524d\u4e0a\u5e02\u8be5\u4ea7\u54c1\u3002&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>NPRA \u8d1f\u8d23\u836f\u54c1\u7684\u76d1\u7ba1\u5ba1\u6279\uff0c\u800c\u9a6c\u6765\u897f\u4e9a\u6cd5\u9662\u8d1f\u8d23\u5224\u5b9a\u4e13\u5229\u6709\u6548\u6027\u53ca\u4fb5\u6743\u4e8b\u5b9c\u3002&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u4e0e\u65b0\u7684\u6388\u6743\u540e\u4e13\u5229\u5f02\u8bae(Post-Grant Opposition) \u5236\u5ea6 \u76f8\u4e92\u4ea4\u7ec7\uff0c\u4e3a\u539f\u7814\u836f\u4f01\u548c\u4eff\u5236\u836f\u4f01\u5e26\u6765\u4e86\u5168\u65b0\u7684\u6218\u7565\u8981\u6c42\u3002&nbsp;<\/li>\n<\/ul>\n\n\n\n<h2 id=\"critical-deadlines-at-a-glance\" class=\"wp-block-heading has-medium-font-size\"><strong>\u5173\u952e\u671f\u9650\u4e00\u89c8<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">2026\u5e747\u67081\u65e5\u81f32027\u5e744\u670830\u65e5\uff1a\u5411 NPRA \u66f4\u65b0\u73b0\u6709\u6709\u6548\u4e13\u5229\u4fe1\u606f\u7684\u8fc7\u6e21\u671f<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">30\u5929\uff1a\u4e13\u5229\u83b7\u6388\u6743\u6216\u73b0\u6709\u4e13\u5229\u72b6\u6001\u53d1\u751f\u53d8\u5316\u540e\uff0c\u987b\u901a\u8fc7 QUEST3+ \u7cfb\u7edf\u4e2d\u7684 E18 \u5b57\u6bb5\u901a\u77e5 NPRA \u7684\u4e25\u683c\u671f\u9650\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">45\u5929\uff1a\u6536\u5230\u7b2c4\u7c7b\u7533\u8bf7\u901a\u77e5\u540e\u542f\u52a8\u6cd5\u5f8b\u7a0b\u5e8f\u7684\u901a\u77e5\u671f\u9650\u3002<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">6\u4e2a\u6708\uff1a\u4e13\u5229\u6388\u6743\u516c\u544a\u540e\u63d0\u51fa\u4e13\u5229\u6388\u6743\u540e\u5f02\u8bae\u7684\u4e25\u683c\u4e14\u4e0d\u53ef\u5ef6\u957f\u7684\u671f\u9650\u3002<\/li>\n<\/ul>\n\n\n\n<h2 id=\"implementation-timeline\" class=\"wp-block-heading has-medium-font-size\"><strong>\u5b9e\u65bd\u65f6\u95f4\u8868<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th class=\"has-text-align-left\" data-align=\"left\">\u65e5\u671f<\/th><th class=\"has-text-align-left\" data-align=\"left\">\u91cc\u7a0b\u7891<\/th><\/tr><tr><td>2026\u5e744\u6708<\/td><td class=\"has-text-align-left\" data-align=\"left\">NPRA \u53d1\u5e03\u300a\u9a6c\u6765\u897f\u4e9a\u836f\u54c1\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u5b9e\u65bd\u6307\u5357\u300b\u8349\u6848\u3002&nbsp;<\/td><\/tr><tr><td>2026\u5e747\u67081\u65e5\u81f32027\u5e744\u670830\u65e5<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u73b0\u6709\u65b0\u836f\u4ea7\u54c1\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u53ef\u5728\u8fc7\u6e21\u671f\u95f4\u901a\u8fc7\u53d8\u66f4\u7a0b\u5e8f\u66f4\u65b0\u5176\u6709\u6548\u4e13\u5229\u4fe1\u606f\u7684\u8fc7\u6e21\u671f\u3002&nbsp;<\/td><\/tr><tr><td>2027\u5e745\u67081\u65e5<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u62df\u5168\u9762\u5b9e\u65bd\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\uff0c\u9002\u7528\u4e8e\u6240\u6709\u7b26\u5408\u6761\u4ef6\u7684\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"what-is-patent-linkage\" class=\"wp-block-heading has-medium-font-size\"><strong>\u4ec0\u4e48\u662f\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e13\u5229\u94fe\u63a5\u662f\u4e00\u79cd\u76d1\u7ba1\u673a\u5236\uff0c\u5c06 NPRA \u5bf9\u836f\u54c1\u7684\u5ba1\u6279\u4e0e\u5176\u5bf9\u5e94\u65b0\u836f\u4ea7\u54c1\u7684\u4e13\u5229\u72b6\u6001\u5173\u8054\u8d77\u6765\u3002\u5728\u62df\u8bae\u7684\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u4e0b\uff0c\u836f\u54c1\u4e0a\u5e02\u5ba1\u6279\u7a0b\u5e8f\u4e0e\u4e13\u5229\u4e89\u8bae\u7a0b\u5e8f\u5c06\u5728\u6d41\u7a0b\u4e0a\u6b63\u5f0f\u5173\u8054\u8d77\u6765\u3002\u7136\u800c\uff0c NPRA \u5c06\u7ee7\u7eed\u4fdd\u6301\u76d1\u7ba1\u4e2d\u7acb\uff0c\u4e0d\u5bf9\u4e13\u5229\u6709\u6548\u6027\u6216\u4fb5\u6743\u884c\u4e3a\u4f5c\u51fa\u5224\u5b9a\u3002&nbsp;<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th class=\"has-text-align-left\" data-align=\"left\">\u73b0\u884c\u5236\u5ea6<\/th><th class=\"has-text-align-left\" data-align=\"left\">\u62df\u8bae\u4e13\u5229\u94fe\u63a5\u5236\u5ea6<\/th><\/tr><tr><td>NPRA \u8bc4\u4f30\u836f\u54c1\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/td><td class=\"has-text-align-left\" data-align=\"left\">NPRA \u5728\u836f\u54c1\u76d1\u7ba1\u5ba1\u6279\u8fc7\u7a0b\u4e2d\u540c\u65f6\u8003\u8651\u4e0e\u4e13\u5229\u76f8\u5173\u7684\u58f0\u660e\u3002<\/td><\/tr><tr><td>\u4e13\u5229\u4e89\u8bae\u4e0e\u836f\u54c1\u76d1\u7ba1\u5ba1\u6279\u7a0b\u5e8f\u76f8\u4e92\u72ec\u7acb\u3002<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u4e13\u5229\u4e89\u8bae\u4e0e\u836f\u54c1\u76d1\u7ba1\u5ba1\u6279\u8fc7\u7a0b\u5efa\u7acb\u7a0b\u5e8f\u4e0a\u7684\u8054\u7cfb\u3002<\/td><\/tr><tr><td>\u5373\u4f7f\u5b58\u5728\u4e13\u5229\u4e89\u8bae\uff0c\u836f\u54c1\u5ba1\u6279\u4ecd\u53ef\u7ee7\u7eed\u8fdb\u884c\u3002<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u4e0a\u5e02\u8bb8\u53ef\u53ef\u80fd\u53d7\u6b63\u5728\u8fdb\u884c\u7684\u4e13\u5229\u8bc9\u8bbc\u6216\u76f8\u5173\u4e13\u5229\u58f0\u660e\u5f71\u54cd\u3002<\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">\u4e13\u5229\u6743\u4eba\u901a\u5e38\u901a\u8fc7\u5176\u4ed6\u6e20\u9053\u83b7\u6089\u4eff\u5236\u836f\u7533\u8bf7\u3002<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u4e13\u5229\u6743\u4eba\u5c06\u6536\u5230\u76f8\u5173\u4eff\u5236\u836f\u7533\u8bf7\u7684\u6b63\u5f0f\u901a\u77e5\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"which-patents-are-covered-by-the-proposed-framework\" class=\"wp-block-heading has-medium-font-size\"><strong>\u54ea\u4e9b\u4e13\u5229\u5c5e\u4e8e\u62df\u8bae\u5236\u5ea6\u7684\u6db5\u76d6\u8303\u56f4\uff1f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u9a6c\u6765\u897f\u4e9a\u62df\u8bae\u7684\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u754c\u9650\u5206\u660e\uff0c\u65e8\u5728\u517c\u987e CPTPP \u6240\u8981\u6c42\u7684\u9ad8\u6807\u51c6\u77e5\u8bc6\u4ea7\u6743\u4fdd\u62a4\uff0c\u4e0e\u56fd\u5185\u516c\u5171\u536b\u751f\u7684\u6839\u672c\u8981\u6c42\u53ca\u836f\u54c1\u53ef\u8d1f\u62c5\u6027\u4e0e\u53ef\u53ca\u6027\u4e4b\u95f4\u53d6\u5f97\u5e73\u8861\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8be5\u5236\u5ea6\u5e7f\u6cdb\u9002\u7528\u4e8e\u62df\u4f9b\u4eba\u7c7b\u4f7f\u7528\u7684\u6240\u6709\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8be5\u673a\u5236\u9002\u7528\u4e8e\u6e90\u81ea\u6240\u6709\u56fd\u5bb6\u7684\u4ea7\u54c1\uff0c\u5e76\u4e0d\u9650\u4e8e\u6e90\u81ea CPTPP \u6210\u5458\u56fd\u7684\u836f\u54c1\u3002\u8be5\u4e13\u5229\u94fe\u63a5\u673a\u5236\u4ea6\u9002\u7528\u4e8e\u5728\u9a6c\u6765\u897f\u4e9a\u5883\u5185\u751f\u4ea7\u7684 \u201c\u4ec5\u4f9b\u51fa\u53e3\u201d (For Export Only, FEO) \u4ea7\u54c1\u7684\u6ce8\u518c\u7533\u8bf7\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7136\u800c\uff0c\u8be5\u5236\u5ea6\u8bbe\u6709\u4f8b\u5916\u4e8b\u9879\u3002\u5176\u4e2d\u6700\u91cd\u8981\u7684\u662f\uff0c\u751f\u7269\u5236\u54c1 (biologic) \uff0c\u5305\u62ec\u751f\u7269\u5236\u836f\u4ea7\u54c1 (biopharmaceuticals) \u3001\u6e90\u81ea\u6d3b\u4f53\u751f\u7269\u7684\u751f\u7269\u5236\u54c1 (biological products)\u3001\u7ec6\u80de\u4e0e\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1 (cell and gene therapy products)\u3001\u5148\u8fdb\u6cbb\u7597\u4ea7\u54c1\uff08advanced therapies\uff09\u4ee5\u53ca\u75ab\u82d7, \u5b8c\u5168\u4e0d\u5c5e\u4e8e\u4e13\u5229\u94fe\u63a5\u673a\u5236\u7684\u9002\u7528\u8303\u56f4\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u5916\uff0c\u5e76\u975e\u6240\u6709\u4e0e\u836f\u54c1\u6709\u5173\u7684\u4e13\u5229\u5747\u53ef\u89e6\u53d1\u4e13\u5229\u94fe\u63a5\u673a\u5236\u3002NPRA\u673a\u5236\u4ec5\u627f\u8ba4\u4ee5\u4e0b\u4e24\u7c7b\u7b26\u5408\u6761\u4ef6\u7684\u4e13\u5229\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4ea7\u54c1\u4e13\u5229:<\/strong>&nbsp;\u660e\u786e\u8981\u6c42\u4fdd\u62a4\u6d3b\u6027\u836f\u7269\u6210\u5206 (Active Pharmaceutical Ingredient)\u3001\u7279\u5b9a\u5236\u5242 (specific formulation)\u3001\u591a\u6676\u578b\u7269 (polymorphs)\u3001\u76d0\u7c7b (salts)\u3001\u916f\u7c7b (esters)\u3001\u5242\u578b (dosage form) \u6216 \u7ed9\u836f\u65b9\u6848 (dosing regime) \u7684\u4e13\u5229\u3002\n[\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u591a\u6676\u578b\u7269\u3001\u76d0\u7c7b\u3001\u916f\u7c7b\u3001\u5242\u578b\u53ca\u7ed9\u836f\u65b9\u6848\u53ea\u6709\u5728\u4f5c\u4e3a\u5b9e\u9645\u4ea7\u54c1\u4e13\u5229 (actual product patent) \u7684\u6743\u5229\u8981\u6c42\u5185\u5bb9\u53d7\u5230\u4fdd\u62a4\u65f6\u624d\u7b26\u5408\u8d44\u683c\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u65b9\u6cd5\u4e13\u5229 (method patent) \u3002]&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u7528\u9014\u4e13\u5229:<\/strong>&nbsp;\u660e\u786e\u8981\u6c42\u4fdd\u62a4\u5df2\u6ce8\u518c\u65b0\u836f\u4ea7\u54c1\u7684\u83b7\u6279\u51c6\u533b\u7597\u7528\u9014\u6216\u6cbb\u7597\u9002\u5e94\u75c7\u7684\u4e13\u5229\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u76f8\u53cd\uff0c\u4ec5\u6db5\u76d6\u836f\u54c1\u5236\u9020\u5de5\u827a (manufacturing process) \u7684\u4e13\u5229\uff0c\u6216\u4ec5\u6db5\u76d6\u4ea7\u54c1\u5b9e\u4f53\u5305\u88c5 (physical packaging) \u7684\u4e13\u5229\uff0c\u5c06\u88ab\u660e\u786e\u6392\u9664\u5728\u5916\uff0c\u4e0d\u80fd\u5728 NPRA \u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u4e0b\u8fdb\u884c\u58f0\u660e\u6216\u4e3b\u5f20\u3002<\/p>\n\n\n\n<h2 id=\"updating-patent-information-via-quest3\" class=\"wp-block-heading has-medium-font-size\"><strong>\u901a\u8fc7 QUEST3+ \u66f4\u65b0\u4e13\u5229\u4fe1\u606f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u9a6c\u6765\u897f\u4e9a\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u7684\u8fd0\u8425\u6838\u5fc3\u662f NPRA \u7684\u5728\u7ebf\u76d1\u7ba1\u63d0\u4ea4\u5e73\u53f0 QUEST3+\u3002&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u4e13\u5229\u94fe\u63a5\u7cfb\u7edf\u6307\u5357\uff0cQUEST3+ \u754c\u9762\u5df2\u8fdb\u884c\u91cd\u5927\u8c03\u6574\uff0c\u7279\u522b\u662f \u201cE18 \u2013 Patent Protection\uff08\u4e13\u5229\u4fdd\u62a4\uff09\u201d \u5b57\u6bb5\uff0c\u8981\u6c42\u65b0\u836f\u4ea7\u54c1\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u7533\u62a5\u4e0e\u8be5\u65b0\u836f\u4ea7\u54c1\u76f8\u5173\u7684\u4e13\u5229\u4fe1\u606f\u3002\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u987b\u586b\u5199\u76f8\u5173 E18 \u5b57\u6bb5\uff0c\u5e76\u6309\u7167\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u7684\u8981\u6c42\u63d0\u4f9b\u89c4\u5b9a\u7684\u4e13\u5229\u4fe1\u606f\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>E18 \u2013 \u53d7\u4e13\u5229\u4fdd\u62a4\u7684\u4ea7\u54c1:<\/strong>&nbsp;\u82e5\u5bf9\u5e94\u7684\u65b0\u836f\u4ea7\u54c1\u53d7\u5230\u9a6c\u6765\u897f\u4e9a\u77e5\u8bc6\u4ea7\u6743\u5c40 (MyIPO) \u6388\u4e88\u7684\u4e13\u5229\u4fdd\u62a4\uff0c\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u5fc5\u987b\u9009\u62e9 \u201cYes\u201d (\"\u662f\")\uff1b\u82e5\u4e0d\u5b58\u5728\u76f8\u5173\u4e13\u5229\uff0c\u4e13\u5229\u7533\u8bf7\u5df2\u63d0\u4ea4\u4f46\u4ecd\u5904\u4e8e\u5ba1\u67e5\u9636\u6bb5\uff0c\u5219\u9009\u62e9\u201cNo\u201d (\"\u5426\")\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>E18.1 \u2013 \u4e13\u5229\u4fe1\u606f:<\/strong>&nbsp;\u82e5\u9009\u62e9\u201c\u662f\u201d\uff0c\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u987b\u63d0\u4f9b\u4e0e\u8be5\u65b0\u836f\u4ea7\u54c1\u7684\u6d3b\u6027\u6210\u5206\u6216\u83b7\u6279\u51c6\u9002\u5e94\u75c7\u76f8\u5173\u7684\u6240\u6709\u6709\u6548\u4e13\u5229\u7684\u5b8c\u6574\u8d44\u6599\uff0c\u5305\u62ec\u51c6\u786e\u7684\u4e13\u5229\u540d\u79f0\uff08\u987b\u4e0e MyIPO \u7684\u5b98\u65b9\u77e5\u8bc6\u4ea7\u6743\u5728\u7ebf\u68c0\u7d22\u4e0e\u7533\u8bf7\u5e73\u53f0 IP Online\u8bb0\u5f55\u4e00\u81f4), \u4e13\u5229\u6388\u6743\u53f7, \u6388\u6743\u65e5\u671f, \u5230\u671f\u65e5\u671f, \u4e13\u5229\u6743\u4eba\u7684\u51c6\u786e\u59d3\u540d\u53ca\u5730\u5740, \u4ee5\u53ca\u4e13\u5229\u88ab\u8bb8\u53ef\u4eba\u7684\u51c6\u786e\u59d3\u540d\u53ca\u5730\u5740\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>E18.2 &amp; E18.3 \u2013 \u6388\u6743\u65e5\u671f\u53ca\u5230\u671f\u65e5\u671f:<\/strong>\u00a0\u7cfb\u7edf\u5bf9\u8fd9\u4e9b\u5b57\u6bb5\u4ec5\u5141\u8bb8\u5f55\u5165\u4e00\u4e2a\u65e5\u671f\u3002\n\u5982\u679c\u67d0\u4e00\u65b0\u836f\u4ea7\u54c1\u5b58\u5728\u591a\u9879\u76f8\u5173\u4e13\u5229\uff0c\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u4ec5\u9700\u586b\u5199\u5230\u671f\u65e5\u6700\u665a\u7684\u4e13\u5229\uff0c\u5373\u63d0\u4f9b\u6700\u957f\u4fdd\u62a4\u671f\u9650\u7684\u4e13\u5229\uff0c\u4ee5\u786e\u5b9a\u4e13\u5229\u94fe\u63a5\u6682\u505c\u673a\u5236\u6240\u9002\u7528\u7684\u6700\u957f\u671f\u9650\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>E18.4 \u2013 \u8bc1\u660e\u6587\u4ef6:<\/strong>&nbsp;\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u987b\u4e0a\u4f20\u89c4\u5b9a\u7684\u8bc1\u660e\u6587\u4ef6\uff0c\u5305\u62ec\u6807\u51c6\u5316\u7684\u58f0\u660e\u8868\u683c (Declaration Form), \u4ee5\u53ca\u76f4\u63a5\u4ece MyIPO \u53d6\u5f97\u7684\u5b9e\u9645\u4e13\u5229\u8bf4\u660e\u4e66\u3002 \u5728\u9002\u7528\u60c5\u51b5\u4e0b\uff0c\u4eff\u5236\u836f\u7533\u8bf7\u4eba\u8fd8\u5fc5\u63d0\u4ea4\u901a\u77e5\u9001\u8fbe\u8bc1\u660e (proof of service of notices) \u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3a\u786e\u4fdd QUEST3+ \u6570\u636e\u5e93\u4e2d\u7684\u4fe1\u606f\u6301\u7eed\u4fdd\u6301\u51c6\u786e\uff0c\u65b0\u836f\u4ea7\u54c1\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u987b\u5728 MyIPO \u6388\u4e88\u65b0\u4e13\u5229\u4e4b\u65e5, \u6216\u5df2\u6ce8\u518c\u836f\u54c1\u7684\u4e13\u5229\u72b6\u6001\u53d1\u751f\u4efb\u4f55\u53d8\u5316\u4e4b\u65e5\u8d77 30 \u4e2a\u65e5\u5386\u65e5\u5185\uff0c\u901a\u8fc7 QUEST3+ \u7cfb\u7edf\u63d0\u4ea4\u76f8\u5173\u76d1\u7ba1\u53d8\u66f4\u7533\u8bf7\u3002\u672a\u80fd\u9075\u5b88\u8be5\u671f\u9650\u53ef\u80fd\u5bfc\u81f4\u884c\u653f\u63aa\u65bd\uff0c\u5e76\u53ef\u80fd\u5bfc\u81f4 NPRA \u65e0\u6cd5\u9488\u5bf9\u8fdb\u5165\u5e02\u573a\u7684\u4eff\u5236\u836f\u5b9e\u65bd\u4e13\u5229\u94fe\u63a5\u6682\u505c\u673a\u5236\u3002&nbsp;<\/p>\n\n\n\n<h2 id=\"four-categories-of-applications\" class=\"wp-block-heading has-medium-font-size\"><strong>\u56db\u7c7b\u7533\u8bf7<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u901a\u8fc7 NPRA \u7535\u5b50 QUEST3+ \u7cfb\u7edf\u63d0\u4ea4\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u65f6\uff0c\u7533\u8bf7\u4eba\u5fc5\u987b\u6839\u636e\u76f8\u5173\u4ea7\u54c1\u7684\u4e13\u5229\u72b6\u6001\uff0c\u5c06\u7533\u8bf7\u5f52\u5165\u4ee5\u4e0b\u56db\u7c7b\u4e4b\u4e00\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th class=\"has-text-align-left\" data-align=\"left\">\u7c7b\u522b<\/th><th class=\"has-text-align-left\" data-align=\"left\">\u8be5\u4ea7\u54c1\u5728\u9a6c\u6765\u897f\u4e9a\u662f\u5426\u5b58\u5728\u6709\u6548\u4e13\u5229\uff1f<\/th><td><strong>\u7533\u8bf7\u4eba<\/strong><\/td><td><strong>\u4e0a\u5e02\u610f\u56fe \/ \u5f71\u54cd<\/strong><\/td><\/tr><tr><td>1<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u5426<\/td><td>\u539f\u7814\u836f\u4f01\/\u4eff\u5236\u836f\u4f01&nbsp;<\/td><td>\u6807\u51c6\u76d1\u7ba1\u8bc4\u4f30\u4e0e\u5ba1\u6279\uff0c\u65e0\u901a\u77e5\u6216\u7b49\u5f85\u671f\u3002&nbsp;<\/td><\/tr><tr><td>2<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u662f<\/td><td class=\"translation-block\">\u4e13\u5229\u6743\u4eba \/ \u88ab\u8bb8\u53ef\u4eba<\/td><td class=\"translation-block\">\u6807\u51c6\u76d1\u7ba1\u8bc4\u4f30\u4e0e\u5ba1\u6279\uff0c\u7533\u8bf7\u4eba\u4ec5\u9700\u7533\u62a5\u4e13\u5229\u4fe1\u606f\u3002<\/td><\/tr><tr><td>3<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u662f<\/td><td>\u4eff\u5236\u836f\u7533\u8bf7\u4eba\uff08\u975e\u4e13\u5229\u6743\u4eba\/\u88ab\u8bb8\u53ef\u4eba\uff09\uff0c\u5e76\u540c\u610f\u5728\u4e13\u5229\u5230\u671f\u524d\u4e0d\u4e0a\u5e02\u8be5\u4ea7\u54c1<\/td><td>\u5b8c\u6210\u76d1\u7ba1\u8bc4\u4f30\u540e\u53ef\u83b7\u5f97\u6ce8\u518c\uff0c\u4f46\u6ce8\u518c\u4ea7\u54c1\u5728\u76f8\u5173\u4e13\u5229\u5230\u671f\u524d\u4e0d\u5f97\u4e0a\u5e02\u9500\u552e\u3002<\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">4<\/td><td class=\"has-text-align-left\" data-align=\"left\">\u662f<\/td><td>\u4eff\u5236\u836f\u7533\u8bf7\u4eba\uff08\u975e\u4e13\u5229\u6743\u4eba\/\u88ab\u8bb8\u53ef\u4eba\uff09\uff0c\u5e76\u4e3b\u5f20\u4e13\u5229\u65e0\u6548\u3001\u4e0d\u6784\u6210\u4fb5\u6743\uff0c\u6216\u62df\u5728\u4e13\u5229\u5230\u671f\u524d\u4e0a\u5e02\u8be5\u4ea7\u54c1<\/td><td>\u8fd9\u5c06\u89e6\u53d1\u62df\u8bae\u7684\u4e13\u5229\u94fe\u63a5\u673a\u5236\uff0c\u5305\u62ec\u5411\u4e13\u5229\u6743\u4eba\u53d1\u51fa\u901a\u77e5\u3002\u5982\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\u88ab\u63d0\u8d77\uff0cNPRA \u7684\u6ce8\u518c\u51b3\u5b9a\u53ef\u80fd\u88ab\u6682\u505c\u6700\u957f12\u4e2a\u6708\u3002&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"what-happens-under-a-category-4-application\" class=\"wp-block-heading\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.313), 18px);\"><strong>\u7b2c4\u7c7b\u7533\u8bf7\u4e0b\u4f1a\u53d1\u751f\u4ec0\u4e48\uff1f<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u63d0\u4ea4\u7b2c4\u7c7b\u7533\u8bf7\u540e\uff0c\u5c06\u542f\u52a8\u4ee5\u4e0b\u7a0b\u5e8f\uff0c\u5e76\u5f00\u59cb\u8ba1\u7b9745\u5929\u901a\u77e5\u671f\u3002\n\u5982\u679c\u4e13\u5229\u6743\u4eba\u5728\u8be5\u671f\u9650\u5185\u63d0\u8d77\u4fb5\u6743\u8bc9\u8bbc\uff0c\u5c06\u5bfc\u81f4\u4eff\u5236\u836f\u5ba1\u6279\u7a0b\u5e8f\u88ab\u81ea\u52a8\u6682\u505c\uff0c\u6700\u957f\u53ef\u8fbe12\u4e2a\u6708\u3002\n\u8fd9\u5b9e\u9645\u4e0a\u5f62\u6210\u4e00\u79cd\u7c7b\u4f3c\u4e8e\u201c\u76d1\u7ba1\u7981\u4ee4\u201d(\"regulatory injunction\") \u7684\u6548\u679c\uff0c\u5373\u5728\u65e0\u9700\u6ee1\u8db3\u6c11\u4e8b\u6cd5\u9662\u9881\u53d1\u521d\u6b65\u7981\u4ee4\u901a\u5e38\u6240\u8981\u6c42\u7684\u4e25\u683c\u6cd5\u5f8b\u6761\u4ef6\u7684\u60c5\u51b5\u4e0b\uff0c\u4e3a\u4e13\u5229\u6743\u4eba\u63d0\u4f9b\u5373\u65f6\u7684\u5e02\u573a\u4fdd\u62a4\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u6b65\u9aa4<\/strong><\/td><td><strong>\u8bf4\u660e<\/strong><\/td><\/tr><tr><td>\u63d0\u4ea4\u4eff\u5236\u836f\u7533\u8bf7<\/td><td>\u4eff\u5236\u836f\u7533\u8bf7\u4eba (PRH Generic) \u5411 NPRA \u63d0\u4ea4\u7b2c4\u7c7b\u7533\u8bf7\uff0c\u5e76\u58f0\u660e\u4ee5\u4e0b\u4e8b\u9879\u4e4b\u4e00\uff1a(a) \u4e0d\u5b58\u5728\u76f8\u5173\u4e13\u5229\uff1b(b) \u76f8\u5173\u4e13\u5229\u5df2\u7ecf\u5230\u671f\uff1b(c) \u76f8\u5173\u4e13\u5229\u65e0\u6548\u6216\u4ea7\u54c1\u4e0d\u4f1a\u6784\u6210\u4fb5\u6743\uff1b\u6216 (d) \u4ea7\u54c1\u62df\u5728\u4e13\u5229\u5230\u671f\u524d\u4e0a\u5e02\u3002 <\/td><\/tr><tr><td>\u9001\u8fbe\u4e66\u9762\u901a\u77e5<\/td><td>\u4eff\u5236\u836f\u7533\u8bf7\u4eba\u5411\u4e13\u5229\u6743\u4eba\/\u88ab\u8bb8\u53ef\u4eba\u53ca\u76f8\u5173\u65b0\u836f\u4ea7\u54c1\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u9001\u8fbe\u4e66\u9762\u901a\u77e5\u3002\u6536\u4ef6\u4eba\u5fc5\u987b\u57287\u5929\u5185\u786e\u8ba4\u6536\u5230\u901a\u77e5\u3002<\/td><\/tr><tr><td>45\u5929\u901a\u77e5\u671f<\/td><td class=\"translation-block\">\u5728\u5df2\u786e\u8ba4\u9001\u8fbe\u901a\u77e5\u5e76\u901a\u8fc7 QUEST3+ \u63d0\u4ea4\u9001\u8fbe\u8bc1\u660e\u540e\uff0cNPRA \u5f00\u59cb\u8ba1\u7b97 45 \u4e2a\u65e5\u5386\u65e5\u7684\u901a\u77e5\u671f\u3002\u5728\u6b64\u671f\u95f4\uff0cNPRA \u7ee7\u7eed\u8bc4\u4f30\u7533\u8bf7\uff0c\u4f46\u4e0d\u4f1a\u4f5c\u51fa\u6ce8\u518c\u51b3\u5b9a\u3002<\/td><\/tr><tr><td>\u6cd5\u5f8b\u7a0b\u5e8f\uff08\u5982\u6709\uff09<\/td><td>\u5982\u679c\u76f8\u5e94\u65b0\u836f\u4ea7\u54c1\u7684\u4e13\u5229\u6743\u4eba\u3001\u4e13\u5229\u88ab\u8bb8\u53ef\u4eba\u6216\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u572845\u5929\u901a\u77e5\u671f\u5185\u5411\u9a6c\u6765\u897f\u4e9a\u6cd5\u9662\u63d0\u8d77\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\uff0c\u5e76\u901a\u77e5NPRA\uff0c\u5219\u4f1a\u89e6\u53d1\u4e13\u5229\u94fe\u63a5\u673a\u5236\uff0c\u5bfc\u81f4NPRA \u6682\u505c\u4f5c\u51fa\u6ce8\u518c\u51b3\u5b9a\u3002<\/td><\/tr><tr><td>\u6700\u957f12\u4e2a\u6708\u7684\u6682\u505c<\/td><td class=\"translation-block\">\u5728\u6536\u5230\u6cd5\u5f8b\u7a0b\u5e8f\u5df2\u7ecf\u542f\u52a8\u7684\u901a\u77e5\u540e\uff0cNPRA \u5c06\u6682\u505c\u5176\u6ce8\u518c\u51b3\u5b9a\uff0c\u6700\u957f\u53ef\u8fbe12\u4e2a\u6708\u3002\u82e5\u6cd5\u9662\u88c1\u51b3\u3001\u53cc\u65b9\u8fbe\u6210\u548c\u89e3\u3001\u6848\u4ef6\u64a4\u56de\u6216\u4e13\u5229\u5230\u671f\uff0c\u5219\u6682\u505c\u671f\u53ef\u63d0\u524d\u7ed3\u675f\u3002<\/td><\/tr><tr><td>\u76d1\u7ba1\u7a0b\u5e8f\u6062\u590d<\/td><td>12\u4e2a\u6708\u6682\u505c\u671f\u5c4a\u6ee1\u540e\uff0cNPRA \u5c06\u6062\u590d\u76d1\u7ba1\u8bc4\u4f30\u5e76\u4f5c\u51fa\u6ce8\u518c\u51b3\u5b9a\uff0c\u65e0\u8bba\u76f8\u5173\u6cd5\u9662\u8bc9\u8bbc\u662f\u5426\u5df2\u7ecf\u7ed3\u675f\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"exceptions-to-the-patent-linkage-mechanism\" class=\"wp-block-heading\" style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.313), 18px);\"><strong>\u4e13\u5229\u94fe\u63a5\u673a\u5236\u7684\u4f8b\u5916\u60c5\u51b5<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u4ee5\u4e0b\u82e5\u5e72\u91cd\u8981\u60c5\u51b5\u4e0b\uff0c\u5305\u62ec45\u5929\u901a\u77e5\u671f\u53ca\u7b2c4\u7c7b\u7533\u8bf7\u6700\u957f12\u4e2a\u6708\u6682\u505c\u671f\u5728\u5185\u7684\u6574\u4e2a\u4e13\u5229\u94fe\u63a5\u673a\u5236\u5c06\u4e0d\u9002\u7528\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5f3a\u5236\u8bb8\u53ef\uff1a<\/strong> \u5df2\u6839\u636e\u300a1983\u5e74\u4e13\u5229\u6cd5\u300b(Patents Act 1983) \u6b63\u5f0f\u6388\u4e88\u5f3a\u5236\u8bb8\u53ef (compulsory license)\u3002<\/li>\n\n\n\n<li><strong>\u653f\u5e9c\u4f7f\u7528\uff1a<\/strong> \u5df2\u6839\u636e\u300a1983\u5e74\u4e13\u5229\u6cd5\u300b\u660e\u786e\u6388\u6743\u653f\u5e9c\u4f7f\u7528\u4e13\u5229\u6743\uff0c\u4ee5\u4fdd\u62a4\u516c\u5171\u536b\u751f\u5e76\u786e\u4fdd\u836f\u54c1\u53ef\u53ca\u6027\u3002<\/li>\n\n\n\n<li><strong>\u56fd\u5bb6\u7d27\u6025\u60c5\u51b5\uff1a<\/strong> \u5728\u516c\u5171\u536b\u751f\u7d27\u6025\u4e8b\u4ef6\u3001\u56fd\u5bb6\u5b89\u5168\u5371\u673a\u6216\u5176\u4ed6\u6781\u7aef\u7d27\u6025\u60c5\u51b5\u4e0b\uff0c\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u4e0d\u4f1a\u9650\u5236\u9a6c\u6765\u897f\u4e9a\u653f\u5e9c\u91c7\u53d6\u4efb\u4f55\u5fc5\u8981\u63aa\u65bd\u3002<\/li>\n<\/ul>\n\n\n\n<h2 id=\"interplay-with-post-grant-opposition-section-55a-of-malaysia-s-patents-act\" class=\"wp-block-heading has-medium-font-size\"><strong>\u4e0e\u4e13\u5229\u6388\u6743\u540e\u5f02\u8bae\u5236\u5ea6\u7684\u8854\u63a5\u2014\u2014\u300a\u9a6c\u6765\u897f\u4e9a\u4e13\u5229\u6cd5\u300b\u7b2c55A\u6761<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u7531\u4e8e\u5217\u5165 NPRA \u6570\u636e\u5e93\u7684\u4e13\u5229\u5177\u6709\u8f83\u9ad8\u7684\u516c\u5f00\u53ef\u89c1\u6027\uff0c\u4eff\u5236\u836f\u4f01\u4e1a\u53ef\u80fd\u4f1a\u6709\u8f83\u5f3a\u52a8\u529b\u5c3d\u65e9\u5bf9\u76f8\u5173\u4e13\u5229\u63d0\u51fa\u6311\u6218\u3002\u9a6c\u6765\u897f\u4e9a\u5bf9\u81ea2025\u5e7412\u670831\u65e5\u8d77\u751f\u6548\u7684\u4e13\u5229\u5f15\u5165\u4e86\u4e3a\u671f\u516d\u4e2a\u6708\u7684\u6388\u6743\u540e\u5f02\u8bae\u7a0b\u5e8f  (post-grant opposition)\u3002\n\u901a\u8fc7\u5bc6\u5207\u76d1\u6d4b\u77e5\u8bc6\u4ea7\u6743\u5b98\u65b9\u516c\u62a5\uff08IP Official Journal, IPOJ) \u4e2d\u65b0\u6388\u6743\u4e13\u5229\u7684\u516c\u544a\uff0c\u4eff\u5236\u836f\u751f\u4ea7\u5546\u53ef\u4ee5\u9009\u62e9\u5728\u4e13\u5229\u6388\u6743\u516c\u544a\u540e\u7684\u516d\u4e2a\u6708\u5f02\u8bae\u671f\u9650\u5185\u63d0\u4ea4\u6b63\u5f0f\u7684\u5f02\u8bae\u901a\u77e5\uff08Notice of Opposition\uff09\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">\u63d0\u51fa\u6388\u6743\u540e\u5f02\u8bae\u7684\u6cd5\u5b9a\u671f\u9650\u4e3a\u81ea\u4e13\u5229\u6388\u6743\u5728 IPOJ \u516c\u5e03\u4e4b\u65e5\u8d77\u6574\u6574\u516d\u4e2a\u6708\uff0c\u4e14\u8be5\u671f\u9650\u4e0d\u5f97\u5ef6\u957f\u3002\n\u5982\u679c\u9519\u8fc7\u8fd9\u4e00\u671f\u9650\uff0c\u901a\u8fc7 MyIPO \u63d0\u8d77\u884c\u653f\u64a4\u9500\u7a0b\u5e8f  (administration cancellation) \u7684\u9014\u5f84\u5c06\u6c38\u4e45\u5173\u95ed\u3002\u6b64\u540e\uff0c\u5982\u4eff\u5236\u836f\u4f01\u4e1a\u5e0c\u671b\u5728\u4e13\u5229\u5230\u671f\u524d\u8fdb\u5165\u5e02\u573a\uff0c\u5219\u53ef\u80fd\u9700\u8981\u4e3b\u52a8\u5411\u6cd5\u9662\u6311\u6218\u4e13\u5229\u6709\u6548\u6027\uff1b\u6216\u63d0\u4ea4\u7b2c4\u7c7b\u7533\u8bf7\uff0c\u63a5\u53d7\u53ef\u80fd\u957f\u8fbe12\u4e2a\u6708\u7684\u76d1\u7ba1\u6682\u505c\uff0c\u5e76\u5728\u6cd5\u9662\u8bc9\u8bbc\u4e2d\u6297\u8fa9\u4e13\u5229\u4fb5\u6743\u6307\u63a7\u3002<\/p>\n\n\n\n<h2 id=\"key-responsibilities-for-stakeholders\" class=\"wp-block-heading has-medium-font-size\"><strong>\u5404\u5229\u76ca\u76f8\u5173\u65b9\u7684\u4e3b\u8981\u8d23\u4efb<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u539f\u7814\u836f\u4f01\u4e1a\uff08PRH NDP\uff09:<\/strong> \u572830\u5929\u671f\u9650\u5185\u53ca\u65f6\u7ef4\u62a4\u548c\u66f4\u65b0\u4e13\u5229\u8bb0\u5f55\uff1b\u572845\u5929\u671f\u9650\u5185\u53ca\u65f6\u56de\u5e94\u7b2c4\u7c7b\u901a\u77e5\uff1b\n\u505a\u597d\u5e94\u5bf9\u65b0\u6388\u6743\u4e13\u5229\u6240\u9762\u4e34\u7684\u884c\u653f\u5f02\u8bae\u7684\u51c6\u5907\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4eff\u5236\u836f\u4f01\u4e1a\uff08PRH Generic\uff09:<\/strong> \u5728\u63d0\u4ea4\u7533\u8bf7\u524d\u8fdb\u884c\u4e25\u683c\u7684\u4e13\u5229\u5c3d\u804c\u8c03\u67e5\uff1b\u786e\u4fdd QUEST3+ \u4e2d\u7684\u4e13\u5229\u58f0\u660e\u51c6\u786e\u65e0\u8bef\uff1b\u5bc6\u5207\u76d1\u6d4b IPOJ\uff0c\u4ee5\u4fbf\u5145\u5206\u5229\u7528\u516d\u4e2a\u6708\u7684\u6388\u6743\u540e\u5f02\u8bae\u671f\u9650\u3002<\/p>\n\n\n\n<h2 id=\"practical-implications-for-patent-practitioners\" class=\"wp-block-heading has-medium-font-size\"><strong>\u5bf9\u4e13\u5229\u4ece\u4e1a\u4eba\u5458\u7684\u5b9e\u8df5\u610f\u4e49<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u9274\u4e8e\u66f4\u65b0 QUEST3+ \u8bb0\u5f55\u7684\u671f\u9650\u4e25\u683c\u9650\u5b9a\u4e3a30\u5929\uff0c\u65b0\u836f\u4ea7\u54c1\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u7684\u6cd5\u5f8b\u53ca\u76d1\u7ba1\u5408\u89c4\u56e2\u961f\u5e94\u786e\u4fdd\u5728\u4e13\u5229\u83b7\u5f97\u6388\u6743\u540e\u7acb\u5373\u901a\u77e5\u5176\u9a6c\u6765\u897f\u4e9a\u5f53\u5730\u7684\u4ea7\u54c1\u6ce8\u518c\u6301\u6709\u4eba\u3002&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u8ba1\u5212\u5728\u9a6c\u6765\u897f\u4e9a\u63a8\u51fa\u4eff\u5236\u836f\u4ea7\u54c1\u7684\u4f01\u4e1a\u800c\u8a00\uff0c\u4ea7\u54c1\u4e0a\u5e02\u65f6\u95f4\u5b89\u6392\u5e94\u5c0645\u5929\u7684\u901a\u77e5\u671f\u4ee5\u53ca\u5728\u542f\u52a8\u4e13\u5229\u4fb5\u6743\u8bc9\u8bbc\u7a0b\u5e8f\u540e\u53ef\u80fd\u957f\u8fbe12\u4e2a\u6708\u7684\u76d1\u7ba1\u6682\u505c\u671f\u7eb3\u5165\u8003\u91cf\u3002&nbsp;<\/p>\n\n\n\n<p 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class=\"wp-block-paragraph\">\u9a6c\u6765\u897f\u4e9a\u62df\u8bae\u7684\u836f\u54c1\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\uff0c\u662f\u8be5\u56fd\u836f\u54c1\u76d1\u7ba1\u4f53\u7cfb\u4e2d\u7684\u4e00\u9879\u91cd\u8981\u53d1\u5c55\u3002\n\u867d\u7136\u8fd9\u4e00\u5373\u5c06\u5b9e\u65bd\u7684\u5236\u5ea6\u4e0d\u4f1a\u6539\u53d8\u9a6c\u6765\u897f\u4e9a\u73b0\u6709\u7684\u5b9e\u4f53\u4e13\u5229\u6cd5\uff0c\u4f46\u5176\u5c06\u5f15\u5165\u4e00\u7cfb\u5217\u65b0\u7684\u7a0b\u5e8f\u6027\u4e49\u52a1\uff0c\u5e76\u8981\u6c42\u5236\u836f\u4f01\u4e1a\u5185\u90e8\u7684\u4e13\u5229\u3001\u76d1\u7ba1\u53ca\u5546\u4e1a\u56e2\u961f\u4e4b\u95f4\u8fdb\u884c\u66f4\u7d27\u5bc6\u7684\u534f\u8c03\u3002&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5236\u836f\u4f01\u4e1a\u53ca\u5176\u6cd5\u5f8b\u987e\u95ee\u5e94\u5c3d\u65e9\u719f\u6089\u62df\u8bae\u5236\u5ea6\uff0c\u5e76\u5728\u9884\u8ba1\u4e8e2027\u5e745\u6708\u5b9e\u65bd\u4e4b\u524d\uff0c\u5ba1\u67e5\u53ca\u5b8c\u5584\u5185\u90e8\u6d41\u7a0b\u3002<\/p>\n\n\n\n<div class=\"wp-block-stackable-button-group stk-block-button-group stk-block stk-25253f8\" data-block-id=\"25253f8\"><div class=\"stk-row stk-inner-blocks stk-block-content stk-button-group\">\n<div class=\"wp-block-stackable-button stk-block-button stk-block stk-14365cf\" data-block-id=\"14365cf\"><style>.stk-14365cf {margin-top:20px !important;}<\/style><a class=\"stk-link stk-button stk--hover-effect-darken\" href=\"https:\/\/henrygoh.com\/downloads\/malaysia-pharmaceutical-patent-linkage.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"stk-button__inner-text\">\u4e0b\u8f7d<\/span><\/a><\/div>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Malaysia\u2019s National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health has proposed the implementation of a formal patent linkage framework for pharmaceutical products. Driven by Malaysia\u2019s obligations under Article 18.53 of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), this administrative mechanism will formally tie the marketing authorization of generic drugs to the [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":190206,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_titles_title":"Malaysia Pharmaceutical Patent Linkage | Henry Goh","_seopress_titles_desc":"Learn about Malaysia\u2019s pharmaceutical patent linkage framework, including key deadlines and its implications for innovator and generic companies.","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"none","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"both","_seopress_redirections_param":"","_seopress_redirections_type":301,"_seopress_analysis_target_kw":"","_seopress_news_disabled":"","_seopress_video_disabled":"","_seopress_video":[],"_seopress_pro_schemas_manual":[],"_seopress_pro_rich_snippets_disable_all":"","_seopress_pro_rich_snippets_disable":[],"_seopress_pro_schemas":[],"_gspb_post_css":"","footnotes":""},"categories":[29],"tags":[],"coauthors":[62,78],"class_list":["post-189917","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletters"],"blocksy_meta":{"has_hero_section":"default","hero_elements":[{"id":"custom_title","enabled":true,"heading_tag":"h1","title":"\u9996\u9875","__id":"LhKibbgie_KB0gs2RY-FN"},{"id":"custom_description","enabled":true,"description_visibility":{"desktop":true,"tablet":true,"mobile":false},"__id":"BbqYAwZOs4SrppsWTpGYE"},{"id":"custom_meta","enabled":true,"meta_elements":[{"id":"author","enabled":true,"label":"By","has_author_avatar":"yes","avatar_size":25,"__id":"dEpg5iR4dgN1t-b3aVXVO"},{"id":"post_date","enabled":true,"label":"On","date_format_source":"default","date_format":"M j, Y","__id":"EEO-00WPIClMUFECodYO2"},{"id":"updated_date","enabled":false,"label":"On","date_format_source":"default","date_format":"M j, Y","__id":"SfeDbq6R6BCdKgmOaUGMp"},{"id":"categories","enabled":true,"label":"In","style":"simple","__id":"vD1AUntpDqW_jvE5JMoOo"},{"id":"comments","enabled":false,"__id":"pUATR_qSkcVRr13kQeee-"},{"id":"estimated_read_time","enabled":false,"__id":"gaq9ZcX0TOHEVzKuc-BAJ"}],"page_meta_elements":{"joined":true,"articles_count":true,"comments":true},"__id":"WePtQFp832cpD-EadLFBS","meta_type":"simple"},{"id":"breadcrumbs","enabled":false,"__id":"n59YLoB9QAklSr1ZGN49A"},{"id":"content-block","enabled":false,"__id":"fpVqR3hcs6qxX6cEA2Gi8"}],"styles_descriptor":{"styles":{"desktop":"","tablet":"","mobile":""},"google_fonts":[],"version":8}},"acf":[],"_links":{"self":[{"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/posts\/189917","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/comments?post=189917"}],"version-history":[{"count":0,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/posts\/189917\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/media\/190206"}],"wp:attachment":[{"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/media?parent=189917"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/categories?post=189917"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/tags?post=189917"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/henrygoh.com\/zh\/wp-json\/wp\/v2\/coauthors?post=189917"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}