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DEEP & FAR

 

 

 

ANDA-½×¤ÎÃľDzզXª«»P²Ä¤K±øÁn©ú~Fed. Cir.2012 (¤Q¤T)

 

 

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¥Ñ©ó³Q¤W¶D¤H­Ì±q¨äANDA ([1]) ±Æ°£¥ô¦ó¤w±M§Q¤§ªvÀø¾AÀ³¯g¡A¦a°Ïªk°|¤§½×µ²: ªü´µ§Q±¶§Q±d¨ÃµL®Ú¾Ú¡± 271(e)(2) ¤§½Ð¨D¡C([2])

ªü´µ§Q±¶§Q±d­º¥ý¥D±i¦a°Ïªk°|¡A¹L©ó¯U¯¶¦aŪ¨ú¡± 271(e)(2)¡C¨ä«ÅºÙ ¡± 271(e)(2) ¤§¡¨¥­¯À¥Î»y©M©ú½T»y¨¥¡¨(¡§plain and unambiguous¡¨ language)¤ä´©µÛ¨ä«IÅv¤§½Ð¨D¡A¤Þ­zªk³W¡¨¤§¬ÛÃö³¡¤À¡¨¡A¦p¤U©Ò¥Ü¡G¡¨®Ú¾ÚÁp¨¹­¹«~¡BÃĪ«©M¤Æ§©«~ªk³W¡A¥ç§Y21 U.S.C. ¡±355(j)¡A¥u­n»¼¥æ(A) ANDA¥Ó½Ð.....¤@ºØ±M§Q©Ò¥D±i¨Ï¥Î¤§ÃĪ«¡A.....«hµø¬°«IÅv¦æ¬°¡C([3]) ªü´µ§Q±¶§Q±d¦]¦¹ÅGºÙ¨ä«Y®Ú¾Ú ¡±271(e)(2) ¥i»{ª¾¤§¥D±i¦Ó±±¶D¡A³Q¤W¶D¤H¥Ó½Ð¡¨ÃĪ«¤§Â²¤Æ·sÃĥӽР(Abbreviated New Drug Applications, ANDA)¡¨¡A§Y¡¨¨Ò¦p²Ä¡¦618¸¹©M²Ä¡¦152¸¹µ¥±M§Q©Ò¥D±i·çµÎ¥ï¥L¥Å¶t¤§¨Ï¥Î¡¨¡CµM¦Ó¡Aªü´µ§Q±¶§Q±d¤§¿ï¾Ü©Ê¤ÞÃÒ¡A¬Ù²¤¡± 271(e)(2) ¤§ÃöÁä©Ê¥Î»y¡A¦Ó±Nªk©w°ò¦¿@ÁY¬°¡¨»¼¥æ¤@ºØ±M§Q©Ò¥D±iÃĪ«¥Î³~ANDA¥Ó½Ð®×¤§³d¥ô¡¨¡A¦Ó«D¨Ï¥Î±ø¤å¤§¹ê»Ú»y¨¥¡A¥HŪ¨ú(actual language of the statute reading)¡¨¤@ºØ±M§Q©Ò¥D±i©Î±M§Q©Ò¥D±i¥Î³~¤§ÃĪ«(a drug claimed in a patent or the use of which is claimed in a patent)¡¨¡C([4])

¨Æ¹ê¤W¡Aªü´µ§Q±¶§Q±d¤§ÅG¸Ñ·½¦Û©ó¬Û¦P¤§»~¾É¡A¥ç§Y¨Ì·Ó¡± 271(e)(2) ¦Ó¥ÑWarner-Lambert­ì§i©Ò´£¨Ñ¡¨§R¸`¤§¤Þ¥Î (abridged quotation)¡¨([5])¡CµM«á²{¦b¡A¥»°|»é¦^ªk«ß¤§¦p¦¹¸ÑªR¡A¦]¨ä°Å±µ¡± 271(e)(2)(A) ¤§²Ä¤@©M²Ä¤G¥y¦Ó¡¨­é°£ªk©w±ø¤å¤§­«­n³¡¤À¡¨(eviscerated an important part of the statutory provision by conflating the first and second clauses of ¡± 271(e)(2)(A) [6])¡C

¦Ó¥»°|¦A»é¦^½×­z: ®Ú¾Ú¡± 271(e)(2) »¼¥æ¥ô¦ó¤w±M§Q¥Î³~ÃĪ«¤§ANDA¡A¦ÛµM¨¬¥Hºc¦¨«IÅv(filing an ANDA for a drug having any patented use automatically constitutes infringement under ¡± 271(e)(2)¡C

 



[1]. In deciding Appellees¡¦ motions to dismiss, the district court held that it could consider certain documents beyond the pleadings, including Appellees¡¦ ANDA filings, Section viii statements, and proposed labeling. Astra-Zeneca, 2010 WL 5376310, at *8¡V9. AstraZeneca complains that the district court committed legal error by considering such documents without allowing it to take discovery. However, the district court was entitled to examine documents ¡§integral to or explicitly relied upon in the complaint¡¨ in evaluating motions to dismiss. In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997). The district court determined, and we agree, that AstraZeneca¡¦s complaints referenced and relied on Appellees¡¦ FDA filings, and the parties do not dispute the authenticity of the documents that were before the court. We therefore see no error in the district court¡¦s decision to consider these documents.

[2]. Id.

[3]. Non-Confidential Br. for Plaintiffs-Appellants at 23(formatting in original)

[4]. 35 U.S.C. ¡± 271(e)(2)(A) (emphasis added).

[5]. See 316 F.3d at 1355.

[6]. id.