Dr Leslie Cannold and Professor Luigi Palombi reply to Assoc. Professor David Brennan’s response to their Fairfax article on Genes and Patents. Click here for the original Cannold/Palombi article. Click here for Brennan’s response.
Also, in a follow up to our earlier analysis of the Digital Economy Act 2010 (UK)(here), Jake Goldenfein looks at the DEA’s approach to “Orphan Works” – “in-copyright” works whose authors cannot be located.
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By Dr Leslie Cannold and Prof Luigi Palombi
Patentability is synonymous with invention. Unless this fundamental threshold of patent law is reached the grant of a patent is invalid. Every law student knows this, and presumably Professor David Brennan does, too.
Professor Brennan (here) suggests that our arguments lacks a “sound basis,” are “backward-looking” and “beg questions of coherence.” Yet he supports none of these contentions with either argument or evidence.
For instance, he says in support of his backward looking charge that, “the justification for patents unambiguously rests at a point in time prior to the existence of such technology.” If anything, this statement would seem to serve those who believe the current law needs updating in line with developments in genomics not foreseen or intended by the original framers of intellectual property law. He claims we are “incoherent” (by which he seems to mean inconsistent) because of his presumption that we do not support the patenting of fish as well as human genes. This was not a question we addressed in our piece, but in fact we do believe no patents should be granted on products of nature, including the unimproved genes of fish. So goes the inconsistency charge.
We could go on, but the central flaw in Brennan’s response is that he declines to respond to the kernel of our argument: that it is legally and morally impermissible to patent human genes because of the unacceptable costs of so doing for Australian taxpayers and patients. Instead, he advances the same tired and unsubstantiated claim that patenting genes must be allowed because “… investment in R&D is commercially risky [and] it will only be undertaken if the promise of a commercial return exists for success.”
This contention is demonstrably false. A recent US government review of genetic testing concluded that “the Federal Government [not the private sector] is the major funder of basic research and likely the major funder of basic genetic research.” Furthermore, history shows that a patent award is not a required inducement for medical inventors. Some of the greatest medical breakthroughs of the 19th and 20th centuries were made without a patent being contemplated or sought. Pasteur, Curie, Fleming, Florey and Salk made their medical inventions without seeking patents. Aspirin was developed in 1898 by Bayer chemist Felix Hoffmann when German law forbade the patenting of a chemical substance. In fact, prior to 1978, it was impossible to patent a pharmaceutical substance in most European countries, yet much of the bounty of modern day medical science accrued before this time.
Recent rulings suggest the existing intellectual property framework may be adequate to ensure human genes isolated from the body are not granted patents. A recent ruling by a forty year veteran judge of the US federal court confirmed, the BRCA 1 and BRCA 2 gene mutations linked to breast and ovarian cancers are not patentable. This is because existing patent law already restricts patents to inventions, not discoveries, and (luckily for them) biotech companies are not the “first and true inventor[s]” of gene mutations that cause disease like breast and ovarian cancer. Judge Sweet found that the “claimed isolated DNA [of the BRCA genes] is not markedly different from native DNA as it exists in nature.” A similar point was made in a 1989 a US federal court judgement that found, on the basis of “the overwhelming evidence, including Amgen’s own admissions,” that, “human erythropoietin (uEPO) and isolated erythropoietin (rEPO) are the same product”. The point, conveniently overlooked by Brennan, is that genes are informational and the information remains identical regardless of the physical location of the gene itself.
If it is the case that existing legal and policy settings in Australia undercut the ability of inventors to create without the prospect of being rewarded by a patent—as Brennan claims—we need to remember that this situation is remedial, not inevitable. Policy-makers could, and we believe should, alter such settings to ensure inventors are incentivised to pursue the knowledge necessary for medical advances, and systems in place to ensure the conversion of medical discoveries into bedside benefits for patients.
Those who believe human genes identified or isolated by corporations should be patentable would do well to reply to such claims by playing the ball, not the person. It is they who must explain how patenting genes is consistent with the existing intellectual property legal and policy frameworks and why, despite demonstrable and serious negative consequences, this framework should be applied to decisions so critical to the preservation of equity and public health.
Dr Leslie Cannold is an author and medical ethicist. Dr Luigi Palombi is director of the Genetic Sequence Right Project at the Australian National University and author of Gene Cartels.
1 Comment | Uncategorized, Patent | Tagged: Patent law, EPO, Genes, gene patent, David Brennan, Amgen, Leslie Cannold, Luigi Palombi, patents, ethics, BRCA, DNA | Permalink
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By Jake Goldenfein
Two days after the UK general election was called in April this year, the UK Digital Economy Act 2010 (DEA) became law. Click here for our earlier review. As parliament was to dissolve within a week, the DEA, passed in a process called ‘wash-up’ whereby parliamentary scrutiny is truncated for the purpose of pushing bills into assent before dissolution. The result was an extraordinarily far-reaching and controversial Bill being passed less than two months after its first reading speech. One victim of the abbreviated legislative process was Clause 43, whose provisions aimed at establishing an ‘orphan works’ scheme in the UK.
The definition of an ‘orphan work’ is in itself controversial, however it generally signifies an in-copyright work whose copyright owner cannot be located. These orphans are problematic as only copyright holders can authorise activities such as reproduction and communication to the public.
A work’s orphanhood prevents a range of activities, including digitisation for many cultural projects or even preservation. Copyright legislation has thus led to a ‘black-hole’ of cultural content in which it is estimated up to 40% of all cultural products exist.
Institutions wishing to utilise works with unknown copyright holders must engage in an often prohibitively expensive search for that rights holder to seek a license. The UK orphan works legislation would have introduced a compulsory statutory licensing regime, allowing a user to obtain a license for an orphan work after demonstrating a ‘reasonable search’ for the copyright holder, and paying an appropriate fee in escrow in case the rights holder later emerged.
There is quite a strong consensus and economic argument in favour of permitting orphan works to be collectively licensed. Such a scheme would assuage the growing and undesirable consequence of copyright law locking-up content whose entry into the public domain would have substantial public benefit. So why did this legislative attempt, as well as previous attempts in other jurisdictions, fail?
Make your legislative intentions clear
In his 2006 article, commentator Ian McDonald discussed the principles that should guide a legislative solution to the orphan works problem. He stated: ‘One touchstone is to clearly define the purpose for which any solution is devised.’ That criterion was insidiously absent from the UK legislative process. This is because orphan works schemes have applications beyond cultural products. There are innumerous contemporary works, orphaned due to digital distribution and copying on the Internet. Any digital text or image without patronage data or attribution is potentially orphaned (depending on the required rigour of the search for the rights holder). This creates problems for professional creatives (especially photographers) whose works are routinely reproduced without attribution or metadata identifying the copyright holder. These groups are legitimately concerned that an orphan works regime creates a mechanism for ‘big publishing’ to utilise compulsory licences for access to cheap images with the effects of reducing the market for new images, and eroding traditional rights to control many uses of copyrighted works.
Recent UK government reports (The Gowers Review of Intellectual Property 2006, Taking Gowers Forward 2007) recognised the problem of orphan works both culturally and commercially and suggested different regimes for dealing with the different uses. However, the proposed DEA provisions did not differentiate between commercial and non-commercial exploitation and the majority of government spin only focused on the liberation of cultural material. The British Library and BBC’s capacious archives were touted as the reason for implementing the scheme. Given the opposition to previous commercial schemes sought in the US, it appeared the UK was successfully garnering support for its scheme by pushing the ‘big culture’ line while quietly including the commercial applications in the same package.
This technique did not get by the UK lawmakers. Lord Howarth of Newport stated in the House of Lords Debate: ‘I am frankly puzzled as to why the Bill was not constructed and designed to show a clear distinction between the treatments of orphan works with little or no commercial value but important scholarly, educational or cultural value, and commercially produced material that is in copyright. It would have facilitated our analysis of it and made it far easier for us to give fair wind to the part that everybody in practice has agreed should be supported. But the two elements of the Bill have been so inextricably tangled up with each other that we have found ourselves in considerable difficulty.’
In reply, Lord Young of Norwood Green (attempting to pass the clause) stated: ‘On the point made by my noble friend about commercial versus non-commercial, the key point is to ensure fairness to rights holders. It is not an arbitrary distinction between commercial and non-commercial use; it is about ensuring that there is an adequate regulation of organisations running orphan works or extended licensing schemes.’
Of course the distinction between commercial and non-commercial is not abundantly clear, but the political spin employed by the government’s response emphasises the quantity of debate and refinement necessary for any orphan works regime to be considered acceptable to a majority
Leaving things to regulations
Another substantial contribution to Clause 43’s failure was its reliance on regulation. Virtually all substantive aspects of the regime would be left to the Secretary of State to implement through regulation. This included: the definition of orphan works, who could operate the licensing schemes, and how they would operate.
While all crucial elements, the lack of a real definition of orphan works in the primary legislation was especially troubling. Because a work is deemed orphan by the legislation, the rigour of the search required to identify the copyright holder is a critical indicator of where the equilibrium between users and rights holders lies. Leaving this to regulation sat uncomfortably with much of parliament, especially in light of the government’s push for flexibility
Orphans still out in the cold
The speed of the DEA’s legislative passage created a quagmire for Clause 43 that could not be overcome. The opponents of the clause argued that too many categories of orphan works were being dealt with indiscriminately. They sought clarification of how the legislative instrument would deal with different industries and different uses of orphan works. On the other hand, supporters of the clause argued that the number of different industries and uses for orphan works required the primary legislation to be vague, such that there would be sufficient flexibility in the regulations.
This was an impasse that the UK House of Commons could not surmount before the election and there was a general consensus that the DEA was an opportunity wasted. However, the Conservatives repeatedly indicated in the debates that this issue would remain high on their legislative agenda, suggesting it won’t be long before another proposed scheme emerges. Perhaps the failure of Clause 43 will compel the Australian Government to be direct, clear and comprehensive with any similar regime it considers in the future.
Jake Goldenfein (LLB(Hons)) is a graduate of the Melbourne Law School
3 Comments | Copyright, Uncategorized | Tagged: Copyright, Digital Economy Act, Digital Economy Bill, Jake Goldenfein, orphan works | Permalink
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Associate Professor David Brennan challenges recent attacks on the ownership of patents on human genes. Also in this edition, Elisabeth Cooke looks at the Twitter phenomenon and the legal implications for “tweeters”.
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By Associate Professor David Brennan
Leslie Cannold and Luigi Palombi in their piece “Patent rubbish for companies to own genes” (published by Fairfax Media on 27 April 2010) attack the grant of gene patents in strong terms; the patents are said to ‘put lives at risk’. It is, however, contestable whether many of their claims have a sound basis. The authors’ stand-point on patents is largely backward-looking. They ask why people, described as ‘victims’, should be deprived of a beneficial technology because of an inability to pay a patent licence fee. In so asking they gloss over that the justification for patents unambiguously rests at a point in time prior to the existence of such technology. Patents are granted to provide a reason for private investment to flow into research and development to address practical problems which have no obvious solution. People can use their inventive abilities to try to improve overall welfare. Resultant solutions might be a more energy-efficient solar cell, or a cure for Alzheimer’s disease, or any other form of technological progress. Because investment in R&D is commercially risky, it will only be undertaken if the promise of a commercial return exists for success. Hence in the prospectus of a typical Australian biotech start-up company, a patent portfolio will feature as the company’s core future asset.
While patent rights in important technologies do impose costs on society, if those technologies were not developed, society is the net loser. Imposing the restriction of patent rights so as to spark improved technologies has long been considered a price worth paying, rather than society going without those technologies altogether. The cost concerns that the authors highlight pertain to the inability of some users to access patented technologies. Those legitimate concerns can be, and have been, addressed by a mix of government subsidies to users, laws compelling patentees to grant licences on reasonable terms, and legal freedoms for experimental use.
Moreover, in striking a cost-benefit balance, patent law has consistently rejected broad rights on discoveries pertaining to natural phenomena. Such discoveries are not in themselves practical solutions. Only if a discovery can be put to some practical use can there be an invention fit for patent protection, and then the protection is usually confined to that solution. Therefore, Amgen’s discovery relating to the human gene encoding for erythropoietin (EPO) – a natural protein that promotes the production of red blood cells and thereby treats anaemia – gave Amgen no rights whatsoever in the EPO gene naturally present in a person. Amgen did not ‘own’ your EPO gene. Rather what patent law essentially gave to Amgen were rights related to the manufacture of synthetic EPO to be used as a treatment for anaemia. It was a treatment not previously available to sufferers. Likewise, the controversial Myriad patents give Myriad no ownership of any gene occurring naturally in a person’s body. What patent law can validly confer upon Myriad are rights related to testing for a genetic predisposition to breast or ovarian cancer, being a diagnostic not previously available to women.
The authors’ focus on human gene technology begs questions of coherence. It implies that R&D to develop a cure for Alzheimer’s should be not given patent incentives if that research (like Amgen’s) is directed to genetically engineering a treatment from a human gene. But what if the research is directed to genetically engineering a treatment from a fish gene? It is unclear whether the authors’ view is that patent incentives should be denied for both types of research, or simply the former. But even if the suggested denial is only for human gene derived cures, the interests of society are not well-served by curtailing patent incentives for private R&D into the pursuit of any Alzheimer’s cure. If there is to be a patent system, it seems absurd that incentives will be extended for (say) an improved clothes peg, but not for a human gene derived Alzheimer’s cure. There is a Senate Committee currently considering the submissions from those who (like the authors) argue that patent incentives should be curtailed for private endeavours to develop such a cure. It is appropriate for the Committee to most carefully consider those submissions, because it must work out what those submissions are really saying. Are they saying that we as a society cannot have that cure? Or that we should not have that cure? Or that we will get that cure anyway by faster and less costly means?
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By Elisabeth Cooke
Created in 2006, Twitter is a free social networking and micro blogging site available to anyone with an Internet connect and an email address. It is based in San Francisco, USA, but is available in French, German, Italian, Japanese and Spanish. There are more than 100 million users worldwide.
‘Tweets’ are posted on the authors Twitter page and are available either to friends and followers or to anyone on the Internet, depending on individual privacy settings.
A ‘tweet’ consists of a maximum 140 characters, expressing all sorts of information and comments. You can follow President Obama (http://twitter.com/BarackObama), leading newspapers around the world, the World Health Organization (http://twitter.com/whonews) or Justin – a guy in the states who tweets all sorts of comments from his 74 year old father (http://twitter.com/shitmydadsays), which I am ashamed to say has become a personal favourite.
Twitter has quickly become a forum to disseminate information across the globe to a tremendously high number of users. Of course, this has opened the door to marketers and spammers the world over. Looking for a coupon or special deals for movie theatres? Be sure to check Twitter! Businesses have begun offering bargains to consumers who provide ‘special offer’ codes from twitter postings.
On April 14 2010, the Library of Congress in Washington DC recently tweeted, ‘Library to acquire ENTIRE Twitter archive – ALL public tweets, ever, since March 2006! Details to follow.’ While it is unclear what actual use the public tweets archive will fill, it demonstrates the level popularity of this social networking phenomenon.
With the ability to speak out and publish an opinion or comment so effortless comes the inevitable question: What happens when things go wrong?
Last year, Courtney Love became the first celebrity to be sued for defamation over comments she posted on her Twitter and MySpace accounts. Clothing designer Dawn Simorangkir (under the label Boudior Queen) filed a complaint in the Los Angeles Superior court suing for defamation, invasion of privacy and infliction of emotional distress. There are 10 allegedly defamatory tweets in question that were all written and posted within twenty-one minutes. The most popular sample of Love’s tweets is “oi vey don’t f— with my wardrobe or you will end up in a circle of corched eaeth hunted til your dead”. The case is currently pending.
The legal implications for Twitter users are currently coming to light. The United States has been working their way through defamation claims resulting from posts on twitter, but we have yet to see the implications of cross boarder ‘tweets’ bringing defamation claims. In the Gutnick case, the High Court found that an article printed in an online magazine in the United States that was downloaded in Australia constituted ‘publishing’ under the act. The court noted that was the cost of an American company doing business in Australia – they needed to be aware of Australian defamation laws.
But where does that leave tweeters? Twitter is not just about doing business – individuals, friends, newspapers, and celebrities use it. Celebrity ‘tweets’ are increasing in media attention. This social medium provides a unique forum that courts are only just beginning to approach. While we have yet to see the legal implications of ‘tweeting’, perhaps we can find out on twitter – the US Supreme Court tweets (http://twitter.com/USSupremeCourt). The High Court of Australia however does not.
Elisabeth Cooke is a JD candidate at the University of Melbourne
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