KSR案對美國生物科技專利顯而易知性審查標準之影響—兼論對我國專利審查之啟示

The study of non-obviousness in biotechnology patents following KSR and its possible impact to Taiwan patent examination

劉晏慈(Yen-Tzu Liu)

指導教授 ： 謝銘洋

國立臺灣大學/法律學院/科際整合法律學研究所/碩士(2010年)

https://doi.org/10.6342/NTU.2010.02739

摘要

生技產業被期待可製造醫藥、解決糧食及環保問題，故為現代及未來發展中最重要的產業之一。然因其研發時間長、成本高，相對之下，製造原料便宜，故以專利保護研發結晶就顯得格外重要。由於我國欲發展生技產業，因此必須對生技產業做更好之保護，故在發明審查基準之中特別建立了生物科技以及製藥相關專利審查基準。此外，我國智慧財產法院設立以來，以進步性駁回專利的比例偏高，顯見進步性於實務上如何判斷格外重要，雖我國已有專章特別保護生技及製藥相關專利，但專章之內容卻略顯不足，使實務上在判斷進步性時，易流於恣意。而由我國專利審查基準觀之，主要之規定係仿照美國創設，因此如欲對我國之規定進行檢討，勢必先瞭解美國法上相關規定。
我國之進步性即為美國法上之非顯而易知性，此要件於專利三要件中，是屬於較主觀之標準。美國實務自1952年將其明文化後，對其實際內涵亦多有爭執，除了聯邦最高法院曾經發展出Graham test來判斷非顯而易知性外，CAFC更就組合發明是否落入顯而易知的範圍內發展出了TSM test。而於2007年KSR案中，聯邦最高法院就實務上向來用以判斷顯而易知的TSM test提出了批評，即向來實務運用狹窄而僵化TSM test判斷非顯而易知之方式有誤，應回歸至寬廣而有彈性之Graham test做判斷。因美國為判例法國家，故此案對實務有拘束力，即其見解改變了向來實務上對於顯而易知的判斷寬嚴。USPTO甚至於2007年及2010年各提出KSR審查指南更新，而於更新之審查指南中，分別就判斷顯而易知提出了其他的判斷法則，並輔以KSR案後，CAFC所作出之判決案例及USPTO於案例中所做出教示，期使專利審查人員及專利申請人能有更具體的依循標準。
惟此案是屬於發展程度較高之機械領域，其見解是否拘束發展程度較低之生物科技領域，不無疑問。由KSR案之後的案例觀之，可發現美國實務認為雖然生物科技領域相對之下為不可預期性較高之領域，然聯邦最高法院之見解仍應拘束下級法院，即KSR案之見解亦應適用到生物科技領域。
我國實務上在判斷生物科技專利時，其依循之標準過於主觀，本文認為應視我國生技產業之現況，適當參酌美國於2007年KSR案後所建立的具體判斷標準，以充實我國現在較為貧乏之生技產業相關專利審查基準。

關鍵字

非顯而易知性 ； 進步性 ； 生物科技專利 ； KSR ； Graham test ； TSM test ； KSR審查指南更新

並列摘要

Because biotechnology can help in health, agriculture and solving environment problems, it becomes an important industry now and in the future. However, it takes long time to develop and costs a lot, but the material is cheap, so it is important to protect the development by patent. We would like to develop bioindustry in our country, so we made a special chapter which is all about biotechnological and pharmaceutical patent in our patent law examination guidelines. The ratio of the courts used to reject the patent by lack of intentive-step is high, so it is important to know how the patent filled this requirement. Though we have a special chapter to protect BioPharma patent, the content is not enough so that the court will be reckless when they have to make a decision. Because most of our examination guidelines is followed the U.S., we must know what is the provisions of U.S. law before we check our law.
The requirement of intensive-step in our country is the non-obviousness requirement in the U.S.. Non-obviousness is the most subjective requirement of patent. The non-obviousness criterion was codified in the 1952 American Patent Act, but there were some arguments. The Supreme Court’s opinion in Graham v. John deere Co. is used to determine if the patent is obvious. The Federal Circuit has made TSM test to analyze if a combined patent is obvious. The Supreme Court in KSR disagreed with the Federal Circuit’s rigid application of the TSM test and favored an expansive and flexible expectation of Graham test. Thus USPTO has developed 2007 & 2010 KSR Guidelines Update. The Office has identified 7 rationales in 2007 KSR Guidelines Updates, and the most four rationales and the case in 2010 KSR Guidelines Update. These two Update make the officers and the applicants much more objective than before.
KSR’s art is about the much more developed field. Can the opinion restrict BioPharma which is much less developed? The cases after KSR showed that though BioPharma is much more unpredictable, the opinion of the Supreme Court in KSR can still restrict them. Even though BioPharma is much more unpredictable, we should use an expansive and flexible expectation of Graham test to analyze the case.

Because the criterion of BioPharma patent in our country is subjective, we have to think the current situation of us, and take into consider of the objective standard of the U.S..

並列關鍵字

non-obviousness ； intensive-step ； biotechnology ； BioPharma ； KSR ； Graham test ； TSM test ； KSR Guidelines Update

參考文獻

1、李奇峰，生技製藥產業專利技術之價值評估模式與投資策略，2010年。

1、Biotechnology Industry Organization

35、Loom Company c. Higgins, 105 U.S. 580 (1881).

31、In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).

1、MILLER, ARTHUR RAPHAEL & DAVIS, MICHAEL H., INTELLECTUAL PROPERTY: PATENTS, TRADEMARKS, AND COPYRIGHT (4th ed. 2007).