2014年4月16日 星期三

優先權日的認定成為侵權訴訟的爭點(Medtronic CoreValve, LLC v. Edwards Lifesciences Corp. (Fed. Cir. 2014))

如果雙方都有產品與專利,訴訟怎麼打。
大約是,擁有較早專利權的人可以取得優勢,不過後進者如果有更好的產品,也有專利,也許也是好的。但是如果有一方沒有專利權,或許就只能處於挨打的份。

這個分析涉及兩間醫療器材公司的相互訴訟,首先爭議在於優先權與專利期限的認定。

Medtronic公司:

Medtronic公司為提供醫療科技解決方案的公司,有一個治療心臟瓣膜不全而提供替代品的產品:CoreValve system




另一對照Edwards的相關瓣膜產品:

Medtronic公司擁有上述產品CoreValve。原本是由Medtronic公司發動一件侵權官司,告Edwards產品侵權,系爭專利為US7,892,281(281案)(claims 3, 4, 7, 12, 14, and 15),但是專利訴訟轉向有效期限的爭議,法院還整理了表格如下(這個可以在訴訟前就做好),專利溯及2000年的法國案。但其實依照公報資訊更能溯及1999年的法國案,之後還進入PCT才進入美國。

根據公報上的家族歷史,這件專利溯及10/412,634,但其優先權日更可溯及1999年的法國專利案,之後進入PCT後才進入美國。因此被告對於不當延長期限很有意見。



US7,892,281揭露一種輸送人工瓣膜的工具(Prosthetic valve for transluminal delivery),權利範圍Claim 1如下,揭露替換有問題的心臟瓣膜的人工瓣膜組,包括有多個小葉片組成的瓣膜、瓣膜支架、有勾子的固定錨。
1. A prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:
a valve having a plurality of leaflets, a base, and a plurality of commissure points;
a valve support comprising a generally cylindrical band comprising a plurality of expandable cells, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is positioned in situ, said generally cylindrical band of the valve support supporting the base and the commissure points of the valve; and
an anchor for engaging the lumen wall when expanded in place for preventing substantial migration of the valve assembly after deployment:
wherein the anchor comprises one or more hooks extending radially outward from the valve support.

方法項則是描述替換瓣膜的步驟,包括提供人工瓣膜組,其中細節有瓣膜、支架有多個可擴張的結構、定位與固定結構等,進入人體後支架部份會塌陷,之後程序為定位、抽出等,使得人工瓣膜取代了原本人體的瓣膜....。
3. A method of replacing a deficient native valve comprising the steps of:
providing a prosthetic valve assembly, the assembly comprising a valve, a valve support comprising a plurality of expandable cells and having the base and the commissures of the valve positioned and secured at or adjacent the expandable cells, the valve support further comprising an anchor;
collapsing the valve support and anchor to fit on a distal portion of a catheter;
advancing the catheter to the deficient native valve to a position within adjacent the leaflets and within the annulus of the deficient native valve;
deploying the valve assembly within the deficient native valve, whereby the valve support expands against the leaflets of the deficient native valve; and
withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve.

對比上述被告Edwards的圖示,裝置大約就是那個"蛇管"的樣吧,方法則除了上述Claim 3以外,不曉得有沒有別的方式?

地方法院:
訴訟爭議為系爭專利的優先權日,這與被告侵權物品的生產日與侵權判斷有關。原告Medtronic公司認為系爭專利權可以溯及2000年,但地院判斷系爭專利的優先權主張有誤,不符美國專利法第119, 120條的規定,並且認定專利優先權日不早於April 10, 2003。

CAFC:
於是,訴訟進入CAFC,CAFC確認地院的判決。

爭議涉及美國專利法第120條規定專利案溯及較早申請日的條件,也就是當後申請案包括或是修改後包括較早申請案的特定參考文獻(if it contains or is amended to contain a specific reference to the earlier filed application),CAFC法官認為,其中"specific reference"是指每一件優先權鏈中的每一個申請案的先前申請案,就是每個優先權鏈中的申請案可能都有自己的較早申請案,這個複雜的鏈產生判定最早日期的爭議。(The Federal Circuit previously held in another case that the "specific reference" requirement means that each intermediate application in the chain of priority to refers to the prior applications.

關鍵就在優先權鏈(chain of priority)中有兩件專利申請案(Applications 6, 8)為其他申請案的部份延續案(CIP),這個就產生CIP案揭露內容是否確實溯及最早申請日的爭議。

CAFC法官同意被告Edwards與地院判斷在此優先權鏈中有兩件申請案的揭露內容無法符合整個281案的優先權鏈,因此判定281案錯誤引用優先權,又因為這個錯誤,表示281案"斷線",接連使得281案可能失去專利性,因為其前案可能造成281案「新穎性不足」

 功課:
引用複數優先權,或是有複雜的優先權鏈,要小心是否有CIP隱含其中;被告侵權者可以朝這方面著手,質疑這類的專利權。

法條參考:
35 U.S.C. 120 (pre-AIA)
http://enpan.blogspot.tw/2010/01/120.html


35 U.S.C. 120 (after AIA)
35 U.S.C. 120 Benefit of earlier filing date in the United States.
An application for patent for an invention disclosed in the manner provided by section 112(a) (other than the requirement to disclose the best mode) in an application previously filed in the United States, or as provided by section 363 which names an inventor or joint inventor in the previously filed application shall have the same effect, as to such invention, as though filed on the date of the prior application, if filed before the patenting or abandonment of or termination of proceedings on the first application or on an application similarly entitled to the benefit of the filing date of the first application and if it contains or is amended to contain a specific reference to the earlier filed application. No application shall be entitled to the benefit of an earlier filed application under this section unless an amendment containing the specific reference to the earlier filed application is submitted at such time during the pendency of the application as required by the Director. The Director may consider the failure to submit such an amendment within that time period as a waiver of any benefit under this section. The Director may establish procedures, including the payment of a surcharge, to accept an unintentionally delayed submission of an amendment under this section.


資料參考:
http://www.patentdocs.org/2014/01/medtronic-corevalve-llc-v-edwards-lifesciences-corp-fed-cir-2014.html

CAFC判決:http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1117.Opinion.1-17-2014.1.PDF

Ron
另有一個角色互換的訴訟:
http://enpan.blogspot.tw/2014/04/edwards-life-scoence-v-corevalve-and.html

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