文/北京集佳知識產(chǎn)權代理有限公司西安分部 潘紅
專利權是一種排他的權力，任何一項專利經(jīng)過一定的專利保護期，就進入公有領域，成為公共財富。專利保護期對于高投入、高回報的各類研發(fā)企業(yè)尤其是醫(yī)藥企業(yè)來說是十分的重要的。例如，醫(yī)藥企業(yè)的利潤收入往往是以日計的，一旦超過專利保護期限，其他企業(yè)則可以生產(chǎn)類似產(chǎn)品，因此專利保護期的延長或縮短將會對其收益帶來巨大影響。
對于一件專利申請而言，授權日開始才算是正式的專利保護，侵犯專利權，嚴格意義上說也是從授權日開始算的。公告日到授權日這段期間屬于臨時保護期，根據(jù)美國專利法第154(d)條規(guī)定，專利權人在該臨時保護期間可以向使用人收取適當?shù)氖褂觅M。然而，這段期間是屬于未決的期待利益，因此該費用可能會遠低于專利侵權賠償額或?qū)＠S可所得數(shù)額。所以，授權日至保護期終止這段時間對于企業(yè)而言才是最重要的期限。
為了避免專利審查的不當延遲而縮短專利有效期限，美國國會于1999年在美國發(fā)明人保護法(AIPA)中對專利期限調(diào)整做了相應規(guī)定，即，專利期限調(diào)整(Patent Term Adjustment, PTA)。美國專利商標局(USPTO)在頒發(fā)專利證書時會對有需要進行專利期限調(diào)整的專利調(diào)整相應的專利保護期限。下面將結(jié)合美國專利法中對PTA的規(guī)定來對美國專利期限調(diào)整進行簡要介紹。
專利期限調(diào)整主要可分為兩大類，即美國專利商標局的審查過程延誤以及申請人延誤。專利期限調(diào)整的計算原則是美國專利商標局的審查過程延誤的天數(shù)減去申請人延誤的天數(shù)和延遲重疊的天數(shù)即可得到最終的PTA天數(shù)。
一、美國專利商標局的審查過程延誤
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—
（i）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
（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—
?。╥）a proceeding under section 135（a）；
（ii）the imposition of an order under section 181； or
（iii）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，美國專利商標局的審查過程延誤可以包括下述三種情況：
“A”延遲，美國專利商標局未能在規(guī)定時間內(nèi)進行審查并向申請人發(fā)出審查結(jié)果，如未在14個月內(nèi)發(fā)出第一次審查意見通知書，收到申請人針對審查意見通知書遞交答辯意見或其他請求后沒有在4個月內(nèi)發(fā)出第二次審查意見通知或授權通知，在申請人繳納授權費后4個月內(nèi)沒有未授予專利權等，這也稱為14-4-4-4延遲規(guī)則，凡是沒有符合上述要求而導致延遲的天數(shù)均被記入專利期限調(diào)整；
“B”延遲，美國專利商標局未能在提交專利申請之日起3年內(nèi)授權專利權，這也稱為3年延遲規(guī)則，凡是沒有符合該要求而導致延誤的天數(shù)也被記入專利期限調(diào)整。需要注意的是，申請人提交繼續(xù)審查請求（RCE），上訴復審等導致的期限延遲不包括在內(nèi)；
“C”延遲，當申請涉及爭議或申訴，或保密要求時，任何由于向?qū)＠麑徟泻蜕显V委員會上訴（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利期限調(diào)整，這也被稱為PTAB規(guī)則。
二、申請人延誤
35 U.S.C.154（b）ADJUSTMENT OF PATENT TERM
（2）LIMITATIONS.
?。–）REDUCTION OF PERIOD OF ADJUSTMENT.—
（i）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(guī)定可知，申請人延遲是指由于申請人個人的原因，導致其沒有在官方規(guī)定的期限內(nèi)及時作出響應而導致的延遲。例如，申請人在收到審查意見通知書3個月內(nèi)沒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(guī)定的期限內(nèi)答復審查意見，遞交相關文件，以及提交各種請求等，以盡量減少由于申請人原因?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)?！睹绹鴮＠ā返?54（b）（2）條規(guī)定，存在延遲重疊的，專利調(diào)整期限的天數(shù)不能超出專利授權所延誤的實際天數(shù)。根據(jù)美國專利商標局的解釋，任何對“B”延遲有影響的“A”延遲，都屬于延遲重疊。
該專利期限調(diào)整是從專利到期日開始計算的，專利到期日加上計算出的實際PTA的天數(shù)即為最終該專利申請的保護期限。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利期限調(diào)整；對于其母案已獲得專利期限調(diào)整的分案，也不適用此專利期限調(diào)整。
因為商業(yè)化往往在專利申請很久以后才發(fā)生，PTA作為延長專利保護期限的一種方式，對生物技術和藥品發(fā)明尤其有利。而且，藥品的研發(fā)費用非常高，專利期限調(diào)整的每一天都會給專利權人帶來巨大的經(jīng)濟收益。我國專利申請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，國家知識產(chǎn)權部門也正在加快推進專利法修改，建立藥品專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利期的損失。
參考文獻：
1.《美國專利法》35 U.S.C.154；
2.《美國專利商標局將改變其專利期限調(diào)整評估方法》，中國發(fā)明與專利，2010年第3期；
3.《頗具特色的美國專利期限調(diào)整》，隆天知識產(chǎn)權代理有限公司，程秀娟。