《Leahy-Smith美國發明法》（Leahy-Smith America Invents Act，簡稱AIA）的最後一部分於2013年3月16日生效實施後，美國專利法即開始產生巨大變動，且將會影響所有在美國新申請的專利。歷經AIA法案而沒有修改的部分，值得注意的就是專利法Section 101（註1）。

但依據最高法院針對Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo)案件所作的判決的結果來看，這部份保持原樣是不幸圴。該案中，被告Mayo在案件中被原告Prometheus控訴其有2項專利(6,355,623 及 6,680,302) 之侵權行為。而此2項專利與如何正確調劑硫代嘌呤代謝物 (thiopurine)等新陳代謝藥物，以適當使用在不同病人身上，使其產生所需的作用有關，用來治療自我免疫功能疾病，像克隆氏病（Crohn's disease）及潰瘍性的結腸炎（ulcerative colitis）等。如果所用的劑量過重，便會有嚴重的副作用（毒性），但如果劑量過低則起不了什麼治療作用。當這2個專利被送件申請時，大家都已經知道這些藥物的代謝物是什麼；最重要的是6-硫代鳥嘌呤 (6-thioguanin, 6-TG)；但大家都不知道這些代謝物濃度與藥物劑量的「正確」『關聯性』為何。

該專利是個方法專利，其請求項指出了使該等藥物用在醫療時發生效力的代謝物門檻水平，並利用該門檻水平去測定所需藥物的劑量。Prometheus則是這專利的專屬被授權人，並在市場上銷售含有該專利處理程序的診斷試劑。　

在歷經長時間不同層級法院的審理後，美國最高法院同意聆聽本案件並決定：(1) 一項新發現的自然法則並不可被專利，及(2) 若其應用方式純粹依賴已知技藝中的元素，則該新發現的自然法則的應用方式通常也不可給予專利。美國最高法院認定該方法專利之專利範圍（請求項）是「將撰寫的重點放在意圖壟斷自然生成代謝物及治療功效及毒性之間的『關聯性』，而這就是自然法則」，而符合專利適格性之請求項則一定要包含至少一個超越自然法則本身的「獨創性概念」。此外，美國最高法院也表示，該請求項內之「投予(藥物)」（administering）、「測定」（determining）及「在於」（wherein）等人為步驟，其並非自然定律，但它們仍不足以轉變請求項的本質，即認定其為自然法則。

美國最高法院並不接受Prometheus於本案採用機械或轉換測試法(Machine-or- Transformation Test，來自同院之2010年Bilsky案判例)，來克服其為「自然法則」而不被准予專利的論點。

他們更進一步拒絕接受美國政府（專利主管機關）認為專利法Section 101應該以限縮的方式來解讀（就是說只要不是單純自然法則的陳述，即能符合專利適格性），及仰賴專利法的其他面向來篩選出真正的發明之相關政策決定。而這實際上正是歐洲專利實務的慣例，也就是說，這些發明在技術上的貢獻會以其據以實施性，及其新穎性／創新步驟等技術特徵來衡量。這種情況的一個很好例子是T836/01決議，其針對某些特定的類似臨床醫療情況，承認使用「已知」治療藥劑的非顯而易見性，因為其在該等病症之臨床治療時，具有顯著的療效。而G2/08則允許撰寫「次要」醫學用途的用途請求項，其唯一的新功能是它將其為科技領域所帶來的貢獻實施於新的投予藥物的法則。但最高法院駁回此決定的理由是因為這將會與過去的法律規定無法銜接。

美國政府之所以提出這個專利政策上的爭議，是因為目前的決定使得許多在診斷、個人化用藥、及藥物基因學領域的技術貢獻很難「被掌握」在一個專利中（撰寫成請求項），而會像Mayo案例中，因為最高法院對於Section 101的解釋而變成無效，特別是如果最高法院繼續斥責這些技術貢獻「只不過是撰寫的功夫」而已。為了回應以上的政策爭點，最高法院已避免以政策的高度去決定個案的結果並形成判決先例，而鼓勵國會去制訂更完善的法律規範好讓法院遵從。目前這個經濟性決定的影響尚未明顯浮現，但已很清楚知道在生物科技的領域，像產業貿易團體BIO及其他具影響力的生物科技公司，對於最高法院這個Mayo決定的結果並不滿意。

目前專利撰稿人還有一線希望，就是法院可以認清在專利法Section 101下，去評估一個處理過程的特定步驟等可專利性，極有可能會與Section 102的規範重疊（可能是103及112）。因此很明顯的，專利代理人未來將需要在撰寫專利項時強調其應用自然法則之「新穎性」及「非顯而易見性」等面向，而且要注意在撰寫請求項時保護範圍不要太廣，以避免「壟斷自然法則本身」。

對照最高法院將Section 101應用在此Mayo案治療方法請求項的反直覺及有趣之態度，對於他們即將判決分子病理協會與Myriad Genetics公司兩造間關於「基因本身」可專利與否問題的案子結果如何，將會顯得十分有趣；這案子牽涉錯縱複雜的生物科技可專利性問題，將對整個生技產業的發展產生重要的影響。

註１. 美國專利法第101條規定：「任何人發明或發現任何新穎而實用的步驟、機器、製品、物的組合或以上各項新穎而實用的改良，符合專利法之基本要件時，均可獲准專利。」－ 35 USC § 101 - Inventions patentable：Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

AIA and a missed opportunity
Stefano John    NAIP  Education & Training Group / European Patent Attorney

Big changes are occurring in US patent Law because of the introduction of the final part of the America Invents Act on the 16th March 2013, which will affect all new patent applications in the US. One area which was not amended by the AIA was Section 101.

This is unfortunate in the light of the Supreme Court judgement given in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo). Mayo dealt with two US patents (6,355,623 and 6,680,302), which deal with finding the appropriate use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn's disease and ulcerative colitis as the drug is metabolized differently by different patients. If the dose is too high, there are too many side effects, and if the dose is too low, the drug doesn't work. When the patents were filed, the metabolites of these drugs were known, (most importantly 6-thioguanine) but the precise correlation between these levels was not known.

The Supreme Court rejected Prometheus' argument that the machine or transformation test (from the 2010 Bilsky decision) applied to this case and overcame the "law of nature" exclusion.

The patent claims were directed to processes which used that correlated level to determine dosage and apply it in treatment methods. Prometheus is the sole and exclusive licensee of the patents-at-issue and has been selling diagnostic tests that embody the claimed processes.

After a long passage through the various courts, the Supreme Court agreed to hear the case and decided that (1) a newly discovered law of nature is itself unpatentable and (2) the application of that newly discovered law is also normally unpatentable if the application merely relies upon elements already known in the art." They found the method claims to be "drafting efforts designed to monopolize the correlations between the naturally-produced metabolites and therapeutic efficacy and toxicity which are natural law" and that patent-eligible claims must include an "inventive concept" that goes beyond the natural law itself. It was also stated that "administering", "determining", and "wherein" steps were not themselves natural laws but that they were not sufficient to transform the nature of the claim.

They further rejected the policy argument set forth by the US Govt. that Section 101 should be read in a limited fashion (i.e. allowing anything as patent eligible that was not a mere statement of a natural law) and relying on other aspects of patent law to sort out true inventions from others. This is in effect what happens in European Practice, where the technical contribution of these type of inventions are measured under enablement and novelty/inventive step provisions. An example of this type of situation was decision T836/01 which recognized the non-obviousness of treating known medicaments for certain similar clinical conditions because of the noticeable contribution in the clinical situation. G2/08 allowed a 2^nd medical use claim, whose only new feature was the administration regime because of the contribution it brought to the technical field. The reason given by the Supreme Court for this rejection was that it would be inconsistent with past precedent law.

The US Govt. set forth this policy argument because the present decision renders many technical contributions in the diagnostic, personalized medicine and pharmacongenomic fields difficult to "capture" in a patent that could not be rendered invalid under the Section 101 bar as set in Mayo, particularly if the Supreme Court decries such actions as "mere drafting efforts". In reply to the above policy point, the Court declined to decide the case's outcome for policy reasons and encouraged Congress to craft better rules for them to apply instead. The economic decision of the impact is not clearly seen yet, but it is clear that the biotechnology sector, as represented by the industry trade group BIO and other influential biotechnology characters, did not appreciate the outcome of the decision.

One ray of hope for a patent drafter was that the Court recognized that the evaluation of specific steps in a given process under Section 101 may overlap with Section 102 (and presumably 103 and 112). It is clear therefore that patent attorneys in the future will need to draft claims to highlight the novel and nonobvious aspect that is applied to the law of nature and take heed to draft a claim is not overly broad so as to "monopolize the law of nature itself".

Facebook 按讚馬上加入北美智權報粉絲團