在案例D'Arcy v Myriad Genetics Inc [2015] HCA 35 (Myriad)中，澳洲高等法院裁決系爭專利claims 1-3並非關於製造/製品（manufacture）的技術，即便專利範圍描述的是產品，但技術實質上是分子核苷酸（nucleotides）中表現的資訊，而此資訊是分子中固有的內容，並非是人為產生的內容，因此不具有可專利性。
案件資訊：
上訴人：YVONNE D'ARCY
被上訴人／專利權人：MYRIAD GENETICS INC & ANOR RESPONDENTS
系爭專利：AU686004
系爭專利的claims 1-3：
1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
（1.一種突變體或多態性BRCA1多勝肽的分離核酸編碼技術，所述核酸與SEQ.ID No:1中所示的BRCA1多肽編碼序列相比，含有選自表中的一或多個突變或多態性，突變可查表12, 12A與14，多態性見表18和19。）
舉例來說，表12如下：
表18：
2. An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a mutant BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No: 1 one or more mutations set forth in Tables 12, 12A and 14.
3. An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a polymorphic BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more polymorphisms set forth in Tables 18 and 19.
---澳洲專利法18(1)：---
Patentable inventions for the purposes of a standard patent
(1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; and
(ii) involves an inventive step; and
(c) is useful; and
(d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee's or nominated person's predecessor in title to the invention.
-----------------------------
定義「核酸」：
每一項請求項都涉及「isolated nucleic acid/分離的核酸」，根據說明書定義，「分離的核酸」包括DNA, RNA，或混和聚合物（mixed polymer），包括天然存在環境中的核酸序列或蛋白質，包括複製的DNA的分離物，以及化學合成的類似物，或通過異質生物合成的物質。並且，看來各方都同意源自人類細胞衍生的核苷酸序列（nucleotide sequence）都可稱核酸。
本案系爭專利涉及「分離核酸編碼技術」，複製人類細胞中原有的核苷酸序列，取得與人類細胞功能等效的序列，即便專利範圍描述的專利標的如一產品（product）。如此，本案例的上訴議題就是上述專利範圍是否符合專利法定義的＂manner of manufacture＂？
在判決前言中提及，立法有其侷限性，因此針對新的技術的公共利益相關議題需要找到各種利益衝突（公眾利益v.發明人權益）的平衡，本案討論源自人類細胞的DNA編碼技術就是此類議題的代表之一，並且因為專利範圍的界線不明，存在可能權利壟斷的疑慮。
定義「manner of manufacture」：
「NRDC / National Research Development Corporation v Commissioner of Patents」法院確立使用已知化學物的未知特性而得出新的目的的用途發明的可專利性。
本案系爭專利涉及的"product"，長久以來的觀念是"product"就是可販售的產品（vendible product），這是有用的判斷，本次法官再進一步定義，具有人為創造的事態，此事態具有經濟意義（economic significance），即構成專利法所設定的「manner of manufacture」。
"a product that consists of an artificially created state of affairs which has economic significance will constitute a 'manner of manufacture'." (emphasis added)
定義「product」:
全院進一步設定所謂「product」，只要是人為創造的事態」即導致經濟有用的結果。
"The Court held that it is sufficient for a product to result in 'an artificially created state of affairs', leading to 'an economically useful result'."
因此，全院認為本案「產品發明 - isolated nucleic acid」包括cDNA，屬於具有經濟效益的人為創造的事態，屬於專利法定義的發明。
"The isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit. The claimed product is properly the subject of letters patent. The claim is to an invention within the meaning of s 18(1) of the Act."
「基因工程」是否排除在可專利標的以外？
以上定義已知如本案系爭專利屬於一種產品發明，具備可專利性，然而，本案系爭專利又屬於基因工程，涉及道德倫理與社會議題，但排除涉及道德與社會規範的發明的專利適格性是一種司法命令（judicial fiat）。法院參考了一位教授的意見，如下，其中表示不僅是基因工程，連同醫療方法與商業系統，都會面對可專利性議題的爭論。
"Although it was important to expand patentable subject matter and remove artificial fetters on patentable subject matter at the time of NRDC, there is no consensus that we should continue to expand the scope of patentable subject matter into all fields of endeavour so as to remove the remaining fetters on patentable subject matter. The continuing debates on whether methods of medical treatment, business systems and genes should be patentable subject matter demonstrate that there is no universal acceptance of an approach that would accept that anything under the sun invented by man is patentable."
以下提出兩個檢查發明是否屬於「manner of manufacture」，第一，是否發明為用於製作產品，或是產生因為人類行為產生的結果的流程；第二，是否發明具有經濟用途。
檢視發明特點，包括：
They characterised the subject matter of the claims as:
1.a compound, not information;（是一種化合物，非資訊本身）
2. an isolated nucleic acid, which is taken out of the genome and removed from the cell and is unable to be the subject of cellular processes of transcription and translation;（從基因取出的分離的核酸，不能是細胞程序的主體）
3. containing the code for a mutant or polymorphic protein; and（包括突變體或是多態性蛋白的編碼）
4. containing a sequence identified by comparison with tables created following extensive research describing the location of the mutations or polymorphisms in DNA.（包括可通過比對表格識別的序列）
法院據此判斷系爭專利有經濟用途。
判決中，經過檢視發明涉及的技術內容（內容太長，有興趣者可看判決原文），法官判定，經以上分析的系爭案發明，無疑地，是為可專利的標的。而全院判決是，系爭案發明是一種產品專利，其描述的分離的核酸並不同於自然發生的產物，甚至參考美國最高法院的決定，判定系爭專利具有專利適格性。
"The Full Court described the impugned claims as claims "for a product set within a context of invention described in the specification: a context of development, through research and work, of the knowledge of the mutations or polymorphisms in question, and of the finding of the gene in question." Their Honours emphasised the character of the claims as relating to "the nucleic acid as isolated from the cell" and differences between the claimed product and the "naturally occurring product"."
Their Honours referred at some length to the decision of the Supreme Court of the United States in Association for Molecular Pathology v Myriad Genetics Inc. That decision was concerned with the application of 35 USC §101 to claims differently expressed from those impugned in this case:
An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID No:2.
The isolated DNA of claim 1 wherein said DNA has the nucleotide sequence set forth in SEQ ID No:1 ("the Myriad claims").
可參考：第1000篇「Association for Molecular Pathology v. Myriad Genetics」美國最高法院判決（https://enpan.blogspot.com/2013/06/1000association-for-molecular-pathology.html）
＂法院認為，在僅自人類基因隔離的技術為不可專利，不過除此之外又增加其他改變基因序列的技術仍可為可專利標的（"created" cDNA相關技術為可核准專利標的。＂
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