WIPO treaty Genetic resources - in comparison to the Nagoya Protocol
Since May 24, 2024, there has been a new WIPO treaty for the use of plants, animals, genetic resources and associated traditional knowledge. But why? The Nagoya Protocol has already been regulating access to and protection of genetic resources and the associated knowledge internationally for 10 years?
Nagoya Protocol: Protection of genetic resources and knowledge based thereon
In Germany, the „Gesetz zur Verpflichtungen nach dem Nagoya-Protokoll“ (NagProtUmsG) of July 1, 2016 is decisive. The Federal Agency for Nature Conservation is responsible for implementation and compliance, with powers that extend to the confiscation and prohibition of uses (§§ 1(3) and 2(2) of this Act). Control mechanisms are regulated by EU Regulation No. 511/2014 (“EU ABS Regulation”).
The legal text refers to the use of biological material and traditional knowledge for research and industrial purposes - but makes no explicit reference to patent law.
The new WIPO treaty of May 24, 2024 seems to want to fill this gap.
However, the new WIPO treaty still raises some questions, which we explore here.
WIPO treaty: Prevention of bio-patents without disclosure of origin
Article 1 and the objectives of this WIPO treaty state that the aim is to "prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with genetic resources."
The aim is therefore to prevent third parties from using plants, animals or traditional knowledge from distant areas for patent applications (a practice known as “bio-piracy”) without disclosing this use and without concluding an agreement on use with the inhabitants of these areas.
However, the obligation to disclose this origin lies with the potential patent applicants. In practice, this raises the question of how non-compliance would be penalized. This is set out in Article 5 of the WIPO Treaty.
Sanctions for non-compliance with the disclosure obligation
The key points in Article 5 of the WIPO Treaty are:
- Sanctions may not be imposed immediately for failure to comply with the duty of disclosure.
- The patent applicant must always be given the opportunity to provide this information subsequently
- Only if the obligation to provide information has been fraudulently omitted can the states impose sanctions in accordance with their national legislation.
It can therefore be seen that the primary aim is to enforce the disclosure of origin, but not - as Article 1 could also be interpreted - to prevent patent applications or to destroy existing patents. The patent applicant must (“shall”) be given the opportunity to submit the previously ignored information. This is to be seen as practical and realistic, all the more so as the assessment of traditional knowledge and the determination of whether this knowledge was known and publicly accessible at the time of the patent application is difficult.
Nagoya Protocol and EPC
In addition, the same applies to the Nagoya Protocol: the EPC, for example, is a multilateral, international agreement that was concluded independently of the EU. Therefore, directives issued by the EU in proceedings before the EPO generally have no effect on the interpretation of legal provisions of the EPC. It is true that Art. 53(a) EPC could apply to the consideration of the provisions of the Nagoya Protocol (immorality). It would have to be decided whether the unauthorized use of biological material with the aim of obtaining a monopoly is immoral or contrary to public policy (see “10 Jahre Nagoya-Protokoll - Eine Bestandsaufnahme”, Bernd Fabry in the magazine Mitteilungen Deutscher Patenanwälte of February 2024, pages 50-51) - a very sensitive topic that extends into the political sphere.
Incidentally, neither the USA and Canada nor Russia have ratified the Nagoya Protocol. This is another question that also arises with regard to the WIPO treaty that has just been adopted: For whom will this just adopted WIPO treaty be binding? Who will ratify and who will not? Do the non-ratifying states have a competitive advantage in a highly dynamic technology sector?
Will the WIPO treaty provide more “Benefit Sharing”?
And may this WIPO treaty give countries rich in biological resources and traditional knowledge more sovereignty and even economic benefit through utilization agreements? Is that even the goal?
In the Nagoya Protocol, it was. Since the UN Conference on Biodiversity in 1992, a fair and equitable distribution of the benefits derived from utilization (“Access and Benefit Sharing” (ABS)) has been a declared international goal.
However, a look at the Nagoya Protocol does not invite optimism. It has not been possible to halt the loss of biodiversity worldwide, nor have any significant amounts of money flowed into developing countries on the basis of the Nagoya Protocol (see “10 Jahre Nagoya-Protokoll - Eine Bestandsaufnahme”, Bernd Fabry in the magazine Mitteilungen Deutscher Patenanwälte of February 2024, page 52).
The search for a fair distribution is still ongoing. In April 2024, new international meetings were held to further develop the ABS system; further meetings are planned until the end of 2025.
Rapid technological progress: Digital Sequence Information
In practice, it is also questionable whether rapid technological progress can lead to a clear geographical definition at all. The regulations in the Convention on Biological Diversity (CBD) and the Nagoya Protocol refer to genetic resources in the form of physical material. However, new technologies are already making it possible to develop new products purely on the basis of digital information on the molecular composition of genetic resources - without having obtained the genetic material directly from the country providing it.
This aspect is taken into account in Article 3 of the new WIPO Treaty. It states that if the country of origin of the genetic resources is not known, the source of the genetic resources should be disclosed.
But does this mean the biological organism from which the genetic resource originates? Or should sequence listing explain exactly how the sequence was obtained? More clarity in the new WIPO treaty would have been nice.
Indeed, you find in the WIPO treaty on organic genes and associated traditional knowledge that the (patent) offices are not obliged to verify the authenticity of this information. The information is to be published by the contracting parties in accordance with the patent procedures, without prejudice to the protection of confidential information.
This can be seen as another indication that patent applications relating to genetic resources from third countries are not to be prevented by the new WIPO treaty. However, the obligation to provide information on the origin of genetic resources should not become an additional burden for the patent offices.
WIPO treaty on organic genes - what does this mean for patent applicants?
It is important for patent applicants to know that they have already been obliged to disclose the origin in the EU and in Germany since the Nagoya Protocol (in Germany without a voluntary obligation to provide information, but there is an obligation to provide information if requested by the Federal Ministry for Nature Conservation (BfN). And according to Regulation (EU) No. 511/2014 (“EU ABS Regulation”), self-disclosure is mandatory anyway). Ignorance does not protect, there is an obligation to clarify and disclose the origin of genetic resources.
And this is also confirmed by the new WIPO Treaty (WIPO treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted by the Diplomatic Conference 24 May 2024).
In this context you may find this interesting, too:
- Patent attorney Malte Köllner on G 3/19 - Tomatoes, broccoli, peppers III - Patents on plants? - Youtube
- Blog article WIPO standard 26 for sequence listings in international patent applications
Any questions about patent protection or patent defence? Please contact us, by phone at +49 69 69 59 60-0 or send us an email info@kollner.eu.
