2019年10月7日 星期一

涉及RCE程序例外的專利期限調整(B delay PTA) - Mayo Foundation v. Iancu (Fed. Cir. 2019)

Mayo Foundation v. Iancu (Fed. Cir. 2019)

本篇關於PTA(Patent Term Adjustment)議題,這是USPTO特有對內督導、對外(專利權人)負責的措施(1999年美國發明人保護法),讓專利權人的權益不會因為官方疏失而受損。

PTA:
- “A” DELAYS.(37 CFR 1.702(a) & 37 CFR 1.703(a))
USPTO延遲發出第一次官方意見(包括核駁或核准)、延遲回覆申請人的回應、答辯、訴願,或是延遲公告領證專利。
- “B” DELAYS.(37 CFR 1.702(b) & 1.703(b))
專利核准公告(issue)並未在申請日後三年內發出,但排除專利審查過程發生的干擾程序(interference proceeding)與有接續審查(continued examination)消耗的時間。
- “C” DELAYS.(37 CFR 1.702 (c)-(e) & 1.703(c)-(e))
干擾程序中發生的延遲、專利涉及保密法規相關的延遲、訴願程序的延遲。
https://enpan.blogspot.com/2012/05/patent-term-adjustment-pta.html

判決文摘錄:


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案件資訊:
原告/上訴人/專利權人:MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
被告/被上訴人:ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE
判決日:September 16, 2019
系爭專利:US8,981,063

本案緣起原告/專利權人Mayo對地方法院在計算系爭專利的專利期限時同意USPTO的算法提出上訴,特別的是本案例是關於審查期間經歷了「延續申請案」的情況,即便有35 U.S.C. § 154(b)(1)(B)保障「3年專利期限」的規定,但是例外的是,當審理案件進入延續程序,如RCE,就可能沒有「3年專利期限」的保障。

[法條]
35 U.S.C. § 154(b)(1)(B)(i)
35 U.S.C. 154 CONTENTS AND TERM OF PATENT; PROVISIONAL RIGHTS
...
(b) ADJUSTMENT OF PATENT TERM.—
(1) PATENT TERM GUARANTEES.—
...
(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.

35 U.S.C. § 154(b)(4)(A)
...
(4) APPEAL OF PATENT TERM ADJUSTMENT DETERMINATION.—
(A) An applicant dissatisfied with the Director's decision on the applicant's request for reconsideration under paragraph (3)(B)(ii) shall have exclusive remedy by a civil action against the Director filed in the United States District Court for the Eastern District of Virginia within 180 days after the date of the Director's decision on the applicant's request for reconsideration. Chapter 7 of title 5 shall apply to such action. Any final judgment resulting in a change to the period of adjustment of the patent term shall be served on the Director, and the Director shall thereafter alter the term of the patent to reflect such change.

(B) The determination of a patent term adjustment under this subsection shall not be subject to appeal or challenge by a third party prior to the grant of the patent.


系爭專利US8,981,063關於癌症、AIDS的B7-H1抗體B7-H1 Antibodies),Claim 1:




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本案上訴議題關於上述B delay

根據判決文,引用案例Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014),說明PTA進入RCE的例外也會在發出核准通知結束。

本案關於RCE等複雜的延續狀態,Mayo提出各階段時間序(從判決文截圖):


從上圖可知,Mayo於2/9/2012提出RCE,不久後提出「衝突程序(interference,關於系爭專利與其他專利範圍的重疊問題)」,這段期間(2年)處於案件close狀態,之後在4/23/2014結束,才又reopen案件審理程序,之後面對RCE後non-Final Action(6/30/2014),到了11/3/2014收到核准通知,最後在3/17/2017領證。


根據Mayo說明,延續程序所花費的時間為「RCE到宣告衝突程序的期間」,就是以上時間序中的「period 1」,也就是主張當時已經宣告專利可核准的狀態(因為衝突程序應該是專利核准後才有的)。但是CAFC認同PTO意見,認為宣告衝突程序並非等於核准通知,也就是認為衝突程序仍是「審查程序」,直到核准通知。

PTO意見:


法院意見:

雖然法院同意進入interference proceeding前有至少一項可核准範圍,但是並未拒絕審查委員還可發出核駁意見,因此法院認為interference proceeding並不代表專利可核准,RCE效力僅在發出notice of allowance才停止,因此本案並不屬於B delay




最終,法院認定衝突程序屬於RCE程序,也就是PTA的例外,所花費時間不能列入專利程序調整

但是,本案判決文後,有法官提出反對意見,顯然這個議題並非有一致的看法,需要繼續有別人來挑戰。

my two cents:
本案爭點是專利權人認為PTO審理系爭專利與其他案(如發明人自己的其他專利)的衝突(interference)審理是基於系爭專利為可核准,因此衝突審理應該列為PTA,這我也同意(這與interference本意有關),但法院與USPTO認為不是,而是在RCE例外的期間,不能列為PTA。

...,這也提醒我們,如果要進入衝突審理,要先確認專利是可核准狀態吧,免得一下子專利期限就少了1~2年。

判決文:http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-2031.Opinion.9-16-2019.pdf(備份:https://app.box.com/s/9kvpl07k0yfpa0stdi6p588x1yg1f74i

資料參考:
https://patentlyo.com/patent/2019/09/patent-term-adjustment-when.html

Ron

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