BRUSSELS, Belgium - The long-awaited and hard-fought European Union (EU) directive to boost biotech patent protection in Europe is already having an effect, say European Commission officials.
The new rule has now been formally adopted at the EU level, and the 15 member states have until July 30, 2000, to bring their national legislation into line with it. However, the law requires member states to take the directive into account when applying national law - even before it becomes directly applicable - according to Dominique Vandergheynst, one of the EU officials responsible for the directive.
Vandergheynst told an industry meeting in Brussels on Sept. 17 that member states are also prevented from taking any measures which could compromise the directive's objectives - including measures in the states' negotiations with non-EU countries. In addition, he said, it is “unthinkable“ that national governments and courts in the EU reach decisions which contradict the spirit of the directive.
Industry continues to welcome the directive, which is seen as putting an end to years of uncertainty in Europe over the protection of biotechnology research. Speaking for London-based SmithKline Beecham plc at the same meeting, European patent attorney Bill Tyrell said the form of the directive was “a victory for common sense,“ particularly because, on one of the key issues - that is, allowing the patenting of materials of human origin, the provisions were not weakened in the drafting process, and therefore give due emphasis to the importance of DNA research in finding cures for presently incurable diseases.
Problems may still lie ahead for industry in the transposition of the directive into national law, because some member states have a generally poor record on respecting legislative deadlines, and because this politically controversial measure may well suffer additional delays at the national level. The European Commission is trying to keep the process on track, and intends to organize a conference of member states in January 1999 to discuss implementation plans.
Another problem arises from the effect of the directive on the European Patent Convention (EPC). It is widely recognized that some amendments will be necessary - particularly with regard to the patentability of transgenic plants and animals, currently exempt from patentability. According to Christial Gugerell of the European Patent Office (EPO), there is a clear intention to adapt the EPC to the directive in all instances where this is necessary. And, he told the Brussels meeting, most changes can be easily accomplished through changes by administrative means. But a change in the articles themselves requires a diplomatic conference, and it is questionable whether this change can be accomplished by the time the directive takes effect.
Other problems will continue to arise from divergences among patent practices on biotechnological inventions at the international level. Some efforts at harmonization are being made. The Japanese Patent Office in particular recently has published a new set of examination guidelines aimed at harmonizing its examination practice with those of other patent offices, such as the U.S. Patents and Trademarks Office (USPTO) and the EPO.
But many differences in law and patent office rules remain, so the day when a single application will result in worldwide protection for a biotechnological invention is still a long way off, the meeting heard.
Meanwhile, transgenic patent numbers in the U.S. continue to climb. According to the USPTO, 103 patents for transgenic animals have so far been issued, with 136 applications allowed by examiners. Applications currently being processed total 231. John Doll, director of biotechnology at USPTO, expects the number of issued patents to be more than 200 within the next six months. The patents so far issued cover 89 mice, three rats, three rabbits and one each of sheep, pig, nematode, bird, fish, guinea pig, abalone and cow. *