First UK patents for cloning issued to creators of Dolly the sheepBMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7230.270 (Published 29 January 2000) Cite this as: BMJ 2000;320:270
The first UK patents for cloning methods were issued last week to researchers at the Roslin Institute, near Edinburgh, Scotland, covering critical aspects of the technology used to create Dolly the sheep.
The patents cover the use of quiescent cells in nuclear transfer and any cloned animals produced as a result. They include claims that cover the possible use of the technology in therapeutic cloning of human cells.
The patents (numbered GB2318578 and GB2331751) are jointly owned by the institute where the technology was developed (the Roslin Institute)and the bodies that funded the research (the UK Biotechnology and Biological Sciences Research Council and the Ministry of Agriculture, Fisheries and Food)
Professor Grahame Bulfield, the director of the institute, commented: “These patents confirm the novelty of [the institute's] cloning technology.”
Two licences have been agreed for use of the method,with rights lasting for 17 years. PPL Therapeutics, a company developed as a result of work at the Roslin Institute, has an exclusive worldwide licence for uses in the production of pharmaceutical proteins in the milk of ruminants and rabbits and for other areas of application. One protein that the company has developed by nuclear transfer technology is currently in phase II clinical trials for cystic fibrosis.
The US Geron Corporation has a licence for all other uses of the nuclear transfer technique. “These patents will reinforce the leading position of our licensees, PPL Therapeutics and Geron Corporation, in the application of cloning technology to develop exciting new therapies for a wide range of debilitating human diseases,” explained Professor Bulfield.
Concern has been expressed that the patenting of the technique could stifle research by groups unable to pay the licence holders for its use. Dr Vivienne Nathanson, head of health policy at the BMA, warned: “It is impossible to predict the impact on research, but there has to be concern when certain companies are able to say who is allowed to use a technique. We can't afford any loss or shortfall in research that may restrict the development of new treatments.”
Dr Richard Nicholson, editor of the Bulletin of Medical Ethics, agreed: “My main concern is that I think this may have a deadening effect on research. It will inevitably reduce the amount of research carried out overall and increase the cost of any therapies that result.”
However, Dr Simon Best, managing director of Geron BioMed, the UK subsidiary of Geron, pointed out that patenting a process does not restrict its use for research purposes, as it only affects commercial uses.
“There is a basic misunderstanding. Patents do not affect research,” he said.