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指 示 出 有 限 數 量 之 可 資 解 決 方 法(finite number of identified, predictable solutions)594，皆屬判斷考量之重點。
再者，於 KSR Int'l Co. v. Teleflex Inc.一案，亦因應巡迴上訴法院 的裁判僵化，而針對法律擬制之所屬技術通常技藝者此判斷標準，闡 釋此PHOSITA 本身亦應具備一定程度之創造力(ordinary creativity)，
某程度上提高判斷標準以減卻過分核發專利權之問題595。是以，於進 步性判斷方法的細緻化後，似隱含著此要件得配合不同技術領域和相 關產業的研發和發展現況，以細緻調整對應的PHOSITA 的判斷水準，
進而妥適地發揮專利進步性之政策功能，達到鼓勵技術產業創新發展 之目標596。
(二) 基因專利之進步性的實務見解發展現況
在回顧並分析基因專利的實務法院見解前，應先簡要敘述基因專利本 身的一般性技術貢獻，亦即，多係將存於自然界卻未知生物功能係如何 運行機制予以解構，以得知具體序列內容和其與功能之間的關聯性，或 是針對已知的序列或生物機制尋找探求出對應的下游功能或上游源頭而 言。其中，所需仰賴的最基礎的知識技術背景，實為基因表現的中心法 則(central dogma)的操作和運用，並與先前技術文件所揭示的已知資訊或 周邊技術工具予以累加，始有機會完成相關研發成果。下述將依照法院 於基因專利之進步性判斷上的態度和標準之時間演進，區分為單純著重 合理成功期待之早期、立論轉移至研究方法前案教示作用之中期597，以 及 KSR 案宣判後採取實值判斷的晚近此三個時間的相關判決加以介紹。
1. 單純著重合理成功期待之早期─以 Amgen 案為例
是以，初期法院對於基因專利的進步性認定，實採取嚴格解釋先 前技術的教示作用和其中的因果關係，進而寬認個案進步性之具備而 言。舉例而言，於1991 年的 Amgen, Inc. v. Chugai Pharm. Co.一案中，
Amgen 公 司 將 可 用 於 治 療 貧 血 (anemia) 的 紅 血 球 生 成 素 (Erythropoietin，簡稱 EPO)的基因序列、互補 DNA 和相關蛋白質作 為專利申請之標的，但在向 Chugai 公司侵權訴訟中遭反訴爭執其未 符合進步性等專利要件598。而本案中的先前技術，乃一科學家提供得
discussion of obvious techniques or combinations, and it often may be the case that market demand, rather than scientific literature, will drive design trends. ”
594 Id. at 421.
595 KSR Int'l Co. v. Teleflex Inc., supra note 591, at 421, “A person of ordinary skill is also a person of ordinary creativity, not an automaton.”
596 Burk & Lemley, supra note 211, at 1648-1651.
597 Song Huang, HIGH TECH LAW INSTITUTE PUBLICATION: THE NONOBVIOUSNESS REQUIREMENT FOR BIOTECHNOLOGICAL INVENTIONS - RESOLVING UNCERTAINTY IN FAVOR OF INNOVATION, 21 SANTA CLARA COMPUTER &HIGH TECH.L.J. 597, 598 (2005).
598 Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1202-05 (Fed. Cir. 1991).
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可引發教示作用之概念(conception)600。再者，法院特別釋明基因序列 係屬於一複雜的化學物質類別，且該時的技術水準於實際操作相關研 (chemical compound)之性質，實應將基因序列等比照為化學物質加以 審查。從而，當系爭發明內容與先前技術文件所揭示的物質具有相類 似的化學結構(structurally similar)時，則 PTO 認為此時通常技藝者即 有受到某程度的教示和啟發，並具有明顯誘因致嘗試著手相類似的結 構型的試驗和開發。執此，一旦有化學結構之相似性即應符合表面證 據(prima facie)之要求，而將形式推定為不具顯而易見性之境。倘若 欲推翻此形式推定之效力，專利申請人實有必要提出系爭發明係具有 不可期待之優勢屬性供實質審查，進而達到推翻或超越先前技術之教 示和研發上的因果關係605。
599 Id.at 1205.
600 Id.at 1206, “Conception requires both the idea of the invention's structure and possession of an operative method of making it.”
601 Id.at 1207, “Based on the uncertainties of the method and lack of information concerning the amino acid sequence of the EPO protein, the trial court was correct in concluding that neither party had an adequate conception of the DNA sequence until reduction to practice had been achieved”
602 Id., “We note that both the district court and the parties have focused on the obviousness of a process for making the EPO gene, despite the fact that it is products (genes and host cells) that are claimed in the patent, not processes. We have directed our attention accordingly, and do not consider independently whether the products would have been obvious aside from the alleged obviousness of a method of making them.”
603 Id. at 1208.
604 Id. at 1208-09.
605 Rebecca S. Eisenberg, Business Law Forum: Nonobviousness—The Shape of Things to. Come:
Pharma's Nonobvious Problem, 12 LEWIS &CLARK L.REV. 375, 377-379 (2008); 亦參見於沈宗 倫，如前註586，頁 333-334。
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案之系爭發明實涉及將名為「肝素結合生長因素 Heparin-binding growth factor(簡稱 HBGFs)」之基因，其等係從牛的子宮(bovine uterine) 及人類胎盤(human placental)加以分離和純化，並完成製備相關之互 補基因607。惟，系爭發明人欲以此基因序列提出專利申請時，卻受到 PTO 以未具備進步性所核駁，原因為於此申請案之前有兩個相關前 案，一為揭露類似於本案 HBGFs 之「肝素結合之大腦細胞分裂素 heparin-binding brain mitogens(簡稱 HBBMs)」的功能及部分胺基酸序 列。並且提供此等蛋白質有位於大腦區塊之傾向(brain-specific)，以 及於不同物種間可能存有同源類似特性(homologous); 另一則為揭示 得如何篩選並純化製備分離DNA 和互補 DNA 之方法608。從而，PTO 明人能夠克服其中差異的技術門檻(gap)和困境(deficiency)612。甚至，
606 Eisenberg, supra note 605, at 379.
607 In re Deuel, 51 F.3d 1552 , 1553 (Fed . Cir. 1995).
608 Id.at 1555-1556.
609 Id.at 1556-1557.
610 Id.at 1557-1558., “the appeal raises the important question whether the combination of a prior art reference teaching a method of gene cloning, together with a reference disclosing a partial amino acid sequence of a protein, may render DNA and cDNA molecules encoding the protein prima facie obvious under § 103.”
611 Id.at 1557-1558, 1560, “No particular one of these DNAs can be obvious unless there is something in the prior art to lead to the particular DNA and indicate that it should be prepared.”;
“…only discloses a partial amino acid sequence, and thus it appears that, based on the above analysis, the claimed genus would not have been obvious over this prior art disclosure.”
612 Id., “the prior art does not disclose any relevant cDNA molecules, let alone close relatives of the specific, structurally-defined cDNA molecules of claims 5 and 7 that might render them obvious. Maniatis suggests an allegedly obvious process for trying to isolate cDNA molecules, but that, as we will indicate below, does not fill the gap regarding the subject matter of claims 5 and 7.”;
“The genetic code relationship between proteins and nucleic acids does not overcome the deficiencies of the cited references.”
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(Natural Killer Cell Activation Inducing Ligand，簡稱 NAIL)」之分離基 因序列片段和相對應之互補基因，其中NAIL 蛋白實作為自然殺手細613 Id.at 1559, “A different result might pertain, however, if there were prior art, e.g., a protein of sufficiently small size and simplicity, so that lacking redundancy, each possible DNA would be obvious over the protein… That is not the case here.”
614 Id., “…the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs.”
615 In re Kubin, 561 F.3d 1351, 1352-1353 (Fed. Cir. 2009).
616 Id.at 1354-1355.
617 Id.at 1354, “Valiante teaches that "[t]he DNA and protein sequences for the receptor p38 may be obtained by resort to conventional methodologies known to one of skill in the art." '690 Patent col.7 ll.49-51.”; “Valiante discloses neither the amino acid sequence of p38 recognized by mAb C1.7 nor the polynucleotide sequence that encodes p38. Sambrook, incorporated by reference (as cited above) in Valiante, describes methods for molecular cloning. Sambrook does not discuss how to clone any particular gene, but provides detailed instructions on cloning materials and
techniques.”
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件亦可提供試驗成功可能性之佐證618。甚至，PTO 亦發見本案之發明 人係使用第一個先前技術的抗體本身，並結合第二個先前技術的方法 以完成本案之發明。實而，發明過程本身早已具備合理成功期待，且 組合相關前案之動機亦受到系爭蛋白本身的商業潛力所誘發，難謂有 符合進步性之要求619。
而巡迴上訴法院贊同 PTO 之結論，但其中的論證上實稍有差異。
首先，上訴法院仍認為應針對系爭發明所欲以專利保護之標的，究屬 物品或方法專利，而擇選相對應得作為檢驗是否具備進步性之先前技 術。而當先前技術和系爭發明同屬於物品或方法類別時，本身的顯而 易見性將較容易直接推定。是以，本案中 PTO 似有以相關前案所闡 釋之選殖和製備相關辨識抗體之方法，直接推定系爭發明所揭示的基 因序列不具進步性之表徵，難謂妥當620。惟，鑒於 KSR 案的實質認 定標準的宣示，上訴法院實須依循並探求相關前案與系爭發明之間的 教示作用和因果關係是否具備實質證據基礎(substantial evidence)以 供支持621。其中，雖然系爭發明人爭執認為第一個和第二個前案的累 加，應僅能教示相關發明人關於製備得辨識類於p38 之 NAIL 的抗體 蛋白，卻未有任何指引出如何利用相關細胞株的培養作為製造mRNA 的來源，以進行反轉錄製備互補基因622。然而，法院認為上開教示作 用的斷點實得透過第三個技術文件揭示老鼠之類於NAIL 的 2B4 的基 因序列進行所DNA 分析並交叉比對，即得予以補充和連結進而成立 教示因果關係。固然，法院發見第三個技術文件中似有說明相關技術 套用至人類上的不確定性，惟考其用詞僅稱有「不知原因的難偵測性 (“somewhat conserved”)」，但法院認為此用語並非謂得判定有顯著反 教示之作用，且基於NAIL 本身具有的商業應用潛力，實認相關發明 人仍保有一定程度的嘗試動能623。法院仍有肯定本案發明人等發見未 有任何前案揭示之NAIL 與 CD48 具有交互作用此性質，具有一定之 技術貢獻，但程度並不顯著，且法院認為倘若單純發現其他研發者未 發見之性質，難謂得符合發明之內涵624。最終，法院遵循 KSR 案的 判斷基準，做出本案發明不具進步性之裁決625。
618 Id.at 1355, “The Board viewed Mathew's teachings to be "cumulative to the teachings in Valiante and Sambrook and merely . . . exemplary of how routine skill in the art can be utilized to clone and sequence the cDNA of a similar polypeptide."
619 Id.
620 Id.at 1356.
621 Id.
622 Id., “…appellants' arguments that Valiante and Sambrook are deficient because they do not provide any guidance for the preparation of cell culture that will serve as a useful source of mRNA for the preparation of a cDNA library…”
623 Id.at 1357.
624 Id.at 1357, 1361.
625 Id.at 1360-1361.