Gene code patents may face Commission curbs

Date: 08/05/02

By Laurence Frost

COMPANIES may have their right to patent parts of the human genetic code restricted under a European Commission review into the rules governing intellectual property and naturally occurring DNA.

The executive is drawing up new proposals on implementing a controversial 1998 directive on biotechnology inventions, amid concern that granting exclusive rights to DNA damages both innovation and access to health services.

Ten out of 15 EU member states are already facing infringement proceedings for failing to implement the directive, almost two years after the deadline passed for transposing it into national law.

Philippe Busquin, the research commissioner, wants to see the scope of intellectual property protection toned down under the review, to be tabled next month by his internal market counterpart Frits Bolkestein.

Busquin's spokesman Fabio Fabbi said the new rules should 'strike a balance' between the protection of intellectual property and other concerns. 'If we protect too much then we risk blocking the innovation process,' he added.

Under current patent rules, any company that 'isolates' a human gene and invents a use for it can be granted exclusive rights to the gene itself.

No other firm or institution can then use the naturally occurring DNA - even for a different purpose using its own techniques - without paying the patent holder for a licence.

A scientific advisory panel set up by Busquin raised serious concerns about the current legal regime in a November 2001 statement.

MEPs and scientists have also voiced alarm over a decision by the Munich-based European Patent Office (EPO) to grant US firm Myriad Genetics exclusive rights to the 'breast cancer gene' (European Voice, 2-8 May).

The intergovernmental, non-EU body is still considering the firm's application to patent a second gene used to identify patients with a high risk of developing the condition.

Bolkestein's spokesman Jonathan Todd confirmed that the review would make recommendations on the scope of future genetic patents - until now a decision taken by EPO lawyers.

'We can't change the substance of the directive but we can give guidance as to how we think it should be interpreted,' said Todd.

But he warned that the Commission would launch legal action unless all EU governments implemented the directive soon after the guidelines were issued. 'If they don't we will be moving fairly rapidly to the second stage of infringement proceedings,' he said.

Any move to weaken genetic patent protection is likely to be fiercely opposed by biotech firms, whose European industry association Europabio insists the current regime is fair.

Companies may have their right to patent parts of the human genetic code restricted under a European Commission review into the rules governing intellectual property and naturally occurring DNA.