Hamburg, Germany - Following a decision by the Administrative Council of the European Patent Organization, the European Patent Office (EPO) will start granting patents on biotechnological inventions on Sept. 1. In accordance with the European Biotech Patent directive human cells and genes will be included as well as genetically modified organisms.

The measure by the Administrative Council was taken to adapt the EPO rules to the European Union's directive on the legal protection of biotechnological inventions adopted by the European Parliament in June 1998. (See BioWorld International, June 24, 1998. p. 1.).

Under the new regulations, patents will be granted on genetically modified plants, animals and micro-organisms as well as on human cells and genes provided the industrial application of a sequence or a partial sequence of a gene is disclosed in the patent application.

However, European patents will not be granted on methods for cloning human beings, modifying the germ line genetic identity of human beings, on processes for uses of human embryos for industrial or commercial purposes, or on processes for modifying the genetic identity of animals that are likely to cause them suffering without any substantial medical benefit.

For the European biotech industry the decision comes as a relief, as about 100 pending patent applications are expected to be decided on soon.

However, while the decision clarifies the blurred situation in general, there remains uncertainties. Following Greenpeace opposition to a patent granted to Plant Genetic Systems and Biogen Inc. for genetically engineered herbicide-resistant plants, the Technical Board of Appeal of the Munich-based EPO had decided in February 1995 "that patent claims for genetically engineered plants, seeds and their progeny are not allowable under the [European] Patent Convention." The board stated that granting patents on plants was an unlawful circumvention of the Patent Convention's provisions that patents on plant varieties could not be granted.

Since then, the EPO has rejected patent applications for genetically engineered plants. Following a rejected patent application for a transgenic plant by Novartis AG, however, the case was brought to the Enlarged Board of Appeal, which will make a decision in spring 2000.

Although the decision of the Administrative Council is binding for the Enlarged Board of Appeal in general, the board can reconsider the implementing regulations. If it rules these regulations are not in accordance with the European Patent Convention, the European Patent Organization member states would have to enter into protracted diplomatic negotiations and a ratification process again.

In addition, the Netherlands, Italy and Norway challenged the controversial European Patent directive and filed a nullity suit at the European Court of Justice, which is still pending.