IntroductionEgenis Co-Director Professor Steve Hughes continues his reflections on gene patents and the courts.
Australia has now picked up the baton and is running in the contested debate over gene patents and their role in public healthcare and the bio-industries. As in the State of New York (see earlier comment 'Quo vadis gene patents?' below), and on similar grounds, opposition is being mounted in a case brought in the Australian Federal Court in Sydney to the patents relating to the BRCA gene variants associated with breast cancer.
BioNews reports that an advocacy group, Cancer Voices, and the law firm Maurice Blackburn have raised their case on the practical proposition that the cancer-related BRCA variants are inventions of nature, and on the ethical consideration that the act of patenting them amounts to the commodification of people’s bodies.
We must wait for the outcome. The response of the patent attorney community has been to warn of a catastrophic decline in investment in the biotech sector if the overthrow of the BRCA patents were to render gene patents unenforceable. So, have the European Patent Office and New York District Court, in resisting the BRCA claims (see below), started a process which will trickle down to other patent jurisdictions? Will the inevitable legal appeals which will follow judgements against gene patent holders be able to keep pace as the dominoes fall , or will they re-establish a precedent which will shore up the stack?
Stormy waters ahead.
Quo vadis gene patents?
Since the announcement by the New York District Court of Judge Sweet’s ruling in favour of an extended group of institutional and private plaintiffs that the patent claims of Myriad Genetics and the University of Utah with respect to alleles at the Brca1 and Brca2 loci are invalid, there has been a reawakening of interest in the question of the general patentability of genes and gene sequences. A well-argued account of the issues at stake was published in the New England Journal of Medicine (7 April), mirrored by an editorial in the influential journal Nature (15 April). Almost coincidentally, claims within the said patent suite had just been highlighted by Kepler, Crossman and Cook-Deegan in the journal Genomics. Their study demonstrated that the monopoly effectively granted to Myriad to operate genetic testing for breast cancer susceptibility inappropriately extended to potentially all human genes, and raised serious issues concerning the effectiveness of institutional practice in patent examination. And now, in a timely volume of Genetics and Medicine, Cook-Deegan and colleagues take a detailed empirical look at the impact of gene-based patent regimes on access to genetic testing and reflect negatively on the consequences of monopoly and exclusivity. Providers of genetic diagnostic tests are in the cross-hairs and those of us with an interest in the interplay of public sector research and intellectual property regimes will sense some serious spectator sport in the offing. Simply put, the findings of Judge Sweet take us back to the intuitive principle that genes and alleles are pre-existing inventions of nature and are thus not appropriate subject matter for patent claims. More specifically, he argued that the Myriad claims related to products which did not have markedly different characteristics from what resides in the genomes of the human population. On these grounds he ruled out both subject matter and methods embodied in the patents. This finding potentially applies to many instances of gene patenting and challenges the common espousal by the patent-awarding authorities and the biotech industries of the counterintuitive principle that purification of DNA sequences is a sufficient transformation of material nature to warrant the award of patents. The investment model of the burgeoning private biotech sector is predicated on this understanding, so we can certainly expect a vigorous response from that quarter. Myriad seem to be unfazed and relatively dismissive of the judgment. Presumably they expect to prevail in an appeal to the Federal Circuit, or if not there, somewhere up the chain to the US Supreme Court.
Of course, it need not end there. The issue of patentable subject matter is only one of the strands for opposition to the diagnostics monopoly instantiated in the Myriad patents. In 2002 the Nuffield Council on Bioethics published the findings of its investigations of the patenting of DNA sequences and pointed out that in the case of sequences used as diagnostic probes, given their potential to block other diagnostic routes for a particular genetic condition, all the criteria of patentability should be applied particularly stringently and even the provision for compulsory licensing in the public interest may be entertained. So the formal criteria of inventive step and obviousness may be revisited, as might the public morality issues of the commodification of human suffering associated with certain alleles at the Brca1 and Brca2 loci. There is no shortage of ammunition for plaintiffs and doubtless a deep war-chest of financial and legal resources available to Myriad and its biotech allies to pursue their appeals.
However shortlived the satisfaction this judgment affords, it has disturbed the notion that gene sequences of potential utility are out there to have claims staked around them. In the light of this small redress to the excesses of Bayh Dole-ism perhaps now is the moment for the science community to re-evaluate its practices in the co-production, sharing and distribution of genetic knowledge in the context of the provision of public goods.
Coda: And Another One Bites the Dust?
The posting of this commentary was delayed as a consequence of the purdah imposed on ESRC investments during the election and formation of a new government in the UK. While this was frustrating for those who wanted to produce a timely comment it has allowed another piece to be added to the tale of biotech patenting.
Patents awarded to the Wisconsin Alumni Research Foundation based on the work of James Thomson on the establishment and maintenance of embryonic stem cells are regarded by some as key to the development of new therapies of tissue regeneration. The final board of appeal of the European Patent Office last November rejected a patent application by WARF, partly on the grounds that it would be 'contrary to public order or morality'. At the beginning of May WARF's patents became news again when the last of the sequence of three linked patents US7,029,913 (fondly known as 913), supported by the US Patent and Trademark Office against oppositions in 2008, was rejected by the same agency’s Board of Appeals and Interferences, on grounds of obviousness under appeal from third-party requesters.
The three claims of this patent related to the culture of human embryo-derived stem cells and were based on examples of culturing primate cells derived from macaques and rhesus monkeys. Claims of this sort certainly have the potential to carve out a large domain of exclusion for other would-be developers of reconstructive therapies, so it will be interesting to follow the next stage of the contest. Will WARF fight back to re-establish its claims or will third-party oppositions succeed against other broad claims in the patent family?
Either way the unfolding drama will add substance to the debate and the claims and counter-claims elaborated concerning the role of this kind of broadly embracing patent on stimulating or inhibiting innovation.