Genes, Patents, Divisive Debate

August 26, 2011

By Dr Chris Dent

The recent discussion around the patenting of genetic materials is remarkable for its stridency. Witness, for example, the current Senate Committee review of the Patent Amendment (Human Genes and Biological Materials) Bill 2010. This post is not to add another voice that speaks the “truth” of a particular position but it is a step back to consider a key principle that constrains the nature and content of other participants.

My perspective is that the debate invites passionate responses because it is sited at the junction of four different (and competing) bodies of knowledge and/or practices:

  • patent law;
  • the science of genes;
    • the nature of entities that seek to commercialise advances in the sciences; and
  • the politics of public health.

Taken together, these different bodies mean that the debate is (necessarily) incomplete.

Patent law

This is not the place for a detailed exploration of patent law. It is sufficient to say that the system started over 400 years ago in a time without significant state infrastructure or a scientific world view that privileged rigorous experimentation (outside the alchemists and their alembics). Since then, the system has adapted to multiple new technologies, different understandings of economics and varied forms of governance. As a result, it is now a complex beast that has highly technical understandings of what is “novel” and “inventive” (both of which are tested against the “prior art” but what constitutes the prior art for each test is different). The law has been developed, in part by the legislature, in part by the courts (to fill the gaps left by Parliament), and in part by the patent office (to fill gaps not yet considered judicially). It is itself, a regulatory technology aimed at encouraging innovation – there is no should about it. There are just rules.

But, some will say, the patenting of genetic material is against these rules, that a genetic invention is not “an artificially created state of affairs”. The problem here is that there is no statement of Australian law saying this. Until an appellate court (to respect the doctrine of precedent) or the Parliament says otherwise, these patents may be granted – whether they are valid depends on a court ruling. It may be stretching it to apply the maxim nulla poena sine lege, but without clarity that such patents are invalid, innovators in the area of gene science are equally allowed to seek a patent for a development with industrial application that has not been forbidden.

Science of genes

Of the four bodies of knowledge, this is the one I know least about. It is, however, central to issue of the patentability of genetic materials. I am not even going to attempt a summary of it. I will, however, assert that it takes years of university training to be an expert in the area – in the same way it takes years of training to understand the nuances of patent law. Even a judge ruling on a dispute over a patent over genetic material does not, despite the best efforts of the professors who act as witnesses, become expert in the science generally – though she or he may have a good grasp of the specifics of the invention in question.

Nature of organisations

Not all organisations that seek to commercialise innovations are profit-driven companies. Those that are have a focus on providing a return on the investment of the owners of the firm. Two issues arise from this. First, it is these entities that the rationale for patents is aimed at. Patents, under current economic theories, are to encourage investment in research and development. Other types of organisations also have a role in the development of genetic innovation, like small start-ups and universities. Neither of these are beholden to shareholders; however, it is not clear that either are immune from a desire to gain patents – in order to gain future funding or for profile purposes. The second matter of importance is that it takes skill to successfully run a company (whether it be research intensive or not) – skills that have developed over years in business. For someone outside business to dictate how to make a profit in a competitive industry is as disrespectful as to accuse a geneticist of not understanding the science of genes.

Politics of public health

The politics of public health relates to the way in which the debate occurs in practice. People and organisations (including government agencies) express an opinion, sometimes backed up by evidence sometimes not, in the public domain – talk-back radio, newspapers, in response to government publication and in Senate Committee hearings. The debate is not a free-for-all; there are (often unspoken) rules and forums of engagement. The debate is also coloured by party political affiliations and economic policy perspectives (including higher education funding and costs of healthcare borne by taxpayers). As with the other three bodies of knowledge, the development of policy by those internal, and external, to the government is a matter of learnt practices – to acknowledge, and accommodate, the interests of diverse stakeholders is not a straightforward task.

My perspective

A key feature of the debate is the dominance of binaries. Much of the discussion focuses on, for example, patent protection versus competition; consumers versus companies; or simply right versus wrong. The approach of this post appears to add another: those within/trained by a particular body of knowledge versus those outside that discourse. The additional binary, however, offers an acknowledgment, and explanation, of the incompleteness of the debate.

The additional binary encapsulates and explains the others as each of these discourses has its own central “truth” that guides the actions of its members. The exclusionary nature of these bodies of knowledge produces an awareness of the “other” – those who remain uninitiated and outside the discourse. That is, the difference in truths and language means that there is a limited capacity for communication with those outside each body of knowledge – an outsider cannot easily comprehend the intricacies of patent law or the science of genes; they can understand it in broad terms (so the communication does not fail totally), but not enough to allow full communication.

In short, the limited understanding across discursive boundaries may be seen in terms of incompleteness or “failure” – there can never be complete, or total, communication. Unless all participants are schooled, to the same extent, in all aspects of the debate, there will always be a degree of miscommunication. Tied to this is that the purposes of the participants differ: the motives of a geneticist are different, for example, than those of a lawyer. The differences in constitutive actions renders problematic the pursuit of complete understanding. This acknowledgement that the debate is (necessarily) incomplete should not be seen as a negative. That there is no resolution itself acknowledges the ongoing processes of governance.

The acknowledgement that the debate is, and will be, incomplete does not mean progress will not be made. There is, after all, no such thing as the “perfect” law; there is, as a consequence, law reform. Of course, progress in this context is a contingent term – what represents progress for one side may be seen as a backward step for the other. Nonetheless, the more communication that acknowledges issues of communication (and this may include the use of empirical research to demonstrate or discount a discourse-bound assertion) the greater the potential for shared fragments of understanding. The competing motivations and practices of the different bodies of knowledge problematises the possibility of total understanding – the efforts that go to shared knowledge and practices offer common ground and a reduction in the issues of translation across discourses.

Chris Dent is a senior research fellow at the Intellectual Property Research Institute of Australia at the Melbourne Law School

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For an example of recent discussion on gene patenting see Fortnightly Review author David Brennan’s recent piece in The Conversation.

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Patent, Trade Mark, Enforcement – the whole kit and caboodle, all in one exciting Bill…

April 7, 2011

By Kimberlee Weatherall

At an IP Academics’ conference in early February, I remember Professor Di Nicol asking, rhetorically, ‘where has all the patent reform gone?’ Di pointed out that we’d had any number of ACIP Reports, ALRC Reports (like that on Gene Patenting), and IP Australia Discussion Papers, all with no actual legislation resulting.

No more.

No doubt many are already aware of the Intellectual Property Laws Amendment (Raising the Bar) Bill. An exposure draft for this Bill was released by IP Australia on 3 March, with comments due last Monday, 4 April. The provisions of the Bill have been discussed at some length elsewhere, too, including some very interesting, thorough discussion of Schedule 1 on the Patentology blog.

In summary, the Bill has 6 Schedules, and mostly deals with patent, although it has some important Trade Mark bits too.

  • Schedule 1 is meant to be about ‘raising the quality of granted patents’, but, in short, it’s about standards for granting a valid patent. It covers everything from changing the way prior art is considered in assessing whether a patent has an inventive step, making the requirement of usefulness a bit more real by requiring a ‘specific, substantial, and credible use’ for the invention; to the effective abolition of ‘fair basis’ and its replacement with a concept of ‘support’ drawn from European law.
  • Schedule 2 proposes a new research exemption in patent, something that has been discussed for years now and is long overdue, to be honest.
  • Schedule 3 is meant to be about ‘reducing delays in resolution of patent and trade mark applications’, which seems to be mostly about finding ways to speed up patent and trade mark oppositions. I’m not entirely convinced the proposals will work, not least because I can’t see anything there that really deals with extensions of time in opposition proceedings that can really extend the time of an opposition. In any event, the proposed changes mostly create a framework within which more detailed regulations will be made. It is hard, therefore, to predict the ultimate outcome of these reforms.  Perhaps more important (and likely more effective) are the proposed amendments to divisional patent applications. ‘Divisionals’ happen (in general) when a patent application is ‘split’ into more than one application. The basic idea is fine, of course, but it can be used in all kinds of interesting strategic ways, including, at the moment, splitting an application off into a divisional when the main application is opposed by someone else – thus getting a patent through faster without the opposition applying to it. Under the proposed changes, applicants will only be able to file divisionals up to the date by which oppositions have to be filed. So, at least if an opposition is filed at the very end of the opposition period, it won’t be possible to split off a divisional patent to avoid the impact of a patent opposition. There are a few other strategic moves that are discussed in the Explanatory Memoranda which will be precluded by this change. The change seems fair to me.
  • Schedule 4 is about ‘assisting the operation of the IP profession’ – and deal with patent attorney privilege (like legal privilege, but for patent and Trade Mark attorneys) as well as some disciplinary stuff, and material about registering attorney firms. Potentially interesting stuff in there that tries to define what counts as giving ‘intellectual property advice’ – raises interesting questions about what bits of what attorneys do, don’t count as giving legal advice.
  • Schedule 5 is about enforcement. It makes some substantial changes to enforcement at the border, mostly by introducing a requirement that people whose goods are seized on the insistence of a trade mark or copyright owner will now have to positively claim their goods (rather than having them returned as a matter of course if legal proceedings aren’t commenced within 10 days by the IP owner). We also have a full re-write of the trade mark criminal offences (creating two levels, summary and indictable, like in the Copyright Act), and the addition of additional damages for ‘flagrancy’ in civil proceedings.
  • Schedule 6 is (allegedly) about ‘Simplifying the IP system’. It covers a miscellaneous collection of stuff, including (a) giving jurisdiction over design matters to the Federal Magistrates’ Court, (b) amending secret use in patent law, (c) ‘fixing up’ aspects of the grace period in patent; (d) a new system to allow the Commissioner to revoke acceptance of a patent prior to grant; and (e) repealing the requirement in s 45 for a patent applicant to inform the Commissioner of the results of certain searches,

With such a smorgasbord of issues, it’s hard to know what to comment on. Much of what I might otherwise have said about the patent stuff has already been said by Patentology: that attempting to raise the bar in inventive step is a good idea but the amendments probably don’t go far enough; that the change in the usefulness requirement is good for biological type inventions where patents have been granted for fairly speculative ‘uses’. (I disagree with Patentology about experimental use I have to say – I think we need the exception in there, although I dread it’s going to end up being narrowly read by our courts).

But here’s a couple of things that haven’t been discussed in the Patentology comments or by Warwick Rothnie:

First, we have a pretty complete re-write of the trade mark criminal offences here, using that awful, awful style of criminal drafting that seems to prevail at a Federal level these days (if you remember the new copyright criminal offences, introduced in 2006, you’ll get the picture – pages and pages of text and none of us any the wiser about what it means because you have to go to the Criminal Code to even begin making any sense of it). I suppose we should be grateful that there’s no proposal here to introduce Infringement Notices, as we had in copyright back in 2006 (then again, it would be hard to justify introducing infringement notices in trade mark when they haven’t even been used in copyright for years after coming into the legislation, wouldn’t it?). But two things are really interesting about the trade mark criminal offences. First, some of the offences apply a standard of ‘negligence’ to the mental element. Thus it will be a summary offence to apply a mark to goods, being negligent as to whether the mark is, or is substantially identical to, a registered trade mark. The first problem is – why would negligence be an appropriate standard here at all? Well, so I thought the Explanatory Memorandum might help here. So I went to look, and it says this:

‘It is appropriate to have a lower fault element of ‘negligence’ for the circumstance elements of the offences because of the unique nature of intellectual property rights. Despite the clear legal position that intellectual property is a form of personal property, evidence has shown that some people see the violation of intellectual property rights as trivial and a ‘victimless crime’. Such attitudes may extend to an unacceptable failure to ascertain the factual circumstances in which their conduct would be criminal. However, consistent with the general approach taken to other forms of personal property, and to copyright goods, a person who uses a registered Trade Mark (what could be another person’s property) should be under an objective obligation to check that the mark is not registered. Otherwise, the effectiveness of the deterrent is undermined, with the risk that intellectual property rights are less protected than tangible property rights. The introduction of an objective negligence standard will assist the effective administration of justice and perform an important educative role in ensuring that people take intellectual property crime seriously.’

OK – what? So hang on, failing to check the trade marks register when you’re applying a mark to goods could be a criminal offence, because one ought to check the register? And we want it to be criminal because that will ‘perform an important educative role’? Last theory on this kind of thing I read suggests over-criminalising behaviour that the average person does not think as criminal is not likely to increase respect for either trade mark law or criminal law.

And I still don’t even know what it means to be [criminally] ‘negligent’ about whether your mark is identical to a registered mark. Doesn’t ‘negligence’ import some kind of understanding of what would be considered appropriate standards of behaviour (you know, reasonable man/woman and all that?) And if that’s true, what is the standard of vigilance about branding activity that is considered socially acceptable these days? Is Woolworths criminally negligent for using ‘honest to goodness’, that being the trade mark of some organic supplier or other? Honestly, I wonder whether they really think these things through sometimes.

Something else that hasn’t got a lot of comment is this new customs scheme for requiring people whose goods are seized to actively claim their goods. I don’t know, and I’ve not thought it through sufficiently, but I wonder whether that is consistent with Article 55 of TRIPS, that says goods shall be returned if the IP owner doesn’t commence proceedings to continue the suspension. I mean, I know that you can have further customs procedures without breaching TRIPS (you can have payable duties and the like), but can you impose a further element (this claim scheme) that is clearly geared entirely towards assisting IP owners in enforcement and that leads to forfeiture, effectively on the grounds of claimed infringement, without legal proceedings? I’m not at all sure about that.

Here’s another interesting little beastie in the Bill. Proposed s 50A of the Patents Act. This would give the Patent Commissioner power to revoke an acceptance any time before grant. The explanatory memorandum says it will help with admin type problems, but it seems to me that it might be used like the equivalent Trade Mark Act provisions are being used – as a kind of opposition-lite, where a prospective opponent writes to the Commissioner asking them to exercise their discretion to revoke – without going through the full opposition process. I see the potential for more strategic game playing, even as the Bill has tried to remove other parts of the Act that have facilitated various interesting patenting and patent dispute strategies.

Overall, too, I wonder about some of the moves in patent. It feels like IP Australia has deliberately sought to shift Australian law closer to European patent law – for example, using European language in relation to support and other documentary requirements. Why Europe? Why European law in particular? Aren’t we meant, under our Free Trade Agreement with the US, to be ‘endeavour[ing] to reduce differences in law and practice between [Australia and the US], including in respect of differences in determining the rights to an invention, the prior art effect of applications for patents, and the division of an application containing multiple inventions’? (AUSFTA Article 17.9.14). I mean, I’m not a big AUSFTA fan, as you may know, but this does look quite a lurch in a different direction, which makes you wonder whether Article 17.9.14 has any relevance at all…

One more thing worthy of comment – Item 86 in Schedule 6 amends, and broadens, another copyright exception. This is the one found in the Patents Act s 226, and allows reproduction and other uses of documents open to public inspection. I’ve said it before, I’ll say it again. Every time the government decides it is going to create a new little copyright exception so it can do something it needs to do, it really ought to be asking itself: why do I have to do this? And wouldn’t it make more sense to introduce a general, fair-use type exception? Honestly???

Kimberlee Weatherall is a senior lecturer at the University of Queensland

This article was cross-posted here at LawFont

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The US Invalidation of Myriad’s Breast and Ovarian Cancer Genes

April 9, 2010

By IPRIA researcher, John Liddicoat

Australia – Patentability of Genes?

A term of reference for the current Senate inquiry into gene patents includes whether naturally occurring gene sequences should be excluded from patentable subject matter. A trigger for the Senate inquiry was that Genetic Technologies, the exclusive licensee of Myriad’s breast and ovarian cancer genes in Australia (BRCA1 & 2), sent infringement notices to some of Australia’s leading cancer research and treatment institutes.

USA – Gene Patent Invalidated

However, Myriad’s BRCA gene patents have since been invalidated by a US court in Ass’n for Molecular Pathology v. United States PTO, Myriad Genetics 2010 U.S. Dist. LEXIS 30629 (S.D.N.Y. Mar. 29, 2010) (Myriad). Subsequently, the invalidation of Myriad’s BRCA gene patents in the US by an American district judge is topical but also causes us to reflect on the state of our own law and question whether the same outcome could be reached here in Australia. The US litigation should inform the current Australian inquiry of approaches to patent law amendments.

The United States Patent & Trademark Office (USPTO) had, prior to the decision, assumed for around 30 years that gene patents, even those with sequences that were identical to naturally occurring genes, constitute patentable material. The recent decision Myriad overturns this assumption.

The Decision

The primary issue in Myriad was whether per se product claims for isolated, and/or purified gene sequences, identical to those in nature, satisfied the products of nature doctrine; there was also an issue of whether diagnostic comparisons of sequences satisfied as a patentable method, but this article will focus on the product claim. The doctrine, which is a product of a series of Supreme Court cases from over 100 years of section 101 of Title 35 U.S.C interpretation, was succinctly articulated by the US Supreme Court in
Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (U.S. 1948)  (Funk) as, ‘manifestations of laws of nature [are] free to all men [sic] and reserved exclusively to none’.

In the landmark case of Diamond v. Chakrabarty, 447 U.S. 303 (1980) the US Supreme Court held that manifestations of natural laws are patentable products when they contain ‘markedly different characteristics from any found in nature’. Subsequently, one of the pivotal arguments in Myriad was whether isolated and/or purified BRCA sequences contain markedly different characteristics to naturally occurring DNA.

Myriad’s primary argument was that the chemical nature of isolated and purified DNA is different compared to its natural counterpart. In particular they argued that cDNA (an “artificial” creation) which is isolated and purified, when compared to genomic DNA is physically quite different. In his decision, Sweet J did find that naturally occurring BRCA DNA had undergone very similar chemical changes in vivo to the creation of cDNA but in deciding whether the isolated sequence had markedly different characteristics focused not on the DNA’s physical composition, but on its function.

Sweet J held that DNA’s function as a carrier of information – directing the production of RNA and proteins – is the relevant characteristic for naturally occurring DNA sequences that must be distinguished. Subsequently, if an isolated and purified gene, that is identical to a naturally occurring sequence is used to make cDNA, RNA or a protein, and the natural characteristics embodied by the sequence do not change, what is being claimed is a product of nature and therefore unpatentable.

Sweet J’s emphases on DNA’s information based characteristics as opposed to its physical characteristics might be most contestable aspect part of his judgment. But beyond the above reasoning, there are several other intriguing aspects to Sweet J’s decision; it is a summary judgment and 20 of the 152 pages in the judgment are devoted to the relevant molecular science.

In view of what is in the judgment, there is more to be articulated about how different isolated sequences may be from their natural counterparts. Similarly there are more detailed arguments to be made about the law, especially about the uniqueness of DNA compared to other chemicals and whether a DNA patent must have a differently encoded function, but we will have to wait for the appeal before we see these issues resolved in full.

Could it Happen in Australia?

s 18(1)(a) of the Patent Act (Cth) dictates that to qualify as patentable subject matter an invention must be a ‘manner of manufacture’ within the meaning of s 6 of the Statute of Monopolies. Relevant to gene patents that mimic nature, the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC) has held that to be a patentable manner of manufacture, the invention must ‘consist in artificially created state of affairs’.

In an opposition hearing Kirin-Amgen Inc v Board of Regents of University of Washington (Kirin), the Deputy Commissioner of Patents found that isolated and/or purified DNA satisfied the artificiality requirement from NRDC. Kirin is not a judicial decision, but it does represent IP Australia’s and the conventional wisdom on naturally occurring gene sequence patents.

Moreover, the High Court in NRDC also explicitly diverged from Funk stating that ‘laws of nature’ is too vague a term and only confuses the issue of patentable subject matter. Consequently, a product of nature doctrine has never been found in Australia and accordingly, Australia does not have a judicial history defining the boundaries of such a doctrine.

A result of the rejection of laws of nature doctrine means that an argument emphasising the information and functional aspects of DNA as a product of nature is unlikely to succeed because there is no ‘manifestations of nature’ argument to rely upon. Similarly, in regards to artificially, there is no requirement for markedly different characteristics and as such, genes isolated from their natural environment, regardless of physical changes, will likely pass this low threshold test. Nonetheless, taking advantage of a US expert commentator’s title in a review of Sweet J’s decision, maybe ‘Pigs Fly’ from the US to Australia.

What appears for certain is that the patenting landscape of genes in the US is changing. With Re Kubin last year ostensibly raising the bar on inventive step (or non-obviousness as it is known in the US) and now Myriad, Australia does appear to be diverging from the US in terms of patent laws for biotechnology. If the Senate inquiry wants to prevent patents for naturally occurring genetic sequences, perhaps they should take a more technology neutral stance and consider whether specifically including a US style products of nature doctrine is the way to achieve this.

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