Crying Over Spilt Milk

The BBC has reported that the application of GTC Biotherapeutics to license Atryn, produced in the milk of transgenic goats, has been refused. The European Medicines Agency (EMEA) has called for more evidence of the benefits of the drug, in order to outweigh the perceived risks associated with the licensing of the medicine. In particular, the EMEA said evidence showing that there was no development of an unfavourable immune response to the drug had not been adequate. The EMEA refusal is noted in a recent press release and its recommendations set out the reasons for refusal in more detail. The BBC report describes this as a major setback for the promises of cheaper living drugs, heralded in the late 1990s but yet to be delivered.

Milking Medicines

GTC Biotherapeutics have applied to the European Medicines Agency (EMEA) to license Atryn, a recombinant form of human antithrombin, extracted from the milk of genetically modified goats. As reported by the BBC, granting of the licence would mean that Atryn will be the world's first medicine to be produced from a genetically modified animal. In Wisconsin, Pharming is working on a herd of transgenic cows that express human lactoferrin in their milk, for which they have just filed a GRAS (Generally Recognized As Safe) notification with the US FDA. In the Netherlands, the same company is milking rabbits for recombinant human C1 inhibitor, for treatment of hereditary angiodema.




"milking a rabbit"

IP and Economic Development

Delegates from Africa's 34 least developed countries have just completed a 2 day regional meeting in Addis Ababa, reviewing the Brussels Programme of Action for 2001-2010. The programme includes a Framework for Partnership and 30 Development Goals. Of particular interest to Patenting Lives is the guiding principle of market considerations (which guides implementation of the Programme along with the other 3 principles of an integrated approach, genuine partnership, and country ownership). This principle includes an emphasis on an appropriate mix of public-private participation (relevant in particular to scientific research and development and patentable technologies). The Programme's work on the role of trade in development as well as a commitment to environmental protection will be potentially important to an understanding of the possible interactions between IP and the transfer of biotechnologies, as well as any interaction between IP regulation and environmental concerns.

Biopiracy by Copyright

A recent letter to Nature by Donat Agosti, American Museum of Natural History, raises some interesting points about the possible interactions between copyright protection and biopiracy. Work in the Patenting Lives Project has been considering some related concerns - particularly in the area of scientific publication and access to the knowledge and information arising from research in biotechnologies. Agosti's letter refers to an earlier commentary piece in Nature, on ZooBank, an open access universal register for animal names, proposed by Andrew Polaszek (Executive Secretary of the International Commission on Zoological Nomenclature, based at the Natural History Museum, London) and others. Agosti's concern is that the mandatory exchange of information under the Convention on Biological Diversity (to which the United States is not a party) is threatened by copyright restrictions on the media used to disseminate taxonomic information and research, and argues that such restrictions place costs on that information beyond the means of many developing (and biodiverse) countries. In this way, copyright is tantamout to biopiracy by removing (limiting) the access to biological information. The related interest in copyright has been similarly relevant to the Patenting Lives Project, so these comments are of particular interest. The ZooBank register proposes an open access solution to this. But the obstacles to the register, potentially posed by copyright, suggest a possibly intriguing contradiction between copyright and the accountability and responsibility of scientific research to its public.

Heated Negotiations on Global Biodiversity Regime

IP-Watch has just published a very good report on the background to the recent CBD negotiations in Spain (see post 6 February). The article makes some very useful obligations on the way in which negotiations proceeded and the negotiating "blocs" apparently formed during the process. As discussed in an earlier post (6 Feb), the interaction between the CBD and WIPO discussions on genetic resources is really in evidence. And indeed, as reported in IP-Watch, focus groups raised this very issue.

Mali Farmers' Jury Reject GM as Threat to Farming Culture

As reported in The Independent, The Mali government is deciding whether to allow GM trials. But during a recent 5 day meeting in Sikasso (a major area for cotton production), Africa's first "farmers' jury" heard many concerns from local farmers. The farmers' jury is an important element of the participation of farmers in developments in agricultural industry, as reported by the Organic Consumers Association. In particular, it was made clear that the decision to trial GM was not merely a question of agricultural production. Rather, the decision must deal with more extensive questions of cultural identity and of traditional agricultural practices as integral to that identity. As stated by Birama Kone, a member of the jury, "GM crops are associated with the kind of farming that marginalises the mutual help and co-operation among farmers and our social and cultural life."

As well as the issues raised by local farmers, Dr Michel Pimbert (pictured) of the International Institute for Environment and Development (which also reported on the result) raised the question of the intrusion of patented products in the local agricultural industry, thus changing the landscape of agricultural communities and practices. Dr Pimbert also raised concerns about the possible dominance of the sector by seed companies: "The idea that the first link in the agricutural chain is controlled by a company is deeply disturbing to small farmers."

America's development agency, USAid, backs the development of GM technology in west Africa. However, the US continues to subsidise its own cotton farmers, directly affecting Mali's cotton industry, according to activists.

Cattle Drug Killing Vultures

In India, it has emerged that a Novartis drug, diclofenac, administered to cattle as a painkiller since the 1990s (used for lameness, mastitis, and other common problems), is leading to serious depletion in the populations of Indian vultures. The drug is a common human anti-inflammatory and, as such, a ban on its veterinary use has been resisted to date for fear that this would decimate public trust in (and thus the market for) its use for humans. According to The Guardian report, the Indian market makes up 90% of the Asian market for diclofenac.

In earlier reports, the declines were attributed to a number of possible factors, including an unidentified virus, however the problem of diclofenac toxicity in vultures was discovered in 2004. Nevertheless, the drug has not been withdrawn from its veterinary use, although the Indian government announced in March 2005 that phasing out of the drug would be imposed. The problem is caused by the administration of the drug to animals close to death. The drug is then present in the carcasses upon which the vultures feed. It has been estimated that over 99% of Indian vultures may have suffered poisoning. Losses are also being experienced in Nepal and Pakistan.

A new report published in the Public Library of Science (PLoS) journal, Biology (an open access publication) claims to have found an alternative in the drug meloxicam. It is hoped that the effectiveness of this drug will overcome the reliance on diclofenac, despite the obstacles faced thus far to the complete phasing out of the drug.

The depletion in vulture populations has also had an impact on local traditional methods of disposing of the dead by sky burials, where vultures pick the bodies clean on what are known as towers of silence. Without adequate populations, such methods are being abandoned in favour of alternatives, such as cremation. The crisis has emerged as one of both biological and cultural cultural diversity.

Draft Global Regime on Genetic Resources

Three draft documents towards an international system regulating genetic resources, their access and use, have been adopted by the Convention on Biological Diversity (CBD) Ad Hoc Open-Ended Inter-Sessional Working Group on Access and Benefit-Sharing. The Working Group has just held its fourth meeting in Granada, Spain, at which drafts were negotiated and ultimately adopted. In his statement at the Opening Session of that meeting, the Executive Secretary of the CBD, Dr Ahmed Djoghlaf, referred to the uncertainty and lack of progress with respect to the operation of Article 15 (Access to Genetic Resources).

The three draft texts (which include a draft international regime, certification of origin, and recommendation on prior informed consent and mutually agreed terms) will be forwarded to the next Conference of the Parties meeting, to be staged in Curitiba, Brazil, 20-31 March.

The process highlights the necessary interaction and communication between attempts to deal with genetic resources in the CBD as well as in the World Intellectual Property Organization (WIPO) Intergovernmental Committee.