? ? 上訴判決書先用10頁詳細(xì)回顧了Hatch-Waxman法案關(guān)于橙皮書專利的條款及立法淵源（建議閱讀有助于整體了解該法案的相關(guān)框架）。重點(diǎn)在于，一旦某專利列入橙皮書，仿制藥及505b2改良藥申請(qǐng)必須對(duì)未過期專利提交PIII或PIV專利聲明，前者為等待專利過期，后者為專利挑戰(zhàn)伴隨默認(rèn)30月（或更長）的訴訟遏制期，在此期間（除非法院給出不侵權(quán)判決）FDA不允許批準(zhǔn)仿制藥及505b2改良藥申請(qǐng)。

? ? 所以，原研方有強(qiáng)烈意愿通過將專利列入橙皮書獲得訴訟遏制期，同時(shí)迫使仿制藥方進(jìn)行耗資耗時(shí)的專利訴訟，以延長產(chǎn)品的市場(chǎng)壟斷。作為在Hatch-Waxman專利挑戰(zhàn)領(lǐng)域有無數(shù)經(jīng)歷的仿制藥巨頭，Teva當(dāng)然明白橙皮書專利的價(jià)值，于是Teva這次作為原研方不遺余力地意圖利用橙皮書來延長其產(chǎn)品的壟斷期。Teva的產(chǎn)品為2004年10月29日獲批的ProAir??HFA?Inhalation?Aerosol?（NDA?No.?021457）吸入制劑，用于治療? bronchospasm?with?reversible?obstructive?airway?disease?in?adults?and?children?12?years?of?age?or?older。該產(chǎn)品的活性成分為albuterol?sulfate，而服用該產(chǎn)品需要用吸入器（inhaler）。Teva在該產(chǎn)品的橙皮書上列入了9項(xiàng)專利，其中5項(xiàng)只和吸入器相關(guān)，和活性成分及制劑無關(guān)。?Teva在被告仿制藥企Amneal提交ANDA后在新澤西聯(lián)邦地區(qū)法院發(fā)起Hatch-Waxman訴訟，指控Amneal侵犯該5項(xiàng)專利。代表性的289專利權(quán)利要求1為：1.?An?inhaler?for?metered?dose?inhalation,?the?inhaler?comprising:a?main?body?having?a?canister?housing,a?medicament?canister,?which?is?moveable?relative?to?the?canister?housing?and?retained?in?a?central?outlet?port?of?the?canister?housing?arranged?to?mate?with?a?canister?fire?stem?of?the?medicament?canister,?anda?dose?counter?having?an?actuation?member?having?at?least?a?portion?thereof?located?in?the?canister?housing?for?operation?by?movement?of?the?medicament?canister,wherein?the?canister?housing?has?an?inner?wall,?and?a?first?inner?wall?canister?support?formation?extending?inwardly?from?a?main?surface?of?the?inner?wall,?anwherein?the?canister?housing?has?a?longitudinal?axis?X?which?passes?through?the?center?of?the?central?outlet?port,the?inner?wall?canister?support?formation,?the?actuation?member,?and?the?central?outlet?port?lying?in?a?common?plane?coincident?with?the?longitudinal?axis?X.Amneal向法院提出動(dòng)議認(rèn)為Teva的這5項(xiàng)不滿足橙皮書的法律要求，應(yīng)予撤除（delist）。

? ? 地區(qū)法院同意，命令Teva撤除該5項(xiàng)專利。Teva不服上訴，并在地區(qū)法院拒絕其上訴期間暫緩執(zhí)行法庭命令的請(qǐng)求后向上訴法院緊急申請(qǐng)獲得了暫緩執(zhí)行的批準(zhǔn)。（另外幾年前sanofi輸?shù)袅岁P(guān)于其胰島筆專利的類似的爭(zhēng)辯，此案向法庭提交了法庭之友函支持Teva。）上訴法院終維持原判。上訴法院的維持原判的理由其實(shí)很簡(jiǎn)單，因?yàn)榉蓷l款明確規(guī)定了可列入橙皮書的兩類專利，權(quán)利要求針對(duì)(claim)產(chǎn)品的活性成分或制劑和產(chǎn)品的申請(qǐng)或獲批的使用方法：…?patent?…?that?-(I)?claims?the?drug?for?which?the?applicant?submitted?the?application?and?is?a?drug?substance?(active?ingredient)?patent?or?a?drug?product?(formulation?or?composition)?patent;?or(II)?claims?a?method?of?using?such?drug?for?which?approval?is?sought?or?has?been?granted?in?the?application.

? ?Teva的吸入器專利顯然不屬于法律規(guī)定的這兩類專利。上訴法庭詳細(xì)分析并拒絕了Teva律師團(tuán)隊(duì)費(fèi)盡心思提出的兩項(xiàng)對(duì)法律條款的錯(cuò)誤解讀：?其一，權(quán)利要求（claim）和產(chǎn)品侵權(quán)不可混為一談；?其二，藥品（drug）和器械（device）不可混為一談。上訴法庭作出結(jié)論：To?list?a?patent?in?the?Orange?Book,?that?patent?must,?among?other?things,?claim?the?drug?for?which?the?applicant?submitted?the?application?and?for?which?the?application?was?approved.?And?to?claim?that?drug,?the?patent?must?claim?at?least?the?active?ingredient.A?combination?product?being?approved ith?an?NDA?does?not?necessarily?make?every?part?of?the?NDA?a?drug.?That?is,?a?drug-device?combination?product?being?approved ith?an?NDA?does?not?make?the?device?parts?a?drug.近美國? ?FTC也加強(qiáng)了對(duì)濫用橙皮書的關(guān)注，警告要求某些原研（包括Teva）主動(dòng)撤回橙皮書中的某些專利，在此案上訴中還提交了法庭之友函反對(duì)Teva。上訴法院此案的判決更明確了橙皮書專利的范圍，應(yīng)該也對(duì)原研不當(dāng)列入橙皮書專利的行為發(fā)出了一個(gè)明確的信號(hào)。作者簡(jiǎn)介：王華律師(Howard ang)擁有近20年的美國律師執(zhí)業(yè)經(jīng)驗(yàn)

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