[Ip-health] TWN Info Service on Biodiversity and TK: WIPO negotiations on IP and Genetic Resources to resume amidst major differences

alexandra bhattacharya alexandra.bhattacharya at gmail.com
Mon Feb 3 01:33:47 PST 2014


*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
Traditional Cultural Expressions 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 International Treaty on Plant Genetic
Resources for Food and Agriculture (ITPGRFA) if access to genetic resources
has been provided in pursuance of the ITPGRFA.]

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].]"*

There are also concerns over 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.+



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