BRUSSELS, Belgium - No new developments in the field of biotechnology justify a review of the European Union rules on patenting biotechnology inventions, the European Commission is insisting, as it tries to hold the line against another assault on the rules it has put in place.
There were "lengthy and thorough discussions" before agreement was achieved on the 1998 directive on legal protection of biotechnological inventions, according to Frits Bolkestein, the European Commissioner responsible for single market legislation. "Much consideration was given during these discussions to the ethical considerations surrounding biotechnological inventions," and the resulting directive "seeks both to address these ethical considerations and to provide the necessary incentives to encourage research and development in the area of biotechnology."
Bolkestein was answering accusations from French Socialist Euro-MP Marie-Noelle Lienemann that current EU law was "wide open to all manner of abuse, depending on the interpretation placed on the relevant texts - and it is commercial logic that is likely to prevail." The Euro-MP claimed, "In an area of human knowledge as fast moving as this one, a review of the relevant legislative texts should be arranged promptly, even if the current versions of those texts were drawn up only recently."
She said it "would be appropriate fundamentally to review the parts of the directive relating to the patentability of human genetic code sequences," as a response to "the civic movements that are developing and the reaction of the scientific community," as well as the UK-U.S. agreement seeking to prohibit commercialization of the human genome. "The prospect of lucrative spin-offs from research will be allowed to ride roughshod over basic principle, because any element of the human body will be considered as patentable as soon as it has been isolated and related to a function," she argued.
But the commissioner dismissed her arguments. Even the UK-U.S. joint statement calling for the basic raw data on the human genome to be made freely available "also recognized that intellectual property protection for gene-based inventions has an important role in stimulating the development of important new health care products," Bolkestein said. He spelled out the distinction the directive makes in this respect. Discoveries, which do not extend human ability, but only human knowledge, are by their very nature not patentable. The mere sequencing of a genome, which belongs to the area of discovery, cannot take advantage of patent protection, he said.
But if a DNA sequence is released from its natural surroundings or is produced via a technical procedure, and is made available for the first time to an industrial application, "there is a step taken from knowing to being able. Such a gene is new in the patent sense and therefore patentable." This is why EU rules allow patents for inventions comprising, or based on, gene sequences, he pointed out.
However, the Commission said it already plans to report in July 2001 on patent developments in biotechnology and genetic engineering, which "will help to ensure that the scope of the directive remains relevant to this fast-moving area of technology."