In 1998, the EU parliament adopted the Biotechnology Directive in order to create a unified vision of what is patentable within biotechnology in Europe. The directive was implemented in Swedish law on 1 May 2004. As a result of the changes introduced, it is now clearer what is allowed to be patented in Sweden.

Patentable biotechnological inventions

• Methods for producing or analysing proteins and their use in an analysis method or in a medicinal product.
• Proteins, DNA sequences, microorganisms and constituents of the human body (for example, cells) which already exist in nature, if they are isolated from their natural environment or produced by a technical procedure, and have not been described previously.
• A gene, which is isolated and given a new task as a medicinal product or diagnostic tool.
• Genetically modified products, such as plants and animals.

Non-patentable biotechnological inventions

• Pure discoveries, such as discovered but not isolated or further described parts of animals, plants or microorganisms.
• Plant varieties and animal breeds. For a definition of plant variety, see chapter 1, section 3 of the Act on the Protection of Plant Breeders' Rights.
• Inventions that are contrary to public order or morality, which society regards as unethical and unacceptable. For example, it is not possible to patent a method for reproductive human cloning as it is contrary to public order and morality. Here you can find more information on biotechnology and ethics.

Invention or discovery?

Something that is only a discovery, such as the identification of a new gene, is not patentable. But if you have studied further what the gene's function is if it is used as a medicinal product or diagnostic tool, then it is an invention that can be patent protected. The protection is often defined as “isolated DNA molecules with (a certain) nucleotide sequence”. In other words, the protection cannot be said to cover DNA in nature, only artificial DNA molecules or DNA which is isolated from the human body and cut down to the piece you are interested in.

Plants and animals?

An invention relating to plants and animals can be patented, if the implementability of the invention is not limited to a certain plant variety or animal breed. Even a microbiological procedure and products of such a procedure, for example plants and animals, can be patented. However, methods consisting of biological procedures, such as cross-breeding and selection, for producing plants and animals cannot be patented.

Read more

Act on the Protection of Plant Breeders' Rights in Swedish (external website)

Boundaries for gene patents – EU Directive 2003/04:55 (external website)