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What is the relation with Intellectual Property Rights?

Which IPR?

Intellectual property rights are not addressed by the Nagoya Protocol and EU Regulation 511/2014. However, the relationship between genetic resources and intellectual property rights has been the subject of discussions in the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO) for a long time already.

Patent rights may concern inventions involving biological materials. A recent amendment to the Dutch national patent act limits patent rights in such a way that third parties are allowed to conduct further research and breeding with protected materials, but not to commercially exploit any products stemming from such research and breeding.

Plant varieties cannot be protected by patents but can be protected by plant breeders' rights instead. Plant breeders' rights allow for breeders' exemption; this means that third parties may freely use a protected variety for further research and breeding and may freely market a new product resulting from such breeding processes.

You may obtain intellectual property rights on products derived from genetic resources obtained under the provisions of the CBD, the ITPGRFA or the Nagoya Protocol – but only under certain conditions that will be specified in your MAT.

Conditions on IPR

Whether you are allowed to obtain intellectual property rights on a product derived from one or more genetic resources obtained under the provisions of the CBD or the Nagoya Protocol will depend entirely on the ABS conditions agreed at the time of seeking access. Benefits can only be shared if benefits are actually generated, and part of the benefits of a commercial product developed from a genetic resource may derive from the revenues obtained from the exploitation of IPR on the product (license income, royalties). It is therefore very important that the MAT concluded at the time of access, which specify your rights and obligations, should include agreed conditions for obtaining IPR and for benefit-sharing. The IPR system applicable is typically the patent right or plant breeders' right, but other forms can also be used such as protection through trademarks or protected geographic origin denominations. These alternative forms may also create benefits that can be shared.

DNA patents

Applying for a patent on the DNA sequence of a gene is unlikely to be successful. Of course you may apply, but you are not likely to be granted the patent, since in most countries determining the DNA sequence of a gene is no longer regarded as an invention. You need to develop such a DNA sequence into a product, for example in accordance with the provisions of the Nagoya Protocol or the ITPGRFA, before patent protection becomes possible. In addition, most patent systems require the utility of products to be shown. If genetic resources used in product development were made available to you under the provisions of the CBD and the Nagoya Protocol, the bilateral agreement (MAT) between you and the provider will specify your rights and obligations.

Specific rules for crops

In the case of crops, both plant breeders' rights and patents qualify as protective legal systems. Part of the genetic resources used in the development of a product may come from the MLS of the ITPGRFA. If that is the case, no negotiations are needed or possible. The SMTA provides fixed benefit-sharing conditions. If the genetic resource that you have accessed is listed in Annex I of the ITPGRFA and made available to you under the SMTA, you may obtain plant breeders' rights on a product derived from that genetic resource. Since such a product contains genes from a genetic resource (whether it be an improved variety that is no longer marketed, a farmers’ variety or a wild relative) made available to you, you will be asked to make a voluntary contribution to the Benefit-Sharing Fund of the ITPGRFA. You may also obtain patent rights on a product containing genes from farmers’ varieties or wild relatives stemming from a genetic resources that you have obtained from the MLS, but this obliges you to share the benefits derived from this patent through the Benefit-Sharing Fund of the ITPGRFA.

Dutch genetic resources not listed in Annex I and obtained from crop plant collections before the entry into force of the CBD will be made available under the same terms and conditions as the genetic materials that form part of the MLS of the ITPGRFA. In this case, the same rules as described above apply for obtaining plant breeders' rights and patent rights. Other countries may follow different policies (access conditions) for this category of genetic resources.

The question of whether EU Regulation 511/2014 also applies to genetic resources accessed under the breeders' exemption from plant breeders' rights is still under discussion within the European Union. The Dutch government holds the opinion that the EU regulation should permit implementation that does not introduce an unreasonable extra burden, nor affects the breeders' exemption. The Dutch national law for implementation of the EU Regulation does not address this issue, so future interpretation of the EU Regulation will determine the eventual relationship between these two legal systems.

Disclosure of origin

Under EU Regulation 511/2014, you do not have to provide proof of the origin of genetic resources used in your research and development when applying for IPR. You must however declare to the competent authorities that you have fulfilled your due diligence obligations as a user at the final development stage of a product developed with the aid of genetic resources or traditional knowledge associated with such resources.

In some countries (for example Denmark and Switzerland), the obligation of disclosure of origin when applying for patent protection of a product developed from genetic resources is also regulated in national law, while other countries encourage applicants for IPR to make such disclosure. When disclosure of origin is required, you should provide the authorities with an internationally recognised Certificate of Compliance or equivalent information on the genetic resources used for the product that you wish to protect by applying for IPR. This is not the case in the Netherlands.