美國專利法書面說明要件之研究

Research of Written Description Requirement in U.S. Patent Act

專利申請書應有兩重要部分，分別為說明書與申請專利範圍。前者是為了確定發明人已將發明內容充分揭露給公眾，以換取國家賦予專利權之對價，後者則決定專利權之權利範圍。
惟說明書內容應揭露至何種程度才算充分揭露？美國聯邦專利法第112條第1項規定了據以實施要件（Enablement）、書面說明要件（Written Description）及最佳實施例（Best Mode）等三要件。據以實施要件之內容為：說明書應將使用及製造之方法或步驟，以完整、清晰、精簡、明確之用語，使該發明所屬技術領域中具有通常知識者亦能製造和使用。書面說明要件乃由美國司法實務所創設，其係指專利說明書所揭露之範圍，必須與申請專利範圍相當，若將專利說明書與申請專利範圍內之元件相比，發現申請專利範圍之元件在說明書漏未描述者，即可能違反該要件，而被判決專利權無效。兩者區別實益在於前者係規範該說明書需使發明能為該技術領域內具有通常知識者製造或使用；後者是確保發明人在申請日時已完成並擁有該發明，以享有申請日之利益。
近年來，美國許多學者及生物科技產業不斷質疑書面說明要件是否過於嚴格，並質疑該要件另一個專利說明書審查要件──「據以實施要件」兩者易產生混淆，而有該要件存廢之爭論。2009年8月21日，美國聯邦巡迴上訴法院接受Ariad公司的聯席審理（En Banc Rehearing）之要求，審判中法院集中討論兩爭點：一、書面說明是否獨立於據以實施要件之外而為獨立要件？二、如果書面說明是獨立要件，那其適用範圍及目的為何？最後法院仍維持以往見解。
反觀我國專利法及司法實務，並未區分書面說明與據以實施要件，僅以第26 條第2 項統稱「充分揭露致據以實施要件」，而實務運作亦偏向美國據以實施要件，是書面說明要件於我國並未受到重視。是故本文建議應在我國法專利說明書揭露義務之規範中增加「書面說明要件」，使說明書所達到之功能更為完善，以提昇說明書之品質並使我國專利制度運作更加細膩完整。

A patent application should consist of two important parts: “Specification” and “Claims”. The purpose of Specification is to make sure that the invention owned by inventor has been sufficiently disclosed to the public, so that the person of ordinary skills in the art may work on and practice the patent, in exchange of the exclusive patent right to the inventor. On the other hand, the Claims decide the scope of the patent.
Nevertheless, how much information should a patent specification disclose in order to be considered a sufficient disclosure? The 35 U.S.C. §112 para.1 requests three elements: “Enablement”, “Written Description” and “Best Mode”. Enablement is the manner and process of making and using the invention, in such full, clear, concise, and exact terms as to enable any person of skilled in the art may make and use the same by interpreting the context of the Enablement. The requirement of Written Description was created by U.S. jurisprudence, which requires that each element of written description in Claims must be the same with Specification; otherwise it may be viewed as an invalid application. The difference between the two aforementioned requirements is that Enablement ensures the public to receive the correct information written in the Specification, so the invention may be used by person of ordinary skill in the art. Instead, Written Description makes sure that the inventor of the patent has actually invented the invention when he/she files the patent application.
Recently, certain U.S. scholars and people from bio-technology industry raises their voice on questioning the strict and harsh requirement of Written Description, and argue that it is often confused with the requirement of Enablement in practice. In 2009.8.21, Court of Appeal of Federal Circuit (CAFC) accepted the “En Banc Rehearing” motion of Ariad Company, and felt the court must clarify two important issues. First, whether Written Description is an independent factor in considering a patent application? Second, if so, what is the scope and purpose of such requirement? The court follows the rules set up by precedents and provides valuable explanation for the two issues.
The Patent Act of our country does not distinguish Written Description from Enablement requirement. On the other hand, it seems to combine the two requirements into the so-called “Disclosure to Enablement” requirement. Our study suggests adding Written Description to our disclosure obligation set forth in our Patent Act based on the experience of the United States, in order to make Specification more functional and to improve the quality of our patent system in a more detailed and complete manner.