第五章 Phillips v. AWH Corp.案未解之議題--解釋申請專利範圍
第四節 其他方案
第四節 其他方案
檢討重新審理解釋申請專利範圍的聲音中，除了改為明顯錯誤的上訴
198 Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 460 f.3d 1349 (Fed. Cir. 2006).
199 See Christian a. Chu, Empirical Analysis of the Federal Circuit’s Claim Construction Trends, 16 Berkeley Tech. L.J. 1075(2001).
審查標準外，亦包含下列幾種方案與其優缺點。
(1)中間上訴(Interlocutory appeal)200：
法源依據為美國聯邦民事訴訟法第 1292(b)條201，規定當具有「不 同 意 見 的 足 夠 主 張 」 (substantial ground for difference of opinion)，對此爭議上訴到上訴審則「可能可以實質上先於下級審法 院的最後判決」(may materially advance the ultimate termination of the litigation)而為決定，此外在最新的專利法修正草案中，也
200 See Kyle J. Fiet, Restoring The Promise of Markman: Interlocutory Patent Appeals Reevaluated Post-Phillips v. AWH Corp., 84 N.C.L. Rev. 1291 (2006).
201 28 U.S.C. 1292(b). (“When a district judge, in making in a civil action an order not otherwise appealable under this section, shall be of the opinion that such order involves a controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance the ultimate termination of the litigation, he shall so state in writing in such order. The Court of Appeals which would have jurisdiction of an appeal of such action may thereupon, in its discretion, permit an appeal to be taken from such order, if application is made to it within ten days after the entry of the order: Provided, however, That application for an appeal hereunder shall not stay proceedings in the district court unless the district judge or the Court of Appeals or a judge thereof shall so order.”)
202 Patent Reform of Act 2007 (S1145). (“Interlocutory Appeals- Subsection (c)(2) of section 1292 of title 28, United States Code, is amended by adding at the end the following: (3) of an appeal from an interlocutory order or decree determining construction of claims in a civil action for patent
infringement under section 271 of title 35.Application for an appeal under paragraph (3) shall be made to the court within 10 days after entry of the order or decree. The district court shall have discretion whether to approve the application and, if so, whether to stay proceedings in the district court during the pendency of such appeal.”)
203 See Gregory J. Wallace, Toward Certainty and Uniformity in Patent Infringement Cases After Festo and Markman: A Proposal for a Specialized Patent Trial Court With a Rule of Greater Deference, 77 S.
Cal. L. Rev. 1383 (2004).
並沒有落差出現204，也就是說無論是否可能較為專業的法院存在，到 了巡迴上訴法院一樣會面臨高推翻率的結果；此外，特別法庭的法官 遴選易非易事，不僅需要具良好的法學素養更要擁有理工知識背景。
(3)Chevron尊重(Chevron Deference)205：
此 方 法 乃 以 行 政 法 (Administrative law) 為 基 礎 ， 源 自 於 Chevronv. Nat＇l Resources Defense council案件206，最高法院在 該案中認為上訴審不應任意推翻行政機關對模糊的條文的解釋，而必 須以合理性(reasonableness)作上訴審查標準，此為基於司法體系對 於行政機關的條文解釋的專業性之尊重，所以專利上訴案件，來自國 際貿易委員會(International Trade commission)以及聯邦地院分別 基於其為正式裁決(formal adjudication)207以及對解釋專利類比於 解釋條文之下，上訴審法院必須給予Chevron尊重；此外該方法更可 配合「當解釋申請專利範圍有多種可能時，應採用最窄之選項原則」
208，此法能促使專利權人在提出專利申請時就基於專利法 112 條等規 定清楚的載明申請專利範圍，若有模糊不清則導致無法計入申請專利 範圍之內的情形，也是應得的懲罰。但是此法的壞處是，從專利局上 訴的案件，因為並非經過「正式裁決」過程，所以無法如同從國際貿 易委員以及地院一致性的來採用Chevron尊重的上訴審理標準，且在 從地院上訴的案件借之以行政法的上訴標準，法理上的差距難以彌 補。
以上三種其他方案，都各自有其考量以及優缺點，但是本文以為，目 前對於地院法官對解釋申請專利範圍的上訴案件，基於法理、司法效率、
與對其他專利法議題，如非顯而易見性、可實施性等有效性的上訴審理標 準一致性考量，仍是明顯錯誤上訴審理標準為較能與現行專利制度運行作 立即性的配合適用。以下將介紹聯邦巡迴上訴法院最新相關判決--Amgen v. HMR 系列案件，此案中各聯邦巡迴上訴法官意見，更加強了明顯錯誤 上訴審理標準實施的必要性以及可能性。
204 See David L. Schwartz, Practice Makes Perfect? An Empirical Study of Claim Construction Reversal Rates in Patent Cases, Michigan Law Review vol.17 (2008).
205 See Tom Chen, Patent Claim Construction: An Appeal for Chevron Deference, forthcoming in 94 Virginia Law Review (2008).
206 Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837(1984).
207 正式裁決在行政法下，應在有公正無私的官員，舉行類似審判形式的口頭聽審，讓雙方得以
提出證據以及交互詰問證人。
208 See r. Polk Wagner, Reconsidering Estoppel: Patent Administration and the Failure of Festo, 151 U.
Pa. L. Rev. 159 (2004).
第五節 討論上訴審理標準最新聯邦巡迴上訴法院案件—Amgen v. HMR 系列案209 Epogen。被告 HMR(與另一被告 Transkaryotic Therapies, Inc., 以下 以 HMR 簡稱)為原告的對手公司，因涉嫌利用 Amgen 公司的 EPO 技術生產 新藥(INDA,Investigational New Drug Application)在 1997 年 4 月被 原告在麻州地院提起確認之訴(Declaratory Judgment)，主張被告侵
209 本系列案地院與上訴審共包含五個案件：Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F.Supp.2d 69(D. Mass. 2001)--AmgenⅠ; Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003)--AmgenⅡ；Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F.Supp.2d 202 (D. Mass.
2004)--AmgenⅢ；Amgen, Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293 (Fed. Cir.
2006)--AmgenⅣ； Amgen Inc., v. Hoechst Marion Roussel, Inc., 469 F.3d 1039 (2006)--AmgenⅤ.
210 Claim 1 of US5955422:
A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.
211 (“therapeutically effective amount” in claim 1 of the '422 patent to require that the claimed EPO increase hematocrit and also be useful in healing or curing the class of patients listed at column 33, lines 22-28 of the specification of the '422 patent:
A therapeutically effective amount is a quantity that produces a result that in and of itself helps to heal or cure. A therapeutically effective amount is one that elicits in vivo biological activity of natural EPO such as those listed in the specification, column 33, lines 24 through 28: stimulation of reticulocyte response, development of ferrokinetic effects (such as plasma iron turnover effects and marrow transit time effects), erythrocyte mass changes, stimulation of hemoglobin C synthesis (see, Eschbach, et al., supra) and, as indicated in Example 10, increasing hematocrit levels in mammals.
Therapeutically effective is to be interpreted as being therapeutically effective with respect to the class of patients listed in the specification, column 33 lines 31 through 36: patients generally requiring blood transfusions and including trauma victims, surgical patients, renal disease patients including dialysis