Like the United States Supreme Court, the High Court of
Australia has determined that Myriad's patents directed to
purified and isolated DNA molecules encoding the BRCA genes are
unpatentable. Indeed, the Australian Court went one step further
than the U.S. Court, holding that non-naturally occurring cDNA
molecules encoding the genes are also unpatentable.
This decision reverses decades of precedent that recognized the
patentability of particular nucleic acid sequences that are
isolated from nature and overturned a decision by the Full Federal
Court of Australia that had confirmed the patentability of such
molecules. The Full Federal Court had held that because the claimed
BRCA gene molecules differed from naturally occurring counterparts
both structurally and functionally as a result of their isolation,
the claims were directed to patentable subject matter. The High
Court, however, focused on the information encoded by the
molecules, rather than functional and structural differences, and
found that since the same information was contained in both the
isolated genomic DNA and in cDNA that retained the relevant
sequence of exons, neither constituted patentable subject
In the U.S., the Supreme Court held that mere purification
and/or isolation of a naturally occurring substance such as DNA is
not enough to confer patentability, but that the substance must
possess "markedly different characteristics" from the
naturally occurring counterpart. The most recent guidance documents
from the U.S. Patent and Trademark Office confirm that this test is
being broadly applied to any substance derived from nature, not
just DNA and other biologic molecules. Accordingly, patent
practitioners and their clients are struggling to determine whether
their innovative efforts to develop products that include a
component derived from nature may be entitled to patent
One may expect a similar result in Australia. Indeed, since the
High Court found that structural differences between cDNA and its
naturally occurring counterpart are insufficient to render the cDNA
as patent-eligible subject matter, one must wonder how much
structural modification would be sufficient. For example, would the
use of recombinant technologies be enough to confer patentability
to a protein that is also found in nature, even if the recombinant
protein has different structural characteristics, such as a
different glycosylation pattern or crystalline structure? Is a
vaccine that relies on only a fragment of a naturally occurring
antigen still patentable? These questions and many more like them
await further answers from the Australian courts.
In the meantime, the High Court has called into the question the
validity of literally thousands of issued Australian patents. The
extent to which this uncertainty serves to chill investment in
biotechnology and other industries in the country remains to be
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