生物科技領域的專利權保護有部分取決於專屬該技術領域之法律。這些專屬生技領域的法律應該包括一些不言自明的道德原則（obvious moral principles)，且僅於不同的專利制度之間略有變化，而其理由也相當明顯，並不必贅言。這些道德觀念的例子涉及「保護人類」、「獲得醫藥和食品」、以及較為複雜的生命倫理學概念，例如「複製」(cloning)和「農民留種權」(breeder's rights)等。

生物科技須有特殊法律規定的另一個原因是因為涉及生命學科的本質。自然(nature)產生了許多奇妙又複雜且高效率的系統用以轉譯"信息"(information)（包含，但不限於，DNA的編碼(coding)）到"行動"(action)（透過化學結構調節，如蛋白質與類固醇）和"活體"(thing)（基本上包括生物組織與生物體，可為具有特定性質之簡單蛋白質到能構成整個動物的生物體）。生物技術專利的特殊問題在於這些轉譯系統有很多都已經被充分了解，而且可以重製。所以，儘管實現"行動"與"活體"的成本和工夫都相當龐大，但其背後的理論其實十分簡單，而這就是生物技術專利眾多問題的根源。

最近的一個關於可否將一個新蛋白質的單株抗體申請專利的判決，就是其中的一個好例子 (Eli Lilly and Co v Human Genome Sciences [2012] EWCA CIV1185)。該人類基因體科學公司（Human Genome Sciences, 下簡稱HGS）為一個藉由解碼人類基因體密碼，用理論推導找到新蛋白質，並藉此提出許多專利申請的公司之一。HGS公司擁有一篇專利，乃基於其發現一種蛋白質，此蛋白質涉及許多不同的用以控制免疫系統的信號傳遞機制。因此，對其進行修飾或產生其生物等效物(biological equivalent)，都有可能對免疫系統產生重要的影響。而其中一種修飾目標蛋白質的方式為將單株抗體與目標蛋白質結合。

因此，當HGS發現該蛋白質以及提出專利申請時，單株抗體可用於治療自體免疫疾病之商業相關性就已經很明確了。而且，生產能與目標蛋白質結合之單株抗體的技術，已被充分理解且可輕易應用於大多數蛋白質。但須特別注意的是，該專利雖然充分描述應該如何產生這樣的單株抗體，卻沒有提供曾經如此生產專一性結合至該目標蛋白質之單株抗體的實施例（編註：實驗數據）。

這案例的爭點圍繞在該單株抗體之申請專利範圍的有效性上。它造爭論說，HGS從來沒有生產過任何此類單株抗體（至少在申請專利時HGS尚未生產過，使該實施時點成為爭點）也未曾做出任何要如此作的努力，但其申請專利範圍卻包含與該單純發現之蛋白質結合的「所有」抗體。因其使用方法未經證明(根據英國法律規定，此為「缺乏工業應用」)，且並沒有充分揭露（依據英國/ EPO法律規定，此為「未可據以實施地揭露」），該抗體以及該抗體之醫藥組合物的專利範圍，就被它造申訴主張應皆被認定為無效。惟英國法庭注意到EPO的判決先例（T18/09決定），該決定表示若使用一般慣用之方法即可識別和產生這種抗體，該申請專利範圍應為已經「可據以實施地揭露」（enablingly disclosed）。

英國法院隨之做出判決，認為該與目標蛋白質結合之抗體之申請專利範圍，不但已經充分揭露以至可獲得專利權的保護，且該抗體也具有工業應用性。但英國法院並不同意含有該抗體的醫藥組合物之申請專利範圍亦為有效地揭露，而認其無效。究其原因為，在該專利申請時，其仍需要進行進一步的研究以尋找特定抗體的醫​​藥價值與其配方（編註：仍須大量實驗，而非可據以實施的揭露），且該抗體的醫藥組合物價值與配方之研究結果被適當揭露時，其自身應可獲得專利權的保護。

此判決對於熟習專利法規的人來說，似乎會很奇怪，因為其似乎表示：一個被有效宣告的產品技術特徵，在同一專利的附屬項宣告中使用，竟會不是有效的宣告。其中的難處，在於使專利法規能夠適用於生物技術專利。但是吾人應當更注意的是，該判決其實是鼓勵大家對於生物技術取得專利，因為其認為對於更上游的研究發現活動（編註：蛋白質與抗體）和更實際的下游應用產品（編註：抗體之醫藥組合物），都以給予專利來獎勵。

延伸閱讀：
孟山都案件的判決首次顯示 歐洲法院對基因序列專利範圍的侵權判定原則
基因改良專利 vs. 專利耗盡原則

Biotechnology and patenting – why so many special rules?
Stefano John    NAIP  Education & Training Group / European Patent Attorney

The protecting of patent rights in the biotechnology disciplines is, in part, determined by laws quite specific to its discipline. These specific laws include ones based on obvious moral principles which vary only slightly across the different patent systems and the reason for them seem obvious enough. Examples of these moral concepts involve the protection of human beings, access to medicine and food and other more complex bioethical concepts such as cloning and breeder’s rights.

The other reason for having specific laws relates to the nature of the discipline. Nature has produced many wonderfully complicated and efficient systems to translate "information" (generally, but not only, DNA coding) into "action" (mediated by chemical structures such as proteins and steroids) and "things" (basically biological tissues and organisms from simple proteins having specific properties to entire animal organisms with specific properties). The issue special to biotechnology is that many of these systems of translation are already known and reproducible. The cost and effort involved in achieving the "action" or "thing" can be considerable, but the theory behind it can be simple enough. Therein lies the problem for many biotechnology patents.

One such example was the recent decision regarding the claiming of monoclonal antibodies on new proteins in Eli Lilly and Co v Human Genome Sciences, [2012] EWCA Civ 1185. Human Genome Sciences (HGS) was one of the companies that filed many patents on proteins they could in theory discern from the decoding of the human genome. HGS held a patent which was based on the discovery of a protein which was involved in many different signalling mechanisms to control the immune system. As a result, modification of the presence, or a biological equivalent thereof, could have important effects on the immune system. One such way to modify the target protein is through monoclonal antibodies which bind to the target protein.

Therefore the commercial relevance of monoclonal antibodies for therapeutic uses in autoimmune diseases was clear at the time of discovery of the original protein by HGS and the filing of their patent. The technology to produce monoclonal antibodies that bind the target protein was also well understood and easily applicable to most proteins. It is important to note that the patent gave sufficient description on how to then produce such a monoclonal antibody, yet gave no example of ever having produced one.

The case revolved around the validity of the claims to such monoclonal antibodies. It was argued that HGS had never produced any such monoclonal antibody (at least not at the time of filing the patent which when it mattered) or made any effort to do so and yet claimed all antibodies that bound the protein by having simply discovered the protein. The claim to the antibody and to the antibody in a pharmaceutical composition were allegedly both invalid as their use had not been proven (lacking industrial application under UK Law) and not been sufficiently well disclosed (not an enabling disclosure under UK/EPO Law). The UK court noted that the EPO precedent (decision T18/09) which stated that mere routine measures can be used to identify and produce such antibodies, and hence that the claim is enablingly disclosed.

The UK court decided that the claim to antibodies that bind the target protein was both disclosed in a manner sufficient to earn a patent right and that the antibody would be of industrial application. It did not however agree that the claims to pharmaceutical compositions which have such antibodies were also validly disclosed. The reasoning was that the effort to find the specific antibody that is of pharmaceutical value and its formulation were further research projects worthy of their own patent right when properly disclosed.

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