歐洲專利範圍元件標示筆記

筆記

一些申請專利範圍中標示元件符號的範例：





EPC Rule 43規範歐洲專利範圍寫作，可參考過去筆記：EPC Rule 43 歐洲專利Claim寫作（About Claims XXXIX）（http://enpan.blogspot.tw/2011/05/epc-rule-43-claimabout-claims-xxxix.html）；Rule 43(7)則是關於專利範圍中如何標示的規定，如過去筆記：歐洲專利Rule 43(7)專利範圍標註編號的筆記（http://enpan.blogspot.tw/2016/10/rule-437.html）。

關於EP申請專利範圍中標示元件符號（reference signs）的問題，其實多數國家可以允許，但是避免被不當解釋或限縮，實務上是不去標示，但歐洲專利局則要求要標示元件符號，其目的不是為了"解釋"專利範圍，而是"瞭解"專利範圍。

最明確的規定在Rule 43(7)：具有元件符號的圖式的歐洲專利申請案（化學案可能沒有圖式），讓申請專利範圍比較清晰，在申請專利範圍中的技術特徵應該較佳地隨著這些元件符號標示在圓括號中，而這些元件編號將不會用來限制專利範圍。

Rule 43 Form and content of claims

(7)

Where the European patent application contains drawings including reference signs, the technical features specified in the claims shall preferably be followed by such reference signs relating to these features, placed in parentheses, if the intelligibility of the claim can thereby be increased. These reference signs shall not be construed as limiting the claim. 

歐洲審查指南（Guidelines for Examination）Part F, Chapter 4中4.19節規定，如果申請案包括圖式，可以加入技術特徵與對應圖示元件符號的連結關係以改善對於申請專利範圍的理解（所以，加入元件符號的目的是要改善對專利範圍的理解）。適當的元件符號應擺在申請專利範圍中元件之後的括號中。

如果有多個不同的實施例，只要將最重要實施例的元件符號加入「獨立請求項」。申請專利範圍應以兩段式撰寫，元件符號不僅加在特徵部分，也要加在前言部分。特別再講，元件符號功能只是讓申請專利範圍容易理解，但不能限制專利範圍。

接著是提到不符規定的標示，曾於http://enpan.blogspot.tw/2016/10/rule-437.html筆記過。

4.19

Reference signs (https://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_4_19.htm)

If the application contains drawings, and the comprehension of the claims would be improved by establishing the connection between the features mentioned in the claims and the corresponding reference signs in the drawings, then appropriate reference signs should be placed in parentheses after the features mentioned in the claims. If there is a large number of different embodiments, only the reference signs of the most important embodiments need be incorporated in the independent claim(s). Where claims are drafted in the two-part form set out in Rule 43(1), the reference signs should be inserted not only in the characterising part but also in the preamble of the claims. Reference signs should not however be seen as limiting the extent of the matter protected by the claims; their sole function is to make claims easier to understand. A comment to that effect in the description is acceptable (see T 237/84).

Rule 43(7)

If text is added to reference signs in parentheses in the claims, lack of clarity can arise (Art. 84). Expressions such as "securing means (screw 13, nail 14)" or "valve assembly (valve seat 23, valve element 27, valve seat 28)" are not reference signs in the sense of Rule 43(7) but are special features, to which the last sentence of Rule 43(7) is not applicable. Consequently, it is unclear whether the features added to the reference signs are limiting or not. Accordingly, such bracketed features are generally not permissible. However, additional references to those figures where particular reference signs are to be found, such as "(13 - Figure 3; 14 - Figure 4)", are unobjectionable.

A lack of clarity can also arise with bracketed expressions that do not include reference signs, e.g. "(concrete) moulded brick". In contrast, bracketed expressions with a generally accepted meaning are allowable, e.g.-"(meth)acrylate" which is known as an abbreviation for "acrylate and methacrylate". The use of brackets in chemical or mathematical formulae is also unobjectionable.

Ron

USPTO重申自己明確性的標準 - Ex Parte McAward

Ex Parte McAward 是USPTO有註記的案例 - Appeal 2015-006416，在此案例中，USPTO/PTAB重申自己明確性的標準，而且與法院的標準（案例Nautilus, Inc. v. Biosig Instruments, Inc.）不一定是一樣的。


Ex Parte McAward案件資訊：
專利申請號：13/435,655
公開號：US 20130255798
訴願號：Appeal 2015-006416
專利申請人：Honeywell International Inc.

本案緣起11/7/2014接獲USPTO終駁意見，理由是Claims 1-20不符35 U.S.C. § 112(b)，Claims 1-7, 10-20不符35 U.S.C. § 103(a)(pre-AIA)。


本案在USPTO的檔案（包括Final OA、Appeal與進入RCE）：https://app.box.com/s/mqr8dyktyajh482sw2ezcvjbjkug8qs2

系爭案關於一種漏水偵測器，其中有漏水偵測器、自動水閥與電路，當偵測到漏水情況，將自動關閉水閥，偵測器可以與外部警報器通訊。


系爭案請求項1：


根據USPTO審查意見，認為請求項1中（如以下摘錄）不明確，讓相關領域一般技術人員無法判斷其專利範圍（metes and bounds），因為其中沒有任何裝置或系統的結構讓這個裝置可以"configured to"執行其中功能。

"configured to be reliably installed by an untrained installer or a homeowner and to not require the services of a plumber or electrician to perform installation, thereby permitting widespread and cost effective adoption"

申請人的答辯是，認為這段話沒有需要特別的知識或工具就可以執行，就如花園軟管連接器或家用牆壁插座，可用以瞭解這段設定（"configuration"）。

明確性：

關於專利範圍的「明確性（definiteness，35 U.S.C. § 112(b)）」的要求如下摘錄，算是基本定義，「專利明確性的要件」就是保護專利權人應有的權利外，更告訴公眾仍然開放的範圍，而且明確到不需要太多知識取輔助瞭解。如果專利範圍不明確，就無法達到這樣，讓專利權人知道被保護的範圍，以及也無法讓公眾瞭解可以迴避的開放之處。


然而，USPTO在審查期間就擔負專利範圍是否明確的把關者，因此，需要先判斷專利範圍，不僅根據專利範圍中的用語，還要根據說明書內容而以合理而最廣的方式（BRI）解釋範圍，這主要是來自案例Phillips v. A WH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en bane)的指示。

因此，何謂明確性？就是，以合理而最廣的方式解釋專利範圍時，來看範圍的邊界是否明確，當參考說明書內容判斷專利範圍中用語不明確，這就建立不明確的初步印象（"prima facie case of indefiniteness"）。案例為In re Packard, 751F.3d1307, 1310 (Fed. Cir. 2014)。

當USPTO作為初步把關後（審查委員需要與申請人互動達到明確性/專利性標準，申請人仍有修正的彈性），專利一旦核准，接下去面對訴訟而需要解釋專利範圍，這時法官擔任第二次明確性的把關，而這時法官面對的是已經固定下來的專利範圍，並參照請求項內容、說明書、審查歷史等證據，以合理而最廣的方式解釋專利範圍。

然而，USPTO/PTAB對於明確性的標準與法院並不需一致，如以下摘錄法院對明確性的態度，因為角色不同，因此標準也不會一致。當USPTO/PTAB採取較嚴格的標準而准予專利後，法院就相對不需要這麼嚴格的標準，相對是比較原則性的要求，如Nautilus案。



針對Nautilus：
第一次判決中，CAFC的態度是如果請求項的範圍根據說明書內容與審查歷史（內部證據）都無法讓相關技術人員了解發明的範疇，才可以因為不明確而無效專利；另一個主要態度是，除非是權利範圍有無法解決的模糊（insolubly ambiguous），否則在權利範圍可以經得起解釋時（可以被解釋時），不能排除具有明確性的可能。

經最高法院原則指示後，第二次CAFC判決：CAFC根據最高法院提出的明確性標準（最高法院認為並未提出新的標準，而是回歸過去長久使用的標準）修改判斷標準，針對"reasonable certainty"的判斷標準，考量何謂「通知相關領域技術人員該專利範疇」的意義後，(1)參考內部證據；(2)參考系爭專利再審程序中的敘述，認為Biosig請求項範圍已經合理而明確地告知相關領域技術人員發明的範疇。

相關案例：
最高法院對明確性的態度 - Nautilus, Inc. v. Biosig Instruments, Inc.（http://enpan.blogspot.tw/2014/06/nautilus-inc-v-biosig-instruments-inc.html）
CAFC第二次對Nautilus v. Biosig作出判決（April 27, 2015）（http://enpan.blogspot.tw/2015/12/cafcnautilus-v-biosigapril-27-2015.html）


回到本案例。

當USPTO審查委員認定系爭案請求項1中 "... configured to be reliably installed by an untrained installer or a homeowner and to not require the services of a plumber or electrician to perform installation, thereby permitting widespread and cost effective adoption." 不明確，因為說明書並未給予足夠的內容支持。

並且，這段內容是以「功能」來界定漏水偵測，缺乏結構特徵，即便系爭案申請人主張相關領域技術人員可以理解，但是說明書並未明確支持的描述（"when read in light of the Specification, fails to further clearly define the structure encompassed by the limitation"）。

PTAB在此訴願案中，用了不小篇幅解釋何謂明確性，也列舉系爭案說明書內容，證明無法支持專利範圍的明確性，甚至在假設說明書有支持的情況，仍讓相關領域技術人員無法得知發明的邊界。


訴願決定：專利範圍中"configured to"這段描述，參考說明書內容且在最廣且合理的解釋下，為模糊而不明確，使得相關領域一般技術人員無法從請求項內容辨別出專利範圍。

"we agree with the Examiner that the claimed "configured" limitation, under the broadest reasonable interpretation when read in light of the Specification, is vague and unclear, and a person having ordinary skill in the art would not be able to discern the metes and bounds of the claimed invention in light of this claim language."

[本篇忽略103議題]

本案訴願決定確認系爭案因為不符112(b)與103(a)不予專利。專利申請人回到原來審查程序，提出修正與RCE，這回修正專利範圍，將爭議中的段落刪除，重新詮釋專利範圍，接著就...再看看。


Ex Parte McAward案USPTO檔案：
https://www.uspto.gov/sites/default/files/documents/Ex%20parte%20McAward%202017_08_25.pdf
（備份：https://app.box.com/s/ns5bplbri7n5ujl2cbx50kog78beyk7c）

my two cents:
本次討論的系爭案發明企圖提供一個「未經訓練的一般人」在「不用特殊工具」下可以安裝的漏水偵測裝置，這個「發明動機」可能可以作為「行銷廣告用語」，吸引消費者注意，但是在取得專利的要件下，仍是需要描述出技術內容，劃定一個技術範圍，因此仍不能排除「技術描述」的正面表述，頂多輔以一些功能描述，但需要避免僅是「不明確的廣告用語」。


一些報導：
http://www.patentdocs.org/2017/08/in-re-mcaward-ptab-2017.html

Ron

35 U.S.C. § 271(g)僅及於專利製程產生的實體物品

案例Bayer  AG  v.  Housey  Pharm.,  Inc.,  340  F.3d  1367,  1374  (Fed.  Cir.  2003)

被上訴人：BAYER AG and Bayer Corporation
專利權人/上訴人：HOUSEY PHARMACEUTICALS, INC.
系爭專利：US4,980,281, 5,266,464, 5,688,655, and 5,877,007

本案緣起一個侵權訴訟，專利權人Housey在District of Delaware提出侵權訴訟，被告Bayer提出專利無效、無法主張與不侵權的簡易判決請求，原告Housey隨即提出回應，強調Bayer直接侵權、共同侵權與誘使他人侵權，主張法條即35 U.S.C. § 271(g)。

被告Bayer的回應是，35 U.S.C. § 271(g)僅適用製程方法，卻不適用如系爭專利的方法中。Housey指控有兩部分侵權物：通過專利方法得到的重要資訊，以及通過專利方法製作的藥（成份）。

通過在美國境內或境外使用專利方法製造的藥品，當被告在美國販售此包括可以判斷目標蛋白質的抑制劑或催化劑的成份的藥品時，應擔負侵權責任；當被告進口使用專利方法得到的研究數據或資訊，被告擔負侵權責任。

而地方法院判決撤銷原告的侵權主張，理由是，35 U.S.C. § 271(g)的規定是針對製程方法製作的物品，與取得資訊的方法不同。

原告上訴CAFC。

系爭專利為同一家族專利，如US5,877,007，關於篩選蛋白質抑制劑與催化劑的方法。


列舉US5,877,007請求項1，此項標的雖為測試細胞（test cell），但是專利範圍係以方法步驟界定使用測試物質抑製或激活靶蛋白的生物化學功能的測試流程。

1. A test cell in which there is present in the cell a target protein, wherein the presence of the target protein induces a change in a selected phenotypic characteristic of the test cell, other than the level of the target protein in the test cell, per se, wherein the change in the selected phenotypic characteristic is comparatively greater in the test cell than in a control cell, and wherein the change in the selected phenotypic characteristic has been found to be responsive to treatment with a test substance that is capable of inhibiting or activating a biochemical function of the target protein, by a method comprising the steps of:

a) providing a test cell in which a target protein is present at a higher level relative to a control cell which produces the protein at a lower level or essentially does not produce the protein;

b) treating the test cell of step (a) containing the target protein of step (a) with a test substance; and

c) examining the treated test cell of step (b) to determine whether an selected phenotypic characteristic that is responsive to inhibition or activation of the target protein of step (a) has been altered by treatment with the test substance of step (b).

上訴議題涉及35 U.S.C. § 271(g)的侵權條件，法院調用字典來解釋271(g)內的用語，如"make"，解釋為製造；也可以解釋為形成計算結果。這樣來看，沒有結果。

再用法條直接解釋，看來法規解釋是在「製造」。

在35 U.S.C. § 271(g)中，有兩個例外條款，這兩個例外條款讓法官能夠前後一致地解釋所述"make"就是製造。

[法條]
35 U.S.C. § 271(g) Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—

(1)

it is materially changed by subsequent processes; or

(2)

it becomes a trivial and nonessential component of another product.

更嚴謹地，法院參考了國會立法的歷史，確認了"make"就是指"product manufactured by a patented process"。
"A subsequent bill in the following year again proposed a precursor of section 271(g): "[i]f the patent invention is a process, whoever without authority uses or sells within, or imports into, the United States during the term of the patent therefor a product produced by such process infringes the patent." S.REP. No. 98-663 at 30 (1984) (discussing S. 1535, 98th Cong. § 2 (1984)). According to the Senate Report, a principal aim of S. 1535 was "[t]o declare it to be patent infringement to import into, or to use or sell in the United States, a product manufactured by a patented process." Id. at 1 (emphasis added)."

綜觀各方面的法律，沒有任何指示是指製作非具體物品以外的意思。
"Id. at 40 (emphasis added). The "manufacturer" was referred to as the "preferred defendant because of its direct knowledge of the process." Id. at 39. The proposed statute also permitted suit against "the persons receiving the goods in this country in the belief that they may be in the best position, apart from the manufacturer, to determine how the goods were made." Id. (emphasis added). Here again, there is no indication of any intent to reach products other than tangible products produced by manufacturing processes."

立法的目的是提供流程專利權人有意義的保護，專利權人可以從美國境內使用未授權的流程中取得賠償，如此，境內的製造才會侵害製程專利的權利，境外的製程不侵權。
"The purpose of this bill is to provide meaningful protection to owners of patented processes. Under current patent law, owners of such patents have remedies for unauthorized use of the process only if the process was used in the United States. As a consequence, while a domestic manufacturer using the patented process would infringe the process patent, a foreign manufacturer who imports the product would not."

這個提醒很重要。新的製程技術的價值反映在產生的新的產品，新的流程可以提昇產品品質，或是新的流程可以允許產品更經濟地被製造。如生物科技，唯有新的流程產生新的物品。因此，流程的專利權人的優勢是提告、販售產品、授權等，如果無法約束製程產生的物品的進口、銷售或使用，將減損製程專利的價值。
"The value of new manufacturing techniques is reflected in the resulting new products. A new process may enhance the quality of the product produced, or the new process may permit the product to be made much more economically. In some cases, for example biotechnology, the new process may be the only method of producing a new product. In all of these instances, the advantage to the process patent owner is realized by suing or selling the product, or licensing others to do so. As a consequence, the unfettered ability of others to import, sell or use a product made by the patented process, severely diminishes the value of a U.S. process patent."

資訊（如知識）的進口是抽象議題，不容易掌控。在此案例中，Bayer指出，擁有被宣稱侵權的資訊的人，可能因為入關美國而被控侵權。
"Finally, reading the statute to cover processes other than manufacturing processes could lead to anomalous results. The importation of information in the abstract (here, the knowledge that a substance possesses a particular quality) cannot be easily controlled. As Bayer points out, a person possessing the allegedly infringing information could, under Housey's interpretation, possibly infringe by merely entering the country."

CAFC在本次判決中，解釋271(g)僅限定在製程專利所製作的具體物品上，而不包括專利流程產生的資訊（"does not include information generated by a patented process"），而在此侵權爭議中，主張的「具體物品」並非由專利流程所製作，因此判斷侵權不成立，確認地院撤銷Housey反訴的決定。

其中有關271(g)的解釋：

（這個片段來源：https://www.eff.org/files/2015/11/10/clearcorrect_v_itc_-_opinion.pdf）

一些重點摘錄：

• 35 U.S.C. § 271(g)規範下的侵權行為及於專利製程製造的具體物品，而不是產生的資訊。（"we conclude that infringement under 35 U.S.C. § 271(g) is limited to physical goods that were manufactured and does not include information generated by a patented process"）
• 35 U.S.C. § 271(g)所述僅在物品的製造方法，而不是收集資訊的方法或是定出直得發展的物質。（"Section 271(g) addresses only products derived from patented manufacturing processes, i.e., methods of actually making or creating a product as opposed to methods of gathering information about, or identifying, a substance worthy of further development.""）
• 當Housey主張：專利法101條規定可專利的"manufacture"建議是271(g)的「製造"made by"」，不應被限定在「製造方法」（"Housey urges that the use of the term "manufacture" in 35 U.S.C. § 101 suggests that "made by" as used in section 271(g) should not be limited to methods of "manufacture." "），但法院回應是：101中的「made」與271(g)無關，不會過廣解釋271(g)（"We see nothing in section 101 that suggests that "made" in section 271(g) should be construed to be broader than "manufacture."）。如此可知，271(g)規範的侵權範圍就是限定在方法專利所製造的「實體物品」上。

判決文：
https://openjurist.org/340/f3d/1367/bayer-ag-v-housey-pharmaceuticals-inc

my two cents:
從案例可知，35 U.S.C. § 271(g)被限定在方法專利所製作的「物品」的侵權行為，而根據一些資訊可知，「35 U.S.C. § 271(g)常用來做Section 337防禦」，也就是，ITC管的是進口美國的侵權議題，卻也僅及於實體物品，不能管道數位內容。

可參考前篇報導：筆記美國專利法第271條（http://enpan.blogspot.tw/2017/11/271.html），若要以271(g)抵禦Section 337，即考量其中侵權排除的項目：(1)it is materially changed by subsequent processes; or (2)it becomes a trivial and nonessential component of another product，相關專利流程已經被重大改變，或是相關製程產品已經變成其他產品中不重要的部分。

資料參考（需登入）：
https://www.law360.com/ip/articles/780027/the-role-of-section-271-g-in-the-wake-of-clearcorrect

其他參考：
ITC管不到數位內容 - In ClearCorrect v. ITC and Align Tech (CAFC 2015)（http://enpan.blogspot.tw/2015/11/itc-in-clearcorrect-v-itc-and-align.html）

Ron

歐洲專利權不及與耗盡的筆記

與前篇筆記同一處的其他章節筆記。

• Article 28（先使用權）
• 在歐洲專利EPC合約國內，即便有公開專利，任何人可以保有相關發明的先使用權（right based on prior use），以及私有權（right of personal possession），可以繼續行使該發明。

• Article 29（專利權耗盡）
• 經授予的歐洲專利權不得延伸到已在歐盟獲得專利權人授權上市的產品之後的行為，除非專利權人有合法理由可以反對商品的進一步商品化行為。

出處：
[專利法院協議（Agreement on a Unified Patent Court, UPCA）]（http://www.epo.org/law-practice/legal-texts/official-journal/2015/etc/se5/p327.html）

Article 28

Right based on prior use of the invention

Any person, who, if a national patent had been granted in respect of an invention, would have had, in a Contracting Member State, a right based on prior use of that invention or a right of personal possession of that invention, shall enjoy, in that Contracting Member State, the same rights in respect of a patent for the same invention.

Article 29

Exhaustion of the rights conferred by a European patent

The rights conferred by a European patent shall not extend to acts concerning a product covered by that patent after that product has been placed on the market in the European Union by, or with the consent of, the patent proprietor, unless there are legitimate grounds for the patent proprietor to oppose further commercialisation of the product.

Ron

歐洲侵權規定筆記

筆記
（這裡筆記僅供參考，還是以原文為主）

專利法院協議（UPCA）中Art. 25, 26分別協議出直接侵權與間接侵權的法院意見，重點有：

• Article 25
• 專利侵權行為及於製造、販售要約、上市、使用、進口以及貯存未經授權的專利產品。
• 禁止未經授權使用專利流程。
• 對於流程專利（process），未經專利權人許可，不能在專利有效的合約國內使用該流程，如此，方法專利及於使用該方法"直接"產生的物品的製造、販售要約、上市、使用、進口以及貯存。

• Article 26
• 專利權及於「間接」使用受到專利保護的物品與方法，只要使用了其中「必要的元件（essential element of that invention）」的手段，而這些手段意圖即為了完成已專利的發明。
• 「間接侵權」不及於使用了專利中的一般常見的物品，除非有第三方誘使某人執行了已專利的發明。
• Article 27(a) to (e)規範了哪些行為不能列為「間接侵權」的行為。

• Article 27
• 此條規範了專利不及於的行為，包括：
• 私下與非商業目的的行為。
• 實驗目的的行為。
• 育種用途的生物材料與開發新植物品種的行為。
• Article 13(6) of Directive 2001/82/EC or Article 10(6) of Directive 2001/83/EC規範的行為。
• 藥劑師為了個別病例開出的處方箋與藥物處理。
• 國際組織在船隻上的行為，以及暫時進入有專利保護的合約國境內。
• 國際組織的飛機或車輛使用的行為，以及暫時進入有專利保護的合約國境內。
• 農民使用自己收穫（或擁有）的產品進行繁殖的銷售，或是經過專利權人同意農業用途的商業行為。
• 農民自行繁殖使用受到保護的牲畜的農業用途、相關材料銷售，或是經過專利權人同意的商業行為。而以上繁殖用途是與相關材料目的是農業活動。
• Articles 5 and 6 of Directive 2009/24/EC產生資訊的使用行為。
• Article 10 of Directive 98/44/EC允許的行為。

[專利法院協議（Agreement on a Unified Patent Court, UPCA）]（http://www.epo.org/law-practice/legal-texts/official-journal/2015/etc/se5/p327.html）

Article 25

Right to prevent the direct use of the invention

A patent shall confer on its proprietor the right to prevent any third party not having the proprietor's consent from the following:

(a) making, offering, placing on the market or using a product which is the subject matter of the patent, or importing or storing the product for those purposes;

(b) using a process which is the subject matter of the patent or, where the third party knows, or should have known, that the use of the process is prohibited without the consent of the patent proprietor, offering the process for use within the territory of the Contracting Member States in which that patent has effect;

(c) offering, placing on the market, using, or importing or storing for those purposes a product obtained directly by a process which is the subject matter of the patent.

Article 26

Right to prevent the indirect use of the invention

(1) A patent shall confer on its proprietor the right to prevent any third party not having the proprietor's consent from supplying or offering to supply, within the territory of the Contracting Member States in which that patent has effect, any person other than a party entitled to exploit the patented invention, with means, relating to an essential element of that invention, for putting it into effect therein, when the third party knows, or should have known, that those means are suitable and intended for putting that invention into effect.

(2) Paragraph 1 shall not apply when the means are staple commercial products, except where the third party induces the person supplied to perform any of the acts prohibited by Article 25.

(3) Persons performing the acts referred to in Article 27(a) to (e) shall not be considered to be parties entitled to exploit the invention within the meaning of paragraph 1.

Article 27

Limitations of the effects of a patent

The rights conferred by a patent shall not extend to any of the following:

(a) acts done privately and for non-commercial purposes;

(b) acts done for experimental purposes relating to the subject matter of the patented invention;

(c) the use of biological material for the purpose of breeding, or discovering and developing other plant varieties;

(d) the acts allowed pursuant to Article 13(6) of Directive 2001/82/EC or Article 10(6) of Directive 2001/83/EC in respect of any patent covering the product within the meaning of either of those Directives;

(e) the extemporaneous preparation by a pharmacy, for individual cases, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared;

(f) the use of the patented invention on board vessels of countries of the International Union for the Protection of Industrial Property (Paris Union) or members of the World Trade Organisation, other than those Contracting Member States in which that patent has effect, in the body of such vessel, in the machinery, tackle, gear and other accessories, when such vessels temporarily or accidentally enter the waters of a Contracting Member State in which that patent has effect, provided that the invention is used there exclusively for the needs of the vessel;

(g) the use of the patented invention in the construction or operation of aircraft or land vehicles or other means of transport of countries of the International Union for the Protection of Industrial Property (Paris Union) or members of the World Trade Organisation, other than those Contracting Member States in which that patent has effect, or of accessories to such aircraft or land vehicles, when these temporarily or accidentally enter the territory of a Contracting Member State in which that patent has effect;

(h) the acts specified in Article 27 of the Convention on International Civil Aviation of 7 December 1944, where these acts concern the aircraft of a country party to that Convention other than a Contracting Member State in which that patent has effect;

(i) the use by a farmer of the product of his harvest for propagation or multiplication by him on his own holding, provided that the plant propagating material was sold or otherwise commercialised to the farmer by or with the consent of the patent proprietor for agricultural use. The extent and the conditions for this use correspond to those under Article 14 of Regulation (EC) No. 2100/94;

(j) the use by a farmer of protected livestock for an agricultural purpose, provided that the breeding stock or other animal reproductive material were sold or otherwise commercialised to the farmer by or with the consent of the patent proprietor. Such use includes making the animal or other animal reproductive material available for the purposes of pursuing the farmer's agricultural activity, but not the sale thereof within the framework of, or for the purpose of, a commercial reproductive activity;

(k) the acts and the use of the obtained information as allowed under Articles 5 and 6 of Directive 2009/24/EC, in particular, by its provisions on decompilation and interoperability; and

(l) the acts allowed pursuant to Article 10 of Directive 98/44/EC.

Supplementary publication - Official Journal EPO：
http://www.epo.org/law-practice/legal-texts/official-journal/2015/etc/se5/p327/2015-se5-p327.pdf

Ron

筆記美國專利法第271條

本篇原本名為「閒聊美國專利法第271條」，因為我的程度也只能閒聊，不過，可能連"閒聊"都不算，還是"降級"到"筆記"比較安全。

35 U.S.C. 271表面上看來是規範了幾種專利侵權型態，簡單來看：

• 271(a) - 規定侵權的行為：製造、使用、販售要約或販售已專利發明（直接侵權）。
• 271(b) - 誘使侵權。
• 271(c) - 販售要約、販售、進口專利物或流程的重要部分元件的共同侵權。
• 271(d) - 濫用或不當延伸專利權的行為：(1)從他人的侵權行為獲利將構成共同侵權；(2)授意或許可他人執行未被同意的侵權行為構成共同侵權；(3)想要實施專利權對抗侵權或共同侵權；(4)拒絕授權或使用專利權；(5)除了專利權人有很大的市場力外，以獲得其他專利或購買產品作為取得專利權授權或專利物品販售的條件。
• 271(e) - 構成與不構成侵權行為的事項，關於DNA、藥品與生化物品的製造、使用、販售、販售要約與進口等行為規範。
• 271(f) - (1)在美國或從美國未經許可供應或致使供應專利物的元件全部或主要部分，而這些部分在美國境外未被組合，而在美國境內組合，仍構成侵權；(2)未經許可供應或致使供應任何專利物的元件，而此元件特別是用在專利物上，而對不侵權的使用不是主要的部分，而此元件在美國境外未被組合，如果在美國境內組合，視為侵權。
• 271(g) - 方法專利及於以該方法製造的物品：未被許可進口美國或在美國境內販售要約、販售或使用經專利程序製造的物品，視為侵權。在方法專利侵權行為中，非商業使用或銷售方法製成的物品，不用賠償，除非沒有足夠的賠償。(1)若製程有重大改變，或是(2)變成另一種物品不重要的部分時，就不是該方法製成的物品。
• 271(h) - 定義本章名詞。

本部落格中有關35 U.S.C. 271議題的報導：

• 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)（http://enpan.blogspot.tw/2017/02/271f1-life-technologies-corp-v-promega.html）
  
  最高法院解釋：271(f)(1)中的"substantial portion"解釋為「大量」或「多的」，而不像是「重要的部分」，因此法院認定所述"單一元件"（"single component"）並不構成271(f)(1)中的"substantial portion"，理由是單一元件並非271(f)(1)指的"多量"。
  在國外製造的「多元件發明的其中之一元件」並不承擔271(f)(1)的侵權責任。
  "The supply of a single component of a multicomponent invention for manufacture abroad does not give rise to §271(f)(1) liability."
• 
  
• 多人共同專利侵權的責任 - Limelight v. Akamai Inc. (Supreme Court 2014)（http://enpan.blogspot.tw/2016/08/limelight-v-akamai-inc-supreme-court.html）
  
  最高法院認為CAFC誤解專利法基於「方法」專利範圍的解釋的侵權判斷，方法專利範圍由多個步驟組成，除非全部步驟被一方實施，否則沒有專利侵權的事實。
  對於「誘使侵權」的判斷，法院引用美國專利法271(f)(1)，如果有一方在美國供應或致使供應專利範圍中全部或實質重要的部分，雖在美國國外生產，但在美國國內組裝，仍可能導致誘使侵權。
• 
  
• 誘使侵權案例討論 - Global-Tech Appliances, Inc. v. SEB S.A. (2011)（http://enpan.blogspot.tw/2015/09/global-tech-appliances-inc-v-seb-sa-2011.html）
  
  誘使侵權要成立，要證明被告已知悉誘導行為會導致專利侵權，誘使侵權定義如下：
  - 主動誘使專利侵權者，視為侵權者，誘使者需引導某侵權行為，且知道這是侵權行為。
  - 誘導侵權與共同侵權（contributory infringement）不同，但曾被認為是同一種侵權行為，也就是協助及教唆直接侵權者（“aiding and abetting of direct infringement by another party”），經§271修法後，分為271(b)的誘使侵權，以及271(c)的販售侵權物元件（component）兩種。
  - 忽視已知專利存在的風險仍不滿足271(b)誘使侵權的規定。
  - 如有足夠的證據證明，刻意視而不見（doctrine of willful blindness）仍滿足犯罪行為（侵權）。
  - 刻意視而不見成立的要件：被告主觀相信有高機率事實存在（專利存在）；被告有故意迴避知悉事實的動作。
• 
  
• 專利權對於商品的影響（權利耗盡） - Impression v. Lexmark (Fed. Cir. 2016)（http://enpan.blogspot.tw/2016/03/impression-v-lexmark-fir-cir-2016.html）
  
  CAFC認為，專利權或是原廠權利是否及於之後買方的使用行為可以透過契約規範，除非這個契約違反其他法律（如反托辣斯法），至少原廠並沒有授權之後再使用、再販售的行為，特別是美國專利法第271條中進口產品仍受專利權限制的規定。
• 
  
• 最高法院對權利耗盡的明確態度 - Impression Products, Inc. v. Lexmark International, Inc.（http://enpan.blogspot.tw/2017/06/impression-products-inc-v-lexmark.html）
  
  （明確保留權利規則，"express-reservation rule"）如此，最高法院的決定表示美國在權利耗盡原則中採取中立立場，除非專利權人明確表明保留權利，否則海外銷售將已經耗盡專利權。因為這個明確立場將影響海外購買者的期待，例如期待權利已經耗盡而可以自由地重新使用與重新銷售。

[相關法條]
35 U.S.C. 271（https://www.law.cornell.edu/uscode/text/35/271）

35 U.S. Code § 271 - Infringement of patent

(a)

Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

(b)

Whoever actively induces infringement of a patent shall be liable as an infringer.

(c)

Whoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.

(d)

No patent owner otherwise entitled to relief for infringement or contributory infringement of a patent shall be denied relief or deemed guilty of misuse or illegal extension of the patent right by reason of his having done one or more of the following: (1) derived revenue from acts which if performed by another without his consent would constitute contributory infringement of the patent; (2) licensed or authorized another to perform acts which if performed without his consent would constitute contributory infringement of the patent; (3) sought to enforce his patent rights against infringement or contributory infringement; (4) refused to license or use any rights to the patent; or (5) conditioned the license of any rights to the patent or the sale of the patented product on the acquisition of a license to rights in another patent or purchase of a separate product, unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent or patented product on which the license or sale is conditioned.

(e)

(1)

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

(2)It shall be an act of infringement to submit—

(A)

an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent,

(B)

an application under section 512 of such Act or under the Act of March 4, 1913(21 U.S.C. 151–158) for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques and which is claimed in a patent or the use of which is claimed in a patent, or

(C)

(i)

with respect to a patent that is identified in the list of patents described in section 351(l)(3) of the Public Health Service Act (including as provided under section 351(l)(7) of such Act), an application seeking approval of a biological product, or

(ii)

if the applicant for the application fails to provide the application and information required under section 351(l)(2)(A) of such Act, an application seeking approval of a biological product for a patent that could be identified pursuant to section 351(l)(3)(A)(i) of such Act,

if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

(3)

In any action for patent infringement brought under this section, no injunctive or other relief may be granted which would prohibit the making, using, offering to sell, or selling within the United States or importing into the United States of a patented invention under paragraph (1).

(4)For an act of infringement described in paragraph (2)—

(A)

the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed,

(B)

injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product,

(C)

damages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product, and

(D)

the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the subject of a final court decision, as defined in section 351(k)(6) of the Public Health Service Act, in an action for infringement of the patent under section 351(l)(6) of such Act, and the biological product has not yet been approved because of section 351(k)(7) of such Act.

The remedies prescribed by subparagraphs (A), (B), (C), and (D) are the only remedies which may be granted by a court for an act of infringement described in paragraph (2), except that a court may award attorney fees under section 285.

(5)

Where a person has filed an application described in paragraph (2) that includes a certification under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and neither the owner of the patent that is the subject of the certification nor the holder of the approved application under subsection (b) of such section for the drug that is claimed by the patent or a use of which is claimed by the patent brought an action for infringement of such patent before the expiration of 45 days after the date on which the notice given under subsection (b)(3) or (j)(2)(B) of such section was received, the courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought by such person under section 2201 of title 28 for a declaratory judgment that such patent is invalid or not infringed.

(6)

(A)Subparagraph (B) applies, in lieu of paragraph (4), in the case of a patent—

(i)

that is identified, as applicable, in the list of patents described in section 351(l)(4) of the Public Health Service Act or the lists of patents described in section 351(l)(5)(B) of such Act with respect to a biological product; and

(ii)for which an action for infringement of the patent with respect to the biological product—

(I)

was brought after the expiration of the 30-day period described in subparagraph (A) or (B), as applicable, of section 351(l)(6) of such Act; or

(II)

was brought before the expiration of the 30-day period described in subclause (I), but which was dismissed without prejudice or was not prosecuted to judgment in good faith.

(B)

In an action for infringement of a patent described in subparagraph (A), the sole and exclusive remedy that may be granted by a court, upon a finding that the making, using, offering to sell, selling, or importation into the United States of the biological product that is the subject of the action infringed the patent, shall be a reasonable royalty.

(C)

The owner of a patent that should have been included in the list described in section 351(l)(3)(A) of the Public Health Service Act, including as provided under section 351(l)(7) of such Act for a biological product, but was not timely included in such list, may not bring an action under this section for infringement of the patent with respect to the biological product.

(f)

(1)

Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

(2)

Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

(g)Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—

(1)

it is materially changed by subsequent processes; or

(2)

it becomes a trivial and nonessential component of another product.

(h)

As used in this section, the term “whoever” includes any State, any instrumentality of a State, and any officer or employee of a State or instrumentality of a State acting in his official capacity. Any State, and any such instrumentality, officer, or employee, shall be subject to the provisions of this title in the same manner and to the same extent as any nongovernmental entity.

(i)

As used in this section, an “offer for sale” or an “offer to sell” by a person other than the patentee, or any designee of the patentee, is that in which the sale will occur before the expiration of the term of the patent.

Ron