BioWorld International Correspondent

BRUSSELS, Belgium - New data released here last week confirmed that the European Union is continuing to lag behind the U.S. on biotechnology patents.

A report from the EU's research services, titled "Key figures 2003-2004," reveals that even on their home territory, EU firms are beaten heavily by U.S. firms in obtaining patents on biotechnology inventions: U.S. firms obtained "a massive" 45.3 percent of biotech patents issued by the European Patent Office in the period assessed by the study, compared to just 34.2 percent by firms in the 15 current EU member states. And even if the firms in the 10 incoming member states were taken into account, the total European share of EPO patents rises only to 34.5 percent.

By contrast, U.S. firms dominate their home territory, with 71.8 percent of biotech patents issued by the U.S. Patent Office during the reference period, compared to just 12.8 percent by the 25 current and future EU member states. The same trend is apparent in "triadic" biotech patents, where protection is obtained simultaneously through the European, U.S. and Japanese patent offices. Those 25 EU states managed just 25.2 percent of the total of triadic biotech patents obtained, while U.S. firms held 53.5 percent.

The EU has a lower share of biotech patents than it does of patents as a whole, the new study reported, attributing the gap to "a relative lack of specialization" in biotechnology. Only Belgium, Denmark and the UK have a larger share of biotech patents than their share of total patents - for example, Denmark has 0.3 percent of USPTO patents as a whole, but 1.2 percent of USPTO biotech patents.

The European Union's senior official responsible for research, Commissioner Philip Busquin, said as the figures were released that it was a "bleak picture." Weakening growth in investment and the increasing brain drain from Europe were major threats to the EU's research base, he warned. The brain drain of people born in the EU is increasing, the study also confirmed. About 75 percent of EU-born U.S. doctorate recipients who graduated between 1991 and 2000 had no specific plans to return to the EU, and more and more are choosing to stay in the U.S. - mainly, they say, because of the quality of work, better prospects and projects, and easier access to leading technologies. Busquin urged EU member states and industry to upgrade their research efforts: "No more lip service: We need action - now," he declared.

Ministers Remain Divided On Stem Cell Research

European Union ministers failed to reach agreement last week on whether to fund stem cell research when they met here to discuss the issue again. The enthusiasm for easing the restrictions on stem cell research shown only days before by most members of the European Parliament was not shared by most ministers.

Strong opposition was expressed by Germany, Austria, Italy, Portugal and Luxembourg, and caution by Spain and Ireland. Only the UK, the Netherlands and Greece expressed strong support for EU funding for that area of research. Meanwhile, the EU's administration, the European Commission, also has flatly refused Parliament's request to ease access to supernumerary embryos. It insisted last week that the cutoff date it had proposed should be retained, so that only stem cells from human embryos conceived prior to July 2002 (when the EU's six-year research program was legally adopted) might be used. EU ministers decided to meet again today in a last-ditch attempt to resolve the matter before the end of the year.

Fischler Reassures Bulgarian Farmers

Franz Fischler, European commissioner for agriculture, offered renewed support for biotechnology when he spoke in Bulgaria at the end of November. "Whilst we in Europe are often quick to vilify biotechnology, there are no two ways about it - it is becoming more and more commonplace and, managed responsibly, it also has enormous potential," he told farmers in the country now bidding to become a part of the European Union.

Fischler reassured them that it was not the role of the EU to take over all national decisions. On the currently contentious issue of co-existence between GM crops and traditional agriculture, for instance, he said: "We in Brussels should step back a few paces to allow national and regional authorities to determine what is the most efficient and cost-effective method of preventing the admixture of GM and other crops.

And, he went on, "The EU has no power when it comes to private liability law, so it is up to the EU's member states to explore the possibility of providing insurance schemes that cater for the accidental admixture of GM and non-GM crops."

Agency Consults On Manufacturing Issues

The European Agency for the Evaluation of Medicinal Products released for consultation a draft note for guidance on comparability of biotechnological and biological products when there are changes in their manufacturing process. It would require manufacturers to demonstrate that changes do not make new nonclinical or clinical studies necessary.

The proposal emerged from the process managed by the International Conference on Harmonization of drug regulatory authorities, which brings together the U.S., Europe and Japan. The industry and other interested parties have until May to respond.