D’Arcy v Myriad Genetics Inc, [2014] FCAFC 115

The Federal Court of Australia Full Court dismissed an appeal by Yvonne D’Arcy seeking to invalidate Claim 1 of Australian Patent No. 686004, held by respondent Myriad Genetics Inc., which claims an isolated sequence of DNA useful for cancer diagnosis, for being unpatentable subject matter.

The Court found that the claim qualifies as a “manner of manufacture” and is thus patentable subject matter pursuant to section 6 of the Statute of Monopolies. [214]

Contrary to the Myriad Genetics Decision in the United States

This decision follows the landmark decision of the Supreme Court of the United States in Association for Molecular Pathology et al v Myriad Genetics, Inc, et al, 569 US 12-398 (2013) regarding the corresponding patent in the United States (Claim 2 of US Patent 5,747,282), which came to the opposite conclusion that an isolated DNA sequence is not patentable subject matter for being a product of nature (at 9).

The Australian Court decision discusses the American decision at length, and endorses the opinion of the majority in the Court of Appeals for the Federal Circuit, which had found the isolated sequence of DNA to be patentable subject matter, but was later overturned by the Supreme Court. [155]

The Australian Court noted that the Supreme Court of the United States rejected the claim to the isolated DNA in the US Patent for being a ‘”product of nature”, but that no such principle exists in Australian patent law. [217]

The Australian Court explicitly stated that it is not engaging in discussion of the policy, moral, or social implications patenting gene sequences, that being a matter for Parliament to decide. [205] The Court noted that the Australian legislature had at one point the opportunity to consider and specifically declined to exclude purified and isolated gene sequences from the scope of patentable subject matter. [161] The Court stressed that the decision was merely an application of Australian patent law. [204-206]

The Australian Patent No. 686004

The claim at issue in the Australian Patent concerns a human gene that indicates predisposition towards breast or ovarian cancer. [2] Claim 1 is pasted below:

“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.” [210]

The claim does not cover the “normal” version of the gene, but instead the mutated versions of the gene that serve as indicators of a predisposition to breast and ovarian cancer, where such mutations are listed in tables in the specification. [210] The Court is clear that the patent does not claim a person’s own DNA, [183] nor the information in the DNA, [210] but the isolated nucleic acid sequence.

Applying the Australian test for the patentability of a new use of a known material, the Court noted that Australian patent law takes the view that it is sufficient for a product to result in “an artificially created state of affairs”, leading to an “economically useful result”. [208] The Court decided that the isolated nucleic acid has indeed resulted in an artificially created state of affairs for an economic benefit, [218] namely the treatment of breast and ovarian cancers. [214]

With reference to the overturned decision by the Court of Appeals for the Federal Circuit in the United States, the Australian Court notes that claim 1 does not claim the genetic code itself, but “an isolated nucleic acid … which is chemically, structurally and functionally different to what occurs in nature.” [194] Endorsing the overturned majority in that decision, the Australian Court echoed that “it is not the chemical change alone, but that change combined with the different and beneficial utility which leads me to conclude that small isolated DNA fragments are patentable subject matter.” [214]

Commentary

It is important to note that this decision is not a rebuke of the American decision that came to the opposite conclusion. Although addressing similar subject matter, the two decisions were concerned with different patent claims and different legal frameworks.

However, the Australian Court did criticize the United States Supreme Court for endorsing Diamond v Chakrabarty, 477 US 303 (1980), which held that a genetically modified organism which showed “markedly different characteristics from any found in nature” could be patentable (Chakrabarty at 310), but rejected isolated nucleic acids as being unpatentable in this case. [215-216]

Note that a different type of DNA segment, known as Complementary DNA (cDNA), was also at issue in the American decision and was not at issue in this case. Strands of cDNA are artificially created segments of DNA that have had the non-coding portions of the DNA removed. The United States decision held cDNA to be patentable subject matter. [136]

There is no corresponding Myriad Genetics case in Canada, but the patenting of genes seems to have been affirmed in Canada in Monsanto Canada Inc v Schmeiser, 2004 SCC 34 at paras 22-24.

Update: A case has been brought before the Federal Court in Canada that similarly puts the patentability of isolated DNA at issue. Read the full summary here.