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| Title: | 由美國法探討專利進步性輔助判斷因素之適用
An analysis of the application of secondary considerations in determining patent non-obviousness requirement under the U.S. law |
| Authors: | 鄭尉岑
Cheng, Wei-Tsen |
| Contributors: | 陳龍昇
鄭尉岑
Cheng, Wei-Tsen |
| Keywords: | 進步性
非顯而易見性
輔助性判斷因素
商業上成功
後見之明困境
TSM標準
KSR案
inventive step
non-obviousness
secondary considerations
commercial succes
hindsight bias
TSM test
KSR v. Telefex |
| Date: | 2025 |
| Issue Date: | 2025-09-01 15:25:39 (UTC+8) |
| Abstract: | 進步性作為專利要件之一，若發明欠缺之，則無法得到專利權之保護，實際上無論於我國或美國，發明是否具備進步性亦常是實務上爭執之重點。判斷進步性是否存在，須以所屬技術領域通常知識者之角度，觀察發明申請專利時之技術，是否能輕易完成該發明，此為我國專利法所明文。然無論是「所屬技術領域通常知識者」、「輕易完成」皆為不確定法律概念，判斷上過於抽象而有其困難。且由於專利審查員審酌進步性時或涉訟法院審酌進步性時，常已距離發明申請專利之時有數個月甚至數年之久，而科技日新月異，審酌進步性時之技術與發明申請專利時之技術會有相當程度的差異。故雖要求審查者須以發明申請專利時之技術判斷進步性，然在已經得知有更先進技術的情況下，要求審查者完全摒除參考實際上有其困難，此即所謂「後見之明困境」。「不確定法律概念」及「後見之明」困擾著我國及美國實務判斷進步性，美國法因此發展出各種客觀標準嘗試避免裁判上之歧異。1982年時，美國聯邦巡迴上訴法院提出TSM標準（Teaching-Suggestion-Motivation）作為判斷非顯而易見性的參考，爭執發明為顯而易見者須提出某種證據能教示、建議或促使通常技術者輕易完成發明，方能證明發明為顯而易見。實務上常以現有技術是否存在教示作為判斷的唯一標準，固然提供法院等專利審查者明確且不會受時間推移影響之指標進行判斷，從而能避開「不確定法律概念」及「後見之明」困境，然2007年時，KSR案法院卻認為僅以TSM標準審酌非顯而易見性係過於僵化的方式，並不利於美國法專利制度之發展，因此不應再以TSM標準作為唯一判斷非顯而易見性之指標。KSR案法院雖解決過於僵化審酌非顯而易見性之問題，然上述問題又再次困擾美國法實務，法院需要其他客觀證據解決「不確定法律概念」及「後見之明」困境。此時，輔助性判斷因素易於司法審查之特性以及不受時間推移而異其判斷之性質亦能避免後見之明，故在KSR案後尤其受到更多關注。
輔助性判斷因素係指非與技術直接相關，而係以間接推理過程觀察發明之技術貢獻，諸如發明取得「商業上成功」、發明「解決長期存在的問題」或「他人抄襲」發明。此類客觀證據不需要對技術相關之問題進行探討，從而降低司法之審查難度，例如「商業上成功」僅須證明發明相關產品銷量卓越、「解決長期存在的問題」僅須證明發明解決了長久以來存在的需求、「他人抄襲」僅須證明有他人有類似產品並有所抄襲，即可能證明發明之進步性。再者，由於輔助性判斷因素屬於客觀證據，故無論何時對其進行審酌判斷皆不會有所差異，因此能避免後見之明困境。例如「商業上成功」的銷量證據、「解決長期存在的問題」的長期存在問題或「他人抄襲」的抄襲證明，皆為不受時間推移造成之後見之明影響之證據。輔助性判斷因素與TSM標準皆同時易於司法審查，又能避免後見之明，且輔助性判斷因素係同時與技術相關之表面證據審酌之證據，不會有KSR案法院稱之僵化適用而忽略技術相關證據之問題，因此近期美國法實務稱輔助性判斷因素係非顯而易見性審查之最具證明力及說服力之獨立證據，給予其相當程度之重視。
相較之下，我國法專利審查基準亦有規範輔助性判斷因素作為肯定進步性因素之一，若能妥適適用於實務，應得相當程度解決進步性審查之不易及後見之明困境。然我國實務上通常僅在無否定進步性因素存在的情況下，方會審酌輔助性判斷因素，甚至常有實務見解認為在比較現有技術，已能明顯可證發明不具進步性時，亦不須審酌輔助性判斷因素，造成輔助性判斷因素在我國根本上無法發揮其易於司法審查及避免後見之明困境。即使有部分案件對於輔助性判斷因素進行審查，然實務上尚未建立可操作之審酌標準供法院參考，多數法院對於如何適用輔助性判斷因素尚不熟悉，導致法院對於輔助性判斷因素之論述過於簡略粗糙。
我國實務既已採取輔助性判斷因素作為判斷進步性之因素之一，應使輔助性判斷因素能發揮其所應達成之功能，而非僅成為專利審查基準中之具文。因此，本文期望能觀察美國法上之輔助性判斷因素之功能、種類及適用情形等面向，並分析我國輔助性判斷因素發展之困境及各種缺失，以美國法之經驗作為我國實務適用輔助性判斷因素往後之修正參考，或能使我國進步性之判斷更為準確且容易。
Non-obviousness is one of the patentability, it cannot be granted patent protection, by lacking of non-obviousness. In both Taiwan and the U.S., whether an invention possesses non-obviousness is often a key point of contention in practice. To determine whether an invention is non-obvious, it must be evaluated from the perspective of a person having ordinary skill in the art (PHOSITA) at the time the patent application was filed. To determine whether an invention is non-obviousness, it must be evaluated from the perspective of a person having ordinary skill in the art (PHOSITA) could have been easily made based on the prior art at the time the patent application was filed. This principle is expressly stipulated in Taiwan’s Patent Act. However, terms such as “ PHOSITA” and “easily made” are indefinite concepts of law, making the evaluation abstract and challenging. Additionally, in both patent examination and litigation, the consideration of non-obviousness usually occurs months or even years after the patent application was filed. Given the rapid advancement of technology, the state of the art at the time of assessment may differ significantly from that at the time of filing. Although the law requires examiners and courts to assess non-obviousness based on the state of the art at the time of filing, it is practically difficult to ignore knowledge of later developments—this is known as the “hindsight bias” problem. These challenges—indefinite concepts of law and hindsight bias—affect both Taiwan and U.S. patent practices. To mitigate inconsistencies in judgement, U.S. law developed several objective standards. In 1982, the U.S. Court of Appeals for the Federal Circuit introduced the Teaching-Suggestion-Motivation (TSM) test as a standard for assessing non-obviousness. According to this test, a party alleging obviousness must provide evidence that something teaches, suggests, or motivates a PHOSITA to combine references and achieve the claimed invention. In practice, the existence of a teaching in the prior art often became the sole criterion for assessing obviousness. While this approach offers patent examiners and courts a clear and time-independent standard for evaluation—thus avoiding the difficulties posed by indefinite concepts of law and the hindsight bias, however, in KSR v. Teleflex (2007), the U.S. Supreme Court criticized the TSM test for being overly rigid, concluding that such an inflexible approach was detrimental to the development of the U.S. patent system. Consequently, the Court held that TSM test should not be the sole determinant of non-obviousness. Although the KSR decision addressed the rigidity of the TSM test approach, it caused indefinite concepts of law and hindsight bias problems again. Given their judicial tractability and temporal objectivity, secondary considerations are capable of mitigating hindsight bias, and thus have garnered heightened attention following the KSR case.
Secondary considerations are those that are not directly related to the the technical features of an invention but are used to observe the technical contribution of the invention through indirect reasoning. Examples include commercial success, long-felt but unresolved needs, and copying by others. Because these factors are based on factual evidence rather than technical analysis, they are easier for courts to assess. Like commercial success can be demonstrated by strong sales of a product based on the invention; Long-felt need is shown when the invention solves a problem that had persisted for an extended period; Copying by others indicates the value and non-obviousness of the invention if competitors have replicated it. Furthermore, as secondary considerations are objective evidence, their probative value remains unaffected by the timing of their evaluation, thereby mitigating the risk of hindsight bias. Examples include sales figures evidence of commercial success, resolution of long-standing problems, and indications of copying by others—all of which are not susceptible to distortion due to the passage of time. TSM test and secondary considerations are both judicially manageable and resistant to hindsight. Moreover, secondary considerations are not subject to the rigidity criticized by the KSR Court, since they still consider with the prima facie of the invention. For these reasons, secondary considerations are now frequently regarded as the most persuasive and probative forms of evidence in U.S. non-obviousness analysis.
In contrast, the Patent Examination Guidelines in Taiwan also stipulate secondary considerations as one of the affirmative factors in determining inventive step. If appropriately applied in practice, secondary considerations should help alleviate the inherent difficulties in assessing inventive step and mitigate the problem of hindsight bias. However, in practice, secondary considerations are typically examined only when no negative factors indicating a lack of inventive step are present. Moreover, courts often held that when a comparison with prior art clearly demonstrates a lack of inventive step, there is no need to further consider secondary considerations. This has resulted in secondary considerations being largely ineffective in Taiwan, failing to fulfill their intended role in facilitating judicial review and preventing hindsight bias. Even in cases where secondary considerations are evaluated, there is still no well-established and operable standard for judicial reference. Most courts remain unfamiliar with the proper application of such considerations, leading to brief and superficial reasoning in their discussion.
Since judicial practice in Taiwan already adopts secondary considerations as one of the factors in determining inventive step, such factors should be allowed to fulfill their intended function rather than being reduced to mere formalities within the Patent Examination Guidelines. Therefore, this thesis seeks to examine the functions, types, and applications of secondary considerations under U.S. patent law, and to analyze the challenges and deficiencies in their development under Taiwan’s judicial practice. Drawing upon U.S. experience may provide a useful reference for refining the application of secondary considerations in Taiwan, thereby improving the accuracy and practicability of inventive step assessments. |
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三、Internet Resources
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6.Oxford English Dictionary, s.v. “secondary (adj. & n.),” December 2023, https://www.oed.com/dictionary/secondary_adj?tl=true (last visited: January 5, 2025).
7.US Amgen ruling keeps generic psoriasis drug off market until 2028，https://reuters.com/legal/amgen-wins-appeal-us-patent-case-over-generic-psoriasis-drugs-2023-04-19/ (last visited: January 30, 2025).
8.USPTO, MPEP (9th ed., Rev. 7, Feb. 2023) ［hereinafter MPEP］, https://www.uspto.gov/web/offices/pac/mpep/old/mpep_E9R07-2022.htm (last visited: May 15, 2025). |
| Description: | 碩士
國立政治大學
法律學系
111651045 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0111651045 |
| Data Type: | thesis |
| Appears in Collections: | [法律學系] 學位論文
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