Pointing to the 2007 PLoS Biology paper on intellectual property rights in synthetic biology co-written with Arti Rai, James Boyle of the Duke Law School has written in the Financial Times (and reprinted at The Public Domain blog) of his fears of the entire sector being locked up by patent and copyright claims by the likes of J Craig Venter.
One of the problems facing synthetic biology is that no-one is really quite sure which IP laws will affect it the most. It has the characteristics of software in some respects - although I believe some of these comparisons are overplayed and run the risk of misleading people as to how synthetic organisms will be designed - and patentable hardware in others.
US IP law may not even have the right infrastructure to deal with synthetic biology. Rick Johnson, who heads up an OECD group on synthetic biology, and who has called the field “an IP law professor’s dream final examination problem”, has argued that lawyers in this field should take a closer look at design rights, which are used in Europe and Asia but hardly at all in the US, as a means of protecting synthetic-biology inventions without the encumbrance that often goes with patents in biotechnology.
“Some of the patents being filed are astoundingly basic, the equivalent of patenting Boolean algebra right at the birth of computer science. With courts now reconsidering both business method and perhaps software patents, and patents over human genes, the future is an uncertain one.”
Just finding them can be an issue. We know that the JCVI has filed a number of patents that cover the techniques the scientists used to construct and transplant the synthetic genome to ultimately create M mycoides-jcvi1.0. And many of them will be assigned to Synthetic Genomics, the company started by Venter and of which leading scientist on the project Hamilton Smith is also a director. However, the assignments are not there in all cases - you need to look for the scientists named as inventors to see which ones are likely to form the Synthetic Genomics patent pool.
At first glance, it looks as though Venter has avoided the reputational mistake made earlier in the project when the group decided to patent a candidate synthetic genome for the experiment: a derivative of M mycoplasma. This does contain some extremely broad claims for an organism with a minimal genome, providing lists of essential genes that such an organism is likely to contain. The patent writers did not take any chances, making claims for a bunch of genetic subsets apparently just in case they should turn out to be useful.
In the press conference to announce the success of the experiment to transplant the M mycoides-jcvi-1.0 genome, Venter claimed: “I have been quite comfortable claiming patents on discoveries.” He went on to confirm that patents have been filed on the techniques used for genome construction.
Venter’s claim of discomfort on patenting discoveries might elicit a hearty laugh from competing researchers. There are certainly patents in the Venter catalogue that cover things such as single nucleotide polymorphisms (SNPs) in the human genome. However, the technique patents may not prove to be all that useful if researchers decide that tuning existing genomes is going to be more successful in the medium term than trying to synthesise and stitch together DNA chains and then do a full reboot on a target cell.
Until science understands how all that DNA works within the cellular machine, trying to assemble a genome from scratch is not going to make much sense. This may change if it turns out to be easier to manipulate genomes in vitro than to alter living cells’ DNA. Right now, alternative techniques are having reasonable success in transforming organisms without recourse to the JCVI/Synthetic Genomics techniques. The foundational nature of these patents may be an illusion, unless another set turns up in the wake of the last experiment in the next few months.
The big problem is likely to be deciding where discoveries end and invention begins, assuming that Venter is as good as his word and is not using an excessively narrow definition of ‘discovery’. We are probably reaching the end of the period in which people attempt to patent individual genes and bits of them. The Myriad Genetics case has exposed them as undesirable.
Synthetic biology is less concerned with the activity of individual genes than with the emergent behaviour of combinations of them: the control algorithms created through the interactions between genes, promoters and transcription factors. This is an area where patent activity is likely to be high and one where it needs to be watched carefully: some may be similar to those that protect electrical circuits. Others may attempt to make much broader claims that cover entire families of ‘transcriptional logic’.
It is worth bearing in mind that genetic engineering has proceeded with some patents looming large. For example, everyone uses GFP despite this entire family of genetic elements being encumbered by patents. At the same time, Myriad showed how it is possible to lock development out of a sector with other patents. The problem is perhaps not so much to decide which patents should or should not be filed but to deal directly with abuses of the system.