{"id":68346,"date":"2026-07-01T00:00:58","date_gmt":"2026-06-30T16:00:58","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=68346"},"modified":"2026-07-15T15:07:39","modified_gmt":"2026-07-15T07:07:39","slug":"%e3%82%b8%e3%82%a7%e3%83%8d%e3%83%aa%e3%83%83%e3%82%af%e5%8c%bb%e8%96%ac%e3%83%a1%e3%83%bc%e3%82%ab%e3%83%bc%e3%81%ae%e3%80%8c%e3%82%b9%e3%82%ad%e3%83%8b%e3%83%bc%e3%83%a9%e3%83%99%e3%83%ab%e3%80%8d","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/ja\/68346\/","title":{"rendered":"\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u30e1\u30fc\u30ab\u30fc\u306e\u300c\u30b9\u30ad\u30cb\u30fc\u30e9\u30d9\u30eb\u300d\u3067\u3082\u7279\u8a31\u4fb5\u5bb3\u306b\u306a\u308b\u306e\u304b\uff1f\u7c73\u56fd\u6700\u9ad8\u88c1\u5224\u62402026\u5e74Hikma v. Amarin\u4e8b\u4ef6"},"content":{"rendered":"
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\u672c\u4ef6\u306f\u6700\u9ad8\u88c1\u5224\u6240\u306b\u4e0a\u8a34\u3055\u308c\u3001\u6700\u9ad8\u88c1\u5224\u6240\u306f2026\u5e746\u67084\u65e5\u306b\u5224\u6c7a\u3092\u4e0b\u3057\u3001\u63a7\u8a34\u88c1\u5224\u6240\u306e\u5224\u6c7a\u3092\u7834\u68c4\u3057\u3066\u3001\u672c\u4ef6\u306b\u304a\u3044\u3066\u88ab\u544aHikma\u306f\u8a98\u5f15\u4fb5\u5bb3\u3092\u69cb\u6210\u3057\u306a\u3044\u3068\u5224\u65ad\u3057\u305f\u3002\u3053\u306e\u5224\u6c7a\u306f9\u4eba\u306e\u6700\u9ad8\u88c1\u5224\u4e8b\u306e\u5168\u54e1\u4e00\u81f4\u306b\u3088\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u30b8\u30e3\u30af\u30bd\u30f3\uff08Jackson\uff09\u5224\u4e8b\u306b\u3088\u3063\u3066\u6cd5\u5ef7\u610f\u898b\u304c\u57f7\u7b46\u3055\u308c\u305f[11]<\/a>\u3002<\/p>\n

\u5224\u6c7a\u3067\u306f\u3001\u7c73\u56fd\u7279\u8a31\u6cd5\u7b2c271\u6761(b)\u306b\u57fa\u3065\u304f\u7a4d\u6975\u7684\u8a98\u5f15\u4fb5\u5bb3\u306e\u4e3b\u5f35\u3092\u884c\u3046\u306b\u306f\u3001\u4ee5\u4e0b\u306e3\u3064\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308b\u3068\u6307\u6458\u3055\u308c\u305f\uff1a\uff081\uff09\u7b2c\u4e09\u8005\u306b\u3088\u308b\u76f4\u63a5\u4fb5\u5bb3\uff1b\uff082\uff09\u88ab\u544a\u304c\u300c\u8a98\u5f15\u3055\u308c\u305f\u884c\u70ba\u304c\u7279\u8a31\u4fb5\u5bb3\u3092\u69cb\u6210\u3059\u308b\u3053\u3068\u300d\u3092\u77e5\u3063\u3066\u3044\u308b\u3053\u3068\uff1b\uff083\uff09\u88ab\u544a\u304c\u76f4\u63a5\u4fb5\u5bb3\u3092\u4fc3\u3059\u305f\u3081\u306e\u300c\u7a4d\u6975\u7684\u306a\u30b9\u30c6\u30c3\u30d7\uff08active steps\uff09\u300d\u3092\u8e0f\u3093\u3067\u3044\u308b\u3053\u3068[12]<\/a>\u3002<\/p>\n

\u305d\u3057\u3066\u3001\u672c\u4ef6\u306f\u7b2c3\u306e\u8981\u4ef6\u3067\u3042\u308b\u300c\u7a4d\u6975\u7684\u306a\u30b9\u30c6\u30c3\u30d7\u300d\u306b\u95a2\u308f\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u7a4d\u6975\u7684\u306a\u30b9\u30c6\u30c3\u30d7\u306b\u306f\u3001\u300c\u76ee\u7684\u3092\u6301\u3061\u3001\u5e30\u8cac\u6027\u306e\u3042\u308b\u8868\u73fe\u304a\u3088\u3073\u884c\u70ba\u300d\u304c\u542b\u307e\u308c\u308b\u3002\u3059\u306a\u308f\u3061\u3001\u53d7\u52d5\u7684\u306a\u884c\u70ba\u3068\u306f\u5bfe\u7167\u7684\u306a\u3001\u300c\u671b\u307e\u3057\u3044\u7279\u8a31\u4fb5\u5bb3\u7d50\u679c\u3092\u4fc3\u9032\u3059\u308b\u300d\u305f\u3081\u306e\u300c\u7a4d\u6975\u7684\u306a\uff08affirmative\uff09\u300d\u884c\u70ba\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3055\u3089\u306b\u3001\u6700\u9ad8\u88c1\u5224\u6240\u306b\u3088\u308b\u5f93\u6765\u306e\u300c\u7a4d\u6975\u7684\u306a\u30b9\u30c6\u30c3\u30d7\u300d\u306e\u5b9a\u7fa9\u306b\u304a\u3044\u3066\u3001\u300c\u88fd\u54c1\u306e\u6d41\u901a\u306b\u95a2\u9023\u3059\u308b\u901a\u5e38\u306e\u884c\u70ba\u300d\u306f\u3059\u3067\u306b\u9664\u5916\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u3046\u3057\u305f\u884c\u70ba\u306f\u8cac\u4efb\u3092\u88cf\u4ed8\u3051\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3068\u3055\u308c\u3066\u304d\u305f[13]<\/a>\u3002<\/p>\n

\u672c\u4ef6\u306b\u304a\u3044\u3066\u3001Amarin\u306e\u4e3b\u5f35\u306f\u3001\u5358\u306b\u8d77\u3053\u308a\u5f97\u308b\u4e00\u9023\u306e\u51fa\u6765\u4e8b\u3092\u63d0\u793a\u3057\u3066\u3044\u308b\u306b\u3059\u304e\u306a\u304b\u3063\u305f\u3002\u3059\u306a\u308f\u3061\u3001\u300cHikma\u304c\u884c\u3063\u305f\u5404\u7a2e\u306e\u8aac\u660e\u3084\u9673\u8ff0\u306b\u3088\u308a\u3001\u533b\u7642\u63d0\u4f9b\u8005\u304c\u2026\u60a3\u8005\u306e\u5fc3\u8840\u7ba1\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u305f\u3081\u306bHikma\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u3092\u51e6\u65b9\u307e\u305f\u306f\u8abf\u5264\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u300d\u3068\u3044\u3046\u3082\u306e\u3067\u3042\u3063\u305f\u3002\u3057\u304b\u3057\u3001\u5224\u6c7a\u3067\u306f\u3001\u3044\u308f\u3086\u308b\u300c\u7a4d\u6975\u7684\u306a\u884c\u70ba\u300d\u306e\u544a\u767a\u306f\u3001\u300c\u66d6\u6627\u306a\u300d\u6587\u8a00\u306b\u300c\u4ed6\u8005\u306e\u884c\u70ba\u306b\u5bfe\u3059\u308b\u63a8\u6e2c\u3092\u4ed8\u3051\u52a0\u3048\u305f\u300d\u3060\u3051\u306e\u3082\u306e\u306b\u57fa\u3065\u3044\u3066\u306f\u306a\u3089\u306a\u3044\u3068\u3055\u308c\u305f[14]<\/a>\u3002<\/p>\n

\u672c\u4ef6\u306e\u88ab\u544aHikma\u306e\u95a2\u9023\u9673\u8ff0\u306f\u3001\u6700\u7d42\u7684\u306b\u7a4d\u6975\u7684\u306a\u884c\u70ba\u3092\u69cb\u6210\u3057\u306a\u3044\u3068\u5224\u5b9a\u3055\u308c\u305f<\/span><\/p>\n

\u4e0a\u8a18\u306e\u57fa\u6e96\u3092\u9069\u7528\u3057\u3001\u6700\u9ad8\u88c1\u306f\u3001Amarin\u306e\u4e3b\u5f35\u306f\u300c\u5358\u306a\u308b\u53ef\u80fd\u6027\u300d\u3092\u63d0\u793a\u3057\u3066\u3044\u308b\u306b\u3059\u304e\u305a\u3001\u305d\u308c\u3060\u3051\u3067\u306fHikma\u306e\u884c\u70ba\u304c\u7a4d\u6975\u7684\u306a\u8a98\u5f15\u4fb5\u5bb3\u3092\u69cb\u6210\u3059\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3068\u5224\u65ad\u3057\u305f[15]<\/a>\u3002<\/p>\n

\u7b2c1\u306b\u3001<\/b> Hikma\u304c\u6307\u6458\u3055\u308c\u305f\u3044\u304f\u3064\u304b\u306e\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u8aac\u660e\u306f\u3001\u5b9f\u969b\u306b\u306f\u6cd5\u5f8b\u3092\u9075\u5b88\u3057\u3066\u3044\u308b\u304b\u3001\u3042\u308b\u3044\u306f\u696d\u754c\u306e\u6a19\u6e96\u306b\u5f93\u3063\u3066\u3044\u308b\u3082\u306e\u3067\u3042\u308b\u3002Hikma\u306e\u6dfb\u4ed8\u6587\u66f8\u306b\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308b\u60c5\u5831\u304c\u6b8b\u3055\u308c\u3066\u3044\u305f\u306e\u306f\u3001\u6cd5\u4ee4\u306b\u3088\u308a\u3001Hikma\u306e\u6dfb\u4ed8\u6587\u66f8\u306f\u524a\u9664\u3055\u308c\u305f\u9069\u5fdc\u75c7\u3092\u9664\u3044\u3066\u3001\u539f\u544aAmarin\u306e\u6dfb\u4ed8\u6587\u66f8\u3068\u540c\u4e00\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u305f\u3081\u3067\u3042\u308b[16]<\/a>\u3002\u307e\u305f\u3001\u533b\u85ac\u54c1\u3092\u5148\u767a\u533b\u85ac\u54c1\u306e\u300c\u540c\u7b49\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u300d\u3068\u8aac\u660e\u3059\u308b\u3053\u3068\u306f\u3001\u901a\u5e38\u306e\u696d\u754c\u306e\u6163\u884c\u3067\u3042\u308b[17]<\/a>\u3002<\/p>\n

\u7b2c2\u306b\u3001<\/b> \u88c1\u5224\u6240\u306f\u8a98\u5f15\u8cac\u4efb\u3092\u69cb\u6210\u3059\u308b\u3088\u3046\u306a\u7a4d\u6975\u7684\u306a\u9673\u8ff0\u3084\u884c\u70ba\u3092\u898b\u51fa\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u88ab\u544a\u306b\u300c\u5358\u306a\u308b\u7701\u7565\u3001\u4e0d\u4f5c\u70ba\u3001\u307e\u305f\u306f\u4f5c\u70ba\u306e\u6020\u6162\u300d\u304c\u3042\u3063\u305f\u3068\u4e3b\u5f35\u3059\u308b\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3002\u4f8b\u3048\u3070\u3001\u539f\u544a\u306f\u3001\u88ab\u544a\u306e\u30b9\u30ad\u30cb\u30fc\u30e9\u30d9\u30eb\u306b\u304a\u3044\u3066\u5fc3\u8840\u7ba1\u4f7f\u7528\u5236\u9650\u306e\u8aac\u660e\u304c\u7701\u7565\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3084\u3001\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u306b\u304a\u3044\u3066\u300cHikma\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u7528\u9014\u304c\u3001\u77e5\u540d\u5ea6\u306e\u4f4e\u3044SH\u9069\u5fdc\u75c7\u306b\u9650\u5b9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u300d\u306b\u8a00\u53ca\u3057\u3066\u3044\u306a\u3044\u3068\u4e3b\u5f35\u3057\u305f\u304c\u3001\u3053\u308c\u3060\u3051\u3067\u306f\u7a4d\u6975\u7684\u306a\u8a98\u5f15\u884c\u70ba\u3092\u69cb\u6210\u3059\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b[18]<\/a>\u3002<\/p>\n

\u7b2c3\u306b\u3001<\/b> \u539f\u544a\u304c\u6307\u6458\u3059\u308bHikma\u306e\u305d\u306e\u4ed6\u306e\u9673\u8ff0\u306f\u3001\u3044\u305a\u308c\u3082\u6975\u3081\u3066\u66d6\u6627\u3067\u3042\u308a\u3001\u8a98\u5f15\u4fb5\u5bb3\u306e\u8cac\u4efb\u3092\u88cf\u4ed8\u3051\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3002\u5177\u4f53\u7684\u306a\u5185\u5bb9\u306f\u4ee5\u4e0b\u306e3\u70b9\u3067\u3042\u308b\u3002<\/p>\n

\uff081\uff09\u60a3\u8005\u5411\u3051\u60c5\u5831\u30ea\u30fc\u30d5\u30ec\u30c3\u30c8\u306b\u304a\u3051\u308b\u5fc3\u8840\u7ba1\u75be\u60a3\u60a3\u8005\u3078\u306e\u526f\u4f5c\u7528\u306e\u8b66\u544a\u3001\u304a\u3088\u3073\u3001\u5f53\u8a72\u85ac\u5264\u304c\u6642\u3068\u3057\u3066\u4ed6\u306e\u7528\u9014\u306b\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u65e8\u306e\u514d\u8cac\u4e8b\u9805\u306b\u3064\u3044\u3066\u3001\u3053\u308c\u304c\u533b\u7642\u63d0\u4f9b\u8005\u306b\u3088\u308b\u4fb5\u5bb3\u3092\u8a98\u5f15\u3059\u308b\u3068\u544a\u767a\u3059\u308b\u3053\u3068\u306f\u3001\u3042\u307e\u308a\u306b\u3082\u8fc2\u56de\u7684\u304b\u3064\u9593\u63a5\u7684\u3067\u3042\u308a\u3001\u4fe1\u6191\u6027\u306b\u6b20\u3051\u308b[19]<\/a>\u3002<\/p>\n

\uff082\uff09\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u304a\u3044\u3066\u6cbb\u7642\u30ab\u30c6\u30b4\u30ea\u3092\u300c\u9ad8\u30c8\u30ea\u30b0\u30ea\u30bb\u30ea\u30c9\u8840\u75c7\u300d\u3068\u8aac\u660e\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u5f53\u8a72\u85ac\u3092\u300cAB\u300d\u30ec\u30fc\u30c6\u30a3\u30f3\u30b0\u3068\u8868\u8a18\u3057\u3066\u3044\u308b\u3053\u3068\u3082\u3001\u4ed6\u8005\u306b\u300c\u7279\u8a31\u4fb5\u5bb3\u3092\u4fc3\u3057\u3066\u3044\u308b\u300d\u3068\u611f\u3058\u3055\u305b\u308b\u3088\u3046\u306a\u9673\u8ff0\u3068\u3057\u3066\u306f\u4e0d\u5341\u5206\u3067\u3042\u308b\u3002\u7279\u306b\u3001\u5f53\u8a72\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u304a\u3044\u3066\u3001Hikma\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u304cVascepa\u306e\u3059\u3079\u3066\u306e\u627f\u8a8d\u9069\u5fdc\u75c7\u306b\u9069\u7528\u3055\u308c\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3053\u3068\u304c\u660e\u78ba\u306b\u3055\u308c\u3066\u3044\u308b\u72b6\u6cc1\u4e0b\u3067\u306f\u306a\u304a\u3055\u3089\u3067\u3042\u308b[20]<\/a>\u3002<\/p>\n

\uff083\uff09\u539f\u544a\u306f\u3001Hikma\u306e\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u306b\u304a\u3044\u3066\u3001SH\u9069\u5fdc\u75c7\u3068\u5fc3\u8840\u7ba1\u9069\u5fdc\u75c7\u306e2\u3064\u306e\u7528\u9014\u306b\u304a\u3051\u308b\u58f2\u4e0a\u9ad8\u306e\u6570\u5024\u3092\u4e26\u3079\u3066\u8a18\u8f09\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u3001\u4ed6\u8005\u306b\u5bfe\u3057\u3066\u7279\u8a31\u4fdd\u8b77\u3055\u308c\u305f\u5fc3\u8840\u7ba1\u9069\u5fdc\u75c7\u3078\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u4f7f\u7528\u3092\u63a8\u5968\u3057\u3066\u3044\u308b\u3068\u4e3b\u5f35\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u88c1\u5224\u6240\u306f\u3001\u3053\u308c\u306f\u5358\u306a\u308b\u61b6\u6e2c\u306b\u3059\u304e\u306a\u3044\u3068\u5224\u65ad\u3057\u305f\u3002\u3053\u306e\u61b6\u6e2c\u304c\u6210\u308a\u7acb\u3064\u305f\u3081\u306b\u306f\u3001\u533b\u7642\u63d0\u4f9b\u8005\u304c\u305d\u308c\u3089\u306e\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u3092\u691c\u7d22\u3057\u3066\u901a\u8aad\u3057\u3001\u5f15\u7528\u3055\u308c\u305f\u58f2\u4e0a\u6570\u5024\u306e\u610f\u5473\u3092\u7406\u89e3\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u533b\u85ac\u54c1\u8ca9\u58f2\u306b\u95a2\u3059\u308b\u80cc\u666f\u77e5\u8b58\u3092\u6301\u3061\u3001\u3055\u3089\u306b\u305d\u306e\u4e8b\u5b9f\u304b\u3089\u3001\u30b9\u30bf\u30c1\u30f3\u88fd\u5264\u3092\u3059\u3067\u306b\u670d\u7528\u3057\u3066\u3044\u308b\u9ad8\u30c8\u30ea\u30b0\u30ea\u30bb\u30ea\u30c9\u8840\u75c7\u60a3\u8005\u306b\u5bfe\u3057\u3066Hikma\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u51e6\u65b9\u3092\u958b\u59cb\u3059\u308b\u3088\u3046\u306b\u4fc3\u3059\u300c\u5fae\u5999\u306a\u63a8\u5968\u300d\u3092\u63a8\u8ad6\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u3089\u306e\u4e00\u9023\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u53ef\u80fd\u6027\u3068\u3057\u3066\u306f\u5b58\u5728\u3059\u308b\u3082\u306e\u306e\u3001\u5408\u7406\u7684\u306b\u8d77\u3053\u308a\u5f97\u308b\u3053\u3068\uff08plausible\uff09\u3068\u306f\u8a00\u3048\u306a\u3044[21]<\/a>\u3002<\/p>\n

\u5099\u8003\uff1a<\/p>\n

    \n
  1. [1]<\/a> Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1396 (2026).<\/li>\n
  2. [2]<\/a> Id. at 1398.<\/li>\n
  3. [3]<\/a> 21 U.S.C. \u00a7 355(j)(2)(A)(vii)(IV).<\/li>\n
  4. [4]<\/a> Hikma Pharms., 146 S. Ct. at 1398.<\/li>\n
  5. [5]<\/a> Id. at 1398.<\/li>\n
  6. [6]<\/a> 21 U.S.C. \u00a7 355(j)(2)(A)(viii).<\/li>\n
  7. [7]<\/a> Hikma Pharms., 146 S. Ct. at 1398.<\/li>\n
  8. [8]<\/a> Id. at 1398-99.<\/li>\n
  9. [9]<\/a> Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 578 F. Supp. 3d 642, 647 (D. Del. 2022).<\/li>\n
  10. [10]<\/a> Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024).<\/li>\n
  11. [11]<\/a> Hikma Pharms., 146 S. Ct. 1396.<\/li>\n
  12. [12]<\/a> Id. at 1397-1398.<\/li>\n
  13. [13]<\/a> Id. at 1399-1400.<\/li>\n
  14. [14]<\/a> Id. at 1400-1401.<\/li>\n
  15. [15]<\/a> Id. at 1401-1403.<\/li>\n
  16. [16]<\/a> 21 U.S.C. \u00a7 355(j)(2)(A)(v).<\/li>\n
  17. [17]<\/a> Hikma Pharms., 146 S. Ct. 1401.<\/li>\n
  18. [18]<\/a> Id. at 1402.<\/li>\n
  19. [19]<\/a> Id. at 1402.<\/li>\n
  20. [20]<\/a> Id. at 1402.<\/li>\n
  21. [21]<\/a> Id. at 1403.<\/li>\n<\/ol>\n

    \u8cac\u4efb\u7de8\u96c6\uff1a<\/b>\u76e7\u980e<\/strong><\/p>\n

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