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DEEP & FAR

 

 

 

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¦¹¥~¡A­Y±µ¨ü³o¨Ç±À´ú©ÊÅG¸Ñ¡A±N¤¹³\­ì¶}µoÃÄ»s³y°Ó¸g¥ÑÀò¨ú¨t¦C¤èªk±M§Q¤§®Ö­ã¡A¦Óºû«ù¨Æ¹ê¤W (de facto) µL´Á­­¿W®a¨Ï¥Î¸ÓÃĪ«¡AµM«á´§»R35 U.S.C.¡± 271(e)(2) ¤§¼C¡A¥H¹ï§Ü¥ô¦óÄvª§¹ï¤â¥HANDA´M¨D®Ö­ã¡A¥H¦æ¾P¥¼¨ü¸Ó±M§Q©Ò²[»\¡A¦Ó³Q®Ö­ã¥Î³~¤§«D±M§QÃĪ«¡C¾Ç¦WÃÄ»s³y°Ó¡A±N³Q¦³®Ä¦a§¹¥þ¸T¤î¶i¤J¥«³õ(Generic manu-facturers would effectively be barred altogether from entering the market)¡C¡¨(Warner-Lambert, 316 F.3d at 1359)

¥»°|¤£¦P·N¦¹¡± 271(e)(2) ¤§¿±µÈÆ[ÂI¡A¨ä«Y¹H¤Ïªk³W¤§³]­p¡C­Y¥¼±M§QÃĪ«¡A³Q¨Ï¥Î©ó¨ä«D±M§Q¤§¥Î³~¡A¦¹«Y ¡± 271(a) ½d³ò¥H¥~¤§§@¥Î(If an off-patent drug is being used for an unpatented use, that is activity beyond the scope of ¡± 271(a).)¡C

©Ò¥H»¼¥æANDA¡A¥H´M¨D¥¼±M§Q¤§ÃĪ«¯à¦æ¾P©ó¥¼±M§Q¤§¥Î³~¡A¨ä«Y¶W¥X ¡± 271(e)(2) ¤§½d³ò(So is filing an ANDA seeking to market an unpatented drug for an unpatented use beyond the scope of ¡± 271(e)(2))¡C