文/北京集佳知识产权代理有限公司西安分部 潘红

　　专利权是一种排他的权力，任何一项专利经过一定的专利保护期，就进入公有领域，成为公共财富。专利保护期对于高投入、高回报的各类研发企业尤其是医药企业来说是十分的重要的。例如，医药企业的利润收入往往是以日计的，一旦超过专利保护期限，其他企业则可以生产类似产品，因此专利保护期的延长或缩短将会对其收益带来巨大影响。

　　对于一件专利申请而言，授权日开始才算是正式的专利保护，侵犯专利权，严格意义上说也是从授权日开始算的。公告日到授权日这段期间属于临时保护期，根据美国专利法第154(d)条规定，专利权人在该临时保护期间可以向使用人收取适当的使用费。然而，这段期间是属于未决的期待利益，因此该费用可能会远低于专利侵权赔偿额或专利许可所得数额。所以，授权日至保护期终止这段时间对于企业而言才是最重要的期限。

　　为了避免专利审查的不当延迟而缩短专利有效期限，美国国会于1999年在美国发明人保护法(AIPA)中对专利期限调整做了相应规定，即，专利期限调整(Patent Term Adjustment, PTA)。美国专利商标局(USPTO)在颁发专利证书时会对有需要进行专利期限调整的专利调整相应的专利保护期限。下面将结合美国专利法中对PTA的规定来对美国专利期限调整进行简要介绍。

　　专利期限调整主要可分为两大类，即美国专利商标局的审查过程延误以及申请人延误。专利期限调整的计算原则是美国专利商标局的审查过程延误的天数减去申请人延误的天数和延迟重叠的天数即可得到最终的PTA天数。

　　一、美国专利商标局的审查过程延误

　　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；

　　（ii）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）；

　　（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.

　　从上述法条规定可知，美国专利商标局的审查过程延误可以包括下述三种情况：

　　“A”延迟，美国专利商标局未能在规定时间内进行审查并向申请人发出审查结果，如未在14个月内发出第一次审查意见通知书，收到申请人针对审查意见通知书递交答辩意见或其他请求后没有在4个月内发出第二次审查意见通知或授权通知，在申请人缴纳授权费后4个月内没有未授予专利权等，这也称为14-4-4-4延迟规则，凡是没有符合上述要求而导致延迟的天数均被记入专利期限调整；

　　“B”延迟，美国专利商标局未能在提交专利申请之日起3年内授权专利权，这也称为3年延迟规则，凡是没有符合该要求而导致延误的天数也被记入专利期限调整。需要注意的是，申请人提交继续审查请求（RCE），上诉复审等导致的期限延迟不包括在内；

　　“C”延迟，当申请涉及争议或申诉，或保密要求时，任何由于向专利审判和上诉委员会上诉（appeals），溯源诉讼程式（derivation proceedings），或者保密命令（secrecy orders）而导致的延误也被记入专利期限调整，这也被称为PTAB规则。

　　二、申请人延误

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

　　（2）LIMITATIONS.

　　（C）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.

　　（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.

　　（iii）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.

　　从上述法条规定可知，申请人延迟是指由于申请人个人的原因，导致其没有在官方规定的期限内及时作出响应而导致的延迟。例如，申请人在收到审查意见通知书3个月内没有作出答复而造成的任何延迟。因此，从申请人角度，尽量在官方规定的期限内答复审查意见，递交相关文件，以及提交各种请求等，以尽量减少由于申请人原因导致的延迟。

　　三、延迟重叠的定义

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

　　（2）LIMITATIONS.

　　（A）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.

　　（B）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. 延迟重叠的天数是指上述“A”延迟与“B”延迟之间重叠的天数。《美国专利法》第154（b）（2）条规定，存在延迟重叠的，专利调整期限的天数不能超出专利授权所延误的实际天数。根据美国专利商标局的解释，任何对“B”延迟有影响的“A”延迟，都属于延迟重叠。

　　该专利期限调整是从专利到期日开始计算的，专利到期日加上计算出的实际PTA的天数即为最终该专利申请的保护期限。需要注意的是，凡适用期末放弃(terminal disclaimer)原则的案件均不适用此专利期限调整；对于其母案已获得专利期限调整的分案，也不适用此专利期限调整。

　　因为商业化往往在专利申请很久以后才发生，PTA作为延长专利保护期限的一种方式，对生物技术和药品发明尤其有利。而且，药品的研发费用非常高，专利期限调整的每一天都会给专利权人带来巨大的经济收益。我国专利申请量多年位居世界第一，且审查人员数量有限，在保证合理的审查周期方面面临着巨大的压力，所以，国家知识产权部门也正在加快推进专利法修改，建立药品专利保护期限补偿制度，以弥补创新药为获得上市批准而造成的有效专利期的损失。

　　参考文献：

　　1.《美国专利法》35 U.S.C.154；

　　2.《美国专利商标局将改变其专利期限调整评估方法》，中国发明与专利，2010年第3期；

　　3.《颇具特色的美国专利期限调整》，隆天知识产权代理有限公司，程秀娟。