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

Abstract

基因科技的研發成果除了得做為研究工具外，終端產品服務如基因檢測或基因治療等則皆具有醫療功能效益，不僅有高度潛能發展成個人化醫療的應用，更有助於減緩國家於健康財政的支出負擔。此外，以基因科學為技術基礎的生物科技產業，亦多被各國列為重點發展的產業類別，且現今尚處於持續向上攀升的態勢。然而，有鑑於基因科技同時具備生物不確定性和累積創新特性，造成專利法在其發展上雖扮演極重要的推動角色，但因為成果多具有上位且必要近用的性質，而與專利法所保障的發明性質以及所享有排他權能呈現某程度上的扞格牴觸，進而在實際適用上產生諸多疑義和問題。是以，究竟如何透過調整和再造專利法和相關法規範的解釋，解決現行適用上的問題，並且增進基因科技的研發動能，促成基礎研究的承接和鼓勵後續創新和商業化，最終帶動整體生技產業的蓬勃發展，實乃本論文的問題核心和研究目標。 對此，本論文將聚焦於基因科技研發成果的專利保護要件解釋上的疑義，以及生技專利的授權實務所面臨的困境應如何處理此二議題，並以美國的法制規範和實務見解作為討論模板，透過文獻回顧和比較分析法，輔以技術評價、產業影響評估和政策評析，提出一整體宏觀性的最佳政策模型，且逐一具體套用至各該政策槓桿的解釋和運用中。是以，本論文乃嘗試透過一次到位的方式，使專利適用於基因科技發明上，得直接調整成最佳的適用狀態，以節省逐步微調或立法再造的成本和不效率，並且真正達成生技產業創新發展之目標。 首先，於第二章詳盡介紹基因序列、基因改良之生物材料、基因檢測和治療方法，以及胚胎幹細胞此四個研發領域的技術內容，以及基因科學在產官學的互動實務和發展現況，並點出歷經誘因機制的轉變所生的適用疑義和近用問題。其次，在第三章則是先探求經濟政策擬定和執行的法理基礎，並闡釋專利法和相關法制具有經濟政策容納性和得依據技術特性予以調整的性質。再者，依憑上開理論基礎提出一較佳的政策模型，即區分專利保護和專利行使階段，前者的專利保護要件的解釋上，應貫徹貼近技術實務和充分誘因保障的政策思維。並且挑選爭議性較高的專利適格性、產業利用性、進步性和據以實施性，以及附隨相關的書面揭露要件，在第四章具體討論適用在本論文所選擇的技術子領域的專利保護要件判斷上，進而提供全面性的實務見解認識和橫向的比較基礎加以介紹和評析。相對的，後者的部分則是依據現行仍維持尚屬公開的授權風氣，僅需採取低度的管制密度的合宜近用政策思維，以維持市場具備適度的自主型塑空間。因此，在第五章就專利近用相關的爭議類型所涉及的專利濫用、相關授權約款細節、授權促進措施、所能主張的試驗免責範疇，以及強制授權、法定授權和介入權的討論中，透過立基於本論文提出的政策模型，加以檢視實務見解和競爭法指導原則所闡釋的合法判斷之妥適性，並且逐一選擇合適的技術子類型作為評論的模板，提供縱向的具體應用情形評估。 最後，在第六章結論的部分，除了重申此政策模型的適宜性，並嘗試將此模型套用至歐洲和我國的專利法和相關法制的解釋和適用上，並提出相關革新的建議，促成各國的專利法制的實際適用均得引介此政策模型，進而成功促成各國生技產業創新發展之目的。

The biotechnology inventions can serve as research tools as well as some end services such as genetic testing or gene therapy. Not only can the biotechnology inventions apply to personal medical treatment, but they can also alleviate the burden on public health subsidization of government. Besides, the biotechnology industry is growing prosperously and its development is also on the top priority of many countries. To deal with the biotechnology uncertainties, patent law ensures great incentives in the innovation of biotechnology R&D. Nevertheless, the nature of the biotechnology inventions, which is hard to distinguish with natural phenomena or is somehow essential for follow-up improvements, makes it hard to become the subject matter of patent law, and conflicts with patent’s exclusive right. In order to spur the innovations of biotechnology and commercialization of basic research, the core issues are how to solve the problems mentioned above. The dissertation focuses on two parts. One is the adjustment of patent law interpretations in biotechnology inventions’ patentability. The other is the solution to the difficulty of the biotechnology patent access. The dissertation intends to propose an optimal policy model, which can be applied to policy levers in patent law interpretations concretely, through literature reviewing, technical analysis, industrial impact assessment and policy consideration of United States’ legal system and related court opinions. The optimal policy model divides patent law into two parts: patent protection and patent using. For patent protection, the explanations of patent law should take technical practices into considerations and ensure ample incentives for biotechnology research and development. For patent using, since the licensing practice of patented inventions still keeps sharing and common in the marketplace nowadays, only loose regulations are needed to ensure the useful access to patented inventions. Chapter four introduces the application of the model to specific subfields, including related court opinions and optimal interpretations of invention’s patentability, useful, nonobviousness, enablement and written description. Chapter five discusses about various types of the patent access controversies, inclusive of patent misuse, licensing clause, licensing-facilitated measurement, research exemption, compulsory licensing and march-in right issues. Still, by applying the model to selected subfield inventions, chapter five evaluates the appropriateness of court opinions and antitrust guidelines. Finally, the conclusion restates the appropriateness of the policy model, and tries to influence the interpretations and applications of Europe and Taiwan patent law. Overall, the dissertation tries to optimize the interpretations and applications of patent law once and for all in order to promote the biotechnology industry developments and reduce the cost and inefficiency of continual further legislations.