規定說明書撰寫要求的常用112(a)(b)(f)：
35 U.S.C. 112 SPECIFICATION.
(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.
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
...
(f) ELEMENT IN CLAIM FOR A COMBINATION.—An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
本篇「Amgen v. Sanofi (Fed. Cir. 2017)」案件資訊：
原告/專利權人/被上訴人：AMGEN INC., AMGEN MANUFACTURING LIMITED, AMGEN USA, INC.
被告/上訴人：SANOFI, AVENTISUB LLC, REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S.
系爭專利：US8,829,165、US8,859,741
本案緣起地方法院判決系爭專利有效，被告Sanofi產品Praluent alirocumab侵權成立，地院發出永久禁制令。
被告上訴CAFC，上訴議題之一是被告Sanofi主張系爭專利說明書不符撰寫規定，無法讓相關領域技術人員據以實施（enablement），並同時使得侵權成立與禁制令等裁決無效，而相關請願則被地院拒絕。案件上訴，進入CAFC。
系爭專利：
系爭專利US8,829,165關於幫助減少低密度脂蛋白膽固醇（壞膽固醇）的抗體，血液中過高的壞膽固醇會造成心臟疾病、心血管疾病，有種稱為statins的藥，但是會造成不利的副作用，也不能讓並能達到健康的水平而需要額外的醫療，因此也產生了替代品 - PCSK9 inhibitor，PCSK9是一種天然蛋白，可以從血液提取壞膽固醇，這就是系爭專利主張的權利範圍。
Claim 1：
1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.
被上訴人（專利權人）Amgen早於2005年開始研發PCSK9（Proprotein convertase subtilisin kexin type 9），研發出藥品Repatha™，使用活性成份"evolocumab"，這是一種單克隆抗體，防止PCSK9破壞LDL-R蛋白（這可以提取壞膽固醇），藥品也獲得FDA認證。
本次上訴人Sanofi也在2007年開始研發PCSK9，並於2011也獲得專利，也取得FDA認證。
到了2014年，本次被上訴人Amgen對上訴人Sanofi的上述研發結果與相關藥物提出侵權告訴，上訴人Sanofi反過來挑戰系爭專利的有效性，質疑揭露內容的可實施性與專利性。
本次議題在於，上訴人提出專利揭露書不滿足據以實施（enablement）要件的證據是否有效？
其中爭議的是，系爭專利申請專利範圍（如以上Claim 1）並非主張以上專利權人獲得FDA許可上市的「Repatha™」或是抗體。根據系爭專利揭露內容（兩件內容一致），共同指向同一2008年優先權，內容描述了實驗中「trial-and-error」過程，描述如何產生並篩選出結合PCSK9以及避免PCSK9破壞可以提取壞膽固醇的LDL-Rs的過程種種，說明書也揭露了X光形成的PCSK9三維結構。
在這樣的揭露內容中，地院作出已經提供足夠揭露內容的判決，否決上訴人的抗議，地院法院指導陪審團怎樣來看一篇說明書是否滿足揭露要求：說明書揭露內容可以讓在專利申請時相關領域技術人員的水平常規地理解此案抗體的產生，就是符合揭露要件。
"the district court instructed the jury, over Appellants’ objection, that written description can be satisfied “by the disclosure of a newly-characterized antigen . . . if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine.”"
事實問題：
關於系爭專利說明書是否揭露到可據以實施性（enablement），因為說明書都是實驗資訊（這可能是FDA要的資料），卻如上訴人所說，沒有揭露到抗體的結構（技術手段），而無法使得相關領域技術人員能據以實施（不用過度實驗）。
專利說明書揭露的要求，簡單來說，就是揭露內容足夠到相關技術領域的技術人員可以據以實施的程度，而且是以專利申請日當日的標準來看，如果是之後的證據，將需要證明這是在申請時技術水平下的判斷。
法律問題：
根據上訴人的意見，CAFC也認同，專利所主張的權利需要揭露專利範圍內具有代表性數量的實施例，或是結構特徵，以讓相關技術人員可以虛擬或是理解相關發明（語意可能需要參考原文）。
"Appellants, however, are also correct that a patent claiming a genus must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.”"
如此，如果證據證明發明沒有揭露足夠數量的實施例可能包括了沒有揭露在專利中的實施例，這樣的證據如果在優先權日前，就可能揭露了主張的發明。（這就是這類事證的證據能力）
"Evidence showing that a claimed genus does not disclose a representative number of species may include evidence of species that fall within the claimed genus but are not disclosed by the patent, and evidence of such species is likely to postdate the priority date. If such evidence predated the priority date, it might well anticipate the claimed genus."
上訴人就是要提出這類的證據才能證實系爭專利說明書揭露不足的問題。（"Appellants sought to introduce evidence not to illuminate the state of the art on the priority date but to show that the patent purportedly did not disclose a representative number of species."）
然而，即便是系爭專利申請日/優先權日後的證據，仍可能顯示系爭專利揭露不足的問題，這在法院也不見得有何定論，不過，說是一般常理。
"post-priority-date evidence of a particular species can reasonably bear on whether a patent “fails to disclose a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus"
這應該是這類發明的基本揭露要求：
"An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.”"
這種「事後證據」也不能無理忽略。
"Appellants purportedly sought to introduce post-priority-date evidence showing that Appellees engaged in lengthy and potentially undue experimentation to enable the full scope of the claims. Such evidence could have been relevant to determining if the claims were enabled as of the priority date and should not have been excluded simply because it post-dated the claims’priority date."
如此，何謂足夠數量的實施例？ 即便是沒有定論，卻因為證據未被充分討論，CAFC認為地院"不當地"排除上訴人關於前述抗體的證據，也就是證明系爭專利違反揭露規定（35 U.S.C. § 112）的證據。其中，當上訴人提出證據，地院認為其中並未描述系爭專利申請時的技術水平，也無關揭露內容是否足夠的議題，而指示陪審團可以忽略這部分證據，不過CAFC因為地院錯誤使用了法律，撤銷地院決定。
CAFC判決(1)地院錯誤排除上訴人有關說明書缺乏據以實施揭露內容的證據，以及(2)不當指引陪審團在此議題的決定，撤銷永久禁制令，但仍同意被上訴人/專利權人對系爭專利非顯而易見性的相關法律爭點。
my two cents:
雖撤銷地院判決，並發回重審，但是專利權人並未失敗，只是因為地院決定的依據有誤。
本案例雖未有最終決定，但仍可得到拿到藥證，卻可能拿不到專利的可能性。
專利說明書要揭露的內容是發明本身，看來是與FDA要求的不同，在專利說明書中，如果有些實驗或是佐證，是可以輔助專利的可實施性，卻不能忽略發明本身，就是指技術手段，如本篇討論，發明是一個藥品，不能僅提出實驗數據，而是要完成揭露藥品的成份與實施態樣。如果將來判決是沒有符合揭露要件，將很尷尬的是，本篇系爭專利的說明書有300多頁，卻可能是拿到了藥證，而拿不到專利的窘境。然而，本案故事仍可能有後續發展。
判決文：
http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-1480.Opinion.10-2-2017.1.PDF
（備份：https://app.box.com/s/yair17m3vxune62vf8xicizam9dlf7jy）
參考資料：
https://patentlyo.com/patent/2017/10/antibody-exception-description.html
後語：（補充一些內容）
(updated on Nov. 7, 2017)
本案留下了一些問題，針對生物醫療類專利的撰寫要求，如「newly characterized antigen」測試？
在地方法院階段，地方法院指示陪審團，只要從專利說明書找到"專利申請時"發明相關領域技術水平得到超越習知抗原的產生方法，即滿足「newly characterized antigen」測試，符合相關領域的說明書撰寫要求。
"...the district court instructed the jury, over Appellants’ objection, that written description can be
satisfied “by the disclosure of a newly-characterized antigen . . . if you find that the level of skill and
knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine.”"
CAFC法官也承認，即便知道這樣的測試條件，卻也難以判斷說明書哪些語句包括「newly characterized antigen」，以及哪些段落對應到發明的相關功能。
"We cannot say that this particular context, involving a “newly characterized antigen” and a functional genus claim to corresponding antibodies, is one in which the underlying science establishes that a finding of “make and use” (routine or conventional production) actually does equate to the required description of the claimed products."
也就是說，這個「newly characterized antigen」測試是難以實做，就回歸112規定與一般性判斷。這個CAFC態度就讓本案發回地院重審。
"The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law’s other requirements are met, one obtains a patent.”"
其他參考：
https://www.finnegan.com/en/insights/federal-circuit-considers-the-newly-characterized-antibody-test.html
Ron
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