2018年10月22日 星期一

美國專利訴訟探索程序筆記

筆記



本篇開門見山,直接說到在美國訴訟的審訊前的「探索程序(discovery)」是十分惡名昭彰的,理由是耗時又耗錢。但是不論是主動或受迫,如果進入探索程序,計畫(planning)與策略(strategy)是本篇文章的重點,在此僅摘錄,有興趣者可以看原文。

在訴訟中,探索是很重要的一環,在探索程序之前,需要全面地進行調查,甚至包括美國境外,使得代理律師能理解訴訟爭議中的事實,讓後續的探索程序更為聚焦與有效率。

(瞭解探索)傳統的探索工具如:文件請求(document request)、質詢(interrogatories)、宣誓作證(de-positions)、傳票(subpoenas)、專家披露(expert  disclosures),同時可包括非正式來源( informal  sources),如:公共圖書館(public  libraries)、網際網路(Internet)與政府資源(government  sources)。

(事前作業)一般在訴訟前的準備也會包括進入探索程序的計畫,包括對專利的整體理解(專利範圍、審查歷史、先前技術、相關證據),並開始「整隊」,包括企業內人員(專利/律師、代理人、工程師、市場/行銷/產品人員),以及外部資源(律師、專家、鑑定機關),並進行蒐證(鑑定、發票、證人、證據與各種證明),以及沙盤推演、法院選擇、考量上述各種探索工具,並評估各種情況下的風險。

可考量「保護令」,區分機密(僅公開給律師)與可公開文件,釐清事件發生的人、事、時、地、物,還有相關利害關係與利益衝突等。

(探索程序)
此篇文章用個流程表示探索程序的一般流程,這裡僅用文字表示:
(1)策略與預備
- 公眾資料庫搜尋、網際網路搜尋、與外部顧問協調,以及內部測試、沙盤推演。

(2)訴訟開始
- 主張「保護令(protective order)」,這是對於探索機密文件的保護,可參考過去報導:在保護令下聘僱律師才能閱覽機密文件 - Huang v. Huawei (Fed. Cir. 2018)(https://enpan.blogspot.com/2018/06/huang-v-huawei-fed-cir-2018.html
- 提供初步揭露(initial disclosures)

(3)用於檢閱用的文件或事物製作(production of documents or things)
- 技術文件
- 市場文件
- 財務文件
- 會議記錄(meeting minutes)
- FDA/regulatory
- 國外訴訟
雙方一定會參考對方在他國的訴訟資訊,但是否對法院有約束,或說"影響",就見仁見智了,例如一些案例:
*國外訴訟無法啟動美國訴訟的討論 - Allied Mineral v. OSMI and Stellar Materials (Fed. Cir. 2017)(https://enpan.blogspot.com/2017/10/allied-mineral-v-osmi-and-stellar.html
*外國答辯歷史可能會是主張範圍的限制 - Gillette Co. v. Energizer Holdings (Fed. Cir. 2005)(https://enpan.blogspot.com/2014/05/gillette-co-v-energizer-holdings-fed.html

- 樣品
(訴訟雙方會要求對方提供樣品與檢驗結果(醫療、生技類需要檢驗結果))

(4)
文字審問(written Interrogations)(寫下質詢對方的問題)
專家證詞(expert testimony)
許可請求(requests for admission)
第三方傳票(subpoenas of third parties)
對於口審或文字證言宣誓(Depositions)(通過面對面的探索取得對方的言論)

(善意提醒)再是要瞭解探索程序各端的權利與義務,不要讓自己的權利睡著了,也不要略應該要做的事,這就需要有經驗的律師,避免法條不熟、程序不懂而輸在起跑點。必要時,若相關爭議與專利審查也有國外案,可以斟酌提供國外的專利訴訟、專利審查歷史、異議程序等。

本篇文章提到,原告可以質詢被告專家意見,反之亦然,也曾有對方專家證詞反對自己有利的案例。

美國訴訟中,專家地位頗高,都是經過宣誓才提證詞,講話有權威,這裡也提到,企業內聘僱專家所講的不是證詞(not testifying),但聘僱專家的報告對訴訟前的預備仍重要。

在美國訴訟中建立的探索相關資訊十分有價值,對國外訴訟也會有幫助,如美國28U.S.C. 1782(a)規定,美國法院可以協助美國居民在國外的訴訟,就包括「探索命令」。

對於醫藥、生技相關資訊,公開資料中,可以看看FDA網站。

(小編用案例的善意提醒)
- 檢驗各種合約,有些合約要小心是否有專利申請前揭露:
申請前商業販售或約定形成的專利權障礙 - Hamilton Beach v. Sunbeam Products (Fed. Cir. 2013)(https://enpan.blogspot.com/2017/05/hamilton-beach-v-sunbeam-products-fed.html
- 查驗疑似侵權產品在整體生態的角色:
供應國外生產的多元件侵權產品的單一元件不構成侵害271(f)(1) - Life Technologies Corp. v. Promega Corp. (Supreme Court 2017)(https://enpan.blogspot.com/2017/02/271f1-life-technologies-corp-v-promega.html
- 查驗權利耗盡:
專利權對於商品的影響(權利耗盡) - Impression v. Lexmark (Fed. Cir. 2016)(https://enpan.blogspot.com/2016/03/impression-v-lexmark-fir-cir-2016.html



其他補充:
本篇著重在醫藥生技類的相關資訊,因此提到「Hatch-Waxman Act」,因為藥品需要FDA許可才能上市而損失專利期限,因此會有特別保障:

"依據美國專利法第155條規定,但此條已經在AIA之後刪除,可參考第156條(Hatch-Waxman Act,1984年通過),食品藥品上市之前應取得美國的負責機關就是FDA(Food and Drug Administration)的許可。如果是應用在1995年6月8日以前獲准的專利上,因為補償檢驗而損失的專利期限可以在保障17年在加上兩年恢復延長時間(restoration extension)。"

編按,35 U.S.C. 155已廢除,"35 U.S.C. 156: EXTENSION OF PATENT TERM"摘錄:

35 U.S.C. 156 EXTENSION OF PATENT TERM.

  • (a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b) if —
  • (5)
  • (A) except as provided in subparagraph (B) or (C), the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred;
  • (B) in the case of a patent which claims a method of manufacturing the product which primarily uses recombinant DNA technology in the manufacture of the product, the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent; or
  • (C) for purposes of subparagraph (A), in the case of a patent which —
    • (i) claims a new animal drug or a veterinary biological product which (I) is not covered by the claims in any other patent which has been extended, and (II) has received permission for the commercial marketing or use in non-food-producing animals and in food-producing animals, and
    • (ii) was not extended on the basis of the regulatory review period for use in non-food-producing animals,
    the permission for the commercial marketing or use of the drug or product after the regulatory review period for use in food-producing animals is the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal.

28 U.S. Code § 1782 - Assistance to foreign and international tribunals and to litigants before such tribunals(https://www.law.cornell.edu/uscode/text/28/1782

(a)
The district court of the district in which a person resides or is found may order him to give his testimony or statement or to produce a document or other thing for use in a proceeding in a foreign or international tribunal, including criminal investigations conducted before formal accusation. The order may be made pursuant to a letter rogatory issued, or request made, by a foreign or international tribunal or upon the application of any interested person and may direct that the testimony or statement be given, or the document or other thing be produced, before a person appointed by the court. By virtue of his appointment, the person appointed has power to administer any necessary oath and take the testimony or statement. The order may prescribe the practice and procedure, which may be in whole or part the practice and procedure of the foreign country or the international tribunal, for taking the testimony or statement or producing the document or other thing. To the extent that the order does not prescribe otherwise, the testimony or statement shall be taken, and the document or other thing produced, in accordance with the Federal Rules of Civil Procedure.
A person may not be compelled to give his testimony or statement or to produce a document or other thing in violation of any legally applicable privilege.
(b)
This chapter does not preclude a person within the United States from voluntarily giving his testimony or statement, or producing a document or other thing, for use in a proceeding in a foreign or international tribunal before any person and in any manner acceptable to him.

資料參考:
http://euro.ecom.cmu.edu/program/law/08-732/Courts/DiscoveryGuide.pdf

Ron

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