3.1 美國
3.1.2 Schering Corporation v. Geneva Pharmaceuticals Inc
美國法院在其後的 Schering Corporation v. Geneva Pharmaceuticals Inc.案124，則透 過「實質隱含理論」（inherent anticipation doctrine）來處理販賣、使用原始藥物是否 構成侵 害活性 代謝 物 專利的 問題。 在該 案 中原告 Schering Corp. 擁有 美國專利 4,282,233(簡稱’233 號專利)和 4,659,716(簡稱’716 號專利)號專利。’233 號專利包含抗
119a “...if as MMD suggests the term“compound” refers to impure TAM created in the body by metabolism, claim 10 could be construed as the removal of impure TAM from human bodies to then be combined pharmaceutically with a synthetic, or pure, carrier, which as a practical matter the Court finds to be a tenuous assertion leading to an absurd result.”
120 Id. at 1054.
121 Id. at 1055-56.
121a “When it canceled claim 2 in response to the examiner's rejection of it as identical to claim 1, MMD necessarily adopted the examiner's interpretation of “compound” as limited to that formed by synthetic means.”
122 Id. at 1055-57.
123 Marion Merrell Dow Inc. v. Baker Norton Pharmaceuticals Inc., 152 F.3d 941 (Fed. Cir. 1998).
124 Schering Corp. v. Geneva Pharmaceuticals Inc., 339 F.3d 1373 (Fir. Cir. 2003).
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組織胺(antihistamine)化合物 loratadine 的請求項，又該化合物可用於抑制過敏反應且 無嗜睡副作用。Schering Corp.則以 loratadine 為活性成分上市品牌名為 CLARITIN®
的原廠藥。’716 號專利則包括 loratadine 的活性代謝物 DCL (descarboethoxyloratadine) 的請求項，DCL 亦為不嗜睡的抗組織胺化合物。’716 號專利直至 2004 年 4 月才到期，
然而’233 號專利則於 2003 年即已到期。在’233 號專利到期後許多藥廠皆欲製造、販 賣 loratadine 之學名藥，依規定該等藥廠皆需取得 FDA 的上市許可。由於 Schering Corp.
在橘皮書中，亦將’716 號專利列為申請上市 loratadine 學名藥可能侵害的專利之一，
因而學名藥廠於提出上市許可申請時便主張’716 號專利無效。Schering Corp.得知後則 對 Geneva 等多家學名藥廠提出侵權訴訟125。
一審法院在請求項範圍解釋時，判定系爭專利請求項的 DCL 係含括「代謝生成」
和「體外合成」，雙方當事人亦皆同意法院為如是解釋。一審法院指出在’233 號專利 中並未明示揭露 DCL，亦未提及 loratadine 的代謝產物。然而依照’233 號專利所揭露 之使用 loratadine 方法，必然會產出 DCL。在上述請求項範圍解釋的適用下，一審法 院判定’716 號專利之 DCL 請求項已「實質隱含」於’233 號專利中，因而該請求項喪 失新穎性，無效，被告學名藥廠並未侵權126。
Schering Corp.其後上訴至 CAFC，二審法院則作出與原審相同判決。 二 審 法 院 表示當單一前案已揭露系爭發明所有技術特徵時，該發明即因喪失新穎性而使專利無 效。此外，即便單一前案欠缺揭露系爭發明的某一技術特徵，但此被遺漏之要件必然 存在或實質隱含在該前案中，則系爭發明仍喪失新穎性 126a。二審法院更指出根據先 前案例，「實質隱含理論」的適用並未要求該領域具通常知識者必須認知其被遺漏要 件實質隱含於前案中，故只要系爭發明未被揭露之技術特徵必然存在或實質隱含在單 一前案中，即便該領域具通常知識者無法認知其被遺漏要件，仍構成「實質隱含理論」
的適用，系爭發明不具新穎性126b。
法院進一步解釋，在先前的 Continental Can127案中，判決理由並非要求該領域具 通常知識者必須可由單一前案中認知到所遺漏要件，始成立「實質隱含理論」。該判
125 Id. at 1375-76 .
126 Id. at 1374,1376.
126a “Moreover, a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.”
126b “Other precedents of this court have held that inherent anticipation does not require that a person of ordinary skill in the art at the time would have recognized the inherent disclosure.”
127 Continental Can Co. v. Monsanto Co., 948 F.2d 1264 ( Fed. Cir. 1991).
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決僅說明法院可透過對該領域具通常知識者的諮詢，以釐清前案所揭露內容，其包含 隱含揭露的技術特徵在內。由於該判決僅要求法院透過該領域具通常知識者之意見以 決定前案的揭露內容，未如原告 Schering Corp.所主張將「該領域具通常知識者對被 遺漏要件有所認知」納入適用「實質隱含理論」的必要條件 127a，因而即便該領域具 通常知識者當時並未認知到’233 號專利實質隱含 DCL 化合物，該化合物仍得適用「實 質隱含理論」，因而喪失新穎性128。
CAFC 更指出本案的狀況與意外喪失新穎性(accidental anticipation)的案例不盡相 同129，因為 DCL 並非在意外或不尋常的情況下產出。研究資料顯示在一般情形下服 用 loratadine 無可避免的會產出 DCL，即 DCL 的生成是病患服用 loratadine 的必然結 果130。法院表示本案與過去審理過的「實質隱含理論」案件或有不同，因過往個案中 proposition that inherency, like anticipation itself, requires a determination of the meaning of the prior art. Thus, a court may consult artisans of ordinary skill to ascertain their understanding about subject matter disclosed by the prior art, including features inherent in the prior art.”
128 Schering Corp. 339 F.3d at 1377-78.
129 相關案例參見 Eibel Process Co. v. Minn. & Ontario Paper Co., 261 U.S. 45 (1923); Tilghman v. Proctor, 102 U.S.
707 (1880).
130 Schering Corp. 339 F.3d at 1378.
130a “In these prior cases, however, inherency was only necessary to supply a single missing limitation that was not expressly disclosed in the prior art. This case, as explained before, asks this court to find anticipation when the entire structure of the claimed subject matter is inherent in the prior art.”
130b Because inherency places subject matter in the public domain as well as an express disclosure, the inherent disclosure of the entire claimed subject matter anticipates as well as inherent disclosure of a single feature of the claimed subject matter.” “In general, a limitation or the entire invention is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art.”
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loratadine 將可能侵害’716 號專利關於 DCL 化合物的請求項，又科學資料顯示服用 loratadine 必然會代謝生成 DCL 化合物。綜合以上本案應當適用「實質隱含理論」，’233 loratadine 即可於人體內生成 DCL，因而法院認定’233 號專利已揭露可使該領域具通 常知識者「據以實施」製造 DCL 的方法132。綜合上述，CAFC 判定 DCL 化合物已實 質隱含於前案’233 號專利中，喪失新穎性，’716 號專利相關之請求項無效，學名藥廠 不構成侵權133。而本案亦於原告 Schering Corp.提出全院聯席審理(Rehearing en banc) 遭拒後，宣告確定134。 Corporation v. Geneva Pharmaceuticals Inc.案件中，可能因雙方當事人對於「化合物」
的字義解釋並無爭議，因而法院並未透過請求項範圍解釋的方式來解決侵權問題，反 以「實質隱含理論」作為論證重點。這樣的理論操作究竟是否恰當，引發學說與實務 的一片討論之聲135。值得注意的是在該案判決後，活性代謝物的「化合物本身」欲取
131 Id. at 1378-80.
131a “To qualify as an enabled reference, the '233 patent need not describe how to make DCL in its isolated form. The '233 patent need only describe how to make DCL in any form encompassed by a compound claim covering DCL...”
132 Id. at 1381. “The '233 patent discloses administering loratadine to a patient. A person of ordinary skill in the art could practice the '233 patent without undue experimentation.”
133 Id. at 1382.
134 Schering Corp. v. Geneva Pharmaceuticals Inc., 348 F.3d 992 (Fir. Cir. 2003).
135 Id. at 993-96; H. Sam Frost, The Unique Problem of Inventions Which Are Fully Enabled and Fully Described, but Not Fully Understood, 20 IPJ-CAN 369 (2007); Ben Herbert, When Nature's Anticipation Inherently Prevents Your Discovery: A New Look at An Over Looked Requirement of Patentability and Its Impact on Inherent Anticipation, 50 JURIMETRICS J. 111 (2009).