108¦~12¤ë¸¹ ¹D ªk ªk °T (332)

DEEP & FAR

 

 

´¼Åv»¡¤Ñ¹D¦a (¤Q¤E)
 

½²²MºÖ¡@«ß®v

¡P¡@¥æ¤j¯è§Þ¨t½ü¾÷²Õ²¦·~

¡P¡@½ü¾÷°ª¦Ò¤Î®æ

¡P¡@½ü¾÷¥ÒºØ¯S¦Ò¤Î®æ

¡P¡@¥x¤jªk«ß¨t²¦·~

¡P¡@«ß®v°ª¦Ò¤Î®æ

¡P¡@ªF§dªkºÓ¥Ò²ÕºÓ¤h

¡P¡@³Ð¥ß¹Dªkªk«ß¨Æ°È©Ò

 

 

 

¤@¡B±M§Q´Á­­½Õ¾ã

CAFC»é¦^USPTO´NSupernus Pharmaceuticals (SP¡B¡§osmotic drug delivery system¡¨¡B¤ÎUSPN 8,747,897¨tª§±M§Q©ó2014®Ö­ã)¤§±M§Q´Á­­½Õ¾ã(PTA)¡A¦]»{¬°­pºâ¿ù»~¡A¥B¶W¶Vªk©wÅv­­¡C¦Ó¦¹¤@¨M©w¡u©Ò¾É­P±M§Q´Á­­½Õ¾ã¤§ÃB¥~±M§Q±MÄÝ©Ê¥NªíµÛ«~µPÃļt¦Ê¸U­p¤§¬ü¤¸¡v¡C

¨tª§±M§Q2006¥Ó½Ð¡B2011¦~¥Ó½ÐRCE¡A¨ÃÀò¹{EP±M§Q²Ä2010189¸¹¡B2012¦~¤K¤ëSandoz²§Ä³EP±M§Q¡B¤Q¤@¤ë±N¦¹²§Ä³´£¥XIDS¡B©ó2014®Ö­ã®É¡AUSPTO ­ã¤©1260¤é´Á­­½Õ¾ã¡CPTA¥D­n°ò©óUSPTO¤§¼f¬d¿ð©µ¡AUSPTO¨ÃÂk¦]¥Ó½ÐRCE¤Î´£¥XIDS¶¡¤§SP¿ð©µ¦Ó¦©´î646¤é¡CSP¶È»{¨ä¤¤100¤Ñ¤§¿ð©µ¡A¦ý¥D±i´N¨ä¾l546¤é¡A§¹¥þ³B©óµL§Uª¬ºA¡CUSPTO©Úµ´¦A¦Ò¼{¦©´î646¤é¡A¨Ã©ó2016¡A¸gUS VirginiaªF°Ï¦a°|ªÖ»{¡CSP«h©ó2017¤W¶D¡ACAFC§P©w¡u¦b¨º546¤é´Á¶¡¡ASPµL¯à¬°¤O¡A¯S§O¬O¦]EPO¤§²§Ä³³qª¾©|¥¼¦s¦b¡C¡v¡B¤Î¡u°ê·|§Æ¾¬PTA±ø¤å¤£·|¤£§Q½ÄÀ»¹³SP´N¥Ó½Ð¤§¶i®iµL¯à¬°¤O¤§¥Ó½Ð¤H¡C¡v

¤G¡B¡u¾P°â¤¤ªý»Ù¡v(¡uOn-Sale Bar¡v)

¬ü°ê³Ì°ªªk°|Kirk T. Bradley¡BLauren C. Bolcar¤ÎNicholas C. Marais©ó2019¦~1¤ë22¤é¦@ÃѨM©wAIA¨Ã¥¼§ïÅÜ¡u¾P°â¤¤¡v(Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.)¤§·N¸q¡A§Y¡G§Y©l¾P°â¨Ã¥¼¤½½Ñ¤j²³µo©ú²Ó¸`¡A¸Ó²Õ»Ù¤´¾A¥Î¡C¸Ô¨¥¤§¡A¨ÌAIA¡A¡uµo©ú¤H¾P°âµo©ú©ó¦³¸q°È«O«ù¯µ±K¤§²Ä¤T¤H¤§¦æ¬°¡A¤´«Y[35 U.S.C.] ¡± 102(a)¤§²ß¥Î§Þ³N¡C¡v

Helsinn Healthcare S.A.»s³yªvÀø¤ÆÀø¤Þµo¤§¤Ï­G»P¹Ã¦R¤§ÃĪ«¡A¨Ã»PMGI Pharma Inc.ñ©w±ÂÅv«´¬ù¤Î¨Ñ°â«´¬ù¡A­Ú«áªÌ±o¬°¦æ¾P¡C«´¬ù¥]§t¾¯¶q¸ê°T(¤½¥¬ª©¸g¸`¿ý)¡A¦ý­n¨D«O±K·½¦Û«eªÌ¤§°]²£¸ê°T¡A¥Bµo¥¬Áp¦X·s»D½Z¡A¨Ã¦VÃÒ´Á·|¥Ó³ø¡Cñ¬ù«á¨â¦~¡A«eªÌ¶}©l¥Ó½Ð°t¤è±M§Q¡A¨ÃÀò­ã¼Æ­Ó±M§Q¡A¨ä¤@¯A¤ÎAIA¡CTeva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA Inc.´M¨DFDA®Ö­ã¦æ¾P§í¨î¤Ï­G¤§¾Ç¦WÃÄ¡A«eªÌ«h©óDistrict of New Jersey±±§i±M§Q«IÅv¡CTeva«h¥D±iµL®Ä¡A¦]±M§Q°t¤è¤wÄÝ¡u¾P°â¤¤¡v¡C¦bAIA«e¡A¦p¦³•¢¥Ó½Ð¤é¤@¦~«e¡A¡uµo©ú©ó¥»°ê¨Ñ¤½²³¨Ï¥Î©Î¾P°â¤¤¡v¡A«h¾A¥Î¸Óªý»Ù¡C´N102(b)±ø¤å¡§the invention was ¡K in public use or on sale in this country¡¨¡A¨µ°jªk°|¤@¦AÄÄÄÀ¡§public¡¨¤D¥Î¥H­×¹¢¡§use¡¨¦Ó«D¡§on sale¡¨¡A¬G¯µ±K¾P°â±oIJµo¡u¾P°â¤¤ªý»Ù¡v¡C¦bAIA¤¤¡A°ê·|­×§ï¤å¦r¨Ã¸m©ó²Ä102(a)±ø¡§the claimed invention was ¡K in public use, on sale, or otherwise available to the public¡¨¡CHelsinn¾Ú¦¹¦Óª§ÅG¡AAIA¥H¥[¦C¡§otherwise available to the public¡¨±ø¥ó¤§¤è¦¡¦ÓÅܧó¡§on sale¡¨¤§·N¸q¡A§Y¨Ì·s¤å¸q¡G¾P°â¥²¶·¨Ïµo©ú¡§available to the public¡¨¡A©l·|IJµo¡u¾P°â¤¤ªý»Ù¡v¡C¦Ó¦]¸Ó¨â«´¬ùÁö¤½½Ñ¤½²³¡A¦ýµo©ú¨Ã¥¼¡¨available to the public¡¨¡A¦]¯S©w¾¯¶q°t¤è·~¸g¸`¿ý¡CTeva«hºÙ°ê·|¤§¦A¥ßªk¡A¨Ã¥¼­×¥¿¡§on sale¡¨¤@»y¡F¦p¦³·N§ïÅܨä·N¸q¡A¥²ª½±µ¦Ó©ú¥Õ¬°¤§¡C¬G¡§or otherwise available to the public¡¨¶È¦b¼W¥[µL®Ä¤§·sÃþ«¬¡A¨Ò¦p¤fÀYºtÁ¿¡C

¦a°|¦P·NHelsinn¤§¬Ýªk¡A¦ý¨µ°jªk°|»é¦^¦Ó»{AIA¨Ã¥¼§ïÅÜ¡u¾P°â¤¤¡v¤§·N¸q¡A§Y¡G¦ý¾P°â«YÄݤ½¶}¡A§Y¦³¸Óªý»Ù¤§¾A¥Î¡F´«¨¥¤§¡Aµo©úµL¶·¤½¶}´¦ÅS¡A¤½²³¥çµL¶·±o¯à½Tª¾¸Óµo©ú¡C¨µ°jªk°|»{¬°Helsinn¤§¬Û¤Ï¸ÑÄÀ§Î¦P¹ï¾P°â¤¤ªý»Ù¤§°ò¦Åܧó¡A³Ì°ªªk°|¤@­P¦P·N¦bPfaff v. Wells Electronics Inc.¤@®×¤¤¹ï¡u¾P°â¤¤¡v¤§¸ÑÄÀ¡C

«e­z§P¨M¹ï¨ä«e¤§AIA±M§Q¥Ó½Ð¦³ÅãµÛ¤§½ÄÀ»¡A¦]®É¥NÁ`¬O·U¨Ó·U¼eÃP©Î·U¡u¤H©Ê¤Æ¡v¡A¦Û2013¦~°_¡AUSPTO¤w¨ÌHelsinn¶D¨D»{©w¡u¾P°â¤¤¡v¡A§Y¨ä©ó¼f¬d«ü«n»¡¡G¨ÌAIA¡A¡§secret sale or use activity does not qualify as prior art¡¨¡C¦¹·N«ü¦Û2013°_¡A¦³¶W¹L¤@¦Ê¸U½g±M§Q¦³µÛ¿ù»~¤§¡u¾P°â¤¤ªý»Ù¡v¸ÑÄÀ¡C

«áÄò®ÄÀ³¡G¡u¤½²³¨Ï¥Îªý»Ù¡v(public-use bar)·|Ä~Äò¥]§t»s³y¤èªk¤Î«~¥Ø¤§¯¦±K¨Ï¥Î¡A¦ÓµLªk¦Ûµ²ªG²£«~°f¦V¤uµ{±Àª¾¤§¤èªk¤Î«~¥ØªÌ¡C