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.
I am sympathetic to the points that have been raised, and share the doubts of the right hon. Member for North-East Hampshire.
This is an area of enormous importance. Pharmaceutical companies have had something of a Jekyll and Hyde career. Wonderful scientists have made miraculous breakthroughs in scientific knowledge and in discovering how our bodies work, and we do not want that to be inhibited, but the way in which the pharmaceutical companies have used patents has not been entirely for the benefit of human kind. Scientists produce their great works, which are handed over to the marketing people who behave in a way that is entirely oriented to making profits for the companies. The marketing people manipulate patents when a drug's patent is running out: the normal practice is to put part of an existing drug into a new drug, give it a new patent and a new name, and harvest the resulting sales.
Scientific progress on the human genome should be shared throughout the scientific community; it should not be used by one single company to obstruct development by all the other scientists in the world, but that, sadly, is likely to happen. A discovery in the field of human biology is different from an invention by a scientist as a result of his own creativity, or from an inventor who registers a unique discovery that is entirely the product of his or her imagination. Discovering a new scientific truth in the field or biology is different. Although the Patent Office cannot make the necessary decisions in such cases, it is right that we understand the potential abuses that can arise from patents on scientific discoveries, which should be available for future development by all scientists, not just one company.
We have had a short but important debate. I am grateful for the way in which the hon. Member for Weston-super-Mare moved his amendment. He will not be surprised by the comments of the right hon. Member for North-East Hampshire and my hon. Friend the Member for Newport, West
It is important to set out what the clause does and does not do. It inserts a new section 4A into the Patents Act 1977 that brings together all the provisions that concern the patentability of methods of treatment and methods of diagnosis, and substances or compositions used in those methods. Subsection (1) makes clear the important fact that such medical methods cannot be patented; that includes medical methods that are biotechnological in nature or that flow from gene-based research. Subsections (2) to (4) relate to substances or compositions that are found to have a use in such a medical method. Those substances or compositions have already been susceptible to patent protection but, as I mentioned on Second Reading, the new provisions avoid the need to use a rather specialised and complex form of wording when obtaining such patent protection. The provisions do not open up patent protection into areas where none was previously available. That applies equally to biotechnological substances or compositions.
Having given those reassurances, I now turn to the area of gene patenting more generally. Our law in this area is governed by the European directive on the legal protection of biotechnological inventions, which was adopted in 1998 and implemented in the UK in 2000. It makes it very clear that neither DNA nor the raw information from the human genome project can be patented. That is because those are discoveries, not inventions. What can be patented, but only under certain circumstances, is genetic material that has been isolated from its natural environment. Those circumstances are where the isolation process is an inventive one that involves a new and technical solution. To put that another way, the directive—and therefore UK law—makes it clear that gene-based inventions will only be patentable if they meet all the usual criteria for any other invention. The invention must be more than just a discovery; it must be new and not obvious in the light of what has gone before, and it must provide a solution to a technical problem.
I am confident that we have in place with our European Union partners, a system that allows those who take important steps forward in this field to obtain patent protection without allowing patents to be taken out on the fundamental discoveries surrounding naturally occurring genetic material. We will continue to work with our European Union partners to ensure that the patent system achieves the right balance in this complex and exciting field, for the public good.
I hope that what I have said is of reassurance. However, if it is not, I hope that what my noble Friend the Minister for Science and Innovation said on 7 June will help. In response to the report by the House of Lords Select Committee on Genetic Databases, he said that we had promised to investigate the impact of UK law on the patenting of genetic sequences. He made it clear that the Government welcomed the findings of the resulting study carried out by the Intellectual
Property Institute on behalf of the Department of Trade and Industry, and that we would look at ways to take forward the issues raised by the report. The Government welcomed the report's main finding—that current law and practice is meeting the needs of both the public and private sectors in this field.
I hope that hon. Members will draw further comfort from that recent statement. It is an example of us keeping the commitment to get the balance right. I hope that, with those words of reassurance and comfort from my noble Friend and me, the hon. Member for Weston-super-Mare will withdraw his amendment.
It is essential that we have addressed this issue again. We must get the balance right between not stifling invention and not barring people from making necessary progress in this very complex area. I am encouraged by the Minister's statement that the Minister for Science and Innovation said something that is very much on the radar. This is a serious issue, and I sincerely hope that it does not come back to haunt us if in some manner we did not find a way to address it more precisely in the Bill. I have borne it in mind that the issue will be addressed and will be looked at on a rolling basis, although I wonder what would happen to amend the patents situation if some problem was discovered. It is important that we have raised the issue, which may be something that we will hear about from people outside the House soon and over time. I hope that it will be dealt with, if needs be, in some other way in future. On that basis, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
'(2) In section 1(1) of the 1977 Act, after paragraph (d) there is inserted—
''(e) the grant of a patent for it is not excluded by section 4A below;''.'.
This technical amendment relates to the revocation of patents under section 72(1) of the Patents Act 1977. At the moment, a method of treatment is not patentable because it is deemed not to be capable of industrial application. That is wrong, because a method of treatment could be capable of industrial application. Nevertheless, it is deemed not to be so. The clause would change to the law to say that a method of treatment will not be patentable. That is a much more straightforward approach, which we welcome, but there are two consequences. First, the Patent Office ought not to grant a patent for a method of treatment. Secondly, if, through the fault of the Patent Office, or for a different reason, the Patent Office does grant a patent for a method of treatment, there has to be an opportunity for the courts to revoke it later.
My amendment would allow the revocation of a grant of a patent that is in breach of new section 4A. Since I tabled my amendment, the Government have tabled their own—a starred amendment, No. 15—which I am satisfied achieves the same result. I do not know whether it is in order for me to say that I would
be content, subject to your guidance, Mr. Amess, to make comments on the Government amendment, but I am happy with it because it seems to accept the principle of the point that I was making in my technical amendment.
I thank the hon. Gentleman for the way he moved the amendment and for showing his ability to scrutinise the Bill effectively by identifying a problem that needs to be resolved. I apologise for tabling amendment No. 15 so late that it affected our being able to discuss it this morning. In the spirit of what the hon. Gentleman said, I hope that the Government amendment, with the different wording that we prefer, meets his requirements.
I have nothing more to say, other than that I hope that the hon. Gentleman will withdraw his amendment in favour of ours. I acknowledge that there is concern about how the revocation procedure could take place. We do not want that to be so.
With your permission, Mr. Amess, we will return to this subject and give the detail an airing during our debate on schedule 2.