(一) 進步性要件內涵之形塑和判斷方式的演進

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性的內涵之涵蓋範圍限定在得直接為商業應用，或屬於特定研究工具的見解，

將不當忽略了基因科技的技術本質和累積創新特性。畢竟，基因科技的研發 成果大多具備著研究工具傾向，亦即，無論是以工具或標的的形式提供後續 研發創新的進行更加順利並增進其效率而言。從而，一旦在實質用途的部分 採取限縮的政策思維，雖然得某程度上抑制專利搶註的問題，卻恐導致研發 成果的延後公開，甚至衍生整體創新研發誘因保障的不足。

故而，本文認為產業利用性此政策槓桿的實施上，應當因應基因科技領 域的研究工具性格，而就現今實務中實質用途之認定上，納入促進研究進行 之面相，再以適度提升特定性之要求，實質認定研發成果本身的研發促進功 能和技術貢獻，作為防範未達有效促進研究發展之發明得獲取專利，進而衡 平公眾利益的保障和研發誘因的維持。並且，藉此以技術發展和產業創新之 思維作為適用操作上的論證依據，更能以貼近生技的研發實務、加速研發成 果的公開時點，達到增進後續研發動能和提升投資的預見性。

第三目 進步性 一、 美國專利法適用現況之介紹

(一) 進步性要件內涵之形塑和判斷方式的演進

1. 初期實務見解和判斷方法架構─Graham 測試步驟和 TSM 判斷

進步性概念起源於1852 年 Hotchkiss v. Greenwood 一案，法院認 為專利申請案之發明，實需具備一定之發明品質(“degree of skill and ingenuity”)，始符合核發專利之標準⁵⁷⁴。隨著後續判決的持續援引和 見解累積，於 1952 年美國國會實將此判例法所創設之要件明訂於專 利法第103 條中，並獨立成為專利保護要件之一⁵⁷⁵。而此一要件的內 涵乃立基於所屬技術領域通常技藝者之角度，觀察專利申請案與相關 先前技術之間的差異，判斷系爭發明所具備之額外功能、效率增進或 改良內容，是否在專利申請時點前的技術基礎上得評價為明顯能輕易 完成，而決定得否該當其門檻要求⁵⁷⁶。實而，於1966 年 Graham v. John

Deere Co.一案將上開進步性要件明文加以具體化，提出具有指標性的

四步驟三要件的判斷方法，又被稱為「Graham Test」⁵⁷⁷，分別如下:

       

574 Hotchkiss v. Greenwood, 52 U.S. 248, 267 (1851).

575 於美國法多稱為「非顯而易見性(Nonobvious)」，而於歐陸法系則多以「發明步驟(Inventive Step)」代稱，我國則係稱之為進步性而言。下述將以非顯而易見性和進步性混用予以表述。

576 35 U.S.C §103, ʻ A patent for a claimed invention may not be obtained…if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains…ʼ (本文自行節錄)

577 Graham v. John Deere Co. of Kan. City, 383 U.S. 1 (1966).

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(PHOSITA)所應具備的技術水準和智識內涵;

(4) 最後，從建立之通常技藝者之角度分析系爭差異的變化，是 否 具 有 非 顯 而 易 見 之 內 涵 ， 並 輔 以 客 觀 性 次 要 因 素 (Secondary Consideration)予以參酌，如獲商業上成功或解決 長久未解之問題等，進而決定系爭發明是否該當進步性之要 標準之發明，實而，係透過「類同技術(analogous art)」加以限定，亦 即，由系爭發明所屬技術之通常技藝者主觀上可能近用，或系爭發明

578 Id. at 17-18., “Under § 103, the scope and content of the prior art are to be determined;

differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or

nonobviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.”

579 Id. at 33., “…an invention is construed not only in the light of the claims, but also with

reference to the file wrapper or prosecution history in the Patent Office. Claims as allowed must be read and interpreted with reference to rejected ones and to the state of the prior art…”

580 In re Clay, 966 F.2d 656, 658-659 (Fed. Cir. 1992), “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.”

581 ROBERT L.HARMON et al.,PATENTS AND THE FEDERAL CIRCUITS, 209-210 (10^th ed. 2011).

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身，實可能產生反教示(teach away)之作用，亦即，對於系爭發明所進 行改良研發的方向提供勸阻之反向指引，而此時發明人仍願意致力去 開拓則應屬專利法制欲鼓勵之研發行為，實應受到進步性之認可予以 鼓勵。惟實際應用上仍需謹慎地從複數技術文件所生之教示作用綜合 評比始得為之⁵⁸³；有以教示的作用程度，當先前技術累加並構築成「明 顯可試(obvious to try)」之程度，並且僅需發明有效地降低試誤(try and error)的次數之效果，而具備「合理成功期待(anticipated success)」，則 新發明很可能被判定不具進步性⁵⁸⁴；又有從系爭發明的技術品質本身，

認為固然與先前技術之化學結構相似，卻僅要產生相較於先前技術一

「不可期待之優勢屬性(unexpected advantageous property)」，實得判定 屬於超越一般情形的教示因果關係，而該當進步性之要求⁵⁸⁵。

最後，就上開先前技術與系爭發明存有差異之教示作用和相關因 果關係，實乃委由法律擬制之所屬技術通常技藝者予以客觀判斷⁵⁸⁶。 是以，此虛擬判斷主體本身所具備之專業和智識水平的建構，對於進 步性要件的政策功能之執行上實扮演極為重要之角色。其中，美國法 院實務於1983 年的 Envtl. Designs, Inc. v. Union Oil Co.一案，提出相 關建構之考量因素⁵⁸⁷，並且認為應聚焦於判斷系爭發明是否應符合非        

582 Wesley A. Demory, Patent Claim Obviousness in Jury Trials: Where's the Analysis?, 6 J. BUS.

&TECH.L. 449, 452-54 (2011).

583 HARMON et al.,supra note 581, at 210-12.

584 In re O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988), “Obviousness does not require absolute predictability of success. Indeed, for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice. There is always at least a possibility of unexpected results, that would then provide an objective basis for showing that the invention, although apparently obvious, was in law nonobvious.”; “For obviousness under § 103, all that is required is a reasonable expectation of success.”然而，該法院闡釋於以下兩種情形，未 屬於達明顯可試之程度而仍有可能具備非顯而易見性。一為客觀上存在多種研發方向的指示，

卻未有能分辨孰者最為關鍵，以至於後續研發仍必須持續試誤始能完成研發；另一則為系爭 發明所屬之技術領域仍屬新興開闢之類別，而客觀上存在著諸多未知的研發風險，抑或是相 關前案僅僅提供一般性程度之指引，難謂能夠有效減卻試誤的成本。Id. at 903, “In some cases, what would have been "obvious to try" would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful….In others, what was "obvious to try" was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it….Neither of these situations applies here” (本文自行節錄)

585 In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987), “…evidence of unobvious or unexpected advantageous properties may rebut a prima facie case of obviousness based on structural similarities.”

586 於 1952 年進步性要件明文化時為避免過往不當側重於發明人本身技藝水準之主觀評價，

則改以法律擬制創設此判斷主體進行客觀判斷。沈宗倫，由專利法教示因果關係論進步性：

以組合專利與類似為中心，國立臺灣大學法學論叢，第42 卷第 2 期，頁 328，2013 年 6 月。

587 Envtl. Designs, Inc. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983), “Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the

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的後設偏見(hindsight bias)，而對於先前技術之教示作用實採取嚴格 之解釋，相對地造成進步性門檻過於寬鬆⁵⁸⁹，招致此專利要件失去本 身作為把關以賦予專利私權所換取之系爭發明的公開，應具備相對高 程度技術品質而供公眾得以享受此利益衡平之政策目的⁵⁹⁰。從而，於 2007 年最高法院於 KSR Int'l Co. v. Teleflex Inc.一案立基於專利法制本 身的鼓勵技術創新精進之政策意旨，批評上訴法院過往對於先前技術 會欲嘗試將相關先前技術進行組合之「原因」，如市場因素(market demand)、改良設計需求(design need) ⁵⁹³，或是客觀技術環境下已有        

inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field.”

588 Id.at 697, “The important consideration lies in the need to adhere to the statute, i.e., to hold that an invention would or would not have been obvious…”

589 Demory, supra note 582 , at 567-69.

590 Rebecca Hays, Biotechnology Obviousness in the Post-Genomic Era:KSR v. Teleflex and In re Kubin, 10 M^INN.J.L.SCI.&TECH. 801, 804 (2009); 沈宗倫，同前註 586，頁 348-49。

591 KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-16, 419, 427 (2007), "…patent for a combination which only unites old elements with no change in their respective

functions …obviously withdraws what already is known into the field of its monopoly and diminishes the resources available to skillful men."; “The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.”; “…the results of ordinary innovation are not the subject of exclusive rights under the patent laws. Were it otherwise patents might stifle, rather than promote, the progress of useful arts.” (本文自行節錄)

592 Id. at 420, “The first error was… look only to the problem the patentee was trying to

solve. The Court of Appeals failed to recognize that the problem motivating the patentee may be only one of many addressed by the patent's subject matter. ”; “The second error … lay in its assumption that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem… Common sense teaches, however, that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.”

593 Id. at 418-19, “…it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does. This is so because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known.”; “The diversity of inventive pursuits and of modern technology counsels against limiting the analysis in this way. In many fields it may be that there is little

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指 示 出 有 限 數 量 之 可 資 解 決 方 法(finite number of identified, predictable solutions)⁵⁹⁴，皆屬判斷考量之重點。

再者，於 KSR Int'l Co. v. Teleflex Inc.一案，亦因應巡迴上訴法院 的裁判僵化，而針對法律擬制之所屬技術通常技藝者此判斷標準，闡 釋此PHOSITA 本身亦應具備一定程度之創造力(ordinary creativity)，

某程度上提高判斷標準以減卻過分核發專利權之問題⁵⁹⁵。是以，於進 步性判斷方法的細緻化後，似隱含著此要件得配合不同技術領域和相 關產業的研發和發展現況，以細緻調整對應的PHOSITA 的判斷水準，

進而妥適地發揮專利進步性之政策功能，達到鼓勵技術產業創新發展 之目標⁵⁹⁶。

在文檔中 專利法在基因科技中的適用及解釋: 以生技產業創新發展政策思維為導向 - 政大學術集成 (頁 175-179)