Legal Uncertainty

Thomas Schweiger, Greenpeace European Unit - April 1999

The assault by the biotech industry on long established, existing rules on patenting has so far only created legal uncertainty. An immense number of cases are pending, there are contradictory rulings or no decisions at all, conflicting laws and competing international treaties. The legal frameworks are in a state of disarray and as yet it is undecided which side will win.

An overview

In 1973, The European Patent Convention (EPC), was concluded to create a common system for granting patents in Europe. Currently there are 20 Member States: the 15 EU countries plus Switzerland, Liechtenstein, Monaco and Turkey.

The European Patent Office (EPO) is the administrative body of the treaty, responsible for granting patents. The EPC and EPO are completely separate from the EU institutions. The EPC prohibits the patenting of discoveries, and explicitly the patenting of plant varieties and animals (Art.53b EPC). But despite these provisions, the EPO started granting patents on plants and animals in the early 1990s In 1995 Greenpeace brought a case against a patent on GM plants granted to PGS.

The EPO's Court of Appeal confirmed in its ruling that plant varieties could not be patented. Consequently, patents on animals and plants were no longer granted. In 1998, in response to pressure from the biotech industry, the European Union enacted a Directive which explicitly allows the patenting of living organisms, such as plants and animals (Directive 98/44/EC on the legal protection of biotechnological inventions).

The provisions of the EU-directive on the patenting of living organisms are thus in direct conflict with those of the EPC. The EU-directive is in no way binding for the EPO. In 1999 the Administrative Council of the EPO decided to incorporate the provisions of the EU Directive into their Implementing Regulations. These Regulations are designed to interpret the treaty and guide patent examiners as to when and how to grant patents.

Since the Implementing Regulations copy the EU Directive concerning patents on living organisms, they now stand in conflict with the text of the EPC concerning the patenting of plant varieties and animals. The legal basis for this decision is unfounded. There is a clear provision in the EPC which says that the treaty language of the EPC takes precedence over the Implementing Provisions (Art 164(2)EPC). In addition, the Administrative Council has no legal mandate to adopt substantive changes of patent law. Despite this, as of 1 September 2000 and following these Implementing Regulation, the EPO has again started to grant patents on living organisms .

The European Union's "Life Patent Directive" ("Directive on the legal protection of biotechnological inventions"), first conceived in 1988, eventually came into force in 1998 as Directive 98/44/EEC (OJ L 213, 30/07/1998, p.0013-0021). It explicitly allows patents on plants, animals and parts of the human body and is thus in contradiction with the rulings of the EPO. EU Member States will have to implement this Directive in their national patent laws, which are based on the EPC, but will find it difficult to accommodate the contradicting contents of both the Directive and the EPC. In addition, the European Court of Justice (ECJ) has yet to rule on the legality of the Directive and may revoke the whole Directive or change parts of it.

The WTO/TRIPs (Trade Related Aspects of Intellectual Property Rights) Agreement is the international treaty which deals with patents on a global level. Article 27(3)b allows for plants and animals to be excluded from patentability under certain circumstances. This Article is being reviewed in 1999 and pressure is mounting from all sides. The industry and the US Government want this exclusion to be deleted, thus forcing the world to accept patents on plants and animals, while the developing countries of the South want the Article to remain in place or even be extended. The position of the EU, with its internal unresolved legal uncertainty, is unclear.

The Convention on Biological Diversity (CBD), signed at the "Earth Summit" in Rio de Janeiro in 1992, is seen by many as being in direct conflict with the TRIPs Agreement as the CBD grants sovereign rights over their biodiversity to the member states, which contradicts patenting.

The International Union for the Protection of New Varieties of Plants (UPOV) is also an international, legally binding treaty, established in 1978, which prohibited the patenting of plant varieties. Its aim was to assure free access to plant varieties for plant breeders so that they have the opportunity to breed or develop new, better plant varieties and crops. Patents would block this essential free access. However, this Convention is also under pressure and subjected to dramatic change. In 1991, a new version was drawn up ("UPOV 91") which would no longer prevent patents on plant varieties. Since many countries, especially from the South, object to this idea, it has not yet been ratified by a large enough number of countries to enter into force.