Info Service on Biodiversity and Traditional Knowledge (Feb14/01)
WIPO: Negotiations on IP and Genetic Resources to resume amidst major differences
Geneva, 3 February (K M Gopakumar) – Member States are to resume negotiations on an international legal instrument on intellectual property and genetic resources at the World Intellectual Property Organization (WIPO).
This will take place at the 26th Session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore on 3-7 February 2014 in Geneva.
The WIPO General Assembly in 2009 provided the mandate for text-based negotiations to conclude an international legal instrument. The mandate of the IGC is to expedite its work with open full engagement of Member States, on text based negotiation with the objective of reaching an agreement on a text(s) of an international legal instrument(s) which will ensure the effective protection of genetic resources (GR), traditional knowledge (TK) and traditional cultural expressions (TCE). See http://www.twnside.org.sg/title2/wto.info/2009/twninfo20091002.htm. The WIPO General Assembly renewed this mandate twice in 2012 and 2013. See http://www.twnside.org.sg/title2/biotk/2013/biotk131001.htm
The consolidated text (comprising proposed text from Member States) on IP and GR proposes a mandatory international disclosure regime to prevent biopiracy i.e. in this context, misappropriation of genetic resources and associated traditional knowledge through IP protection. This instrument also proposes prohibition of patenting or any other IP protection for genetic resources or their derivatives found in nature.
This instrument is to complement the access and benefit-sharing regime established under the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit Sharing.
Developed countries and the biotechnology industry lobby, which want to have easy access to genetic resources in developing countries, are opposing the instrument and often blocking the progress of the negotiations.
There is no consensus regarding the legal nature of the instrument. While developing countries want to have the instrument in the form of a legally binding treaty, developed countries are opposing the idea of a treaty. As mentioned above, the WIPO Assembly mandate is to conclude an international legal instrument; therefore developing countries of the view that the mandate is for negotiating a treaty. However, the WIPO General Assembly decision is to take the final call on the nature of the instrument by deciding on convening a diplomatic conference. (A Diplomatic Conference is convened to conclude the negotiations of a treaty.)
The WIPO General Assembly held on 23 September – 2 October 2013 mandated three sessions of the IGC prior to the next Assembly session in September 2014 focusing on different themes. While the focus of the 26th Session is on IP and GR the 27th Session for the duration of ten days in April 2014 will focus on both TK and TCE. Three days at the 28th Session will focus on all three issues.
The Assembly in 2014 September is expected to take stock of the progress made in the text and to decide whether to convene a diplomatic conference. The Assembly can decide to hold additional meetings after taking into account the budgetary process.
Half a day of the first day of the 26th session (3 February) is dedicated for a meeting of ambassadors and senior capital-based officials. According to a WIPO circular this half-day meeting is “proposed as an interactive, open and frank exchange”. Therefore the WIPO international bureau poses the following questions to the ambassadors and senior capital based officials:
“1. In respect of GR, TK and TCE
a. What is the policy issue that needs to be resolved as a priority and why?
b. What should be dealt with an International legal instrument and what could be left to deal with at the national level?
c. What suggestions are there for common ground on the issues that need to be resolved internationally?
2. Regarding the process as a whole, what new negotiating pathways and modalities might there be to make further progress?”
A developing country delegate termed these questions as repetitive especially question 1 (b) and 1 (c). The same delegate further commented that the questions fail to recognize the progress in the negotiation and still want to ponder the “new pathways and modalities”.
The consolidated text on GR is dated 8 February 2013. Since then there has been little change in the text. (http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_26/wipo_grtkf_ic_26_4.pdf)
The heavily bracketed negotiating text contains three parts viz. list of terms, preamble, policy objectives and articles.
The seven articles of the text are: subject matter of protection; beneficiaries; scope of the protection or legal obligation; relationship with international agreements; international cooperation; transboundary cooperation; technical assistance and capacity building.
However, the most critical provision is the mandatory disclosure mechanism.
Article 3 sets out the detailed requirements of disclosure. These include the trigger of disclosure requirement (3.3), exclusions from disclosure requirements (3.6), Contents of Disclosure (3.7), Actions of IP offices (3.8), relationship with the Patent Cooperation Treaty and Patent Law Treaty (3.13), and sanctions and remedies (3.14-3.16). Many of these provisions are still in square brackets indicating the lack of convergence.
According to the consolidated draft provisions the applicant is to disclose the following 11 elements with regard to the genetic resources covered by an IP application: However there is no consensus among Member States on these elements. These elements are: a) [Provider country]; b) [Source in provider country]; c) [Internationally Recognised Certificate of Compliance, or evidence of compliance, with ABS requirements, including PIC (Prior Informed Consent) where relevant]; d) [Certificate of origin]; e) [Country of origin]; f) [If Country of origin not known, information on the source that the [inventor] [developer of intellectual property] had physical access to]; g) [Statement that origin is not known]; h) [Statement that source is not known]; i) [Primary source, or if not known, the secondary source]; j) [Written and oral information regarding [traditional knowledge associated with genetic resources] [associated traditional knowledge], [their derivatives] for enabling search and examination of the [patent] [intellectual property] application including the details of the holder of the traditional knowledge]; k) [a copy of the standard material transfer agreement stipulated in the ITPGRFA if access to genetic resources has been provided in pursuance of the ITPGRFA.]
(The ITPGRFA is the International Treaty on Plant Genetic Resources for Food and Agriculture.)
Apart from the disclosure requirement, detailed provisions are provided with regard to the actions of the office on obtainment of disclosure from the applicant. Important actions proposed in Article 3.10, 3.11 and 3.12 are:
“3.10 A simple notification procedure should be introduced to be followed by the [patent] [intellectual property] offices every time they receive a declaration; it would be adequate to identify in particular the Clearing House Mechanism of the CBD/ITPGRFA as the central body to which the [intellectual property] [patent] offices should send the available information.
3.11 [Genetic resources and their [derivatives] as found in nature or isolated therefrom shall not be considered as [inventions] [intellectual property] and therefore no [patent] [intellectual property] rights shall be granted.]
3.12 [Intellectual property] [Patent] offices receiving patent applications containing disclosures should inform a competent government agency that the respective State is declared as the source”.
Further, there are provisions to provide sanctions and remedies in case of non-compliance with disclosure requirements (non-disclosures or wrongful disclosures). The draft text currently contains three options. One of the proposed options include refusal of patents, revocation or invalidation [Article 3.15. 9(c) to (e)].
Developed countries do not want a mandatory disclosure regime and proposes non-mandatory requirement as an alternative to Article 3. The proposed option reflected in the draft text as Article 3.17 and 3.18 reads:
“3.17 [Intellectual property] [Patent] disclosure requirements shall not include a mandatory disclosure relating to genetic resources [, their derivatives] and [associated traditional knowledge] [traditional knowledge associated with genetic resources] unless such disclosure is material to the patentability criteria of novelty, inventive step or enablement.
3.18 [Intellectual property] [Patent] applicants shall be under no requirement to disclose the source, origin or other information relating to genetic resources in [intellectual property] [patent] applications [unless such information is material to the patentability requirements of novelty, inventive step or enablement.]]”
Another area of contention is the provision on exclusion from the disclosure requirement. Developed countries propose the exclusion of traditional knowledge in the public domain [Article 3.6(d)]. This exclusion would drastically limit the effectiveness of disclosure requirements. The proposed exclusions under Article 3.6 are:
“(a) all human genetic resources including human pathogens; (b) [derivatives];
(c) commodities; (d) traditional knowledge in the public domain; (e) genetic resources found outside of national jurisdictions; and (f) all genetic resources acquired before the national implementations of [the Convention on Biological Diversity and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity.”
Yet another area of North-South disagreement is with regard to the subject matter of protection. Developing countries want to apply disclosure requirements to genetic resources as well as their derivatives. Developed countries, on the other hand, want to limit the disclosure to only if the IP protection is directly based on genetic resources. Article 1.1 reads:
“1.1 [[Protection under this instrument] [This international legal instrument][shall] [extend] apply to any [intellectual property] [patent] right or application [derived from [utilization of]] [directly based on] genetic resources, [their derivatives] and [associated traditional knowledge] [traditional knowledge associated with genetic resources].]”
Further, there are concerns also on the proposed article on establishment of a database on genetic resources and associated traditional knowledge. There is a view that such database may have the potential to accelerate biopiracy by providing the information on genetic resources and associated traditional knowledge in an easily accessible format. The information in the database can be used to develop derivatives based on generic resources, especially by biotechnology companies based in countries which are not party to the CBD such as the United States.+