2014年4月18日 星期五

當公眾利益遇上產品禁制令(Edwards Life Scoence v. CoreValve and Medtronic (Fed. Cir. 2014))

可參考前篇:
http://enpan.blogspot.tw/2014/04/medtronic-corevalve-llc-v-edwards.html

此時角色轉換。

前一篇的CAFC案:Medtronic CoreValve, LLC v. Edwards Lifesciences Corp. (Fed. Cir. 2014)
本篇討論CAFC案:Edwards Life Scoence v. CoreValve and Medtronic (Fed. Cir. 2014)

Edwards也對Medtronic提告,系爭專利為US 5,411,552,命運不同了,此案於美國Delaware地方法院判定侵權成立,法院判賠7千萬美金與1百多萬的權利金。此階段否決了Edwards提出的永久禁制令(permanent injunction),此時是2010年。到了上訴法院,法官確認賠償金額,但是對永久禁制令的決定反還地院,此時是2012年。

系爭專利US 5,411,552揭露植入人體的人工瓣膜以及相關導管裝置(Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis),主要的爭議範圍為Claim 1:
1. A valve prosthesis for implantation in a body channel, the valve prosthesis comprising a collapsible elastical valve which is mounted on an elastical stent, the elastical valve having a plurality of commissural points, wherein the stent comprises:
cylindrical support means which is radially collapsible for introduction within the body channel and which has a plurality of circumferentially-expandable sections such that the cylindrical support means is radially expandable for being secured within the body channel; and
a plurality of commissural supports projecting from one side of the cylindrical support means in a direction generally parallel to the longitudinal axis thereof for supporting the commissural points of the collapsible valve, at least one circumferentially-expandable section of the cylindrical support means lying between each of the commissural supports, such that the collapsible valve may be collapsed and expanded together with the cylindrical support means for implantation in the body channel by means of a technique of catheterization.



這個早於1994年申請(溯及1993年母案)的時間也是個爭議:

 過了一年,到了2013年,Edwards提出初步禁制令 (preliminary injunction)請求,因為Edwards在市場上的銷售被Medtronic的產品(MCS)影響,地院於2014年聽證後發出初步禁制令。但給予7個工作天讓廠商提出緊急上訴。因而,Medtronic緊急請求暫時解除(stay)美國聯邦法院對Medtronic 公司的大主動脈的心臟瓣膜取代系統的初步禁制令。禁制令包括禁止販售,以及禁止對採用此產品的醫療院所的教育訓練。

這有關公眾利益,人命相關!
Medtronic的聲明表示應"暫時解除"此禁制令,理由是會影響實施過期專利技術而無須死亡的一些可治癒的病患,若過期專利不當延長專利權,又不能訓練相關人員將有害公眾健康

上述聲明觸及兩個問題,根據Patently-O部落格所載,其一為公眾利益為考量暫緩禁制令的參考?因為顯然Medtronic的產品比Edwards更好、更安全,可以幫助無法透過Edwards產品治癒的病患,這樣是否也是會影響禁制令?
另一為即使侵權成立,但是系爭專利已經過期,系爭專利已於2012年5月到期,但是美國食品藥物管理局(FDA)因為審查商品延誤而可延長專利權(被告認為不當延長!),且Edwards產品也非專利所涵蓋的產品,但這樣是否可以暫緩禁制令?
(1) that the public interest weighs in favor of denying injunctive relief and (2) that the patent is not enforceable because it has expired (infringement has already been determined).

補充:
這裡有個小議題,因為FDA的審查而延長專利權,但是此延長時間的專利權僅及於相關產品的使用(“limited to any use approved for the product.”),這也成為被告侵權Medtronic的爭點之一;更根據案例Merck v. Kessler (Fed. Cir. 1996),此案法院解釋專利權延長的部份僅關於相關產品(“the product on which the extension was based”);不過地院法官仍根據美國專利法第156條規定認定Medtronic的產品使用方法侵權

35 U.S.C. 156 Extension of patent term.
(b) Except as provided in subsection (d)(5)(F), the rights derived from any patent the term of which is extended under this section shall during the period during which the term of the patent is extended -
(1) in the case of a patent which claims a product, be limited to any use approved for the product -


於是,Medtronic上訴CAFC。

Edwards Life Scoence v. CoreValve and Medtronic (Fed. Cir. 2014)

本案尚待CAFC判決。
 
Ron
資料參考:Patently-O

沒有留言: