BRUSSELS, Belgium — Better patent protection for biotech products in Europe has come another step closer with the adoption by the European Union (EU) Council of Ministers of a common position on the subject.
The council — made up of national ministers from EU member countries — said last week the European Commission's 1996 draft directive on biotech patents is headed along the right lines, and most of the European Parliament's suggested amendments last year are acceptable.
The biotech industry has welcomed this latest stage in the long process of improving the protection of biotechnological inventions in Europe — a process that dates to the late 1980s.
The Forum for European Bioindustry Coordination (FEBC) — a coalition of the dozen principal industry sectors in Europe that make use of biotech — said Monday the council's common position "represents a balanced position" and urged rapid completion of the legislative process.
The final stage, procedurally, is for the European Parliament to give the common position a second reading. If all goes to plan, the final EU seal could be put on the new rules by July 1998.
The new text will not deliver everything industry might have wished. It is a political compromise among many conflicting views. But if approved, it will bring some much-needed certainty to patent protection and will offer broader scope for covering inventions.
Inventions focusing on plants or animals will be patentable if the technical feasibility of the invention is not limited to one plant variety or a specific animal species. This means that it will be possible to deliver patents for inventions susceptible to industrial applications, even when they apply to a product containing biological material, or to a procedure for producing, processing or using biological material.
And biological material separated from its natural environment or produced via a technical procedure may form the subject of an invention, even if it preexisted in the natural state.
Crucially, an element separated from the human body or produced by a technical procedure may constitute a patentable invention, provided the industrial application is clearly specified in the application for a patent.
The new text will designate certain inventions as non patentable — but accepting some limitations is the price the industry is prepared to pay to bring some certainty into this tangled European domain.
Human Cloning Not Patentable
Excluded areas include inventions of plant varieties and animal species; essentially biological procedures for the production of plants or animals; and the human body at any stage of its constitution or development, or simple discovery of its components, including the sequence or partial sequence of a gene.
Another clause prohibits patenting inventions for commercial use that would be contrary to public order or morality: in particular, this applies to procedures for cloning humans and to the use of human embryos for industrial or commercial purposes.
Also excluded are procedures for modifying the genetic identity of animals that could cause suffering without any medical benefit for man or animals, and animals produced using such procedures.
The text that has won council endorsement also requires informed consent to be obtained if the invention concerns biological material of human origin, or if it uses this material. An indication of the geographical origin of the biological material of plants or animals also must be specified.
In addition, the text provides for creation of an independent ethics committee to consider all ethical aspects of biotechnology and its use.
In its comments, the FEBC stressed that the council decision "represents an important and positive signal" from the member states on the European Commission's proposal, which was amended last year to take account of many of the suggestions that emerged from the European Parliament's first reading of the proposal.