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Overview and Licensing and Agreement Aspects Related to Genetic Resources

Tuesday, June 28, 2016   (0 Comments)
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Overview and Licensing and Agreement Aspects Related to Genetic Resources

By Debora Plehn-Dujowich, Ph.D., J.D. 

Several recent international conferences have centered on the issue of genetic diversity and traditional knowledge.  Some resulting treaties propose that parties enter into agreements for access and benefit sharing (ABS).  Proposed agreements include material transfer agreements and exclusive or non-exclusive license agreements.  This article will provide an overview of the Convention on Biological Diversity, the Nagoya Protocol and the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), and will also provide a summary of related licensing and agreement issues.

The 29th session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) occurred in February 2016 at WIPO in Geneva, Switzerland after a 1.5-year hiatus.  The topic around genetic resources, traditional knowledge and folklore and benefit sharing has been in discussions in various global fora for about fifteen years.

The discussion regarding having a disclosure requirement for the source or origin of genetic resources, traditional knowledge and folklore began in the Doha Round of negotiations at the World Trade Organization (WTO) fifteen years ago, in 2001.  The Doha Declaration was passed in 2001 in Doha, Qatar.  It stated that each member has the right to grant compulsory licenses and to determine the grounds upon which such licenses are granted.

The Convention on Biological Diversity (CBD) is a separate treaty.  It is an environmental treaty separate from WTO or WIPO.  CBD allows for countries to sustain and have sovereignty over their genetic resources.  The US participates as an observer in CBD.  The US signed but never ratified the treaty.  However, if US companies do business in any country that is party to the treaty they must comply with its provisions.  The full text of the treaty is available at: https://www.cbd.int/convention/text/

The main goals of CBD are:

1. Conservation of biological diversity
2. Sustainable use of its components
3. Fair and equitable sharing of benefits arising from genetic resources

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a supplementary agreement to the CBD.  It was adopted on October 29, 2010 and entered into force on October 12, 2014.  The focus of the Nagoya Protocol is on access and benefit sharing (ABS) for genetic resources.  Developing countries having genetic resources want to obtain a benefit from granting access to those genetic resources to other countries or to foreign corporations.

The discussions on whether there should be a disclosure requirement for the source of origin of genetic resources in patent applications shifted to WIPO and the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC).

In general, developing countries such as India and Brazil are in favor of a mandatory disclosure requirement, and developed countries such as the US, Canada, Japan and Korea are opposed to it.  Some developing countries propose that the remedies available for failure to disclose genetic resources include the revocation of the patent.  The US is opposed to any remedy that would include the invalidation of a patent.  The US delegation before the IGC is composed of USPTO representatives and State Department representatives, both of which are opposed to any mandatory disclosure requirement and to any remedy that would include the invalidation of a patent.

The EU supports in principle a disclosure requirement,2 as long as violation of the disclosure requirement does not invalidate a patent.

Report on the 29th IGC
I attended the 29th IGC conference at WIPO in Geneva, Switzerland as AIPLA’s representative from February 15-19, 2016.  During the conference, attendees focused on the following two issues:

1. Whether there should be a disclosure requirement for the use of genetic resources and/or traditional knowledge; and
2. Whether databases should be set up where patent offices (and possibly applicants) could search for genetic resources and/or traditional knowledge to prevent the erroneous granting of patents.

Discussion centered around what form the disclosure would take, and whether the disclosure should be mandatory or voluntary, or if disclosure should even be necessary at all.  Developing countries and indigenous groups were most in favor of the disclosure requirement, but expressed reservations regarding the use of databases.

The issue of databases is separate from the issue of disclosure.  The delegations of the US, Canada, Norway, Republic of Korea and Japan put forward a joint recommendation regarding databases.3  They propose that Member States should facilitate, as appropriate, the creation, exchange and dissemination of, and access to, databases of and/or regarding genetic resources and traditional knowledge associated with genetic resources.

They also propose the following:
Member States should provide legal, policy or administrative measures, as appropriate and in accordance with national law, to prevent patents from being granted erroneously with regard to claimed inventions that include genetic resources and traditional knowledge associated with genetic resources where, under national law, those genetic resources and traditional knowledge associated with genetic resources: 
(a) Anticipate a claimed invention (no novelty); or 
(b) Obviate a claimed invention (obvious or no inventive step).

Developing countries and indigenous groups expressed reservations regarding the use of databases because they feared that they would encourage free dissemination of the information contained therein. At the end of the conference, no agreement was reached regarding either the disclosure requirement or the implementation of databases.  Discussion on these and other topics will continue during the 30th Intergovernmental Committee, which will take place at WIPO in May, 2016.  I will attend as AIPLA’s representative once again.

For more information regarding the conference, and to download conference documents, see http://www.wipo.int/meetings/en/details.jsp?meeting_id=3898.   For a summary of the decisions of the 29th IGC and an Annex with a list of outstanding issues to be tackled at the next IGC, see http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_29/wipo_grtkf_ic_29_ref_decisions.pdf. 

The 30th IGC will meet at WIPO in May 2016, and is anticipated to be more substantive.  Industry groups are encouraged to speak.  IPO has been very vocal in the past and made several statements at the 29th IGC expressing their opposition to a mandatory disclosure requirement in patent applications.  BIO attended the 29th IGC in order to observe the proceedings.  The Chair of the IGC Ian Goss met with industry groups such as IPO and BIO during the 29th IGC to receive their input on the proceedings.  BIO’s position and IPO’s position are in line with those of the U.S. delegation.4

Model Agreements
On the WIPO website there is a database of actual and model biodiversity-related access and benefit-sharing agreements.5 Some examples include:
Model access and benefit Sharing Agreement between Access Provider and Access Party, proposed by the Australian Government
Model Access and Benefit Sharing Agreement between Australian Government and Access Party
Model Material Transfer Agreement suggested by Biotechnology Innovation Organization (BIO), formerly known as Biotechnology Industry Organization.
Model Material Transfer Agreement between the American National Cancer Institute (NCI) and Applicant Investigators
Material Transfer Agreement for Plant Genetic Resources held in trust by the [Center]
WIPO only provides these model agreements as examples, and under the Nagoya Protocol each party is free to develop its own agreement related to access and benefit sharing.

The issue of Genetic Resources and Traditional Knowledge has been brewing for fifteen years and is clearly not going away anytime soon.  Stakeholders should become familiar with the discussions being held on these topics at WIPO and in other fora, to ensure that their interests are being fully represented.

1 Debora Plehn-Dujowich is the Chair of the American Intellectual Property Law Association (AIPLA) Biotechnology Committee. Debora is a partner and co-founder of Prismatic Law Group, PLLC.  See www.prismaticlaw.com
2 See http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_8/wipo_grtkf_ic_8_11.pdf
3 See Document WIPO/GRTKF/IC/29/5 available at:  http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_29/wipo_grtkf_ic_29_5.pdf
4 See http://www.ipo.org/index.php/daily_news/ipo-opposes-disclosure-requirement-for-genetic-resources-and-traditional-knowledge-in-patent-applications/
5 See http://www.wipo.int/tk/en/databases/contracts/list.html


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