Patents Bill

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Paul Flynn (Newport, West) (Lab): 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.

Mr. Sutcliffe: 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

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on the mechanisms. The hon. Members for Weston-super-Mare and for Gordon (Malcolm Bruce) are clearly concerned about the scope of gene patenting and want to amend clause 1 as a result.

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

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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.

Brian Cotter: 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.

Mr. Arbuthnot: I beg to move amendment No. 1, in clause 1, page 1, line 20, at end add—

'(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

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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.

The Chairman: Order. It would be more in order to make fuller comment on that amendment when we come to it.

Mr. Sutcliffe: 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.

Mr. Arbuthnot: I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 1 ordered to stand part of the Bill.

Clauses 2 and 3 ordered to stand part of the Bill.

Clause 4

Revocation

11 am

Brian Cotter: I beg to move amendment No. 11, in clause 4, page 3, line 7, at end insert—

'(2) In section 73 of that Act after subsection (3) there is inserted—

(4) The comptroller shall not take action under subsections (1) or (2) later than six months after the grant of a full patent unless the action falls within section 2 subsection (4).

(3) In section 74 of that Act in subsection (1) after ''in issue'' insert ''within six months of the grant of a full patent''.'.

This is another issue of great importance. Hon. Members will note that the key part of the amendment is the insertion of ''six months''. Under current law, if a small business's patent is infringed, it can approach the alleged infringer and request it to pay licence fees for exploiting an invention. However, the alleged infringer may be a larger company. Many of the issues that I raised on the Floor of the House concerned the great difficulty faced on a range of issues, but particularly patents, by small businesses, which are often a David taking on a Goliath.

If the alleged infringer is a large company, it is likely to issue a counter legal claim questioning the validity of the small firm's patent. It is estimated that about 80 per cent. of time spent on patent cases in court is spent questioning the validity of a patent, rather than on its infringement. That is because a larger company is

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often backed by a team of expert intellectual property lawyers. In debate in the House, I put forward the example in which a judge put up his hands in horror at the costs involved in a fairly simple case that ran for four days; it was £80,000, I think, or perhaps a lot more—a large figure, anyway.

Large companies are often backed by a team of experts and are able to pursue matters with intellectual property lawyers who have great expertise. Such companies have the time and money to spend hour upon hour in court presenting even the most spurious arguments to undermine the validity of the patent that they are alleged to have infringed. That is of grave concern. If a small firm loses such a case, and its patent is ruled to be invalid, it may be liable to pay the other side's court costs, which is another issue of grave concern. It is therefore unsurprising that many small firms drop their infringement cases before they even get to court. In paying for a patent in the first place, a small business should have the right to assume that the Patent Office has done its work thoroughly and has ensured that there are no other such inventions in existence before establishing a patent as valid.

The amendment would introduce a six-month time limit after a patent is adopted during which any party could challenge its validity. After that, the validity of the patent could no longer be questioned in court. There would be two benefits. First, the amendment would give small firms more certainty. It would reassure them that, in using the patent process, they were acquiring for their invention a protection that really meant something and that the validity of their patent would not be challenged years down the line.

Secondly, the amendment would encourage people to keep an eye on the patent process and on which patents had been granted in their field. According to the Patent Office, 30 per cent. of money spent on research and development is wasted on developing ideas that have already been patented. Introducing a six-month limit would encourage companies to keep a closer eye on developments in their field, and thus to save money on unnecessary R and D. I would be pleased if the Minister accepted this key amendment.

 

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Prepared 15 June 2004