The BRCA patents, which claim both breast cancer diagnostic methods and the BRCA DNA molecules, have courted significant controversy both in Australia and the US in recent years. In terms of the Australian situation, two Senate enquiries considered the impact of granting gene patents and Federal Court litigation was subsequently initiated by Cancer Voices Australia to challenge the patentability of the claims to the BRCA DNA molecules. The outcomes from both the Senate enquiries and the Federal Court have unequivocally supported maintaining the patentability of isolated nucleic acid molecules, although the Federal Court decision is currently under appeal.
In terms of the US situation, the patentability of genes has been judicially challenged in the case of Association for Molecular Pathology v Myriad Genetics. The US Federal Appeal Court twice upheld the patentability of isolated nucleic acid molecules. However, on appeal to the Supreme Court, a unanimous decision was handed down on 13 June 2013 ruling that naturally occurring DNA molecules are not patentable. Specifically, the Court ruled that naturally occurring DNA molecules are a product of nature and not eligible for patenting merely by virtue of the fact of having been isolated.
This decision is in direct contrast to the reasoning of the Australia Federal Court Myriad decision where the Court held that an isolated nucleic acid molecule is patentable, even where the sequence of this molecule is the same as the sequence of the native molecule. The Court’s view was that the removal of nucleic acid material from its natural environment gives rise the “artificial state of affairs” which is required under Australian law. The US Supreme Court did, however, clarify that nucleic acid molecules in which the order of the naturally occurring nucleotides has been altered, such as cDNA, do remain patentable. Such molecules are not a “product of nature” since they represent a molecular sequence which is not found in nature.
Impact of the Myriad decision on biotechnology patents in the US
This decision reverses decades of accepted practice in relation to the patentability of genes. It also sets US patent law at odds with that of all other developed countries, where isolated nucleic acid molecules remain patentable. From a practical point of view, in terms of isolated DNA molecules this decision is likely to have a relatively small impact since the advent of the full genome sequencing of many organisms has effectively destroyed the novelty of claims directed to the genes which form part of these genomes. Accordingly, although prior to the recent Myriad decision these molecules were patentable subject matter in the US, and remain so in most other jurisdictions, the fact is that patents are now rarely granted for naturally occurring nucleic acid molecules since publication of the relevant genome sequence usually destroys novelty.
It is in respect of other “products of nature”, however, that this decision may lead to more serious consequences. Bioentities such as proteins, natural compounds and cells extracted from any animal, plant or other natural environment are often simply isolated from their natural environment. The question which therefore now arises is whether these types of non-DNA biological entities will still be regarded as patentable in the US simply because they are isolated or will an applicant have to demonstrate a difference between the claimed molecule and the native molecule. To this end, the USPTO has recently generated interim guidelines, for its patent examiners, which attempt to quarantine the Myriad decision to isolated nucleic acid molecules. These guidelines state:
Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter…Claims clearly limited to non-naturally occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally-occurring nucleotides has been altered...remain eligible.
However, issuance of these guidelines is not a bar to any party electing to test the scope of the Myriad precedent by judicially challenging the validity of a patent directed to any natural product. Accordingly, the irony in relation to this decision is that its impact may, in fact, be most acute in relation to the patentability of biological entities other than DNA.