Full Federal Court Confirms Isolated DNA and RNA are Patentable

In D’Arcy v Myriad Genetics Inc [2014] FCAFC 115, five judges in the Full Federal Court of Australia have unanimously upheld a Federal Court decision that isolated nucleic acid such as isolated DNA and RNA is patentable subject matter in Australia.

From our initial review, the Full Federal Court decision sets out not only the scientific reasoning, but also briefly discusses how the decision relates to policy and the patent system. This is important for those with only a casual interest in the issue of ‘gene patents’ as it is frequently known:

At 204:

This case is not about the wisdom of the patent system. It is about the application of Australian patent law, as set out in the Act and as developed by the courts since the Statute of Monopolies.

At 205:

It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability. That has been considered by the ALRC and by Parliament and has not occurred. It is not a matter for the court, but for Parliament to decide. Parliament has considered the question of the patentability of gene sequences and has chosen not to exclude them but to make amendments to the Act to address, in part, the balance between the benefits of the patent system and the incentive thereby created, and the restriction on, for example, subsequent research.

At 206:

This case is about whether, under Australian law and the concept of patentable invention as discussed by the courts, in particular by the High Court in NRDC, the challenged claims of the patent are to patentable inventions, that is, whether they are properly the subject of letters patent. NRDC is not to be applied in a narrow sense. The principles of patentability as there discussed are principles which are apposite to the present case and with which, with respect, we fully agree. Questions of novelty and inventive step do not arise. Novelty has not been challenged and it is not in dispute that an inventive step was involved in the invention as claimed in the challenged claims.

At 207:

In Australia, there is no statutory or jurisprudential limitation of patentability to exclude “products of nature”. To the contrary, the High Court has specifically rejected such an approach. A mere discovery is not patentable and an idea is not patentable, but a “manner of manufacture”, as that term has been developed, is.

The Court discussed the features of the claims (which were considered to be novel and involve an inventive step):

At 210:

The appeal centres on claim 1 of the patent; that is, to ‘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’. There are a number of features of the subject matter of the claims:

  • It is to a compound; a nucleic acid. It is not a claim to information.
  • It is to the isolated nucleic acid; i.e. a nucleic acid taken out of the genome and removed from the cell. Isolated nucleic acid cannot be the subject of cellular processes like transcription and translation as can its naturally occurring counterpart; it has been removed from the cellular environment and thus from natural cellular processes (e.g. intron removal, dependent upon the spliceosome). It can only be transcribed and translated by artificial intervention. In the absence of transcription and translation, or following their malfunction, mutations may arise, resulting in disease or an increased risk thereof.
  • It contains the code for a particular polypeptide; a mutant or polymorphic protein.
  • It contains a sequence identified by comparison with tables created following extensive epidemiological research which describes the location of the mutations or polymorphisms as they exist in DNA. The DNA was constructed and these locations identified by the work of the inventors.
  • The nucleic acids have admitted valuable economic use.

The Full Court viewed that the products (the subject of claim 1) are different to the gene comprising the nucleic acid sequence as it exists in nature, and the isolation of the nucleic acid also leads to an economically useful result – the treatment of breast and ovarian cancers.  It was considered that this is surely what was contemplated by a manner of new manufacture in the Statute of Monopolies. The Full Court concluded that the isolated nucleic acid, including cDNA, has resulted in an artificially created state of affairs for economic benefit, and is therefore patentable.

The Appellant has 28 days to file a special leave to application for appeal to the High Court.  In the event a special leave application is filed, one or more Justices of the High Court will then determine whether to grant leave to appeal.

BSc(Hons) MCommrclLaw PhD FIPTA GAICD

Mark’s work focuses on the preparation and prosecution of patent applications in Australia and internationally, due diligence, freedom to operate and invalidity advice for the pharmaceutical, biotechnology, health and medical device industries.