What are some of the big IP-related developments in
Australia in the past year?
You can split the developments into legal
developments and policy developments.
In terms of legal developments and case law, it's really
been the year of patents being the dominant subject matter in
IP litigation. There hasn't been as much this year in terms of
trade mark or copyright.
The big decision in the past year is from the High Court on
the patentability of medical treatment methods [Apotex v
Sanofi-Aventis]. A lot has already been said about the
case, but I think one part that is interesting is that a clear
majority, three out of five members of the High Court, drew a
distinction between methods of medical treatment (i) by
pharmaceutical, and (ii) by medical procedure by a doctor. Only
the former has been found by this decision to be inherently
patentable; the inherent patentability of the latter has been
left open by the majority of the court. The majority in fact
said that the latter was "unlikely" to be patentable.
We are also waiting for the Full Federal Court to come to
some sort of consensus on the issue of computer-implemented
inventions. In the meantime, how courts in the United States
rule on these issues is of great interest here in Australia, so
there are eyes on how the Supreme Court will rule in Alice
Finally, we are waiting, and I emphasise the word waiting,
for the Full Federal Court decision on the patentability of
gene sequences. In the first instance [in Cancer Voices
Australia v Myriad Genetics] the Federal Court held that
DNA sequences were inherently patentable. We thought that there
would be a decision by the end of last year, but it still
hasn't come yet.
So for this year, patents have been the big topic in IP in
Australia. What's more, these cases go toward the very
foundational and fundamental issue of what is or isn't
Has the new government brought about any changes in IP
There has been a complete absence of policy statements by
the new government on innovation or intellectual property.
Personally, I think this is hugely problematic, and it looks
like the government doesn't care about innovation and
intellectual property's contributions to economic
When I talk to other people in this space they share a
What actions there have been have not been encouraging. For
example, we had a National Commission of Audit to determine
basically what can be cut or reduced in the budget. One item
that came up was the Advisory Council on IP (ACIP), and the
Commission's recommendation was to have a review on whether the
ACIP was needed. While this is not a clear recommendation to
abolish the body, this call is in my perspective totally wrong,
to potentially remove at this moment this source of outside
advice about intellectual property. But it does seem to be
consistent with this deafening silence on IP and
What does the ACIP do?
The ACIP advises the government on IP matters. Members are
representatives from IP-related industries, professionals like
IP lawyers and academics. The body has been key to help bring
about important changes to IP laws. For example, one recent
change is the introduction of an exception to patent
infringement for experimental use.
Has the government taken any positions on more specific
Australia had a major review of the copyright laws in the
digital age. The review, from the Australia Law Reform
Commission (ALRC), recommended several changes, such as a fair
use exception to copyright infringement [Australia has several
specific fair dealing exceptions, rather than the more flexible
fair use test like the one used in the US]. The government
seems to have dismissed this report with a, 'no thanks', which
is kind of extraordinary.
Given that the report was commissioned by the previous
government under a different political party, is this dismissal
No, in that sense it's not surprising. However, the
government seems to be taking a very conservative view on these
issues, and that view seems to be that everything is just fine.
But the fact that we had commissioned such a major report to
look into this topic seems to indicate that things aren't just
Are there any other policy statements on copyright issues
from the government?
About the only policy statement that has come out is that
the government wants to renew its efforts to get the internet
service providers (ISPs) and the copyright holders to come to
an agreement about online infringement, like some sort of
three-strikes policy. There had been discussions between the
two camps, but since the High Court [in Village Roadshow v
iiNet] found that the ISPs were not liable, there hasn't
been much movement because the copyright users have no
The government wants to renew this process, and it may rely
on the threat of legislation to move things along. The
legislation could be something such as imposing liability on
the ISPs, or perhaps introducing a safe harbour provision of
some sort or a three-strikes policy for online
Are there any other issues that you think will be
dominating the discussion?
The executive arm of the government accepted an ethical
exception to patentability which would exclude inventions where
commercial exploitation would be "wholly offensive". This began
under the old government and it doesn't appear that the new
government has changed its mind. We're still awaiting the
legislation for that.
I think the issue of gene patents will be an interminable
debate that's going to resurface. What the Full Federal Court
holds in the Myriad decision won't end it because
there is a lot more to it than just the issue of specific gene
Last year, you released a study about the patents
surrounding blockbuster drugs in Australia and the issue of
evergreening. Are you working on any follow-up research?
In that earlier study, we looked at some of the costliest
drugs in Australia and found that many of those drugs were
attached to many patents not held by the patent holder of the
active pharmaceutical ingredient (API). Instead, they were
either held by generic manufacturers or by a manufacturer that
held patents to APIs in other drugs but not this particular
As a follow-up to that study, we are looking at how long
these secondary patents were held and for any patterns there.
If you renew a patent, an economist would say that it is a
proxy of its value, because a patent that isn't very valuable
would not be renewed. We looked at that renewal data to see if
there are any statistically significant patterns in renewal
rates depending on the type of the invention and the type of
From our research thus far, we have found that those secondary
patents that were applied for by the originator of the active
compound are held for a statistically longer time than those
applied for by another major research pharmaceutical agency or
a generic. The differences appear to be meaningful.
common preconceptions, the USPTO actually grants its
claims more narrowly than Australia or the EPO"
We also found that one type of secondary patents that
surround the API is held for longer than others, that category
being a delivery mechanism or formulation for the API.
We also looked at whether the renewal rates for the
secondary patents were related to how successful the primary
compound was. We looked at data from the Pharmaceutical
Benefits Scheme (PBS), which subsidises the cost of drugs in
Australia. With this data, we look at how much each drug costs
the government as a measure of how valuable and successful they
To be clear, all the drugs involved can be considered
blockbusters, so the idea of low success is relative here. We
are distinguishing the really big blockbusters from the smaller
We found that the success of the original drug does not
cause a significant difference in the renewal rates of the
secondary patents. The value of the API does not appear to be
driving the magnitude of the renewal of the secondary
Are you working on anything else?
I'm also doing research on the way three patent offices, the
Australian patent office, the USPTO and the EPO examined the
same claims. For this research we found patents that were
granted in all three offices and looked at how each one treated
the claims. The thrust is to compare the patent offices'
treatment of identical claims and see if there are significant
differences in outcome.
We found that contrary to common preconceptions, the USPTO
actually grants its claims more narrowly than the other two
offices, and the EPO generally grants the same claims more
narrowly than the Australian patent office. If you use
narrowness as a proxy for how stringent a patent office is,
then the USPTO is actually the most stringent, in contrast to
the common belief that the EPO is the strictest.
As part of this research, we checked out the prosecution
history for each claim, and we found that the US is generally
producing more prior art than is found by an EPO search or an
Australian search. Given that it has more of this prior art,
the US tended to narrow the scope of claims more than the other
two offices. The differences we found thus far are