文/北京集佳知識(shí)產(chǎn)權(quán)代理有限公司西安分部 潘紅
專(zhuān)利權(quán)是一種排他的權(quán)力，任何一項(xiàng)專(zhuān)利經(jīng)過(guò)一定的專(zhuān)利保護(hù)期，就進(jìn)入公有領(lǐng)域，成為公共財(cái)富。專(zhuān)利保護(hù)期對(duì)于高投入、高回報(bào)的各類(lèi)研發(fā)企業(yè)尤其是醫(yī)藥企業(yè)來(lái)說(shuō)是十分的重要的。例如，醫(yī)藥企業(yè)的利潤(rùn)收入往往是以日計(jì)的，一旦超過(guò)專(zhuān)利保護(hù)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(hù)期的延長(zhǎng)或縮短將會(huì)對(duì)其收益帶來(lái)巨大影響。
對(duì)于一件專(zhuān)利申請(qǐng)而言，授權(quán)日開(kāi)始才算是正式的專(zhuān)利保護(hù)，侵犯專(zhuān)利權(quán)，嚴(yán)格意義上說(shuō)也是從授權(quán)日開(kāi)始算的。公告日到授權(quán)日這段期間屬于臨時(shí)保護(hù)期，根據(jù)美國(guó)專(zhuān)利法第154(d)條規(guī)定，專(zhuān)利權(quán)人在該臨時(shí)保護(hù)期間可以向使用人收取適當(dāng)?shù)氖褂觅M(fèi)。然而，這段期間是屬于未決的期待利益，因此該費(fèi)用可能會(huì)遠(yuǎn)低于專(zhuān)利侵權(quán)賠償額或?qū)＠S可所得數(shù)額。所以，授權(quán)日至保護(hù)期終止這段時(shí)間對(duì)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(dāng)延遲而縮短專(zhuān)利有效期限，美國(guó)國(guó)會(huì)于1999年在美國(guó)發(fā)明人保護(hù)法(AIPA)中對(duì)專(zhuān)利期限調(diào)整做了相應(yīng)規(guī)定，即，專(zhuān)利期限調(diào)整(Patent Term Adjustment, PTA)。美國(guó)專(zhuān)利商標(biāo)局(USPTO)在頒發(fā)專(zhuān)利證書(shū)時(shí)會(huì)對(duì)有需要進(jìn)行專(zhuān)利期限調(diào)整的專(zhuān)利調(diào)整相應(yīng)的專(zhuān)利保護(hù)期限。下面將結(jié)合美國(guó)專(zhuān)利法中對(duì)PTA的規(guī)定來(lái)對(duì)美國(guó)專(zhuān)利期限調(diào)整進(jìn)行簡(jiǎn)要介紹。
專(zhuān)利期限調(diào)整主要可分為兩大類(lèi)，即美國(guó)專(zhuān)利商標(biāo)局的審查過(guò)程延誤以及申請(qǐng)人延誤。專(zhuān)利期限調(diào)整的計(jì)算原則是美國(guó)專(zhuān)利商標(biāo)局的審查過(guò)程延誤的天數(shù)減去申請(qǐng)人延誤的天數(shù)和延遲重疊的天數(shù)即可得到最終的PTA天數(shù)。
一、美國(guó)專(zhuān)利商標(biāo)局的審查過(guò)程延誤
35 U.S.C.154（b）ADJUSTMENT OF PATENT TERM
（1）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；
（iii）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
（iv）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—
（i）any time consumed by continued examination of the application requested by the applicant under section 132（b）；
（ii）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
（iii）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—
（i）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(guī)定可知，美國(guó)專(zhuān)利商標(biāo)局的審查過(guò)程延誤可以包括下述三種情況：
“A”延遲，美國(guó)專(zhuān)利商標(biāo)局未能在規(guī)定時(shí)間內(nèi)進(jìn)行審查并向申請(qǐng)人發(fā)出審查結(jié)果，如未在14個(gè)月內(nèi)發(fā)出第一次審查意見(jiàn)通知書(shū)，收到申請(qǐng)人針對(duì)審查意見(jiàn)通知書(shū)遞交答辯意見(jiàn)或其他請(qǐng)求后沒(méi)有在4個(gè)月內(nèi)發(fā)出第二次審查意見(jiàn)通知或授權(quán)通知，在申請(qǐng)人繳納授權(quán)費(fèi)后4個(gè)月內(nèi)沒(méi)有未授予專(zhuān)利權(quán)等，這也稱(chēng)為14-4-4-4延遲規(guī)則，凡是沒(méi)有符合上述要求而導(dǎo)致延遲的天數(shù)均被記入專(zhuān)利期限調(diào)整；
“B”延遲，美國(guó)專(zhuān)利商標(biāo)局未能在提交專(zhuān)利申請(qǐng)之日起3年內(nèi)授權(quán)專(zhuān)利權(quán)，這也稱(chēng)為3年延遲規(guī)則，凡是沒(méi)有符合該要求而導(dǎo)致延誤的天數(shù)也被記入專(zhuān)利期限調(diào)整。需要注意的是，申請(qǐng)人提交繼續(xù)審查請(qǐng)求（RCE），上訴復(fù)審等導(dǎo)致的期限延遲不包括在內(nèi)；
“C”延遲，當(dāng)申請(qǐng)涉及爭(zhēng)議或申訴，或保密要求時(shí)，任何由于向?qū)＠麑徟泻蜕显V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(dǎo)致的延誤也被記入專(zhuān)利期限調(diào)整，這也被稱(chēng)為PTAB規(guī)則。
二、申請(qǐng)人延誤
35 U.S.C.154（b）ADJUSTMENT OF PATENT TERM
?。?）LIMITATIONS.
（C）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.
（ii）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(guī)定可知，申請(qǐng)人延遲是指由于申請(qǐng)人個(gè)人的原因，導(dǎo)致其沒(méi)有在官方規(guī)定的期限內(nèi)及時(shí)作出響應(yīng)而導(dǎo)致的延遲。例如，申請(qǐng)人在收到審查意見(jiàn)通知書(shū)3個(gè)月內(nèi)沒(méi)有作出答復(fù)而造成的任何延遲。因此，從申請(qǐng)人角度，盡量在官方規(guī)定的期限內(nèi)答復(fù)審查意見(jiàn)，遞交相關(guān)文件，以及提交各種請(qǐng)求等，以盡量減少由于申請(qǐng)人原因?qū)е碌难舆t。
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(shù)是指上述“A”延遲與“B”延遲之間重疊的天數(shù)?！睹绹?guó)專(zhuān)利法》第154（b）（2）條規(guī)定，存在延遲重疊的，專(zhuān)利調(diào)整期限的天數(shù)不能超出專(zhuān)利授權(quán)所延誤的實(shí)際天數(shù)。根據(jù)美國(guó)專(zhuān)利商標(biāo)局的解釋?zhuān)魏螌?duì)“B”延遲有影響的“A”延遲，都屬于延遲重疊。
該專(zhuān)利期限調(diào)整是從專(zhuān)利到期日開(kāi)始計(jì)算的，專(zhuān)利到期日加上計(jì)算出的實(shí)際PTA的天數(shù)即為最終該專(zhuān)利申請(qǐng)的保護(hù)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(diào)整；對(duì)于其母案已獲得專(zhuān)利期限調(diào)整的分案，也不適用此專(zhuān)利期限調(diào)整。
因?yàn)樯虡I(yè)化往往在專(zhuān)利申請(qǐng)很久以后才發(fā)生，PTA作為延長(zhǎng)專(zhuān)利保護(hù)期限的一種方式，對(duì)生物技術(shù)和藥品發(fā)明尤其有利。而且，藥品的研發(fā)費(fèi)用非常高，專(zhuān)利期限調(diào)整的每一天都會(huì)給專(zhuān)利權(quán)人帶來(lái)巨大的經(jīng)濟(jì)收益。我國(guó)專(zhuān)利申請(qǐng)量多年位居世界第一，且審查人員數(shù)量有限，在保證合理的審查周期方面面臨著巨大的壓力，所以，國(guó)家知識(shí)產(chǎn)權(quán)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(hù)期限補(bǔ)償制度，以彌補(bǔ)創(chuàng)新藥為獲得上市批準(zhǔn)而造成的有效專(zhuān)利期的損失。
參考文獻(xiàn)：
1.《美國(guó)專(zhuān)利法》35 U.S.C.154；
2.《美國(guó)專(zhuān)利商標(biāo)局將改變其專(zhuān)利期限調(diào)整評(píng)估方法》，中國(guó)發(fā)明與專(zhuān)利，2010年第3期；
3.《頗具特色的美國(guó)專(zhuān)利期限調(diào)整》，隆天知識(shí)產(chǎn)權(quán)代理有限公司，程秀娟。