此案為2010年CAFC判決，涉及美國專利說明書揭露程度（35 U.S.C. 112, first paragraph, (a)）影響發明的可專利性的決定，CAFC對於說明書揭露程度的態度是：說明書揭露與可實施性（enablement）不同，說明書揭露不足將導致專利無效，不是專利可實施就可以，而是有更高的揭露標準。
"We now reaffirm that § 112, first paragraph, contains a written description requirement separate from enablement, and we again reverse the district court’s denial of JMOL and hold the asserted claims of the ’516 patent invalid for failure to meet the statutory written description requirement."
35 U.S.C. 112 SPECIFICATION. (post-AIA)
(a) IN GENERAL.--The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention .
案件資訊：
系爭專利：US6,410,516
專利權人：President & Fellows Of Harvard College, Massachusetts Institute Of Technology, Whitehead Instittue For Biomedical Research
侵權被告：Eli Lilly and Company
本案緣起
系爭專利（申請號：08/464364，優先權溯及1986年的申請案06/817441）關於一種基因轉錄調控的技術（Nuclear factors associated with transcriptional regulation ），其中表示基因的「轉錄因子NF-κB」中的核因子（nuclear factor）可以透過改進的蛋白質-DNA的化驗方法識別與分離出來（by improved assay for protein-DNA binding. ），用以增強免疫球蛋白基因。
系爭專利發明人發現「轉錄因子NF-κB」存在於細胞中，成為無活性複合物與蛋白抑製劑，但可透過細胞外刺激而被活化，因此被釋放出來。一旦「轉錄因子NF-κB」被活化而釋放出來，將游走細胞核，因此激化具有此「轉錄因子NF-κB」的基因轉錄，藉此可以抵禦細胞外的攻擊。不過，當這類刺激過量，對人類有害，於是發明人透過人為干擾的方式影響「轉錄因子NF-κB」活性，降低有害的病症。這就是系爭專利的技術要點。
專利權人Ariad於2002年對Lilly提出侵權訴訟，系爭申請專利範圍：Claims 80, 95, 144, 145，已下列舉Claim 80，此項為claims 7, 8的附屬項。
80. [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-κB-mediated intracellular signaling, the method comprising altering NF-κB activity in the cells such that NF-κB-mediated effects of external influences are modified, wherein NF-κB activity in the cell is reduced] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.
95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-κB-mediated intracellular signaling, the method comprising reducing NF-κB activity in the cells such that expression of said genes is reduced], carried out on human cells.
144. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells] wherein reducing NF-κB activity comprises reducing binding of NF-κB to NF-κB recognition sites on genes which are transcriptionally regulated by NF-κB.
145. [A method for reducing bacterial lipopolysaccharide-induced expression of cytokines in mammalian cells, which method comprises reducing NF-κB activity in the cells so as to reduce bacterial lipopolysaccharide-induced expression of said cytokines in the cells], carried out on human cells.
地方法院階段：2006年4月作出侵權成立，專利有效（專利並未缺乏可實施性、揭露內容）等的決定，同時否決被告Lilly的JMOL的motion。於是Lilly上訴CAFC。
CAFC階段：
經上訴人Lilly提出專利因為不符35U.S.C.112(a)的無效主張，CAFC法官初判否決地院陪審團的決定，認為各項系爭請求項因為說明書不符揭露要求而判定無效，專利權人Ariad提出聯席法官重審的請願，經同意後，案件將討論以下兩個問題（是否112(a)規定表示說明書揭露要求不同於可實施性的要求？如果答案是"不同"，那所謂的揭露書要求為何？）：
(1) Whether 35 U.S.C. §112, paragraph 1, contains a written description requirement separate from an enablement requirement?
(2) If a separate written description requirement is set forth in the statute, what is the scope and purpose of that requirement?
聯席法官再審結果：17位表示支持Lilly意見；1位支持原告Ariad；其餘7位沒有意見。
35 U.S.C. §112, paragraph 1文字其實很清楚，不過討論起來卻是各說各話，我們一般認為專利說明書揭露程度就是讓相關領域的技術人員可以據以實施就好，揭露到讓人理解發明為何，以及如何達成。
這部分可參考中華民國審查基準第二篇第一章中「1.3說明書的記載原則」規定：可據以實現要件。
"說明書作為技術文件，應明確且充分揭露申請專利之發明，使公眾能利用該發明，而申請人能據以主張該發明。因此，說明書形式上應敘明發明名稱、技術領域、先前技術、發明內容、圖式簡單說明、實施方式及符號說明等；其內容應明確且充分揭露申請專利之發明，使該發明所屬技術領域中具有通常知識者能瞭解該發明的內容，並可據以實現，簡稱可據以實現要件。說明書之記載是否已明確且充分揭露，須在說明書、申請專利範圍及圖式三者整體之基礎上，參酌申請時之通常知識予以審究。審查時，若說明書之記載未明確或未充分揭露申請專利之發明，
無法使該發明所屬技術領域中具有通常知識者瞭解其內容並可據以實現者，應以違反專利法第26 條第1 項為理由，通知申請人申復或修正。
說明書應明確且充分揭露，指說明書之記載必須使該發明所屬技術領域中具有通常知識者能瞭解申請專利之發明的內容，而以其是否可據以實現為判斷的標準，若達到可據以實現之程度，即謂說明書明確且充分揭露申請專利之發明。"
「可據以實施要件」自然為專利權人Ariad的主張：
被告Lilly則提出過去歷史，認為專利說明書的揭露要求包括：揭露內容，以及讓相關技術人員可以實施的要求，也就是說明書揭露與據以實施是兩個分別的要件：
對此爭議，CAFC法官站在Lilly這邊：
CAFC法官引用多件過去美國最高法院的案例，藉以支持自己的看法，有關據以實施與說明書揭露程度等意見，比如：
Schriber-Schroth
[1] to require the patentee to describe his invention so that others may construct and use it after the expiration of the patent and [2] to inform the public during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not.
Gill v. Wells
(1) That the government may know what they have granted and what will become public property when the term of the monopoly expires. (2.) That licensed persons desiring to practice the invention may know,during the term, how to make, construct, and use the invention. (3.) That other inventors may know what part of the field of invention is unoccupied.
Festo
[T]he patent application must describe, enable, and set forth the best mode of carrying out the invention. These latter requirements must be satisfied before issuance of the patent, for exclusive patent rights are given in exchange for disclosing the invention to the public. What is claimed by the patent application must be the same as what is disclosed in the specification; otherwise the patent should not issue. The patent also should not issue if the other requirements of § 112 are not satisfied . . . .
關於本案例中有關干擾「轉錄因子NF-κB」活性的技術，CAFC認為所謂「足夠的說明書」應要求有詳細的定義，如結構、方程式、化學式、物理特性或其他內容，使得足以區隔其他材料的基因的內容：
當然，以上討論主要是圍繞在化學/生技相關技術領域，這也是法院的想法，法官承認在某些技術領域「發明的描述（"describing an invention"）」與「是否可以據以實施（"enabling one to make and use it"）」差異不大；不過，不總是這樣！但判斷原則是，如果請求項界定了一些功能、功效，說明書足夠支持的標準就相對較高。
結論：
根據以上討論，以及在說明書揭露程度的共識下，認為系爭專利請求項範圍因為沒有足夠的揭露內容而無效。
後語：
本案例提供各位撰寫專利說明書的工程師參考，原則就是說明書應揭露到「讓人足以理解而據以實施」，更進一步，還有補入細節（結構、方程式、物理或化學特性），讓人可以區隔出該發明與其他的差異。
判決原文：
http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1248.pdf
（備份：https://app.box.com/s/cea3wtwa63h0fjwxn77v6vfdwzxogr4f）
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