BioWorld International Correspondent

BRUSSELS, Belgium - Europe will fall behind its competitors if intellectual property for biotechnology is not better covered, the European Commission said in a statement Thursday. The Commission was commenting on a new report it compiled on the state of protection for biotechnology inventions in Europe, released the same day.

The conclusions of the report stress the need for all member states to "fully and swiftly" implement the 1998 directive on the legal protection of biotechnological inventions. Otherwise, Europe's prospects will be damaged "in this crucial sector," it said.

So far, only six member states have transposed the EU directive into their national legal systems: Denmark, Finland, Ireland, the United Kingdom, Greece and Spain. The legal deadline for implementation was more than two years ago.

"Given the considerable amount of high-risk investment that is often required in biotechnology, particularly genetic engineering, adequate patent protection is essential to encourage the investment required to create jobs and maintain EU competitiveness," the Commission said.

The report highlights four provisions of the directive that have proved contentious and have delayed national implementation in many EU countries: compatibility with international agreements, patentability of plants and animals, patentability of elements isolated from the human body or otherwise produced, and exclusions from patentability.

To help push the process forward and to overcome the resistance still impeding national action in many member states, the Commission will, in November, set up a group of experts in economics, law and natural sciences to examine controversial issues linked to biotechnology patenting and to help it prepare future annual reports. It will focus on the scientific, legal and economic aspects, leaving the ethical questions to other EU bodies already studying those aspects.

Two of the Commission's most senior officials lent their weight to the conclusions. Dutch Commissioner Frits Bolkestein, responsible for the EU's single market, said, "A clear and equitable patent regime applied consistently across the EU is crucial if we are to exploit fully the medical, environmental and economic potential of biotechnology." He said that without full implementation of the directive, "Europe's biotech sector will be working with one hand tied behind its back and will fall further and further behind."

And Belgian Commissioner Philippe Busquin, responsible for science and research, added, "Patent law has a direct impact on research and innovation - and the progress of research has an impact on patent law."

The Commission's report is the first in a series of annual reports looking at the development and implications of patent law in the field of biotechnology and genetic engineering. It also elaborates on some of the controversial issues currently under discussion at the international, European and national levels. It identifies two areas of particular interest for more detailed analysis: the scope for patents related to sequences or partial sequences of genes isolated from the human body, and the potential patenting of human stem cells and cells lines obtained from them. It estimates that by 2005 the European biotechnology market could be worth over €100 billion.

EuropaBio, the European industry association for the biotechnology industries, greeted the report with acclaim. Bo Hammer Jensen, chairman of the intellectual property working group at EuropaBio, said the issues covered by the report "do not provide any basis for delaying the implementation" of the EU rules by the member states.

"It is high time now that this important tool for protecting our innovations is put in place in all member states," said Hugo Schepens, EuropaBio secretary general. "Entrepreneurs and researchers in the EU need the best and simplest patenting tools possible. Without them, you cannot be serious about the knowledge-based economy."

EuropaBio also offered its cooperation to the new group of EU experts in assessing the further issues identified by the report.