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Sunovion Pharma., Inc. v. Teva Pharms. USA, Inc. 
(Fed. Cir. Sept. 26, 2013)(¨µ°jªk°|ªk©xLourie¡BSchall¤ÎReyna¥D«ù¡F·N¨£®Ñ¡GLourie)
(¥ÑD.N.J., Wigenton, J. ¤W¶D)
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®×¥ó¥»½è¤Î·í«eª§ÂI¡GSunovion¤½¥q¹ï¦a¤èªk°|±Â¤©¤£«IÅv²©ö§P¨Mªº·N¨£¡A´£¥X¤W¶D¡C¡¦673¸¹±M§Q«ü¦V¤@ºØ¥ª«¬¦õ¤Ç§J¶©(eszopiclone)[1]³æÃè¹³²§ºcª«ÃĪ«²Õ¦Xª«¡A¥ª«¬¦õ¤Ç§J¶©¬O½Ð¨D¶µ¤¤´¦ÅSªº¤Æ¾Ç¤Æ¦Xª«ªº¥ª«¬Ãè¹³²§ºcª«¡A¥¦¦b¥~®ø±Ûªº§Î¦¡¤U«h³QºÙ¬°¦õ¤Ç§J¶©(zopiclone)¡CÁp¨¹ÃĪ«­¹«~ºÞ²z§½­n¨D¨C¤@¿õ¾|¥§´µ¶ð¥]§t¤£¦h©ó(NMT)¦Ê¤À¤§0.3¥ª«¬¦õ¤Ç§J¶©©Ò¹ïÀ³ªº¥ª±ÛÃè¹³²§ºcª«¡A¥k«¬¦õ¤Ç§J¶©¡C¦a¤èªk°|±N¨ä§P¨M³¡¤À°ò©ó©Ò¥D±iªº½Ð¨D¶µ¤¤¡u°ò¥»¤W¨S¦³¡vªº­­¨îªº¥Î»y¸ÑÄÀ¤Î¹p­}³Õ¤h¹ï¥¦À³¸Ó­n¿í¦u¥¦ªº¤º³¡¥Í²£·Ç«hªº«OÃÒ¬°«e´£¡A¦a¤èªk°|¸ÑÄÀ¸Ó¥Î»y¡u°ò¥»¤W¨S¦³¡v·N«ü¡u¤Ö©ó¦Ê¤À¤§0.25ªº¥ª±Û²§ºcª«¡v¡C¦b¤W¶D¤¤¡ASunovion¤½¥q¥D±i¸Ó½Ð¨D¶µ­­¨îÀ³¬°¡u¥D­n¬O¡A¦ý¤£§¹¥þ¨S¦³¥ª±Û²§ºcª«¡A¨ä¥]§t¤j©ó¥ª¤Ç§J¶©Á`­«¬ù¦Ê¤À¤§90­«¶qªº¥k±Û²§ºcª«¡v¡CÁp¨¹¨µ°jªk°|»é¦^Sunovion¤½¥qªº¸ÑÄÀ¡C¸Ó³N»y¡u°ò¥»¤W¨S¦³¡v¶È¥X²{¦b½Ð¨D¶µ¤¤¡A¦Ó¥¼¥X²{¦b®Ñ­±±Ô­z¤¤ªº¥ô¦ó¦a¤è¡A¦ý¦b¥Ó½Ð¹Lµ{¤¤¡A¬°¤F§JªAÅã¦Ó©ö¨£©Ê®Ö»é¡A¥Ó½Ð¤H«ü¥X½d¨Ò1¡A¤Î§e°e¦@¦Pµo©ú¤H³¯­z¡u¦p©Ò­z½d¨Ò1¡vªº¥ª¤Ç§J¶©ªº¥k±Û²§ºcª«¡u¯Âºé«¬¡v¥]§t¡u§C©ó¦Ê¤À¤§0.25ªº¥k±Û²§ºcª«¡vªº«Å»}®Ñ¡C°ò©ó¥Ó½Ð¹Lµ{´Á¶¡ªº¨º¨Ç³¯­z¤Î¨ä¥L¸ê®Æ¡AÁp¨¹¨µ°jªk°|½T»{¤F¦a¤èªk°|ªº¸ÑÄÀ¡C¾¨ºÞ½T»{¤F¸Ó¸ÑÄÀ¡AÁp¨¹¨µ°jªk°|±À½¤F¦a¤èªk°|ªº¤£«IÅvªºµô¨M¡C

Sunovion¤½¥q¦ó¥H³Ó¶D¡G¹p­}³Õ¤hªº­×¥¿Â²©ö·sÃĥӽдM¨DFDA¹ï§t¦³¦Ê¤À¤§0.0~0.6¥ª±Û²§ºcª«ªº¾Ç¦W¥ª«¬¦õ¤Ç§J¶©³\¥i¡CÁp¨¹¨µ°j¤W¶Dªk°|ªí¥Ü¡A¥Ñ©ó©Ò½Ð¨Dªº½d³ò¸¨¤J¥Î»y¡u°ò¥»¤W¨S¦³¡v¡A³o¤@¨Æ¹ê¥»¨­³y¦¨«IÅvªºµ²½×¡C¹p­}³Õ¤hª§ÅG¹D¡A¥¦¨S¦³«IÅv¡A¦]¬°¥¦ªº¤º³¡¥Í²£·Ç«h­n¨D¥¦ªº¾Ç¦W¥ª«¬¦õ¤Ç§J¶©²£«~¥]§t¦Ü¤Ö¦Ê¤À¤§0.3ªº¥ª±Û²§ºcª«¡A¹p­}³Õ¤h¶i¤@¨B´£¨Ñ¥¦À³¸Ó¾P°â§t¦³0.3~0.6¥ª±Û²§ºcª«ªºÃĤùªº»{ÃÒµ¹¦a¤èªk°|¡C³Ì«á¡A¹p­}³Õ¤hÅGºÙ¹D¡A¦b¥¦¤W¥««á¡A¦pSunovion¤½¥qªº´ú¸Õµ²ªGÀ³Åã¥Ü¤F¤@­Ó¸û¤pªº¦Ê¤À¤ñ¡ASunovion¤½¥q¬O¥i¦Û¥Ñ¹ï¹p­}³Õ¤h´£¥X§i¶Dªº¡CÁp¨¹¨µ°jªk°|¨Ã¥¼³Q¹p­}³Õ¤hªº¥ô¦ó½×­z©Ò»¡ªA¡C

¦bHatch-Waxmanªk®×ªº¬[ºc¤U¡A¥Ó½ÐANDAªº¦æ¬°¬O¥qªkºÞÁҥتº¤U«IÅvªº§Þ³N©Ê¦æ¬°¡A¦ý³Ì²×ªº«IÅv°ÝÃD¬O¥Ñ¶Ç²Îªº±M§Qªk­ì«h©Ò¨M©w¡A¨Ã»EµJ©ó¥¿¦b½Ð¨DFDA³\¥iªºANDA¥Ó½Ð¤Hªº²£«~¡A¹p­}³Õ¤hªº¦æ¬°µLªk§JªA¥¦½Ð¨DFDA³\¥i©M§Æ±æ¦¬¨ìFDA³\¥i¾P°â¦b¨tª§±M§Q½d³ò¤ºªº¤@²£«~ªº¨Æ¹ê¡Cªk°|©ú½T¦aªí¥Ü¡A·í¥L¥¿¦b½Ð¨D©M¦³¥i¯à¦¬¨ìFDA³\¥i¦Ó¾P°â¦b³Ð·sªÌªº±M§Q½d³ò¤ºªº¤@²£«~¡A°ò©ó¥¦«D±`³Wªº¤ÎµLªk±j¨î°õ¦æªº¡u«OÃÒ¡v¡A­ã³\¹p­}°jÁ׫IÅvÀ³¸Ó¤£²Å¦X±M§Qªkªº°ò¥»­ì«h¡C

 

Pronova Biopharma Norge v. Teva Pharma. USA, Inc. (Fed. Cir. Sept. 12, 2013)

(¨µ°jªk°|ªk©xDyk¡BO¡¦Malley¤ÎWallach¥D«ù¡F·N¨£®Ñ¡GO¡¦Malley)

(¥ÑD. Del., Robinson, J. ¤W¶D)

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®×¥ó¥»½è¤Î¨ã³¯ª§ÂI¡G¨ã³¯ª§ÂI«Y¬°¡¦667¸¹±M§Q¤¤¥D±iªºµo©ú¬O§_¦b¡¦667¸¹±M§Q¥Ó½Ð®×¥Ó½Ð«e¶W¹L¤@¦~´N¤w¥ÑPronova¤½¥qªº«e¨­¤½¥q¹ï¥~¤½¶}¡C¨ãÅ骺»¡¡Aªk°|³Q´£½Ð¼f²z«Yª§±M§Q¤¤¥D±iªº¹w´Á¥Î³~(°ª¥Ìªo¤Tà­¦å¯gªºªvÀø)¥H¥~ªº¨Ï¥Î¡A¬O§_ºc¦¨±M§Qªk²Ä102(b)±ø¤Uªº¤@µL®Ä¤Æªº¤½²³¥Î³~¦¹¤ÀÂ÷ªº°ÝÃD¡C

¦a¤èªk°|¹E¦æªk©x¼f²z¨Ã»{©wTeva²©ö·sÃĥӽЪº²£«~«I¥Ç¤F©Ò¦³¡¦667¸¹±M§Q¤Î¡¦077¸¹±M§Q´£¥Xªº¥Ó½Ð±M§Q½d³ò¡A¦Ó¥B¸Ó¨â¥ó±M§Q¬O¦³®Ä¨Ã¥i¹ê¬Iªº¡CTeva¤½¥q¤W¶D¡CÁp¨¹¨µ°jªk°|±À½¨Ãµo¦^¸Ó®×¥ó¦Ü¦a¤èªk°|­«¼f¡A¨Ã«ü¥Ü§@¥X§Q©óTeva¤½¥qªº§P决¡C

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¦U¤è¬Ò¦P·N¡A¾Ú«ÅºÙ©Ò¥D±iªº¤Æ¦Xª«ªºµL®Ä¤Æªº¥Î³~¯A¤Î¡u±NÀò±M§Q¡vªºÃĪ«ª©¥»¡A³o·N¨ý¡A¥»µo©ú¦b³Q«ÅºÙªº¤½¶}©Î°Ó·~¤Æ¨Ï¥Îªº·í®É¤w¸g©ú½T¦a³Q¥I½Ñ¹ê¬I¡C

Teva¤½¥q©Ò«ÅºÙªº¸Ó¤½¶}¨Ï¥Îµo¥Í¦b1987¦~9¤ë8¤é¡A¦b¡¦667¸¹±M§Q¥Ó½Ð®×´£¥X¥Ó½Ð«e¶W¹L¤@¦~¡CNorsk Hydro¡APronova¤½¥qªº«e¨­¤½¥q¡A±H°eK-80¤A°òà­组¦Xª«²GÅ骺¤p²~µ¹¸t¤å´Ë¯S·Oµ½Âå°|ªºVictor Skrinska³Õ¤h¡CÂÇ¥ÑPronova¤½¥q©Ó»{¡A³Q¹B°eµ¹Skrinska³Õ¤hªº¼Ë¥»²Å¦X©Ò¦³¡¦667¸¹±M§Q´£¥Xªº¥Ó½Ð±M§Q½d³ò¡C¦b¯Ê¥F¥ô¦ó§Î¦¡ªº«O±K¨óij¤U¡A³o¨Ç¼Ë¥»³Q±H°eµ¹Skrinska³Õ¤h¡C¦¹¥~¡ASkrinska³Õ¤h§@ÃÒ¡A¨Æ¹ê¤W¡A¥L»PÂå¾Ç¬Éªº¨ä¥L¦¨­û¤À¨ÉÃö©ó¸Ó¼Ë¥»¸ê°T¡A¥B¨Ã¥¼¥H¾÷±K¹ï«Ý¸Ó¸ê°T¡Cªk°|¤]»{©w¡A³Q´£¨Ñµ¹Skrinska³Õ¤hªº¼Ë¥»¨Ã¨S¦³¥¦­Ì¨Ï¥Î¤è¦¡ªº¦æ¬°ªº¥ô¦ó­­¨î¡Cªº½T¡APronova¤½¥q¬Æ¦Ü¤£ª¾¹DSkrinska³Õ¤h¦¬¨ì¼Ë¥»«á¡A¥L¹ï¥¦­Ì°µ¤F¤°»ò¡C³Q°e©¹Skrinska³Õ¤hªº¼Ë¥»¨ã¦³¤ÀªR¾ÌÃÒ¡A¸Ó¤ÀªR¾ÌÃÒ´¦ÅS¸Ó¼Ë¥»²Å¦X¡¦667¸¹±M§QÃö©ó¨C­Ó³½ªo¤Æ¦Xª«¬Û¹ï¿@«×ªº¨C­Ó±ø¥ó­­¨î¡C«á¨Ó¡ASkrinska³Õ¤h°õ¦æ¤F¥L¦Û¤vªº¤ÀªR´ú¸Õ¥H½T©w³o¨Ç¿@«×¡C³Ì«á¡Aªk°|­«µø¼Ë¥»¤§¥X³f³Q°e¥æµ¹¬Y­Ó¸Ó»â°ì¤¤¨ã¦³°ª«×ª¾ÃѪº¤Hªº¨Æ¹ê¡A¥H¤Î¸Ó¼Ë¥»¨Ï±o©Ò½Ð¨Dµo©ú¤¤ªº¨C¤@­Ó­n¥ó§Y¥i³Q½T©w¡C

ªk°|»é¦^¤FPronova¤½¥q©Ò¥D±iªº¡u¬°¤F¨Ï¤½¶}¨Ï¥Îµo¥Í¡A¸Ó¤Æ¦Xª«»Ý­n¥H±M§Q¤¤©Ò¥D±iªº¤è¦¡³Q¨Ï¥Î¡v¡Aªk°|¤Ï¦Ó§@µ²¡u·í¤@¤Æ¦Xª«³Q´£¨Ñµ¹¸Ó»â°ì¤¤¨ã¦³°ª«×ª¾ÃѪº¤H¦ÓµL­­¨î¡B¸Ó¤Æ¦Xª«ªº°t¤è¬O³Q¸Ô²Ó´¦ÅSªº¡A¦Ó¥B¸Ó°t¤è¨ü¨ì½T»{´ú¸Õ®É¡A¤£¦A»Ý­n¨ä¥L¦æ¬°¨Ï±o¸Ó¨Ï¥Î¦¨¬°¤@µL®Ä¤Æªº¨Ï¥Î¡v¡C

ªk°|©Úµ´¦Ò¼{·í¨Æ¦U¤è©Ò´£¥X¨ä¥LÃö©ó¡¦667¸¹±M§QµL®Ä©Êªºª§ÂI¡A¦Ó»{©w±M§Qªk²Ä102(b)±øijÃD¬O¨M©w©Êªº¡Cªk°|¤]©Úµ´¦Ò¼{Ãö©ó¡¦077¸¹±M§Qªºª§ÅG¦]¬°¥¦¦b¥»®×¨¥µüÅG½×«e¤w©¡º¡´Á­­¡C

 

Teva Pharma. USA, Inc. v. Sandoz, Inc. (Fed. Cir. July. 12, 2013)
(¨µ°jªk°|ªk©xRader¡BMoore¤ÎBenson¥D«ù¡F·N¨£®Ñ¡GMoore)
(¥Ñ¯Ã¬ù«n°Ï¦a¤èªk°|¡AJones, J.¤W¶D)
 

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¦b¨ä¥Ó½Ð±M§Q½d³ò¸ÑÄÀ©R¥O¤¤¡A¦a¤èªk°|¨S¦³¸Ô²Ó¦a°Ï¤À¤£¦P¤W¤U¤å¤¤©Ò³Q¨Ï¥Î³N»y¡u¤À¤l¶q¡v¡C¦a¤èªk°|»é¦^¤F³Q§iªº»¡ªk¡A¨ä¿×¤§¡u¤À¤l¶q¡v¬O¤£½T©wªº¡A¦]¬°¥¦¥i¯à¬O«üMp¡BMn¡BMw©Î¥t¤@ºØ¥­§¡¤À¤l¶q«×¶qªk¡C¥¦±N¡u¤À¤l¶q¡v¸ÑÄÀ¬°Mp¥B¡B»{¬°¸Ó¥Ó½Ð±M§Q½d³ò¤£©ú½Tªº¡C¸g¹Lªk©x¼f²z«á¡A°Ïªk°|»{¬°¡A©Ò¥D±iªº¥Ó½Ð±M§Q½d³ò¤£¬OÅã¦Ó©ö¨£©Ê¤WµL®Äªº©Î¯Ê¥F¾Ú¥H¹ê¬I©Ê¡A¥BMylan¤½¥q©MSandoz¤½¥q©Ò³Q«ü±±ªº²£«~«I¥Ç¤F©Ò¥D±iªº¥Ó½Ð±M§Q½d³ò¡CÁp¨¹¨µ°j¤W¶Dªk°|±À½¤F¦a°Ïªk°|Ãö©ó¤@¨Ç©Ò¥D±iªº¥Ó½Ð±M§Q½d³ò¨Ã«D¤£©ú½Tªºµô¨M¡A¨Ã½T»{¤F¦a¤èªk°|ªº¨ä¾lµô¨M¡C

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