In mainstream news recently there has been much of talk of the work of Dr J. Craig Venter, an American scientist mostly famous for leading the project to map the human genome and a Vietnam war veteran and showman known as the Henry Ford of biotechnology. Ventner has declared that he has created life in his lab.
In the words of The Daily Mail
In a world first, which has alarmed many, maverick biologist and billionaire entrepreneur Craig Venter, built a synthetic cell from scratch.
The research team headed up by Dr Ventner of J. Craig Venter Institute (JCVI) Rockville, Maryland, USA has sequenced the genetic code of a bacterium and then used computer data and undisclosed chemicals to construct a copy. The genetic code contains DNA “watermarks”, including famous quotations and the names of the scientists behind the research, which are there to prevent unauthorised copying, as are patents, of which more later.
The press release stated that the invention was likely to be a boon to second-generation agrofuels making it possible to feed people and cars simultaneously, and that synthetic biology, could help clean up the environment, save us from climate change, and address the food crisis. Also known as synbio, synthetic biology claims to go beyond genetic engineering to create new life from nothing but a combination of nanoscale biology, computing, and engineering.
The increasing use of fossil fuels is contributing to the environmental challenges of global climate change; air, water, and land pollution; and loss of biological diversity … We are developing novel genomic-driven strategies to address global energy and environmental challenges. Recent advances in the field of synthetic genomics present seemingly limitless applications that could revolutionize production of energy, chemicals, and pharmaceuticals and enable carbon sequestration and environmental remediation â€¦ we are uniquely positioned to ignite a biological industrial revolution, and we are committed to unlocking the keys to a clean energy future through genomics.
JCVI’s new synthetic genome has been nicknamed Synthia. Synthia was inserted into the cell or shell of an existing bacterium. Hence Ventner et al cannot perhaps quite lay claim to the seed of life, more the ability to sow or should that be sew. The host cell is previously deprived of its natural genome, presumably against its will, and starts with the Synthia genome instead to begin producing Synthia’s synthetic proteins instead of its own.
Venter insists that his team has participated in White House-level bioethical reviews, and is being thoughtful about the implications of their work. But observers are lining up to raise ethical and moral concerns, and have expressed fears relating to misuse, accusing the team involved of playing God and tampering with the essence of life.
Ventner has had plenty of time to consider the implications, or plenty of time to come to terms with them, as he has been working on synthetic life for a decade. He has said:
It is our final triumph. This is the first synthetic cell. It’s the first time we have started with information in a computer, used four bottles of chemicals to write up a million letters of DNA software, and actually got it to boot up in a living organism. Though this is a baby step, it enables a change in philosophy, a change in thinking, a change in the tools we have.
You may remember the similar fuss over genetically modified (GM) crops, although you probably donâ€™t know that a few days past a GM potato trial was approved in Yorkshire. There are even larger questions posed by synbio and the creation of novel life forms: How could their accidental release into the environment be prevented or even the effects of intentional release evaluated? Who will control the spread and creation, and how will they do so? How will research be regulated? Should we engineer life in this way when the safety questions are so vast? Who should decide? And thatâ€™s putting the ethical, moral, philosophical or religious questions aside.
Here at Lawdit our concerns and interests are more prosaic. Namely, that JCVI has filed for patent protection. Having partially funded JCVI’s research, the U.S. government’s Department of Energy holds certain as yet undefined rights to the Venter Institute’s US 2007 0 122 826 and Patent Cooperation Treaty (PCT) international application WO 2007 047 148.
Criticism has been raised about JCVIâ€™s use of intellectual property rights on more than one occasion, with accusations of ‘bio-piracy’ and the alleged ‘commodification of life’. In particular Professor Sir John Sulston, chair of Manchester Universityâ€™s Institute of Science, Ethics and Innovation; a leader of the initial public effort to sequence the human genome and long-standing critic of gene patenting.
Ventner had been beating the public efforts to be the first to sequence the human genome when his work was assimilated into the public effort. But Sir John was a fierce critic of Dr Venterâ€™s private-sector effort; his attempts to hold human genetic data as proprietary information; and to patent genes.
Sir John used a recent Royal Society seminar to discuss a new report from his institute entitled Who Owns Science to comment that the claimed patent protection is too broad and damaging to innovation:
I hope very much these patents wonâ€™t be accepted because they would bring genetic engineering under the control of the J Craig Venter Institute (JCVI). They would have a monopoly on a whole range of techniques.
The elephant in the room is the constant spectre of political and ethical controversy over whether patents advance technology by providing inventors, scientists, companies, and universities with a reason and protection to create, or alternatively hamper the development of technology. On the one reading, a patent provides a time-limited monopoly in return for the publication /release of an invention; on the other, patents provide damaging and stifling monopolies for the essentially random, and by definition unworthy, entity that invented. Or worse still, that bought.
A spokesman for Dr Ventner said:
There are a number of companies working in the synthetic genomic/biology space and also many academic labs. Most if not all of these have likely filed some degree of patent protection on a variety of aspects of their work so it would seem unlikely that any one group, academic centre or company would be able to hold a ‘monopoly’ on anything.
In any event it is also always possible that the patents wonâ€™t make it through, or at least not with the claims as filed. The Canadian based ETC Group (an ‘international organization dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights’ with the full name of Action Group on Erosion, Technology and Concentration and intended to be pronounced et cetera … or in shorthand the biotech watchdog) has challenged JCVI’s patent on ethical and public safety grounds.
ETC previously won a 13-year challenge to a Monsanto master-GM-soybean patent (on insufficiency) but their present challenge looks less promising, as JCVI’s Synthia research was backed by the U.S. government, BP (peculiar bedfellows at the moment), and Exxon Mobil. And in the GM soybean case, much of the argument came from Monsanto who initially opposed it â€“ until they bought it.
(Interestingly the allegations regarding GM crops are that a) the use of pesticides goes up, and b) crop yields go down; and a circle of corporate dependency is created. A warning about a) false dawns and b) public relations.)
ETC also argue that the Ventner claims as filed are too broad, stating that JCVI’s lawyers have:
constructed a legal rats’ nest of monopoly claims that may entangle the entire field of synthetic biology [including] proprietary claims on basic research steps such as adding synthetic DNA to a living organism [which]pretty much sum up the current field of synthetic biology.
Speaking as lawyers we can only tip our hats, but expect that between them the United States Patents and Trademarks Office (USPTO), other patent offices / courts across the globe and the ETC will ensure that in order to be granted the patent claims will be tightly narrowed.
So the comments about market domination must be viewed through the lens of previous technological advances. Patent law, and patent lawyers, have been around probably since 14th Century Italy. In modern times Microsoft couldnâ€™t stop Firefox, Java, Linux and the rest. There are generally workarounds, the market does not always favour the best way of doing things (R.I.P. Betamax), patent offices and even governments will have their say and so will the courts.
Leading US case Diamond v. Chakrabarty restricted the ability to patent life forms, by excluding naturally-occurring organisms from such monopoly rights. Diamond v. Chakrabarty (1980) was a United States Supreme Court case where in a 5-4 ruling, the court ruled in favour of Indian inventor Chakrabarty, who had developed a useful bacterium capable of breaking down crude oil to deal with spillages, and upheld his patent.
The court ruled that patents could be issued for anything under the sun that is made by man.
Chief Justice Warren Burger wrote:
The relevant distinction is not between living and inanimate things,
..but rather between naturally existing and human-made inventions, and because the bacterium was created in a laboratory through cross breeding, it was not nature’s handiwork, but the product of human ingenuity and research.
Synthia and (her?) ilk may allow biotech companies to avoid this distinction by creating synthetic versions of natureâ€™s handiwork. In alarmist terms Synthia may create a precedent allowing a corporate land grab of nature.
Meanwhile the lower court 2009 Myriad Genetics case in the US, currently under appeal, filed by professional medical organizations, doctors, and patients (under the auspices of the grandly titled American Civil Liberties Union) may invalidate patents for naturally-occurring genes. Such patents have been issued in the US on the grounds that such genes are isolated and purified to a non-naturally-occurring state. We will watch the appeal…