Patenting of biotechnology

If the requirements for obtaining a patent are met and the invention is not covered by any of the exceptions in the patent law, then you can patent such inventions. The requirements are that the invention must be new, inventive, and industrially applicable.

A more detailed description of the provisions governing the patenting of biotechnological inventions can be found in Sections 1-1b, 8a-c and 15a of the Norwegian Patents Act (patentloven), as well as in the Examination Guidelines (patentretningslinjene), part C, chapter IV, points 2a-2a.11, see links at the bottom of the page.

It is possible to obtain a patent for inventions that regard plants and animals, as well as methods for the production of plants and animals that are not exclusively biological.

Plants and animals can be patented if the use of the invention is not technically limited to a specific plant variety or animal breed. For example, you can obtain a patent for a genetically modified plant that is characterized by a high tolerance for cold, provided that the characteristic is not limited to a single plant variety.

Plant varieties, animal breeds and essentially biological methods cannot be patented

The term "essentially biological method" includes methods that contain or consist of the crossbreeding of entire plant or animal genomes with subsequent selection. Such methods are exempt from patenting even if they also contain steps of a technical nature.

Plant breeder’s right

In countries that are members of the international convention on the protection of new varieties of plants, the UPOV convention, to which Norway is also a member, protection is granted in accordance with the national law on plant breeders' rights. This act is administered by The Plant Variety Board, the State's supervisory institution in agriculture.

Discoveries of biological material that you find in its natural environment should be considered unpatentable.

Biological material that has undergone some form of processing, for example an isolation process, can be patented if the material can be used to solve a technical problem. This also applies to human material.

Technical inventions that violate human dignity

Such inventions are exempt from patenting for ethical reasons. Read more about these exceptions.

The Norwegian Industrial Property Office follows a restrictive practice when assessing applications that regard naturally occurring biological material. The requirements for inventiveness and the scope of protection must be strictly enforced to prevent it from being too easy to obtain a patent, and to ensure that patent protection is not extended too far.

In this area, Norway must be in line with the most restrictive EU countries. With current patenting practice in the EU, this means that the Norwegian Patent Office is harmonized with the EPO.

In national patent applications that regard or use biological material from humans, it must be stated in the application that the person or persons from whom the material originates have consented to the relevant use of the material in accordance with the Act Relating to Biobanks.

The purpose of this disclosure obligation is for the patent system to highlight and support the principle of self-determination over one's own body. We do not require documentation showing that consent has been obtained or that you state who the material originates from. This is for privacy reasons.

Breach of the duty of disclosure is punishable as far as it follows from Section 166 of the Criminal Code.

All inventions that have a commercial exploitation contrary to public order or morality are exempt from patenting.

The Ethical Board for Patent Cases

The Norwegian Patent Office must consult with the Ethical Board for Patent Cases if we are in doubt as to whether the commercial exploitation of an invention is compatible with public order or morality. The board is organized as a committee under the National Committee for Research Ethics in Science and Technology and shall provide the Norwegian Industrial Property Office with a better decision-making basis for assessing whether the commercial exploitation of an invention is contrary to public order or morality.

Deadline for complaining that a patent is contrary to public order and morality.

You must submit an objection about this within three years from the day the patent was granted, as opposed to the normal nine months. The purpose of the extended deadline is to make it both easier and cheaper to revoke a patent that contravenes basic ethical norms in Norwegian society. In order to prevent groundless objections being submitted related to such considerations, a fee has been set for submitting such an objection more than nine months after the patent has been granted.

In the Norwegian Patents Act, there is an indicative list of inventions that cannot be patented for this reason. This applies, among other things, to these:

Due to large investment costs, it is important for the pharmaceutical industry that they have the opportunity to obtain industrial property rights protection for their products that come onto the market. A patent gives the exclusive right to exploit the invention for a limited period of time (maximum 20 years). Patenting helps make results known to the technological field, and thus contributes to further research into new medicines and innovation in the area.

What can be patented?

You can obtain a patent for new therapeutically active compounds and pharmaceutical formulations.

Procedures for treatment by surgery, therapy, or diagnosis performed on living humans or animals are, however, exempt from patentability. The exception does not cover products, compounds or compositions for use in such methods.

The "effective" patent period for pharmaceuticals is often significantly shorter than for other patented inventions, because pharmaceuticals must go through an extensive trial before they are granted marketing authorization and can be marketed. An option has therefore been introduced to apply for an extended protection period for medicinal products of up to five (5) years.