Clause 1 - Methods of treatment or diagnosis
Patents Bill
10:30 am
Mr Brian Cotter (Shadow Minister (Trade & Industry), Trade & Industry; Weston-Super-Mare, Liberal Democrat)
I beg to move amendment No. 9, in clause 1, page 1, line 20, at end add— '(5) The comptroller will undertake periodic review of the efficacy of subsection 1 above in providing protection against monopolisation of scientific discoveries in humane genome technology relating to subsection (1).''.'. The amendment aims to add a new subsection to the end of the clause. It is important that I emphasise that we are talking about a periodic review, which is a response to concerns in the wider world about the issue. DNA patenting has been allowed under European, United States and Japanese law since the first DNA patents were filed 20 years ago. To date, thousands of DNA molecules, cells and proteins produced by genetic engineering have been patented. Many medicines that use patented DNA are on the market. They include treatments for cancer, anaemia, diabetes and vaccines for hepatitis B. Some patient groups, such as the Genetic Interest Group, and many of those involved in research into genetically inherited disorders, have welcomed patenting. They see it as a spur to promote research into rare inherited diseases and as a way of putting the newly acquired genetic information in the public domain. However, there are concerns that the creation of monopoly rights over genes and the royalties that are payable to patent holders may lead to prohibitive costs for users of screening services. Dr. R. G. Elles of the United Kingdom Clinical Molecular Genetics Society, writing in the Bulletin of Medical Ethics in January 1997, warned that: ''The issue of gene patenting first came to our attention through a demand for royalty payments on the use of the cystic fibrosis gene sequence from the Hospital for Sick Children in Toronto in Canada in early 1993 . . . negative effects of gene patenting can be recognised and measures need to be taken to control them.'' Therefore, many argue that rather than providing incentives for research, the patenting of living material merely restricts research by other laboratories. That is a key and important point, which the Minister should address. An EU directive on the legal protection of biotechnological inventions was translated into UK law in the Patents Regulations 2000. The new regulation was supposed to help the biotechnological sector by introducing a legal framework based around the patent system which would allow biotech companies to make appropriate decisions about
investment and research, and encourage innovation by allowing them to benefit from the commercial risks that they were taking. None the less, hon. Members expressed concern on Second Reading about the ambiguity of the regulations and exactly what could be patented. The Minister nobly tried to quell those fears by stressing that raw, fundamental information on the genetic code was not patentable. He also stressed that it would be different if the genetic material were isolated from its natural environment by means of an invented process involving a new technical solution. Therefore, certain gene-based inventions might be patentable provided that they satisfied the normal criteria for any invention. However, Dr. Lynne Jones was less concerned about a gene that could be patented just because it had been discovered than about the simple patenting of that discovery covering all uses of that gene, regardless of whether they were known at the time of the patent. That concern was repeated a couple of years later in a report published by the Nuffield Council on Bioethics in July 2002, which concluded that companies were being granted exclusive rights over the use of genes in diagnosis, research and treatment, thus preventing other scientists from working on any aspect of that gene. The Nuffield report concluded that, as a result of that, research into AIDS and diseases such as cancer and malaria was being held up because patents on human genes were being granted too readily to pharmaceutical companies. I appreciate pharmaceutical companies' need to invest and to put a lot of money into making progress so that they can take advantage of their work, but that, none the less, is a genuine concern. When the Government were implementing the EU directive on the legal protection of biotechnological inventions in 2000, they agreed that that issue should be addressed and that they would not wish to introduce regulations that would allow a company to control a range of processes that were consequential to an initial patent, and thus prevent valid and proper applications taking place in the future. That is a key point, and, difficult as it may be to see a way around it, it has to be addressed. The Government said that they would ask the committee of the World Intellectual Property Organisation, a special UN agency, to investigate the matter. What is the outcome of that request? Will they reassure us that there is sufficient protection under UK law to ensure a proper balance between promoting innovation and ensuring that future research is not unreasonably restricted by the patents process? This is a can of worms and a difficult issue. My amendment asks for something to which the Minister could say no. However, I repeat that we would be asking the comptroller to ''undertake periodic review of the efficacy of subsection 1 . . . in providing protection against monopolisation of scientific discoveries''. I hope that the Minister will either look at that and return to it before the end of our proceedings, or accept that there is a big problem. I look forward to his response.
10.45 amMr. Arbuthnot: On a question of typography, I think that the amendment is meant to read ''human'' rather than ''humane'' genome technology.
Although I am sympathetic to the points raised by the hon. Member for Weston-super-Mare, I am not attracted to the method that he has chosen to address them. I do not believe that the Patent Office can act as a branch of the Competition Commission. It has expertise in many areas, but monopolies is not one of them. I am not quite sure what the Patent Office would do if one of the reviews suggested in the amendment found that a monopoly did exist. The purpose of the Patent Office is limited, namely to protect new inventions. Although the consequences of that protection are a monopoly in certain terms for about 20 years, it would be beyond the scope of the Patent Office to police the consequences by trying to root out monopolies.