Biotech patent report derailed yet again

By Anna McLauchlin

Date: 10/11/04

A EUROPEAN Commission report on patenting biotechnology inventions has been delayed, to the disappointment of EU biotech companies who were hoping it would bring more regulatory certainty to their work.

The report was supposed to clarify which gene-based inventions can be patented under the 1998 EU biotech patents law.

Biotech companies argue that such patents are vital to attract investors and protect their investment.

The European Commission was supposed to adopt the report in November 2003, but it was blocked by disagreement within the EU executive.

It was then to be adopted on 29 October of this year, at the last meeting of the Prodi Commission. But when the incoming Commission was withdrawn on 27 October it was shelved once again.

"All the industry needs is legal certainty," said Johan Vanhemelrijck, secretary-general of the European Association for Bioindustries (EuropaBio).

"The biotech patents directive should have given this certainty but it needed clarification which might have been in the report. This further delay is not sending a good message to the industry."

The biotech patents directive allows companies to patent gene sequences and inventions related to the more sensitive issue of stem cells.

But there has been concern that the law does not draw a sufficiently clear line between what can and cannot be patented. Because of the controversy, most EU countries have failed to get the law through their national parliaments.

Intended to be implemented by the end of July 2000, the law has yet to come into force in 11 member states.

The European Court of Justice has already declared six member states in breach of EU law - Greece, France, Luxembourg, Belgium, Germany and Austria - and cases are still pending against Sweden, Italy and the Netherlands.

According to the report that would have been adopted on 29 October, the Commission will launch a consultation process to see whether further legislation is needed to determine what stem-cell inventions can be patented, in the hope that this will make the law easier to implement at national level.

The most controversial point is whether the directive should allow the patenting of inventions relating to 'therapeutic cloning', whereby researchers cultivate cells with the same genetic information as the person into whom they will be implanted.

But with the new Commission, the plans may change again. Vanhemelrijck says the delay is one of several issues hindering EU biotechnology companies.

"It's typical of the 'EU illness' that affects legislation and all the time Europe is losing business because of it," he said.

"The approval process for plant biotechnology takes too long, the approval process in the health care biotech directive is too expensive and there is no common EU patent.

"It's not surprising so many companies are heading to the US."

According to EuropaBio, the US biotechnology industry has three times more revenue and twice the number of jobs than in the EU, despite having 30% fewer biotech companies.

But opponents of 'live' patenting argue that it prevents further innovation.

The German Green MEP Hiltrud Breyer, who voted against the biotech patent proposal, said that research institutes had protested that patents would make research too expensive for them.

"And you don't know who owns the gene and who you have to pay licence fees to," she said. "That's why member states have not been able to implement the directive, because it should not be possible to patent human parts."

A European Commission report on patenting biotechnology inventions is expected to bring more regulatory certainty to the work of EU biotech companies. Due to internal discrepancies it was neither adopted in November 2003 nor at the Prodi Commission's last regular meeting on 29 October 2004.

European Commission: DG Internal Market: Industrial Property: Biotechnological inventions http://ec.europa.eu/comm/internal_market/en/indprop/invent/index.htm

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