End of an era for DNA patenting

[Guest guest]

End of an era for DNA patenting

http://www.news-medical.net/?id=21788

Human DNA patents are unlikely to be the barrier to medical and

scientific innovation that they were first feared to be, according

to new findings published this week.

In fact in recent years new guidelines at patent offices, legal

developments, commercial sentiment and the growing volume of genetic

information in the public domain have together raised the bar on

patentability of genes and other genetic material.

In particular, rigorous examination and prohibitive costs are

discouraging speculative patent applications in Europe.

The findings are the result of 18 months of research funded by the

European Community and carried out by Dr M Hopkins, Dr Surya

Mahdi, Mr Pari Patel and Professor Sandy M at SPRU - Science

and Technology Policy Research, at the University of Sussex, UK.

The race to patent human DNA began in the 1980s, when scientists in

industry and academia started unraveling the human genetic code,

culminating in the publication of a full draft of the human genome

in 2001. As the human genome project published its results, so

biotech businesses, pharmaceutical companies, and universities

rushed to file patent applications to protect their stake in a fast-

developing field. This stoked fears that DNA sequences important for

research into the causes of disease such as cancer or diabetes would

no longer be available for study, or that resulting drugs and

diagnostics might only be available at excessive prices.

The authors identified 15,600 cases of inventions where patents had

been filed claiming human DNA sequences (tiny strands of genetic

material) at the world's leading Patent Offices in the USA, Europe

and Japan.

They then interviewed patent holders - including some of the world's

leading pharmaceutical companies - to find out what they intended to

do with their patents. Their findings include:

To date, just one third of these inventions have actually been

granted patents by one of the three patent offices studied - others

were refused, have still to be processed or have been withdrawn by

the applicant because the invention was considered to be no longer

technically or commercially viable.

The US patent office has granted far more of these patents, which

has led to concerns in the USA about access to research and

diagnostics, particularly for some cancers. By contrast the patent

offices in Japan and Europe have only granted between 3% and 5% of

patent applications. Furthermore researchers in Europe benefit from

laws which allow the use of this knowledge for non commercial

research without patent infringement.

Patent examiners are more stringent, particularly in Europe and

Japan, in rejecting applications that aren't supported by sufficient

biological evidence.

Commercial interest in DNA patent applications remains, but

increasingly the DNA is just a part of a more complex invention.

Overall, such filings are likely to be made in much lower numbers

than seen in the past.

Professor says: " A combination of policy change and

developments in the commercial and scientific environment means that

obtaining patents on DNA sequences has become generally more

difficult and in some cases less commercially attractive. We believe

these changes are in the interests of academic and commercial

researchers, as well as patients. "

Dr Hopkins says: " Patents are still necessary, however, as medical

research is expensive and society needs to reward and encourage

ingenuity. Developing a drug, for example, costs several hundred

million dollars. Patent offices have focused increasingly on giving

due rewards while rejecting overly broad or frivolous applications. "