{"id":10343,"date":"2025-01-23T13:34:46","date_gmt":"2025-01-23T13:34:46","guid":{"rendered":"https:\/\/www.dhenne-avocats.fr\/?post_type=lexique&#038;p=10343"},"modified":"2026-10-22T23:11:02","modified_gmt":"2026-10-22T23:11:02","slug":"exception-bolar","status":"publish","type":"lexique","link":"https:\/\/www.dhenne-avocats.fr\/ja\/lexique-propriete-intellectuelle\/exception-bolar\/","title":{"rendered":"\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\uff08exception Bolar\uff09"},"content":{"rendered":"<p><br \/>\n<\/p>\n<p><strong>\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\uff08exception Bolar\uff09<\/strong>\u306f\u3001\u7279\u8a31\u306b\u3088\u308b\u4fdd\u8b77\u671f\u9593\u4e2d\u306b\u3001<strong>\u8ca9\u58f2\u627f\u8a8d\uff08AMM\uff09<\/strong>\u306e\u6e96\u5099\u306b\u5fc5\u8981\u306a\u4e00\u5b9a\u306e\u884c\u70ba\u3092\u884c\u3046\u3053\u3068\u3092\u8a31\u5bb9\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u305d\u306e\u7bc4\u56f2\u306f\u9069\u7528\u3055\u308c\u308b\u6cd5\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u4f8b\u5916\u306f\u3001\u3042\u3089\u3086\u308b\u7814\u7a76\u958b\u767a\u6d3b\u52d5\u3092\u5bfe\u8c61\u3068\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u305d\u308c\u5358\u72ec\u3067\u5546\u696d\u7684\u4e0a\u5e02\u3092\u6b63\u5f53\u5316\u3059\u308b\u3082\u306e\u3067\u3082\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<h3><strong>\u539f\u5247<\/strong><\/h3>\n<p>\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\u306f\u3001\u7b2c\u4e09\u8005\u304c<a href=\"https:\/\/www.dhenne-avocats.fr\/ja\/lexique-propriete-intellectuelle\/brevet\/\"><strong>\u7279\u8a31<\/strong><\/a>\u6a29\u8005\u306e\u540c\u610f\u306a\u304f\u3001\u88fd\u54c1\u3001\u4e00\u822c\u7684\u306b\u306f\u533b\u85ac\u54c1\u306e<a href=\"https:\/\/www.dhenne-avocats.fr\/ja\/lexique-propriete-intellectuelle\/autorisation-de-mise-sur-le-marche-amm\/\"><strong>\u8ca9\u58f2\u627f\u8a8d\uff08AMM\uff09<\/strong><\/a>\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u898f\u5236\u4e0a\u306e\u7533\u8acb\u8cc7\u6599\u3092\u6e96\u5099\u3059\u308b\u76ee\u7684\u3067\u3001\u7279\u8a31\u767a\u660e\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u8a8d\u3081\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u4f8b\u5916\u306f\u3001\u7279\u8a31\u306e\u6e80\u4e86\uff08\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u6570\u5e74\u3092\u8981\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\uff09\u3092\u5f85\u3064\u3053\u3068\u306a\u304f\u3001\u5f8c\u767a\u533b\u85ac\u54c1\u306e\u4e0a\u5e02\u306b\u5fc5\u8981\u306a\u4f5c\u696d\u306b\u3067\u304d\u308b\u9650\u308a\u65e9\u671f\u306b\u7740\u624b\u3059\u308b\u3053\u3068\u3092\u4f01\u696d\u306b\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001<strong>\u7af6\u4e89\u3092\u4fc3\u9032\u3059\u308b<\/strong>\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3><strong>\u56fd\u969b\u7684\u304a\u3088\u3073\u6b27\u5dde\u7684\u6587\u8108\u306b\u304a\u3051\u308b\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\uff1a<\/strong><\/h3>\n<ol>\n<li><strong>\u7c73\u56fd<\/strong>\uff1a\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\u306f\u3001\u7c73\u56fd\u306b\u304a\u3044\u3066\u30011984\u5e74\u306e<strong>Drug Price Competition and Patent Term Restoration Act<\/strong>\u3001\u3044\u308f\u3086\u308b<a href=\"https:\/\/www.fda.gov\/drugs\/abbreviated-new-drug-application-anda\/hatch-waxman-letters\"><strong>Hatch-Waxman Act<\/strong><\/a>\u306e\u67a0\u7d44\u307f\u306e\u4e2d\u3067\u8a8d\u3081\u3089\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u6cd5\u5f8b\u306f\u3001\u5f8c\u767a\u533b\u85ac\u54c1\u306e\u88fd\u9020\u696d\u8005\u304c\u3001<strong>\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/strong>\u3078\u306e<strong>AMM\u7533\u8acb<\/strong>\u3092\u6e96\u5099\u3059\u308b\u305f\u3081\u3001\u7279\u8a31\u306e\u6e80\u4e86\u524d\u306b\u88fd\u54c1\u306e\u88fd\u9020\u304a\u3088\u3073\u8a66\u9a13\u3092\u958b\u59cb\u3059\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u4ed5\u7d44\u307f\u306f\u3001\u7279\u8a31\u6e80\u4e86\u524d\u306b\u898f\u5236\u4e0a\u306e\u6e96\u5099\u3092\u884c\u3046\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong>\u6b27\u5dde\u9023\u5408<\/strong>\uff1a<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/FR\/TXT\/PDF\/?uri=CELEX:32004L0027\">\u6307\u4ee42004\/27\/EC<\/a>\u306b\u3088\u308b\u6539\u6b63\u5f8c\u306e\u6307\u4ee42001\/83\/EC\u7b2c10\u6761\u7b2c6\u9805\u306f\u3001\u540c\u6761\u7b2c1\u9805\u304b\u3089\u7b2c4\u9805\u306b\u5b9a\u3081\u308b\u624b\u7d9a\u306b\u5fc5\u8981\u306a\u7814\u7a76\u304a\u3088\u3073\u8a66\u9a13\u3001\u306a\u3089\u3073\u306b\u305d\u308c\u306b\u4f34\u3046\u5b9f\u52d9\u4e0a\u306e\u8981\u4ef6\u3092\u3001\u7279\u8a31\u6a29\u304a\u3088\u3073SPC\u306e\u52b9\u529b\u304b\u3089\u9664\u5916\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u624b\u7d9a\u306f\u3001\u7279\u306b\u5f8c\u767a\u533b\u85ac\u54c1\u304a\u3088\u3073\u4e00\u5b9a\u306e\u985e\u4f3c\u751f\u7269\u5b66\u7684\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u898f\u5247\uff08EC\uff09\u7b2c469\/2009\u53f7\u306fSPC\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u3053\u306e\u4f8b\u5916\u3092\u5c0e\u5165\u3057\u305f\u6cd5\u4ee4\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/li>\n<li><strong>\u4e16\u754c\u8cbf\u6613\u6a5f\u95a2\uff08WTO\uff09<\/strong>\uff1aWTO\u306e\u67a0\u7d44\u307f\u3067\u4ea4\u6e09\u3055\u308c\u305f<a href=\"https:\/\/www.dhenne-avocats.fr\/ja\/lexique-propriete-intellectuelle\/accord-sur-les-adpic\/\"><strong>\u77e5\u7684\u6240\u6709\u6a29\u306e\u8cbf\u6613\u95a2\u9023\u306e\u5074\u9762\u306b\u95a2\u3059\u308b\u5354\u5b9a\uff08TRIPS\u5354\u5b9a\uff09<\/strong><\/a>\u306f\u3001\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\u306b\u95a2\u3059\u308b\u7279\u5225\u306e\u898f\u5b9a\u3092\u542b\u3093\u3067\u3044\u307e\u305b\u3093\u304c\u3001\u4e00\u5b9a\u306e\u5834\u5408\u3001\u7279\u306b\u4fdd\u5065\u5f53\u5c40\u3078\u306e\u7533\u8acb\u3092\u76ee\u7684\u3068\u3059\u308b<strong>\u5f8c\u767a\u533b\u85ac\u54c1\u306e\u88fd\u9020<\/strong>\u306b\u3064\u3044\u3066\u3001\u7279\u8a31\u306e\u6392\u4ed6\u6a29\u306b\u5bfe\u3059\u308b\u4f8b\u5916\u3092\u8a8d\u3081\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ol>\n<h3><strong>\u30dc\u30fc\u30e9\u30fc\u4f8b\u5916\u306e\u9069\u7528\u8981\u4ef6<\/strong><\/h3>\n<p>\u30d5\u30e9\u30f3\u30b9\u3067\u306f\u3001<a 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