Australian High Court Holds Isolated Genetic Material Not Patentable

Unanimous decision of the High Court of Australia holds that Myriad's claims to its groundbreaking discoveries are outside the boundaries of patentability...

The High Court of Australia has allowed the D’Arcy appeal against the patentability of isolated nucleic acids. Both the Federal Court and the Full Court of the Federal Court had upheld the patentability of isolated nucleic acids, with the Full Court holding that an isolated nucleic acid is chemically, structurally and functionally different from a nucleic acid inside a human cell. As such, the Full Court held that it qualified as a manner of manufacture since such isolated nucleic acids constituted an artificially created state of affairs for economic benefit.

However, the High Court allowed the appeal, holding that the invention claimed is not a manner of manufacture. While isolated nucleic acids with specified variations from naturally occurring nucleic acids are a product of human action, the High Court held that the information contained therein is still essentially the same as in the naturally occurring nucleic acids. Such a finding seems to create an exception to the principle, stated in the High Court’s 1959 decision NRDC v Commissioner of Patents, that an artificially created state of affairs giving economic benefit is sufficient for being a manner of manufacture.

In holding that isolated genetic material is outside the scope of a manner of manufacture it implies that finding otherwise would require legislative change. It is notable that the rejection of patentability in this decision is wider in scope than the US Supreme Court’s decision. The Supreme Court’s decision held that synthetically created strands of nucleotides known as complementary DNA (cDNA) could be patent eligible, while isolated DNA is not patent eligible. However, the High Court specifically rejected this distinction, holding that both are patent ineligible since they both contain essentially the same information as naturally occurring DNA.

IP Australia has launched a short public consultation on its proposed examination practice in light thereof. It is proposed that the following will not be patent eligible:

• Naturally occurring human and non-human nucleic acid sequences encoding polypeptides or functional fragments thereof - either isolated or synthesised.
• cDNA.
• Naturally occurring human and non-human coding RNA - either isolated or synthesised.

The scope of this exclusion is clarified by the following list which are proposed to still be patent eligible on account of not merely representing information coding for a polypeptide:

• Naturally occurring isolated regulatory DNA (e.g. promoters, enhancers, inhibitors, intergenic DNA)
• Isolated non-coding (e.g. "Junk") DNA
• Isolated non-coding RNA (e.g. miRNA)
• Naturally occurring isolated bacteria
• Naturally occurring isolated virus
• Isolated polypeptides
• Synthesised/modified polypeptides
• Isolated polyclonal antibodies
• Chemical molecules purified from natural sources (e.g. new chemical entities, antibiotics, small molecules)
• Isolated cells
• Isolated stem cells
• Probes
• Primers
• Isolated interfering/inhibitory nucleic acids (e.g. antisense, ribozymes)
• Monoclonal antibodies
• Fusion/chimeric nucleic acids
• Transgene comprising naturally occurring gene sequences
• Vectors/microorganisms/animals/plants comprising a transgene

Author: Quinn Miller

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