Biotech Patent Directive
This article was originally published in RAJ Devices
Executive Summary
Sweden issues draft law to implement EU directive
Sweden issues draft law to implement EU directive
The Swedish government has issued a legislative proposal in order to implement EU Directive 98/44/EC on the legal protection of biotechnological inventions1. The proposal, which has been referred to the parliament (Riksdagen) for approval, would amend the current Patent Act (SFS 1967:837) and the Act on protection of plant breeders’ rights (SFS 1997:306). If approved, it would come into force on 1 May 2004.
Under the current Swedish Patent Act, it is possible to patent DNA sequences related to human, animal and plant genes. In the proposal, there is no intention to expand the scope of biotechnological inventions that are legally protected. Rather, the aim is to make the regulations concerning the patenting of biotechnological inventions more stringent. In summary, the amendments are as follows:
- ? the border between discovery and invention will be clarified;
- ? the human body (or parts of human bodies) cannot be patented in their natural condition. The amendment is intended to protect the dignity and integrity of human beings;
- ? a gene must have a concrete industrial use (eg manufacturing of medicinal products) outside the body for fulfilling the requirements for patentability. It will not be possible to patent only the discovery of a gene;
- ? the existing clause that prohibits the patenting of inventions for which the patent's professional use would go against public interest and good ethics, is supplemented with examples of inventions that can never be patented, eg methods for human cloning or changes to the genetic identity of human reproductive cells; and
- ? in the application it will be mandatory to provide the geographical origin of biological material from the plant and animal kingdom, which is referred to or used in an invention. This will facilitate the control of regulations and agreements of fair distribution of the profit to the genetic sources.
The Swedish government will appoint a group consisting of various representatives of the public, which will focus on following the development and evaluating the need for future adjustment of the regulations. The group will also assess the need for actions in order to avoid negative effects for the health and welfare system and the research community in Sweden.
Background
In July 2003, the European Commission announced that it had referred Sweden and seven other EU member states to the European Court of Justice for their continued failure to implement Directive 98/44/EC, despite the Commission's efforts to cooperate closely with these countries to accelerate the implementation procedure. Member states were required to transpose the directive into national law by 30 July 2000.
INGEGERD WENNERBECK
References
1. Lagrådsremiss. Gränser för genpatent m.m.- genomförande av EG direktivet om rättsligt skydd för biotekniska uppfinningar, 13 November 2003