專利制度是知識經濟時代最為重要的一種智慧財產權形式，不但對於技術創新居功厥偉，在國際商業活動中也占有極具份量的地位。而在取得專利的三大要件中，以非顯而易知性（即我國進步性）最為棘手，蓋其本身屬於不確定之法律概念，而容有裁量空間。 非顯而易知性發軔於美國判例法，其後由實務主導其發展。在指標性案例KSR判決中，最高法院揭示了非顯而易知性的審查架構，以Graham四要件法則為根柢，並輔以顯可嘗試原則及彈性運用的TSM檢測法，整體而言KSR判決提高了非顯而易知性的適格門檻。在後KSR時代，CAFC在機械工業、醫藥品與生物科技等領域分別依不同程度適用KSR見解。2009年In re Kubin案確認KSR見解可適用於不可預測性較高之基因生技領域，近幾年來顯可嘗試原則也獲得高度重視。 相較而言，我國進步性審查主要依據智慧財產局所制定的專利審查基準，但行政審查常有過於直觀簡略之嫌；法院判決則在「發明所屬領域中具通常技術者之技術水準」與「該領域具通常技術者參酌先前技術所揭露之內容及申請時的通常知識，是否能所能輕易完成系爭申請發明之整體」此兩步驟的論證上較為欠缺，整體而言達成進步性結論之心證揭露程度不足，對於當事人有突襲性裁判之虞。 本研究基於上述觀察所得，對美國與我國關於非顯而易知性概念之認知與實踐進行比對，並分別就審查實務面與產業因應面提出微薄建議，以期借鏡美國法經驗使我國未來實務操作更趨完善。 / Patent system is one of the most important forms of intellectual property rights in the era of knowledge economy, not only indispensable for technological innovation, also of great influnce in the international business activities. Among the three requirements of patentability, “Non-obviousness” (ie, “Inventive Step” in Taiwan) is the most difficult to fulfill, due to the uncertainty of its legal concept and the room for discretion. Non-obviousness was carved out in the U.S. case law and continuously developed by the court rulings. In the benchmark case KSR v. Teleflex, the Supreme Court articulated that the examination framework of non-obviousness is based on Graham four factors, along with other principles like “Obvious to Try” and the TSM test in a more flexible way. In general, KSR lifted the eligibility threshold for non-obviousness. It has been applied in different degrees by the Court of Appeals for the Federal Circuit to various fields such as machinery industry, pharmaceuticals and biotechnology in the post-KSR era. Then it was recognized in 2009 In re Kubin case that the KSR opinion is applicable to the unpredictable field, gene biotechnology, for instance. Besides, the “Obvious to Try” principle has been gaining much attention in recent years. In comparison, both administrative and juducial examinations of inventive step in Taiwan are mainly based on the “Substantive examination guidelines for invention patent” issued by the Intellectual Property Office. However, the administrative review is often reckoned to be too intuitive and rough, and the court decisions are considered to be made with less expression on “the level of the PHOSITA” and “whether a PHOSITA with the reference to prior arts and common knowledge can complete the whole invention without difficulty.” In all, the lack of revealing the reasoning on the inventive step conclusion might expose the parties in danger of surprise judgements. Based on the above observations, this study compared the cognition and practice of non-obviousness both in the United States and in Taiwan, and as a result, presented some primary suggestions in light of the United States’ experience toward both the practice and industries, so that our inventive step examination practice in the future could be improved.

本論文研究主題係針對生物技術專利的要件的探討外，更探討跨學科領域的結合所形成的專利制度，如何透過實務的見解來具體化專利的要件，本文希望嘗試透過探討法律層面的專利取得要件及專利審查基準的認定外，更進一步希望透過法院實務的見解，來具體化專利要件之內涵，架構其中一段完整生物技術專利要件之評估，除作為本論文探討的具體內容。

化學發明是專利申請領域別中另一個重要的領域，醫學藥品的龐大商機是重要的推手，因為大多數藥物的活性成份為有機小分子化合物，且研發一新藥，須費時10到15年，研發經費估計高達26億美金，各大專利藥廠當然積極申請專利，保護投資。另一方面，Hatch-Waxman Act鼓勵學名藥可以盡早上市，使一般民眾能以較便宜的價格取得所需藥品。在美國藥品市場數千億美元的商機吸引下，學名藥廠積極挑戰專利藥廠之專利權。其中非顯而易知性要件認定，為雙方訴訟爭點。 然，化學發明的非顯而易知性要件認定之所以異於機械、電子、電機等技術，在於我們無法準確預測在奈米尺度的化學反應與分子的物性與化性，因而產生化學反應結果的不可預期性。而藥物研發是先從資料庫中，篩選出具一定活性的化合物作為先導化合物，經由取代基的引入、改變，或官能基的置換，結合活性與化合物結構關係（SAR），達成先導化合物結構最佳化，以快速、準確的找出候選藥物分子，進入臨床實驗。 2007年，美國聯邦最高法院在KSR案，針對非顯而易知性，重申Graham 案建立的非顯而易知性判斷法則的重要性，與重新適用顯而易知的嘗試。KSR判決後，許多文章討論KSR判決將不只針對機械組合發明，同時也將會對醫藥化學發明非顯而易知性之認定標準，產生一定的影響。 本論文研究KSR判決後， CAFC使用顯而易知的嘗試、與先導化合物分析（lead compound analysis）判斷準則，於醫藥產業化學發明專利的非顯而易知性的判決。CAFC於涉及組合藥物或配方調配案件，使用顯而易知的嘗試審查基準；使用先導化合物分析，都涉及系爭藥物中「活性成份結構」的非顯而易知性認定，CAFC針對不同類型的化學發明案件，採用了不同的審查基準。 KSR判決雖然重新啟用「顯而易知的嘗試」判斷準則，且CAFC適用「顯而易知的嘗試」的案件，亦明顯的增加。唯，本論文研究發現，於醫藥產業化學發明專利的非顯而易知性的判決，仍明顯高於對非藥品相關案件。 / Chemical invention is one of key art in patent application driving from the huge market size of medicines, in which active ingredients are organic molecules. The average cost to research and develop each successful drug is estimated to be $2.6 billion US dollars, and took 10 to 15 years. In other word, whether pharmaceutical companies can recover their investment in drug development heavily depends on the patent protection of their drugs. On the other hand, the Hatch-Waxman Act introduced in 1984 created the generic drug pathway to the market, so general public can obtain the drugs at a affordable price. However, within this framework, the validity of drug patents are often challenged by generic manufactures, mainly the "non-obviousness" requirement in patent system. During this lengthy and expensive drug discovery, chemist often entails making small modifications to lead compounds to establish structure-activity relationship (SAR) to speed up the process. Those modifications might be deemed “obvious to try”—and then studying the largely unpredictable, yet critical, resulting biological effects. In 2007, the Supreme Court of the United States, in KSR decision, reasserted that a prima facie case of obviousness may be determined by the framework set forth in Graham and "obvious to try" test. Since then, there are predictions that KSR decision will have a substantial impact in pharmaceutical and life sciences arts. This study, we examine the CAFC ruling in pharmaceutical arts regarding to "non-obviousness" issue by "obvious to try" and "lead compound analysis" test after the KSR decision. And found that the "non-obviousness" judgment of the chemical invention patent in the pharmaceutical industry was still significantly higher than that of the non-drug-related cases.