The Supreme Court of the United States today held in Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. (2013) that isolated naturally occurring DNA sequences are not patent eligible. This may have implications for analogous proceedings, which are on foot in Australia.
Australian litigation
The Federal Court of Australia held in February of this year that isolated naturally occurring DNA and RNA are patentable subject matter (see our previous blog post here). That decision considered Myriad Genetics Inc's (Myriad) Australian patent no. 686004, which relates to a gene associated with human breast and ovarian cancer known as the 'BRCA1' gene. The decision is the subject of an appeal to the Full Court of the Federal Court.
US Supreme Court decision
Myriad's US patents have also been the subject of litigation, which ultimately resulted in an appeal to the Supreme Court of the United States. In its unanimous decision delivered on 13 June 2013, the Court rejected the argument that isolating a DNA sequence from the rest of the chromosome is patent eligible. As the Court stated:
"To be sure, [Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention" at page 12.However, the Court drew a distinction between naturally occurring DNA and complementary DNA (cDNA) sequences. The DNA of genes in the body contain 'coding' and 'non-coding' regions. The body reads the whole sequence and cuts out the 'non-coding' portions to make a related sequence known as mRNA that the body can then go on to read and make proteins. cDNA can be made in a lab by copying the mRNA back into DNA. Therefore the cDNA contains only the 'coding' regions, as the 'non-coding' portions were cut out earlier in the mRNA. In short, cDNA is something new, created with human effort and is not a 'product of nature'.
The Court held that the BRCA cDNA was patent eligible. The Court commented that in some instances, even cDNA molecules may not be patent eligible if it is indistinguishable from a naturally occurring sequence. This may occur if a DNA sequence is so short that it consists only of 'coding' regions, meaning that the mRNA did not have any work to do in cutting out the 'non-coding regions' resulting in a cDNA sequence that is identical to the naturally occurring DNA sequence.
The Court emphasised what its decision did not represent – that is, it does not consider the patentability of DNA which has been altered in other ways, such as by scientifically altering the naturally occurring nucleotides. It is also important to note that, like the Australian case, it does not consider any other aspect of patentability (eg. novelty, obviousness) and did not consider any methods of analysis of the human genome.
Comment
In relation to the Australian proceedings, with the appeal set to be heard on 7 August 2013, it will be interesting to see if the Federal Court takes a similar approach.
Given the narrow scope of the decision, its implications for the biotech industry is fairly limited. For Myriad Genetics, while its claims over isolated, naturally occurring DNA sequences are now invalid under US law, it has maintained its exclusive rights over the cDNA sequences. Consequently, competitors of Myriad may be able to offer genetic testing for the BRCA1 and BRCA2 genes provided the relevant cDNA molecule is not used.
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