MUNICH

The prospects for a clarification of Europe's rules on the patenting of transgenic animals and plants brightened last week when the European Parliament's legal affairs committee approved — with amendments — a revised directive drawn up by the European Commission in Brussels.

The way is now paved for approval of the directive — which covers biotechnological inventions and allows the patenting of human genes, as well as of transgenic animals and plants — in the parliament's plenary session next month. An earlier draft directive was rejected by the parliament two years ago (see Nature> 374, 103; 1995).

Approval is expected despite a vociferous minority of members of the parliament, particularly those representing ‘green’ parties, who oppose the patenting of life on moral grounds. Others argue that the draft directive is important because it clarifies the European Patent Convention, the book of rules for the European Patent Office (EPO) which was drawn up before the advent of genetic engineering.

The convention explicitly excludes from patentability animal and plant ‘varieties’ — in order to protect plant breeders' rights — although animals and plants are patentable. This ambiguity has led to a two-year halt by the EPO in the issuing of patents relating to animals and plants that are the products of biotechnological inventions.

In 1995 an EPO board of appeals ruled against the issuing of a patent covering a procedure producing herbicide-resistant plants and the plants and seeds arising from the process to the Belgian company Plant Genetics Systems. The board argued that a transgenic plant represents a collection of plant varieties (see Nature 381, 178; 1996).

In consequence, the EPO has had to put on hold more than 1,100 applications for patents covering plants, and nearly 500 patents covering animals, until the law is clarified. It has put on hold any ruling in the appeal against its most high-profile animal patent application, the Harvard oncomouse.

The new wording in the draft directive, as amended by the legal affairs committee, states that “inventions which concern plants or animals may be patented if the practicability of the invention is not technically confined to a particular plant or animal variety”.

This wording clearly distinguishes species and varieties, says Christian Guggerell, an expert on biotechological inventions at the EPO. If used as a guide by the EPO, even though it is independent of the commission, it would allow the backlog of applications to be processed, he believes.

But first the EPO requires new case law of its own. The next case to be considered by an EPO board of appeals will probably concern an application brought by the company Ciba-Geigy now part of Novartis.

The board of appeals, which could rule as early as next autumn, could refer to the more precise wording on plants and plant varieties in the commission's draft directive to help it to interpret its own more imprecisely written rules.