治療方法專利保護之研究─以生物技術治療方法為主

Abstract

摘 要 治療方法之可專利性，美國與歐日專利法制各有不同，但治療方法在生物技術發展的衝擊下，二大專利體系已有調和與折衷之現象。本研究期藉由各國治療方法專利保護現況之研究，並以生物技術治療方法為主軸，探討治療方法給予專利保護之利弊、有關治療方法未來專利保護可行性及其限制等議題，以供相關研究之參考。本文以比較法研究方法作為法制分析之基礎，分析法學論著文獻、條約、法條、我國及國外案例等素材，另導入本國生技產業現況分析，以及國內醫師對此一議題看法之社會分析，並探討實務上專利說明書有關治療方法撰寫之方式，以切合實際。

本研究先以實際專利說明書之舉例，彰顯討論議題所在。次以美國、歐洲專利公約各會員國、日本、中國大陸、以及我國關於治療方法之法制比較為範圍，作為論文探討之基礎。再就生物技術發明應用與各國專利保護演進過程加以討論分析，並探討生物技術治療方法應否專利保護之問題。第四章則進行本研究有關生物技術治療方法專利保護可能性、生物技術治療方法行為之認定、治療方法給予專利保護之利弊分析與我國可能准予專利範圍及其限制等核心議題論述。第五章分析美日歐對生物技術應用治療方法所採行之因應立法政策，以供我國法制檢視之參佐。第六章則綜合前述各章分析比較，嘗試提出幾種開放治療方法准予發明專利之可能選擇及對應建議，並就相關之配套法制加以剖析，以作為未來就此議題檢討之參考。

由於治療方法是否准予專利，牽涉醫事法與專利法立法目的衝突與平衡之問題，並關係病患醫療權益維護、醫師執業倫理尊重與生技產業發展鼓勵等三方利害之衡平兼顧，且有關法制之變革或因應措施，應以病患醫療權益之維護為首要考量。本文希藉由治療方法之本質作不同分類，以探討各種治療方法專利之可能性，用較精緻之法制建構以兼顧各面向之權益。因此，於第七章就我國未來開放各種治療方法可專利範圍及其優先順序作一建議以作為結論，期能有助於未來對此相關問題檢討時之進一步研究。

Abstract The legal systems concerning patentability of methods of treatment are different in the U.S., Europe and Japan. However, for the influence of the development of biotechnology there have been certain signs of harmonization between the patent laws of U.S. and Europe, Japan. This study, researched into the protection of patent among countries and focused on process of biotechnology treatment, discusses the advantages and disadvantages of grant of patent for methods of treatment, the feasibility and limitation to the protection for the patent of methods of treatment in the future to give some suggestions for the reference of relevant studies. The essay based on legal system analysis by way of comparison of law analyzes the materials of law review, treats, statures, and both domestic and foreign cases. On the other hand, for the practical purpose it also introduces the analysis of local biotechnology industry, social analysis of opinions of doctors in practice at issue and discusses the writing type of patent specification regarding methods of treatment in law practice.

Firstly, the research illustrates the questions with cases regarding patent description to underline the point of topic. Secondly the chapter compares the U.S. legal systems with E.U., Japan, China, and Taiwan about methods of treatment as a basis for further discussion. In the next chapter, the main points to discuss are application of invention for the biotechnology and progress of protection for patent in different countries. There are also researches to the questions of whether to offer patent protection for the methods of treatment by biotechnology process in this chapter. The forth chapter proceeds with explanation of central points to the essay including the feasibility of the protection for the patent of methods of treatment, definition of biotechnology treatment, the advantages and disadvantages of grant of patent for methods of treatment, the coverage and limitation of a patent that is offered probably to the methods of treatment in Taiwan. Fifth chapter analyzes the legislative policies in the U.S., Europe and Japan in the need of application of biotechnology in medical process to provide references for the reexamination of legal system in Taiwan. Summarizing the comparison and analysis of the said chapter, sixth chapter tries to submit several possible options and suggestions to the grant of patent of invention for methods of treatment and analyzes relevant legal systems to provide references to the topic for review in future.

The revision of patent law regarding patentability for the methods of treatment involving the patient benefit, professional respect of the doctor, and encouragement of biotechnology industry should take the patient interests as the top priority of consideration and maintain a balance for the conflict between medical law and patent law. According to the essence and category of medical treatments, the essay tries to keep a balance among different interests on the topic of patentability of methods of treatment and construct an elaborated legal system. Therefore, in seventh chapter the conclusion is reached by the suggestions for the scope and priority of patentability of different methods of treatment in the future in Taiwan and the expectation for the thesis that will be helpful for further research to review relevant issues.