Patent applications based on genetic resources
Published (reviewed and quality assured)
Justification for indicator selection
MAIN ADVANTAGES OF THE INDICATOR
- Data availability (freely available) and geographic coverage are good.
- The indicator may encourage further work to refine the classification codes.
- No rationale references available
The indicator shows the share of European patent applications that are based on genetic resources.
The following types of patent applications would be considered 'European patent applications':
- Patent applications presented to the national intellectual property offices of the pan-European countries;
- Patent applications presented to the European Patent Office (EPO) under the EPC (European Patent Convention); and
- Patent applications presented to the European Patent Office or the World Intellectual Property Organization (WIPO) under the PCT (Patent Cooperation Treaty), when pan-European countries are mentioned among the designated Contracting States of the PCT in which protection is sought.
The CBD (art. 2) defines 'genetic resources' as genetic material of actual or potential value. 'Genetic material,' in turn, is defined as any material of plant, animal, microbial or other origin containing functional units of heredity. Nevertheless, there is still no conclusive answer to what resources and uses are covered by these definitions. The methodology proposed for this indicator attempts to address this uncertainty.
In this regard, it is also worth noting that while access and benefit-sharing provisions refer solely to genetic resources, the CBD also contains references to the importance of equitable sharing of the benefits arising from the utilization of knowledge, innovations and practices of indigenous and local communities.
No units have been specified
Policy context and targets
Information on the number of patents being sought or granted for products and processes developed on the basis of genetic resources would provide critical insight into the role and relevance of genetic resources in diverse economic sectors and, potentially, the degree to which such role and relevance have been recognized and equitably rewarded. Since the number of patents granted in the pan-European region is significant - nearly 35 % of patents in force at the end of 2004 were granted by the contracting States of the European Patent Convention (EPC) - the information could, moreover, potentially inform not only regional but also global policies(1).
The fair and equitable sharing of benefits arising from the use of genetic resources is one of the main objectives of the CBD. The implementation of the CBD goals and provisions on benefit-sharing, however, has proved difficult. Intellectual property rights, especially patents, act as incentives for trade and investment that thus promote the creation of benefits from the use of genetic resources. Nevertheless, the existence of patents for inventions based on genetic resources has also raised a number of ethical concerns and concerns on the impacts on science and innovation.
(1) Trilateral Statistical Report, 2005. In 2005, the European Patent Convention entered into force in Latvia, which so became the 31st EPC Contracting state. By the end of the year, the members of the underlying European Patent Organization were: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. Other states have agreements with the European Patent Office to allow applicants to request an extension of European patents to their territory. These states are: Albania, Bosnia-Herzegovina, Croatia, the Former Yugoslav Republic of Macedonia, Serbia and Montenegro. Other states that have recently expressed their intention to join the organisation are Norway, Malta, and Croatia.
Relation of the indicator to the focal area
Percentage of patent applications directly relates to access and benefit sharing, as it concerns the documentation of the use of genetic diversity for commercial or other use though a patent. Documenting such use is essential to enable an assessment of whether benefits from the use are equitably shared.
No targets have been specified
Related policy documents
No related policy documents have been specified
Key policy question
What share of European patents is biodiversity-related?
Methodology for indicator calculation
'Classification codes' are awarded to patent publications to facilitate the retrieval of information on inventions in particular technological fields. As they systematize and allow retrieval of information on inventions covered by patent publications, classification codes can also be used for a number of additional purposes, including locating and sorting through inventions based on genetic resources.
There are several classification systems that operate at the national, regional, and international level. Of these systems, the International Patent Classification (IPC) and the European Classification system (ECLA) are particularly relevant for the indicator. The IPC is the main classification system at the international level, currently being used by over 90 countries and five international patent organizations. It is frequently revised, with the latest version of the IPC - IPC 8 - containing approximately 70 000 classifiers. To ensure the proposed indicator can be compared with other patent-based information and be considered in the CBD and other international negotiations, it would make sense to take the IPC as its basis. The challenge is then to find, within the IPC, the classifications codes relevant for inventions based on genetic resources.
The steps for calculating the indicator would then be the following:
1. Determining the total number of patent applications in the pan-European region. The first step is to determine the total number of European patents applications including those presented nationally, regionally and internationally.
2. Identifying the patent applications for inventions based on genetic resources. The patent applications under each and all the relevant IPC classifiers then need to be determined. Both the total number of biodiversity-based patent applications and the specific number for certain sectors and technologies would be established.
3. Calculating the percentage that the patent applications for inventions based on genetic resources constitute in considering the total number of patent applications.
The key decision is therefore which IPC classification codes to use.
One option is to aim for a broad coverage indicator. An extensive selection of codes has been proposed to ensure all possible patent applications using genetic resources are being captured. See Annex 2 for a list of the potentially relevant codes. As can be seen from the list, there may of course be codes that capture applications that are not based on genetic resources. Further work is therefore required in order to refine the list, or to allow for more specific filtering within the codes proposed.
An alternative proposed here as a first proxy for the indicator is to use a narrow but well established set of classification codes, the ones used by OECD for patent applications for biotechnology, many of which are based on genetic resources. See Annex 1 for the list of codes proposed. The indicator would be a proxy for broader trends in the use of the components of biodiversity and related traditional knowledge in inventions. It also has the benefit of having been already used and refined by the OECD.
OECD has selected these codes through the following steps:
1. Analysis of the IPC classification, starting at the section level, followed by sub-sections, classes, sub-classes, groups and sub-groups.
2. Keyword search, identifying the IPC codes wherein these keywords are used most frequently.
3. Analysis of patents owned by biotechnology firms (OECD, 2005).
It should be noted that the OECD definition is currently being revised to include comments and suggestions received from experts and relevant stakeholders. The WIPO International Bureau, for instance, has put forth a number of additional classifications codes that it considers should be taken into account.
Of course, none of these lists match the exact scope of the proposed indicator as currently construed - 'inventions based on genetic resources.' The OECD definition for biotechnology patents is narrower, while the work of WIPO and Oldham (2006 a. and b.) on biodiversity more general is broader. In the latter, additional work would thus be necessary to determine the specific significance of patent information resulting from the calculation of the indicator to the benefit-sharing provisions in the CBD. On the contrary, narrower approaches such as the one developed by the OECD for biotechnology could be considered to follow a stricter definition of the use of genetic resources and thus be used in the implementation of the proposed indicator.
Nevertheless, given that the definition of 'genetic resources' remains imprecise at international level, a more comprehensive methodology that could later be narrowed down remains the most useful approach in the long term to a patent-based indicator for benefit-sharing.
Methodology for gap filling
No methodology for gap filling has been specified. Probably this info has been added together with indicator calculation.
- A framework for biotechnology statistics OECD, 2005
- Biodiversity and the Patent System: Towards International Indicators Oldham, Paul, 2006. ESRC Centre for Economic and Social Aspects of Genomics (CESAGen), Global Status and Trends in Intellectual Property Claims. Issue No 3, 2006.
- Biodiversity and the Patent System: An Introduction to Research Methods Oldham, Paul, 2006. ESRC Research Centre for Economic and Social Aspects of Genomics Research Document, Year II No 6 March 2006.
EEA data references
- No datasets have been specified here.
Data sources in latest figures
No uncertainty has been specified
Data sets uncertainty
No uncertainty has been specified
MAIN DISADVANTAGES OF THE INDICATOR
- While methodology is straightforward, and data exist, using the PATSTAT database will require more time and work.
ANALYSIS OF OPTIONS
Ideally, the broader set of classification codes could be used to ensure that all applications related to biodiversity are captured. But since an indicator based on the broad set without further work may result in an overestimation, it is proposed to use an indicator based on applications for biotechnology patents as a proxy.
Short term work
Work specified here requires to be completed within 1 year from now.
Long term work
Work specified here will require more than 1 year (from now) to be completed.
Work descriptionSUGGESTIONS FOR IMPROVEMENT 1. The calculations could start right now on some databases — e.g. esp@cenet . Because PATSTAT is not fully operational, there would be some time needed to work out the user interface. 2. Looking at both patent applications and granted patents may be required in order to obtain the more thorough, clear, and reliable data needed for an access and benefit‑sharing indicator. Patent applications are important as the first publication of inventions. They also often remain the only information available until the grant of the patent, which may take years. Many patent applications, however, will never become granted patents. The invention protected by a patent may, similarly, differ from the one proposed by the patent application as a result of the formal and substantive examination processes. 3. The indicator should be re‑defined as the percentage of all patent publications using components of biodiversity and related traditional knowledge. Other indicators could be developed to build on the resulting information. In addition to the overall percentage of patents for inventions relevant for benefit‑sharing, information on the shares by countries and industries, as well as data on the origin of the resources and related knowledge, would be helpful to measure and monitor the implementation of the CBD. 4. Existing work on IPC classification codes relevant for biodiversity should be the basis for the calculation of the proposed indicator. The list of classification codes developed by Dr Oldham (Annex 2) would provide more comprehensive information on the use of biodiversity in new products and processes. However, a methodology based on these codes would need to be further refined to ensure the relevance of information for the implementation of the CBD benefit‑sharing requirements. 5.PATSTAT, as a worldwide patent publication database designed for statistical use, would be the most appropriate basis for the calculation of the proposed indicator. Initial difficulties in developing scripts and user interfaces are outweighed by the benefits in terms of certainty and comparability of the resulting information. The main advantages of using PATSTAT are: 1. PATSTAT is designed for statistical use. 2. It will be widely used for this purpose by all main patent offices, making the indicator easily comparable. 3. If additional indicators were developed or additional information was sought on the basis of the proposed indicator, PATSTAT allows more fields to be searched than esp@cenet .
No resource needs have been specified
Deadline2099/01/01 00:00:00 GMT+1
Work descriptionCOSTS RELATED TO DEVELOPING, PRODUCING AND UPDATING THE INDICATOR (as available) Esp@cenet is available through the website of the EPO. PATSTAT would not be as widely available — it is not intended for general searches by the public but for statistical use. However, organisations could have access to it free of charge by merely agreeing to its terms. Access should not be a problem, therefore, for calculating the indicator. The suggested methodology provides a reasonably straight‑forward approach to the calculating the proposed indicator, provided the data and tools necessary for such a calculation are available. According to experts consulted, the sole database to provide such data and tools in the manner required for systematic statistical use would be PATSTAT. However, as PATSTAT is only now becoming available, significant work remains in setting up the necessary scripts, developing an adequate interface system, and training research and technical personnel. As a result, the initial calculation of the proposed indicator would require at least five to six months and require considerable financial support. Nevertheless, it is expected that, once the process has been set up, a yearly updating of the indicator would not be expensive or time-consuming. Nevertheless, the wide coverage of the obtained results might still pose a problem, with additional work and time needed to determine the specific relevance of patent information.
No resource needs have been specified
Deadline2099/01/01 00:00:00 GMT+1
Responsibility and ownership
EEA Contact InfoKatarzyna Biala