文/北京集佳知識產(chǎn)權代理有限公司西安分部 潘紅

　　專(zhuān)利權是一種排他的權力，任何一項專(zhuān)利經(jīng)過(guò)一定的專(zhuān)利保護期，就進(jìn)入公有領(lǐng)域，成為公共財富。專(zhuān)利保護期對于高投入、高回報的各類(lèi)研發(fā)企業(yè)尤其是醫藥企業(yè)來(lái)說(shuō)是十分的重要的。例如，醫藥企業(yè)的利潤收入往往是以日計的，一旦超過(guò)專(zhuān)利保護期限，其他企業(yè)則可以生產(chǎn)類(lèi)似產(chǎn)品，因此專(zhuān)利保護期的延長(cháng)或縮短將會(huì )對其收益帶來(lái)巨大影響。

　　對于一件專(zhuān)利申請而言，授權日開(kāi)始才算是正式的專(zhuān)利保護，侵犯專(zhuān)利權，嚴格意義上說(shuō)也是從授權日開(kāi)始算的。公告日到授權日這段期間屬于臨時(shí)保護期，根據美國專(zhuān)利法第154(d)條規定，專(zhuān)利權人在該臨時(shí)保護期間可以向使用人收取適當的使用費。然而，這段期間是屬于未決的期待利益，因此該費用可能會(huì )遠低于專(zhuān)利侵權賠償額或專(zhuān)利許可所得數額。所以，授權日至保護期終止這段時(shí)間對于企業(yè)而言才是最重要的期限。

　　為了避免專(zhuān)利審查的不當延遲而縮短專(zhuān)利有效期限，美國國會(huì )于1999年在美國發(fā)明人保護法(AIPA)中對專(zhuān)利期限調整做了相應規定，即，專(zhuān)利期限調整(Patent Term Adjustment, PTA)。美國專(zhuān)利商標局(USPTO)在頒發(fā)專(zhuān)利證書(shū)時(shí)會(huì )對有需要進(jìn)行專(zhuān)利期限調整的專(zhuān)利調整相應的專(zhuān)利保護期限。下面將結合美國專(zhuān)利法中對PTA的規定來(lái)對美國專(zhuān)利期限調整進(jìn)行簡(jiǎn)要介紹。

　　專(zhuān)利期限調整主要可分為兩大類(lèi)，即美國專(zhuān)利商標局的審查過(guò)程延誤以及申請人延誤。專(zhuān)利期限調整的計算原則是美國專(zhuān)利商標局的審查過(guò)程延誤的天數減去申請人延誤的天數和延遲重疊的天數即可得到最終的PTA天數。

　　一、美國專(zhuān)利商標局的審查過(guò)程延誤

　　35 U.S.C.154（b）ADJUSTMENT OF PATENT TERM

　?。?）PATENT TERM GUARANTEES.

　　（A）GUARANTEE OF PROMPT PATENT AND TRADEMARK OFFICE RESPONSES.—Subject to the limitations under paragraph（2），if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to—

　?。╥）provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after（I）the date on which an application was filed under section 111（a）； or（II）the date of commencement of the national stage under section 371 in an international application；

　?。╥i）respond to a reply under section 132， or to an appeal taken under section 134， within 4 months after the date on which the reply was filed or the appeal was taken；

　?。╥ii）act on an application within 4 months after the date of a decision by the Patent Trial and Appeal Board under section 134 or 135 or a decision by a Federal court under section 141， 145， or 146 in a case in which allowable claims remain in the application； or

　?。╥v）issue a patent within 4 months after the date on which the issue fee was paid under section 151 and all outstanding requirements were satisfied； the term of the patent shall be extended 1 day for each day after the end of the period specified in clause（i），（ii），（iii），or（iv）， as the case may be， until the action described in such clause is taken.

　　（B）GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY.— Subject to the limitations under paragraph（2）， if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application under section 111（a）in the United States or， in the case of an international application， the date of commencement of the national stage under section 371 in the international application not including—

　?。╥）any time consumed by continued examination of the application requested by the applicant under section 132（b）；

　?。╥i）any time consumed by a proceeding under section 135（a）， any time consumed by the imposition of an order under section 181， or any time consumed by appellate review by the Patent Trial and Appeal Board or by a Federal court； or

　?。╥ii）any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph（3）（C）， the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.

　　（C）GUARANTEE OR ADJUSTMENTS FOR DELAYS DUE TO DERIVATION PROCEEDINGS， SECRECY ORDERS， AND APPEALS.— Subject to the limitations under paragraph（2）， if the issue of an original patent is delayed due to—

　?。╥）a proceeding under section 135（a）；

　?。╥i）the imposition of an order under section 181； or

　?。╥ii）appellate review by the Patent Trial and Appeal Board or by a Federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability，

　　the term of the patent shall be extended 1 day for each day of the pendency of the proceeding， order， or review， as the case may be.

　　從上述法條規定可知，美國專(zhuān)利商標局的審查過(guò)程延誤可以包括下述三種情況：

　　“A”延遲，美國專(zhuān)利商標局未能在規定時(shí)間內進(jìn)行審查并向申請人發(fā)出審查結果，如未在14個(gè)月內發(fā)出第一次審查意見(jiàn)通知書(shū)，收到申請人針對審查意見(jiàn)通知書(shū)遞交答辯意見(jiàn)或其他請求后沒(méi)有在4個(gè)月內發(fā)出第二次審查意見(jiàn)通知或授權通知，在申請人繳納授權費后4個(gè)月內沒(méi)有未授予專(zhuān)利權等，這也稱(chēng)為14-4-4-4延遲規則，凡是沒(méi)有符合上述要求而導致延遲的天數均被記入專(zhuān)利期限調整；

　　“B”延遲，美國專(zhuān)利商標局未能在提交專(zhuān)利申請之日起3年內授權專(zhuān)利權，這也稱(chēng)為3年延遲規則，凡是沒(méi)有符合該要求而導致延誤的天數也被記入專(zhuān)利期限調整。需要注意的是，申請人提交繼續審查請求（RCE），上訴復審等導致的期限延遲不包括在內；

　　“C”延遲，當申請涉及爭議或申訴，或保密要求時(shí)，任何由于向專(zhuān)利審判和上訴委員會(huì )上訴（appeals），溯源訴訟程式（derivation proceedings），或者保密命令（secrecy orders）而導致的延誤也被記入專(zhuān)利期限調整，這也被稱(chēng)為PTAB規則。

　　二、申請人延誤

　　35 U.S.C.154（b）ADJUSTMENT OF PATENT TERM

　?。?）LIMITATIONS.

　?。–）REDUCTION OF PERIOD OF ADJUSTMENT.—

　?。╥）The period of adjustment of the term of a patent under paragraph（1）shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.

　?。╥i）With respect to adjustments to patent term made under the authority of paragraph （1）（B）， an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of 3 months that are taken to respond to a notice from the Office making any rejection， objection， argument， or other request， measuring such 3-month period from the date the notice was given or mailed to the applicant.

　?。╥ii）The Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.

　　從上述法條規定可知，申請人延遲是指由于申請人個(gè)人的原因，導致其沒(méi)有在官方規定的期限內及時(shí)作出響應而導致的延遲。例如，申請人在收到審查意見(jiàn)通知書(shū)3個(gè)月內沒(méi)有作出答復而造成的任何延遲。因此，從申請人角度，盡量在官方規定的期限內答復審查意見(jiàn)，遞交相關(guān)文件，以及提交各種請求等，以盡量減少由于申請人原因導致的延遲。

　　三、延遲重疊的定義

　　35 U.S.C.154（b）ADJUSTMENT OF PATENT TERM

　?。?）LIMITATIONS.

　?。ˋ）IN GENERAL.— To the extent that periods of delay attributable to grounds specified in paragraph（1）overlap， the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed.

　?。˙）DISCLAIMED TERM.— No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer. 延遲重疊的天數是指上述“A”延遲與“B”延遲之間重疊的天數?！睹绹鴮?zhuān)利法》第154（b）（2）條規定，存在延遲重疊的，專(zhuān)利調整期限的天數不能超出專(zhuān)利授權所延誤的實(shí)際天數。根據美國專(zhuān)利商標局的解釋?zhuān)魏螌Α癇”延遲有影響的“A”延遲，都屬于延遲重疊。

　　該專(zhuān)利期限調整是從專(zhuān)利到期日開(kāi)始計算的，專(zhuān)利到期日加上計算出的實(shí)際PTA的天數即為最終該專(zhuān)利申請的保護期限。需要注意的是，凡適用期末放棄(terminal disclaimer)原則的案件均不適用此專(zhuān)利期限調整；對于其母案已獲得專(zhuān)利期限調整的分案，也不適用此專(zhuān)利期限調整。

　　因為商業(yè)化往往在專(zhuān)利申請很久以后才發(fā)生，PTA作為延長(cháng)專(zhuān)利保護期限的一種方式，對生物技術(shù)和藥品發(fā)明尤其有利。而且，藥品的研發(fā)費用非常高，專(zhuān)利期限調整的每一天都會(huì )給專(zhuān)利權人帶來(lái)巨大的經(jīng)濟收益。我國專(zhuān)利申請量多年位居世界第一，且審查人員數量有限，在保證合理的審查周期方面面臨著(zhù)巨大的壓力，所以，國家知識產(chǎn)權部門(mén)也正在加快推進(jìn)專(zhuān)利法修改，建立藥品專(zhuān)利保護期限補償制度，以彌補創(chuàng )新藥為獲得上市批準而造成的有效專(zhuān)利期的損失。

　　參考文獻：

　　1.《美國專(zhuān)利法》35 U.S.C.154；

　　2.《美國專(zhuān)利商標局將改變其專(zhuān)利期限調整評估方法》，中國發(fā)明與專(zhuān)利，2010年第3期；

　　3.《頗具特色的美國專(zhuān)利期限調整》，隆天知識產(chǎn)權代理有限公司，程秀娟。