美國最高法院於2013年6月13日對於AMP v. Myriad案（下稱Myriad案）發佈一個全體一致決的判決：基於美國專利法USC§101條的規定，單離的DNA並不具專利適格，而不受專利權的保護。但須注意，於某些情況下cDNA(體外的DNA複製品)仍具專利適格，因為cDNA是人造的。

這是個令人震驚的判決，也具有重要的衍生影響。第一點要注意的是，這Myriad案判決推翻了美國專利商標局 (USPTO) 多年的專利實務，且美國已核准及公告了許多涉及單離的DNA序列之專利。世界上其他國家也使用類似的實務運作，例如歐洲通常慣行的專利實務做法是允許(1)單離，且(2)具有功能的DNA申請專利。而DNA序列專利須具備此二要件之理由，是當具有巨大商業利益的人類基因定序列工程開始於千禧年時，可避免投機性專利來壟斷人類的基因組(human genome)。直到現在，美USPTO的實務作法亦類似，即允許分離的DNA序列受專利保護。且為滿足美國專利法USC§112條的要求(如美國最高法院對Fisher案之判決所示)，當專利請求項被核准時，必須揭露該DNA序列的功能。於是一般人皆相信，美國最高法院將判決繼續允許單離的DNA申請專利。他們更因現在單離DNA被判決不准專利而感到詫異。

該判決與USPTO原實務作法分歧的主要原因，是美國最高法院視DNA序列為「資訊」，而不是化學的化合物。儘管DNA的化學結構僅由其所帶的鹼基(base)序列信息所定義（而其化學組成皆相同），但照通常的專利實務做法，仍將DNA序列視為化學化合物，並撰寫專利說明書和授予其專利。雖然如此實務作法反映了自然界是如何使用DNA的，但美國最高法院並不同意此作法，並作出結論認為：DNA的用途是透過其鹼基序列而傳遞資訊，因此應屬資訊。而這從自然界單離的資訊，仍由自然所構成，因此並不具備專利適格性。

這解答立即引起更多的問題，第1個問題是：如果DNA序列只傳遞信息，為什麼人造​​cDNA是被允許專利呢?法院給出的理由是：cDNA可被專利保護，是因為他們缺乏基因組DNA之內含子(intron)。這理由似乎非常武斷且僅適用於某些特定情況（假設某基因組DNA不包括內含子的話 － 該cDNA也就不能得到專利保護）。

第2個問題是：對於那些已撰寫完畢並授證的涉及DNA序列之專利，其主要專利請求項仍是將單離的DNA序列視為化學結構，則其又將被如何處理？若主要的獨立專利請求項已經被認為無效，則在同一發明概念下的其他專利請求項，也將失去依託而無效，若其辯稱其他請求項與主要獨立項並不屬同一發明概念，則如此的專利即為非單一發明，違反美國專利法USC§112條的規定，將成為眾箭之矢。

第3個問題是：如何撰寫生物技術專利？世界上其他地區的工程師仍維持原來作法，視單離的DNA序列為化學化合物，並據此撰寫各國專利申請案。他們應如何管理因這判決對於撰寫美國專利申請案所造成的差異？專利的審查基準應該由USPTO來發布，而USPTO也已經依據該判決頒布了一個初步的審查基準，要求審查員核駁單離的DNA專利申請案；這是因為USPTO受美國最高法院判決約束的緣故。然而，還不清楚USPTO計劃如何處理這些世界其他國家認為應可核准，但美國最高法院已經判決不允許核准的專利申請案。世界各地的生物科技專利律師都很感興趣的等待著USPTO官方對於此事所發布的正式審查基準。

第4個問題是：這致使物品專利請求項無效之自然標的物專利不適格，能貫徹到何地步？例如前述情況之一的生物技術診斷專利，鑑於該判決的結論，可能會失去一些涉及DNA序列的部分專利請求項，但基於同一判決，仍允許具有高度商業價值的方法專利請求項可繼續受到專利保護，因而仍保障促使其進行進一步研究的商業誘因的安全。但是，由自然界產物所衍生的新化合物，又將被如何對待呢？吾人或許會這樣主張：欲保護這樣的產品／發現的主要方法，即是保護它的化學結構以及它的用途。讓我們以奈米技術或藥物產品為例，他們很像DNA，其結構與用途有著緊密的相關，可能就有資訊的傳遞；但這是否意味著，僅因為在被單離之前，它們即已存在於自然界，而依據USC§101條的規定，該產品就不能被專利保護呢？USPTO似乎不大可能把這原則貫徹到如此境地。但令人驚訝的是，美國最高法院的判決並未設定任何的限制，說該USC§101條規定僅適用於DNA。

另一個須思考的議題是，此判決與近期美國案例Mayo v. Prometheus (下稱Mayo案)之間的關係（編註：如前文《醫療診斷技術的可專利性爭議》所述）。Mayo案是關於一個基於某些使病患對於藥物治療感受性增加或減少的特定DNA序列存在與否之診斷與治療方法。美國最高法院於該Mayo案判決，依據USC§101，認為僅以該發現此些特定DNA序列之創新方法為專利請求項標的物，並不具專利適格性而不能被授予專利。有人會根據美國最高法院Mayo案判決與此Myriad案的結論而推論：生物技術產業可能會開始擔心，至少在美國，以專利來保護以DNA為基礎的發明的可能性是很小的。

這種擔憂可能是正確的，但還為時過早。畢竟，抑制美國以及世界其他國家之生物技術相關發明動機，特別是利用專利的排他性上，並不是USPTO所感興趣的。筆者認為比較明智的做法是等待USPTO發佈正式的審查基準，來告訴大家，什麼可允許專利，什麼則不允許專利。

極有可能的是，USPTO會發佈審查基準，允許發明者和專利律師自我規範並找出新的方式來保護以DNA為基礎的發明。同時，筆者認為比較聰明的做法是依據上述判決結論，來檢視你近期的生物技術專利組合。很顯然地，無論其最終結果為何，上述判決代表著一個生物技術專利實務上之顯著變化。

註：對於本Myriad判決的解讀是，在自然界中即已存在的基因序列，即使被分離，也是不可申請專利的。美國最高法院於此案判決，重申「自然法則、自然現象和抽象概念」都不能申請專利，因為這些於自然界中即存在的基因序列，僅僅將其分離，是發現，並非發明，並不能申請專利。但是，美國最高法院於同案判決也認為，那些經過重組、轉殖等「人為改造」而具有特定功能之基因序列，例如cDNA，其為自然DNA於體外的人為複製品，仍然可以申請專利。另，純化的自然物，仍為自然物，並不能申請專利，但其純化的方法，當然具有專利適格性。同理，單離的自然DNA，仍為自然DNA，並不能申請專利，但其單離的方法或單離後使用的方法，仍具有可專利性。　－　陳宜誠律師

Association for Molecular Pathology v. Myriad (2013) – The isolated DNA is not patentable
Stefano John    NAIP  Education & Training Group / European Patent Attorney

The US Supreme Court issued on 13th June 2013, in a unanimous opinion, that isolated DNA is not protectable by patent rights because they are not patent eligible subject matter under USC§101 . There was a caveat – cDNA (an “in vitro copy of DNA”) can, in certain circumstances, be protectable as it is man made.

This is a striking decision with important ramifications. The first aspect to notice is that this decision goes against USPTO’s practice for many years, which was to issue patents in the US on isolated DNA sequences. The rest of the world has also used a similar system – for example in Europe, it has been common practice to allow claims to DNA sequences if i) they are isolated and ii) there is a function associated with it. The reason for having the two requirements associated with the DNA sequence was to prevent speculative patent monopolization of the human genome when it was being sequenced at the start of the Millennium by large commercial interests. In the US, the USPTO’s practice has been similar up to now – to allow for isolated DNA sequences. The functionality of the DNA sequences was also required as the claims granted still needed to satisfy USC§112 (eg. See Fisher decision by US Supreme Court). It was thus believed that the US Supreme Court would allow claims to isolated DNA sequences and hence it was a surprise that they were not allowed.

The main reason for this result diverging from USPTO practice is that the US Supreme Court treated DNA sequences as information instead of chemical compounds. It has been common practice to draft and grant patents where DNA sequences are treated as chemical compounds – albeit the chemical structure of the sequences being defined only by the information of the sequences of DNA bases (the chemistry being the same). This approach reflects Nature’s use of DNA. The US Supreme Court disagreed with this practice and concluded that the purpose of DNA is to simply impart information through their sequence of bases and thus is information. This is information which is isolated from Nature, but constructed by Nature and thus not patent eligible.

This immediately raises more questions than answers – if DNA sequences impart only information, why would man-made cDNA be allowable? The reason given by the court is that cDNA is protectable only because they lack the introns to genomic DNA. This seems very arbitrary and applicable in some cases (i.e. what happens if genomic DNA does not have introns – no patent protection through cDNA)

The second question is what happens to all the patents that have been drafted and granted involving DNA sequences, where the main claim is directed to isolated DNA sequences as chemical structures? If the main independent claim is now rendered invalid, the unifying concept of the different claims granted is no longer there and the patents can become prone to attacks of being multiple inventions under USC§112.

The third question is how to draft a biotech patent? The rest of the world maintains the old practice of treating isolated DNA sequences as chemical compounds and drafting applications according to this practice. How should they manage for the difference now created in the US by this decision? Guidance should come from the USPTO. The USPTO has issued only a preliminary guidance reflecting the Court’s decision on not allowing claims to isolated DNA. This is because the USPTO is bound by the decision of the US Supreme Court. It is however unclear yet how the USPTO plan to allow patents that the rest of the world feels are allowable and that the above decision does not allow them to grant. Practicing biotech attorneys across the world await the official USPTO guidelines on the matter with much interest.

The fourth question is how far can the natural subject matter objection be taken to invalidate product claims? Biotechnology diagnosis patents, such as the one in the above case, that involve DNA sequences may lose some of the claims in light of the above decision, but the method claims which allow their use to be commercially significant remain protected by the decision and thus the commercial incentive for their further research is safe. But what about a new chemical product which is derived from Nature? It could be argued that the main way of protecting such a product/discovery would be to protect its chemical structure as well as its uses. Let us cite nanotechnological or pharmacological products for example. It could be argued that, like DNA, their structure is tied to their use, possibly to impart information. Does this mean that the product is not protectable under USC§101 because it was available in Nature before being isolated? It seems unlikely that the USPTO would go so far, but it is striking that the decision of the US Supreme Court does not set any limits on the applicability of USC§101 to DNA only.

Another issue to consider is the relationship of this decision to the recent US case in Mayo v. Prometheus. Mayo involved a method of diagnosis and treatment which was based on the presence of certain DNA sequences which meant patients were less or more susceptible to medication. The US Supreme Court determined that the only innovative and new part of the method being claimed involved the discovery of these DNA sequences and this was also not patentable subject matter under USC§101. If one then adds that conclusion to the conclusion from this decision, the Biotechnology sector may start worrying that there is little possibility of protecting their DNA based inventions with patents, at least in the US.

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