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Australian Biotechnology Patents

The Australian landscape surrounding biotechnology patents is muddled with various contradictory statements between judgements and Patent Office practice.

The Australian Law Reform Commission last published a missive in 2010 on the patentability of biotech inventions. Usefully, this report started with the following statement: "The Organisation for Economic Co-operation and Development has noted:

Patents are especially important for biotechnology firms as many of them have no activity other than R&D and therefore do not directly exploit their inventions: they sell them, or the right to exploit them, to other firms. A legal property right is therefore needed for the seller to be protected."

This study found that most gene patents filed in Australia originated from overseas. This is no great surprise, as foreign applications outnumber local application in every country of the world, bar the US and (recently) China. This makes sense - few countries have the capabilities to develop the same number of inventions in a given field as the rest of the world combined. Unhelpfully, the report only cited studies conducted from 1995 to 1999, and could do with an update.

The Inquiry was careful to ensure that owners of gene/bio patents were not subject to higher levels of patent eligibility, which could be deemed to be discriminatory. It was stated that "While the Inquiry’s Terms of Reference instruct the ALRC to report on the impact of patenting laws and practices related to ‘genes and genetic and related technologies’, in general, the ALRC does not believe that concerns about the patenting of inventions involving genetic materials and technologies should be addressed by provisions in the Patents Act dedicated only to these types of inventions."

A more recent publication entitled Decoding Gene Patents in Australia was published in 2015. This occurred following Australia's highest court holding that natural nucleic acid sequences cannot be the subject of a patent (below). The Australian Patent Office (IP Australia) has, however, regularly granted patents with claims defining gene sequences. According to the authors, IP Australia states on their website that the following is patentable subject matter:

"A standard patent can also be obtained for inventions involving:
  • genotypically or phenotypically modified living organisms, for example, genetically modified bacteria, plants and non-human organisms (patenting of plant varieties is described in Plant Breeder’s Rights)

  • isolated DNA, RNA, chromosomes and genes (including human DNA and genes)

  • isolated products of such DNA, RNA and genes including polypeptides and proteins

Examples of patentable inventions include:
  • synthetic genes or DNA sequences

  • mutant forms and fragments of gene sequences

  • an isolated DNA coding sequence for a gene

  • an isolated protein expressed by a gene

  • vectors (such as plasmids or bacteriophage vectors or viruses) containing a transgene

  • methods of transformation using a gene

  • host cells carrying a transgene

  • higher plants or animals carrying a transgene

  • organisms for expression of a protein from a transgene

  • general recombinant DNA methods such as PCR and expression systems

More recently, the Myriad case became the first judicial consideration in Australia on the issue of whether a patent can be granted for claims that protect "naturally occurring" nucleic acid—either DNA or RNA—that has been “isolated” (Cancer Voices Australia v. Myriad Genetics Inc. (2013) (FCA 65) (1)). This case considered whether a naturally occurring nucleic acid that has been isolated is patentable subject matter in Australia and meets the "manner of manufacture" test for patentability.

In 2014, the Full Federal Court (five judges) unanimously dismissed the appeal and affirmed that isolated nucleic acids (i.e., whether it be DNA or RNA) are patentable subject matter in Australia (D'Arcy v. Myriad Genetics Inc [2014] FCAFC 115).

This was unceremoniously overturned in the High Court which unanimously held that an isolated nucleic acid (coding for mutations in the BRCA1 gene, associated with breast and ovarian cancers) does not qualify as proper subject matter for patent protection.

Applications in Australia that only claim "isolated" nucleic sequences (and not non-naturally occuring sequences) are thus at risk of being considered patent ineligible.

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