TWN Info Service on Biodiversity and Traditional Knowledge (Feb14/05)
7 February 2014
Third World Network

WIPO: Divergence over full mandatory disclosure for IP and genetic resources

Geneva, 7 February (Alexandra Bhattacharya and Edward Hammond) – International mandatory disclosure requirements to prevent misappropriation and promote fair and equitable benefit sharing from the use of genetic resources, their derivatives and associated traditional knowledge continue to be very contentious along a North-South divide.

At the ongoing 26th session of the Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore (IGC) of the World Intellectual Property Organization (WIPO), a new version of the negotiation text was circulated late afternoon of 5 February.

The US had proposed new language adding to its “No Disclosure Requirement” which is now 4.1 of the “Consolidated Document Relating to Intellectual Property and Genetic Resources Rev.1”(“Rev.1” indicating the first revision of the original Consolidated Document (WIPO/GRTKF/IC/26/4)that was the basis for the beginning of the week’s negotiations and which has been significantly changed).

There is now also new language under the section “Defensive Measures” which has been split into the following Subsections: (i) The Prevention Of The Erroneous Grant Of Patents And Development Of Voluntary Codes Of Conduct (5.1 Of Rev.1),(ii) Due Diligence  (5.2 Of Rev.1), (iii) Database Search Systems And (iv) Database Search Systems at WIPO Portal Site. 

A number of the new elements introduced into the text stem from the resubmitted Joint Recommendation on the Use of Databases for the Defensive Protection of Genetic Resources and Traditional Knowledge associated with Genetic Resources (wipo/grtkf/ic/26/6) by the delegations of Canada, Japan, the Republic of Korea and the US and also the Joint Recommendation on Genetic Resources and Associated Traditional Knowledge (wipo/grtkf/ic/26/5) by Canada, Japan, Norway, the Republic of Korea and the US.

There are also textual changes to Policy Objectives; Article 1 (Subject Matter of the Instrument), Article 2 (Scope of Instrument), and Article 3 Disclosure Requirement where a significant change has been the splitting of Sanctions and Remedies into Pre-grant and Post-Grant.  (An Article on “Beneficiaries”, which in draft form highlighted the interests of indigenous people and local communities, has also been deleted in the revised text.)

There have been meetings of the Expert Group comprising a maximum of 6 delegates from each region and two delegates from the Indigenous Caucus on Tuesday and Wednesday morning, as well as informal consultations on Tuesday afternoon. The Rev. 1 document was prepared by the Facilitator of the informal consultations, Mr. Ian Goss (Australia) and co-facilitators Chandni Raina (India) and Emmanuel Sackey (Ghana).

The IGC session is taking place in Geneva from 3 to 7 February.

On “No New Disclosure Requirement”, the text which has been proposed by the US reads: “Patent  applicants may only be required to state where the genetic resource can be obtained if that location is necessary for a person skilled in the art to carry out the invention.

In complete contrast, the text championed by developing countries all along requires that any intellectual property (IP) application that cover genetic resources, their derivatives and associated knowledge, shall inter alia disclose the source and country of origin, provide information on compliance with national access and benefit sharing (ABS) laws and requirements, including prior informed consent (PIC).  As proponents of mandatory disclosure, developing countries have also included text on Sanctions and Remedies at both the pre-grant and post-grant stages of IP applications. They have also sought to limit “exclusions” to the disclosure requirement, mostly proposed by the European Union and other developed countries, although specific delegations have varying concerns on this issue.

According to sources, a developing country delegate in the Expert Group meeting on 5 February questioned whether the US was saying was that no country could go beyond the duty of disclosure as found in US law itself. The delegate reportedly said that, “we are having to address a historical wrong and that is why we have been here for 15 years,” stressing that if nothing could be added to the disclosure requirement as found in US Law then “this is not the result we want”.

The IGC plenary chaired by Ambassador Wayne McCook (Jamaica) resumed at 10 am on Thursday, 6 February with Member States invited to make preliminary comments on the Facilitator's text.

There was a general sense, at least from statements of developing countries, that the text had been taken forward although a number of key issues were yet to be resolved. There were a number of questions and request for further information on the text on “Defensive Measures” that has been proposed by the United States and Japan.

(Defensive measures include measures for prevention of erroneous grant of patents and development of voluntary codes of conduct national database search systems and a database search system at the WIPO portal site. These are provisions favored by developed countries particularly the US instead of a mandatory disclosure requirement in the text.  Developing countries generally regard these measures as potential supplements to a disclosure requirement, and have concerns about them, including technical capacities and confidentiality of information placed in the databases.  The latter concern is also strongly expressed by indigenous people, who fear their sacred and specialized knowledge could be compromised by its distribution in intellectual property office databases.)

A number of countries (including India, and the European Union) stated that they would make further technical comments during the Expert Group meeting. Issues highlighted for further discussion included the definition of misappropriation, revocation as part of post grant sanctions and remedies, and whether there should be references to “IP offices” or “Patent Offices”.

The EU offered specific comments on the text. With regard to “Policy Objectives” it was of the opinion that there was no clear definition of misappropriation and therefore there was a need for a clear chapeau for this section. It called for the word “IP” to be replaced with “patents”, an attempt to limit the applicability of any resulting agreement to patent applications alone, rather than also to other forms of intellectual property, such as plant breeder’s rights.

With respect to Article 1 (Subject Matter of Instrument), it welcomed the improved clarity but only supported disclosure as it applies to patents.

With respect to Article 2 (Scope of Instrument), the EU said it was not sure about the operative benefits of the section.

(The current  draft text on Policy Objectives reads as follows:

Prevent the misappropriation of genetic resources [their derivatives] and associated traditional Knowledge through the IP Rights system by:

  1. ensuring that IP Offices have access to the appropriate information on genetic resources [their derivatives] and associated traditional knowledge to prevent the granting of erroneous IP Rights;
  2. enhancing transparency in the IP system; and
  3. ensuring [complementarity] [mutual supportiveness] with international agreements, as appropriate, relating to the protection of genetic resources [their derivatives] and/or associated traditional knowledge.

Article 1 reads:

1.1  This international legal instrument shall apply to any [IP][Patent] right or application [derived from [utilization of] [directly based on] genetic resources, [their derivatives] and associated traditional knowledge.

Article 2 on scope reads:

2.1 This instrument provides measures to support the prevention of misappropriation of genetic resources [their derivatives] and associated traditional knowledge through the [IP] [Patent} system.)

The EU also raised some issues with the section on Sanctions and Remedies (3.4) noting that the instrument should have a firm ceiling and the inclusion of revocation of patent was strong. It also preferred to drop the reference to fraud as found in 3.4 (b)(ii) as it was unclear how a patent office would detect fraud.

It generally supported the section on Exclusions (from disclosure requirement) as found in 3.6 but thought that there was need for further discussion.

(The disclosure requirements section comprises 7 sections on “Disclosure Requirements” that developing countries regard as central to the instrument and that developed countries are resisting.)

Switzerland said that the instrument should have several objectives and it did not agree with the newly introduced focus on prevention of misappropriation because there were several objectives which should be on an equal footing. It added that by including a disclosure requirement, we intend to introduce transparency, especially in the ABS system (but not the patent system). It welcomed the distinction between post grant and pre grant sanctions. It underlined that “the instrument we are negotiating should set maximum standards” and ensure certainty.

Uruguay, on behalf of the Group of Latin American and Caribbean countries (GRULAC),welcomed a “cleaner and more flexible document”.

France stated that the concept of equality and indivisibility which came out of the French Revolution was also found in the French Constitution. In this context, the French Constitution did not recognize distinct “peoples” and as such France had difficulty in accepting references to “ indigenous peoples” in the text.

The Chair noted that this was a “ recurring issue” and there was a need to function in the real world and therefore the specific elements would need to be addressed by supplementary approaches. He proposed the bracketing of the letter “s” in the word “peoples”. He called for reflection on definitional challenges and to begin an informal conversation on the issue. 

The representative of Tupac Amaru expressed surprise regarding the statement by France and asked France to refrain from constantly referring to the issue regarding indigenous peoples particularly as it had already been resolved in the UN.

(The UN Declaration on the Rights of Indigenous Peoples was adopted by the UN General Assembly in September 2007.)

The US said that there was a need to clarify some definitional aspects of the text. With regard to the last two paragraphs in the preamble, it stated it had not been sufficiently discussed and so should be put in brackets. With regard to Policy Objectives, the US said it preferred the usage of “Patent Offices” instead of IP Offices in bullet (a).

(According to sources, in the Expert Group meetings some developing countries viewed this as an attempt to limit the scope of the instrument to patents and not to other forms of IP.)

In Policy Objectives, the US wanted to replace “through the IP system” with “in the context of the patent system”.

(The last two preambular paragraphs read as follows:

Recognize that those accessing genetic resources and associated tk in a country should comply with that country’s national law providing protection for the gr and associated tk

Patent offices shall have a mandatory requirement for disclosure, as elaborated in this international legal instrument, when patenting of genetic resources would cause harm to the interests of indigenous [peoples] and local communities”.)

Canada like the US, said that the last two paragraphs of the preamble should be placed in brackets. This issue was also raised by Japan. In particular, the last paragraph of the preamble was operative and should be discussed as past of operative language.

With regard to Policy Objectives it also mentioned the need for “IP rights” to be replaced with “patents”. It reserved its right to comment later on the chapeau as this was dependent on the definition of misappropriation. On defensive protection, Canada said that this section was a “stand-alone section” and not complementary to the Disclosure Requirement.

Bolivia said that it recognized the work done to date; however it wanted action by IP offices to be included in the text (as found in Articles 3.11 and 3.12 of the previous version of the draft text).

South Africa on behalf of the African Group said that the “document was a good basis for negotiations”. It added that there was need for “High-level principles to be a guide”. It welcomed language on subject matter and scope. It said that the location of misappropriation in the chapeau was consistent with our discussions. A few areas under disclosure may require more fine tuning as did the section on exclusions.

South Africa said that the section on Relationship with the Patent Cooperation Treaty (PCT) and Patent Law Treaty (PLT) (3.7) should be deleted.

(3.7 proposes that the PCT and PLT be amended to allow mandatory disclosure requirements in domestic legislation, thus raising concerns that it may render disclosure a voluntary action rather than a an international legally binding mandatory requirement.)

With regard to defensive measures, South Africa said that the measures were acceptable as long as they were in line with dealing with the issue of misappropriation. It also welcomed the insertion of the section on due diligence (5.2) but said this should apply to the entire document and should be mainstreamed into the entire text.

With regard to the proposal on the“one click portal” (on the WIPO website), South Africa said that this section also required to be subjected to high level principles.

Norway said that Article 1 (Subject Matter) should be deleted as it had no operational function. It stated that in addition to the disclosure requirement it also supported defensive measures such as databases. It also raised concerns regarding the revocation of patents as found in 3.4(b)(iii).

Indonesia on behalf of the Like Minded Countries stated that the Group regarded that the revised text could serve as a workable document for negotiations to move forward. There was, however, a need to engage further on sanctions and remedies. There was also need for a cautious approach with regard to “exclusions”. Indonesia added that it needed more time to study the proposal on databases and how they could work as practical tools.

Iran said that the text was one step forward and presented a higher level of clarity and coherence between different articles. It stated that the instrument should aim at including all GRs, their parts and components, derivatives and their associated TK.

It further said that although measures under defensive protection did hold some merit, and if they are merged with the disclosure requirements, then both can serve as a platform for the granting of erroneous IP rights.

India said that revocation of patents as part of sanctions was an important issue, and that there was need for understanding that patent rights were not inviolable. It stated that it needed more time to reflect on the specificity of the databases proposed, particularly with regard to the confidentiality of information which was lodged in the databases.

China said it was delighted to see the simpler text.  It however queried whether the databases proposed under defensive measures were the same or of different types. It also attached great importance regarding the confidentiality of the information found in the databases.

Nigeria made four broad comments:

  • The process should be establishing a mandatory floor while giving patent and IP offices significant policy space to advance public interest.
  • Sanctions and Remedies:  There was always a delicate balance between the desire to innovate and how public interest is advanced and how sanctions were calibrated. There was need to take into account that there are levels of culpability which may not always rise to fraud.
  • Para. 3.7 which references the PLT and PCT was unnecessary and outside the scope of the IGC.
  • The principle of due diligence ought to constructively examined and should permeate the entire document .

Ghana referred to 4.1 (No New Disclosure Requirement), which was new language proposed by the US on 5 February during the Expert Group discussion, and said that the new text deviated significantly from the scope of the instrument which was misappropriation. It said that the reference to “novelty” should be inserted back and not focus on a person skilled in the art carrying out the invention.

The Expert Group convened at 10 am on Friday, 7 February where the outcome of the informal consultations (which were expected to focus and further refine the two key issues of Disclosure Requirements and Defensive Measures) was expected to be shared.  The second revision of the text is also expected on the last day of the session.