biopharmaceutical patents

For pharmaceutical companies, the development of effective and binding patents is often key to their efforts to successfully bring new products to the market. However, it is an understatement to suggest that the area can be a complex one.

This is particularly true when it comes to biological patents, or biopatents. It is often seen as difficult to design such documents, particularly as very few first time examples have been successful. However, the benefits of getting it right initially are potentially lucrative, as refusals can prove to be expensive for manufacturers in terms of revenue lost.

Such issues could soon rise in profile, as a major project has been launched in the UK which looks set to highlight compounds and genetic issues that organisations are keen to patent as they look to develop new products.

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Global health charity the Wellcome Trust is behind the scheme, which is aimed at decoding the genomes of 10,000 people over the next three years. Launched to coincide with the tenth anniversary of the completion of the first draft of the human genome, the UK10K programme will be one of the largest of its kind ever undertaken. The aim is relatively simple – to uncover rare genetic variants that could play a key role in human diseases and potentially lead to new treatments.

Dr Richard Durbin, principal investigator on the project from the Wellcome Trust Sanger Institute, said: "Although genetics over the past five years has yielded a rich harvest of hundreds of variants associated with disease, much more remains to be discovered.

"With this award, we are seizing the chance to use technological advances in DNA sequencing to find variants that have even greater consequence for health."

While the benefits of the scheme appear obvious, the launch has also once again shone a spotlight on the use of biopatents, particularly in relation to genes. Debate around the issue has rumbled on for some time and came to prominence once more in the US recently when a verdict was given over the use of isolated DNA sequences in patents owned by Myriad Genetics.

Speaking at the launch of the new Wellcome Trust initiative, biologist John Sulston suggested that it is vital that genetic information of any form is not included in patents, as it could impact on the ability for some people to receive the medication or help they need.

According to the Guardian, the expert, who led the British contribution to the Human Genome Project, said: "The fact of the matter is that many human genes have patent rights on them and this is going to get in the way of treatment, unless you have a lot of money. And it's going to get in the way of research."

He explained that he is firmly in support of genetic manipulation tools being in the public domain. "This is not just a philosophical point of view, it's actually the case that monopolistic control of this kind would be bad for science, bad for consumers and bad for business, because it removes the element of competition," he added.

The ethical debate around biopatents in relation to DNA sequencing is likely to rage on for some time, making the design of such documentation a difficult area for many firms to fully understand without expert help. However, the issue will not take anything away from the important role the new UK10K project will play in building on past genetic advances.

Sir Mark Walport, director of the Wellcome Trust, clearly outlined his hopes for the scheme. He said: "The involvement of clinicians, researchers and, most importantly, the thousands of people who have donated DNA samples, will help us to correlate genetic variation with individual variation in health and disease, and help to deliver on the long-term promise of the Human Genome Project."

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