美國專利法揭露充分性要件之研究

Abstract

本論文研製之主題是在介紹專利要件中之揭露充分性及其判斷的基準。在本文是以美國專利法中有關揭露充分性的認定為中心來討論在揭露充分性要件之適用。又，生物技術之領域之揭露充分性之認定更困難，因為此類技術具有本質上不可預期性、第三人實驗進行難易性、生物體取得困難性等特質。 在專利上之所以存在揭露充分性，是為求能達成所給了之專利權與發明人所貢獻之發明之間有公平對價。在美國法的有關揭露充分性的認定可分成三個要件，分別是可據以實施性，書面說明與最佳實施態樣。 美國之「可據以實施性」就是要保護熟悉該項技術之人士可以依據說明書之揭示內容製造與使用發明人所揭示之發明技術。在判定上此要件是以熟悉該項技術為判定之人士，以據以製造與使用為判定的客體，時間則是以申請時為基準、方式則是以是否涉驗過度實驗為中心。實驗是否過度則與生物技術相關發明是否需要寄存有之決定有密不可分的關係。 美國法之書面說明要件是由美國上訴法院所創設的要件，此要件則是要求發明人必須明確地在說明書中表現其在發明當就已具有所請求之發明，並將之傳達給第三人知曉。利用此要件的適用不但課予發明要有清楚揭示發明之義務，更可避免發明人對申請專利範圍為不當的修正。 美國專利法之最佳實施態樣要件，則要求發明人必須揭示其發明當時所知最佳實施態 俾避免發明人隱匿其所知的最佳實施該發明之內容。此要件只是要求發明人對最佳發明之揭示內容要比可據以實施性更多、更詳盡。在美國法中違反此要件後果嚴重，往往造成專利無效，甚至會與有行為不當等嚴重法律效果。 . .最後，在了解美國專利法內容後，本文認為我國專利法中有關揭露充分性之相關規定，有必要進一步的修正，即就可以據實施內容明定其是據以製造與使用，同時將書面說明要件引入我國法制中並於專利法中明確規範。此外，本文建議將專利寄存規定自專利法中刪除，而在專利施行細則再行規定，俾以利專利機關可以因應技術變化與寄存機關所具有的能力而為其它必要處置。

This thesis comprises an introduction of sufficiency of disclosure in U.S. patent law and the application of such requirement. Sufficiency of disclosure is difficult to assess, particularly in biotechnology, because of the unpredictable nature of the subject, the necessity to conduct further experimentation by others and the accessibility of organisms in biotechnique. Sufficiency of disclosure imposes an obligation upon an inventor so as to ensure that the people in society receive something of value to justify the patent rights of 20 years conferred to an invention, as procured by the patent owner. An invention described in the specification must meet enablement, written description and best mode requirements, so that the sufficiency of disclosure mandated in U.S. patent Law can be satisfied. In regard to enablement, the specification of an invention must teach a person skilled in the art how to make and use the full scope of the invention without undue experimentation so as to meet this requirement. Whether or not the experimentation conducted by those skilled in the art when making and using the same invention based on the disclosure in the specification originally filed is undue is crucial to an inventor when considering the necessity of deposit organisms in a depositary authorities in biotechnological cases. Written description established by U.S. Court of Appeals of Federal Circuit requires that the specification of an invention must clearly demonstrate that the inventor was in possession of the invention at the time the patent application was filed and conveyed it clearly to those skilled in the art. Thus, this requirement not only imposes a much higher obligation of disclosure of a claimed invention to the inventor but also functions to restrain amendment of claims during patent prosecution. The purpose of the best mode requirement is to prevent inventors from obtaining patent protection while concealing from the public the preferred embodiments of their inventions. This requirement imposes to an inventor a disclosure obligation higher than that by enablement so that the preferred embodiments contemplated by the inventor at filing can be clearly specified in the specification. If the specification of an invention does not satisfy this requirement, the patent obtained may be held unenforceable. Sometimes, violation of the best mode requirement will be deemed as violation of this duty of candor, which is referred to as inequitable conduct. Having understood the application of the sufficiency of disclosure in U.S. patent law,the research suggested that the enabling requirement in the Patent Law in our country may be further amended to specify that the specification of an invention should enable those skilled in the art to make and use the invention. Furthermore, written description should be introduced in our country and clearly stipulated in our patent law. The stipulation of our Patent Law directed to the deposit of organisms should be deleted and should be instead be included in the Enforcement Rule of the Patent Law, so that the Patent authority of our country may take necessary measure to ensure availability of organisms.