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學名藥廠得以要求修改範圍過廣的使用規則為由提出反訴
國際智財新知
文/政大智財所99級 林家綺
[1]，學名藥廠具有反訴之法定基礎。若專利藥廠在橘皮書(Orange Book)上使用規則(use codes)[2]最高法院在2012年4月17日推翻CAFC對Caraco Pharmaceutical Laboratories, Ltd. v Novo Nordisk A/S一案之判決並發回重審。最高法院認為基於21 U.S.C.§355 (j)(5)(C)(ii)(I)範圍過廣，超出專利所保護之範圍，而影響學名藥廠取得FDA市場銷售許可，則學名藥廠得以要求修改為由提出反訴[3]。
學名藥廠在申請ANDA時，必須查對橘皮書上專利藥所登錄的專利，並提出四種證明[4]之一，始可取得FDA之市場銷售許可。在本案中，學名藥廠Caraco Pharmaceutical Laboratories, Ltd.（下稱Caraco）係透過Paragraph IV第四種證明方式，告知專利權人專利藥廠Novo Nordisk A/S（下稱Novo），申請ANDA的學名藥並沒有侵害其專利。惟專利權人在接獲通知後的45日內可提起專利侵權訴訟，中斷FDA對於學名藥ANDA的審查作業。Novo在接獲通知後對Caraco提起專利侵權訴訟，而Caraco則提出反訴，質疑Novo在橘皮書上使用規則之敘述並未準確涵蓋其專利範圍。
系爭專利為Novo的6’677’358（簡稱’358專利），為Re37’035口服降血糖藥物組合專利（簡稱’035專利）之使用方法專利。’358專利[5]範圍僅包含三種FDA核准之降低血糖方法中之其中一種[6]，然而在橘皮書上的使用規則中，Novo卻描述專利也包括其他兩種FDA核准之方法。
此案爭點為Caraco是否具法定基礎，挑戰Novo橘皮書上使用規則在敘述上之正確性。Novo認為358專利中包含「至少一種」使用方法(at least one use)，故Caraco應不具反訴之法定基礎。
CAFC認為21 U.S.C.§355 (j)(5)(C)(ii)(I)中可被挑戰之專利資訊(patent information)應僅限於專利號碼(patent number)及專利到期日(expiration date)。’358專利並無專利號碼及到期日之爭議，同時，’358專利已包含其中一種藥物使用方式，而Caraco並無法提出該專利未保護「任一種」(any)使用方法之證據，因此Caraco不具備反訴之法定基礎。
最高法院審理後，駁回CAFC判決，認為學名藥廠具反訴之法定基礎，可以對橘皮書上過廣的使用規則請求修改而提出反訴。
最高法院認為CAFC對於21 U.S.C.§355 (j)(5)(C)(ii)(I)的解釋過於狹隘。最高法院指出，21 U.S.C.§355 (j)(5)(C)(ii)(I)在定義上或顯模糊，在適用上產生疑義，此時則應回歸立法目的去思考—此法條的目的在於提供機會讓學名藥廠能挑戰專利藥廠在使用規則中不當的描述方式。最高法院也呼籲國會應儘快修法，讓相關法規在適用、解釋上更明確，以符合當初立法之目的。
[1] 21 U.S.C.§355 (j)(5)(C)(ii)(I): The [ANDA] applicant may assert a counterclaim seeking an order requiring the [NDA] holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) on the ground that the patent does not claim . . . an approved method of using the drug .
[2] 專利權人必須向FDA提出界定專利範圍「使用規則」(use codes)。惟FDA並未審查所列專利資訊之正確性或其與藥品之關聯性。
[3] Caraco Pharmaceutical Laboratories, Ltd. v Novo Nordisk A/S, No. 10–844 (U.S. April 17, 2012).
[4] The Federal Food, Drug, and Cosmetic Act requires that an ANDA contains a certification to each patent listed in the "Orange Book." A generic ANDA must provide some indication as to why the generic application should be approved despite any patent rights held by the branded manufacturer. This explanation is typically identified as a Paragraph I, II, III, or IV certification. Paragraph I Certification indicates that the Orange Book lists no patents relevant to the ANDA. Paragraph II Certification indicates that the listed patents have expired.
Paragraph III Certification indicates that the generic manufacturer will stay off market until the patents expire. Paragraph IV Certification indicates that the generic manufacturer believes that the listed patents are either invalid or would not be infringed by the generic compositions. Patent Exclusivity, available at http://fdadrugcompliance.com/resources/anda/exclusivity/. (Last visited: May 4, 2012)
[5] Novo originally owned a patent for the repaglinide compound, known as the ’035 patent, but it expired in 2009. In 2004, Novo also acquired a method-of-use patent for the drug, called the ’358 patent, which does not expire until 2018. That patent—the one at issue here—claims a “method for treating [diabetes by] administering . . . rep- aglinide in combination with metformin.” 601 F. 3d 1359, 1362 (CA Fed. 2010).
[6] Novo currently holds a patent for one of the three FDA-approved uses of repaglinide—its use with metformin. But Novo holds no patent for the use of repaglinide with TZDs or its use alone.
http://iip.nccu.edu.tw/app/news.php?Sn=325
國際智財新知
文/政大智財所99級 林家綺
[1]，學名藥廠具有反訴之法定基礎。若專利藥廠在橘皮書(Orange Book)上使用規則(use codes)[2]最高法院在2012年4月17日推翻CAFC對Caraco Pharmaceutical Laboratories, Ltd. v Novo Nordisk A/S一案之判決並發回重審。最高法院認為基於21 U.S.C.§355 (j)(5)(C)(ii)(I)範圍過廣，超出專利所保護之範圍，而影響學名藥廠取得FDA市場銷售許可，則學名藥廠得以要求修改為由提出反訴[3]。
學名藥廠在申請ANDA時，必須查對橘皮書上專利藥所登錄的專利，並提出四種證明[4]之一，始可取得FDA之市場銷售許可。在本案中，學名藥廠Caraco Pharmaceutical Laboratories, Ltd.（下稱Caraco）係透過Paragraph IV第四種證明方式，告知專利權人專利藥廠Novo Nordisk A/S（下稱Novo），申請ANDA的學名藥並沒有侵害其專利。惟專利權人在接獲通知後的45日內可提起專利侵權訴訟，中斷FDA對於學名藥ANDA的審查作業。Novo在接獲通知後對Caraco提起專利侵權訴訟，而Caraco則提出反訴，質疑Novo在橘皮書上使用規則之敘述並未準確涵蓋其專利範圍。
系爭專利為Novo的6’677’358（簡稱’358專利），為Re37’035口服降血糖藥物組合專利（簡稱’035專利）之使用方法專利。’358專利[5]範圍僅包含三種FDA核准之降低血糖方法中之其中一種[6]，然而在橘皮書上的使用規則中，Novo卻描述專利也包括其他兩種FDA核准之方法。
此案爭點為Caraco是否具法定基礎，挑戰Novo橘皮書上使用規則在敘述上之正確性。Novo認為358專利中包含「至少一種」使用方法(at least one use)，故Caraco應不具反訴之法定基礎。
CAFC認為21 U.S.C.§355 (j)(5)(C)(ii)(I)中可被挑戰之專利資訊(patent information)應僅限於專利號碼(patent number)及專利到期日(expiration date)。’358專利並無專利號碼及到期日之爭議，同時，’358專利已包含其中一種藥物使用方式，而Caraco並無法提出該專利未保護「任一種」(any)使用方法之證據，因此Caraco不具備反訴之法定基礎。
最高法院審理後，駁回CAFC判決，認為學名藥廠具反訴之法定基礎，可以對橘皮書上過廣的使用規則請求修改而提出反訴。
最高法院認為CAFC對於21 U.S.C.§355 (j)(5)(C)(ii)(I)的解釋過於狹隘。最高法院指出，21 U.S.C.§355 (j)(5)(C)(ii)(I)在定義上或顯模糊，在適用上產生疑義，此時則應回歸立法目的去思考—此法條的目的在於提供機會讓學名藥廠能挑戰專利藥廠在使用規則中不當的描述方式。最高法院也呼籲國會應儘快修法，讓相關法規在適用、解釋上更明確，以符合當初立法之目的。
[1] 21 U.S.C.§355 (j)(5)(C)(ii)(I): The [ANDA] applicant may assert a counterclaim seeking an order requiring the [NDA] holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) on the ground that the patent does not claim . . . an approved method of using the drug .
[2] 專利權人必須向FDA提出界定專利範圍「使用規則」(use codes)。惟FDA並未審查所列專利資訊之正確性或其與藥品之關聯性。
[3] Caraco Pharmaceutical Laboratories, Ltd. v Novo Nordisk A/S, No. 10–844 (U.S. April 17, 2012).
[4] The Federal Food, Drug, and Cosmetic Act requires that an ANDA contains a certification to each patent listed in the "Orange Book." A generic ANDA must provide some indication as to why the generic application should be approved despite any patent rights held by the branded manufacturer. This explanation is typically identified as a Paragraph I, II, III, or IV certification. Paragraph I Certification indicates that the Orange Book lists no patents relevant to the ANDA. Paragraph II Certification indicates that the listed patents have expired.
Paragraph III Certification indicates that the generic manufacturer will stay off market until the patents expire. Paragraph IV Certification indicates that the generic manufacturer believes that the listed patents are either invalid or would not be infringed by the generic compositions. Patent Exclusivity, available at http://fdadrugcompliance.com/resources/anda/exclusivity/. (Last visited: May 4, 2012)
[5] Novo originally owned a patent for the repaglinide compound, known as the ’035 patent, but it expired in 2009. In 2004, Novo also acquired a method-of-use patent for the drug, called the ’358 patent, which does not expire until 2018. That patent—the one at issue here—claims a “method for treating [diabetes by] administering . . . rep- aglinide in combination with metformin.” 601 F. 3d 1359, 1362 (CA Fed. 2010).
[6] Novo currently holds a patent for one of the three FDA-approved uses of repaglinide—its use with metformin. But Novo holds no patent for the use of repaglinide with TZDs or its use alone.
http://iip.nccu.edu.tw/app/news.php?Sn=325
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