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Bioprospecting of Genetic Resources in the Deep Seabed

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Patent<strong>in</strong>g life forms, <strong>in</strong>clud<strong>in</strong>g genetic resources,<br />

has ethical aspects which cannot be overlooked.<br />

Concerns have been expressed that patent<strong>in</strong>g <strong>of</strong> a source<br />

material, e.g. genetic resources or organisms, may lead<br />

to compromis<strong>in</strong>g a grow<strong>in</strong>g proportion <strong>of</strong> biodiversity,<br />

discovered or yet-to-be found, from unconditional use<br />

over time. It is essential to ensure that <strong>the</strong> resources or<br />

organisms have been legitimately accessed and that<br />

benefits aris<strong>in</strong>g out <strong>of</strong> <strong>the</strong> utilization <strong>of</strong> <strong>the</strong> source genetic<br />

resources are shared between owners <strong>of</strong> <strong>the</strong> resources<br />

and users. This is especially true for deep seabed genetic<br />

resources, <strong>the</strong> status <strong>of</strong> which as open-access or common<br />

heritage <strong>of</strong> humank<strong>in</strong>d is still disputed, but <strong>the</strong> potential<br />

commercial applications <strong>of</strong> which are numerous. Not<strong>in</strong>g <strong>the</strong><br />

emergence <strong>of</strong> a consensus regard<strong>in</strong>g <strong>the</strong> better suitability<br />

<strong>of</strong> sui generis systems <strong>of</strong> IPR to biological material and<br />

traditional knowledge, Oldham concludes that some<br />

resources are too important, <strong>in</strong> terms <strong>of</strong> <strong>the</strong> present and<br />

future public benefit, to be subject to strong <strong>in</strong>tellectual<br />

property protection. 374<br />

It appears that <strong>the</strong> extension <strong>of</strong> patentability to biological<br />

and genetic material has not been based on sufficient<br />

economic analysis and that <strong>the</strong> positive benefits expected<br />

from patent protection with regard to trade, foreign<br />

direct <strong>in</strong>vestment and technology transfer have not been<br />

evidenced. 375 Never<strong>the</strong>less, grant<strong>in</strong>g IPRs over <strong>in</strong>ventions<br />

derived from novel resources has some benefits. Patents<br />

can be part <strong>of</strong> <strong>the</strong> legal and commercial framework used<br />

to generate benefits from <strong>the</strong> use <strong>of</strong> genetic resources and<br />

agreements concern<strong>in</strong>g patent ownership, while licens<strong>in</strong>g<br />

exploitation can help def<strong>in</strong>e how access is granted and<br />

benefits are shared.<br />

5.4.2. Activities <strong>of</strong> <strong>the</strong> World Intellectual Property<br />

Organization 376<br />

WIPO promotes <strong>the</strong> protection <strong>of</strong> <strong>in</strong>tellectual property<br />

throughout <strong>the</strong> world through cooperation among its<br />

180 Member States and <strong>in</strong> collaboration with o<strong>the</strong>r<br />

<strong>in</strong>ternational organizations. WIPO implements this<br />

mandate by, <strong>in</strong>ter alia, adm<strong>in</strong>ister<strong>in</strong>g various multilateral<br />

treaties deal<strong>in</strong>g with <strong>the</strong> legal and adm<strong>in</strong>istrative aspects <strong>of</strong><br />

<strong>in</strong>tellectual property.<br />

In 1998, WIPO established a programme on global<br />

<strong>in</strong>tellectual property issues to explore, among o<strong>the</strong>rs,<br />

<strong>the</strong> <strong>in</strong>tellectual property aspects <strong>of</strong> biodiversity and<br />

biotechnology, and <strong>the</strong> protection <strong>of</strong> traditional knowledge.<br />

The WIPO General Assembly established, <strong>in</strong> 2001, an<br />

Intergovernmental Committee on Intellectual Property and<br />

<strong>Genetic</strong> <strong>Resources</strong>, Traditional Knowledge and Folklore (IGC).<br />

This Committee provides <strong>the</strong> ma<strong>in</strong> forum with<strong>in</strong> WIPO for<br />

discussions on <strong>in</strong>tellectual property aspects <strong>of</strong> access to<br />

genetic resources and benefit-shar<strong>in</strong>g and <strong>the</strong> protection<br />

<strong>of</strong> traditional knowledge. It is worth not<strong>in</strong>g that WIPO uses<br />

<strong>the</strong> term “genetic resources” as def<strong>in</strong>ed by Article 2 <strong>of</strong> <strong>the</strong><br />

CBD as “genetic material <strong>of</strong> actual or potential value.”<br />

At its fourth session <strong>in</strong> 2002, <strong>the</strong> IGC agreed to develop<br />

a pilot database <strong>of</strong> contractual practices and clauses<br />

relat<strong>in</strong>g to <strong>in</strong>tellectual property and access to genetic<br />

resources and benefit-shar<strong>in</strong>g. A document prepared by <strong>the</strong><br />

Secretariat for <strong>the</strong> IGC’s fifth session <strong>in</strong> July 2003 provides<br />

an overview <strong>of</strong> <strong>in</strong>tellectual property aspects <strong>of</strong> contracts<br />

relat<strong>in</strong>g to biological materials and associated traditional<br />

knowledge. 377 The document notes that due to <strong>the</strong> central<br />

role <strong>of</strong> confidentiality <strong>in</strong> <strong>the</strong> patent system, its ma<strong>in</strong>tenance<br />

is crucial until appropriate protection is <strong>in</strong> place. This is<br />

frequently done by enter<strong>in</strong>g <strong>in</strong>to stand alone confidentiality<br />

agreements, which generate legal certa<strong>in</strong>ty by stipulat<strong>in</strong>g<br />

that <strong>the</strong> party provid<strong>in</strong>g <strong>the</strong> material considers it to be<br />

confidential, supplied for an express purpose, not to be<br />

used for o<strong>the</strong>r purposes, and not to be disclosed to third<br />

parties. 378 O<strong>the</strong>r elements proposed for <strong>in</strong>clusion <strong>in</strong> such<br />

contractual arrangements <strong>in</strong>clude a description <strong>of</strong> <strong>the</strong><br />

<strong>in</strong>formation covered by <strong>the</strong> agreement, <strong>the</strong> nature <strong>of</strong> <strong>the</strong><br />

protection required, <strong>the</strong> scope <strong>of</strong> <strong>the</strong> permitted disclosure<br />

and use, ownership and management <strong>of</strong> fur<strong>the</strong>r IPRs,<br />

and monitor<strong>in</strong>g and report<strong>in</strong>g on <strong>the</strong> use <strong>of</strong> confidential<br />

<strong>in</strong>formation. 379<br />

Respond<strong>in</strong>g to an <strong>in</strong>vitation from <strong>the</strong> sixth COP to <strong>the</strong> CBD<br />

(April 2002), WIPO prepared a technical study on patent<br />

disclosure requirements related to genetic resources and<br />

traditional knowledge, 380 which was subsequently adopted<br />

by WIPO’s General Assembly and presented at <strong>the</strong> seventh<br />

meet<strong>in</strong>g <strong>of</strong> <strong>the</strong> CBD COP <strong>in</strong> February 2004. Disclosure<br />

<strong>of</strong> orig<strong>in</strong> is particularly relevant to deep seabed genetic<br />

resources, <strong>the</strong> status <strong>of</strong> which as common heritage <strong>of</strong><br />

humank<strong>in</strong>d or resources open-access is still largely disputed.<br />

The study aims to analyze methods, consistent with<br />

<strong>in</strong>ternational patent-related obligations, to disclose with<strong>in</strong><br />

patent applications, among o<strong>the</strong>r th<strong>in</strong>gs, genetic resources<br />

used <strong>in</strong> <strong>the</strong> development <strong>of</strong> <strong>the</strong> <strong>in</strong>vention, <strong>the</strong> country<br />

<strong>of</strong> orig<strong>in</strong> <strong>of</strong> <strong>the</strong> resources and evidence <strong>of</strong> PIC as well as<br />

associated traditional knowledge, <strong>in</strong>novations and practices<br />

used <strong>in</strong> <strong>the</strong> development <strong>of</strong> <strong>the</strong> claimed <strong>in</strong>ventions.<br />

WIPO’s study proposes various scenarios for disclosure,<br />

which revolve around <strong>the</strong> follow<strong>in</strong>g requirements:<br />

disclosure <strong>of</strong> orig<strong>in</strong> or source <strong>of</strong> genetic resources used <strong>in</strong> an<br />

<strong>in</strong>vention (or <strong>in</strong> some way connected with <strong>the</strong> development<br />

<strong>of</strong> <strong>the</strong> <strong>in</strong>vention); and disclosure <strong>of</strong> <strong>the</strong> legal context <strong>in</strong><br />

which relevant genetic resources were accessed (this may<br />

<strong>in</strong>clude provid<strong>in</strong>g evidence that <strong>the</strong> access complied with a<br />

certa<strong>in</strong> procedure or legal standard). 381 The study notes <strong>the</strong><br />

need to clarify <strong>the</strong> l<strong>in</strong>k between <strong>in</strong>put, i.e. <strong>the</strong> source genetic<br />

material, and <strong>in</strong>vention and whe<strong>the</strong>r this l<strong>in</strong>k is sufficient to<br />

trigger any particular disclosure requirement. This raises <strong>the</strong><br />

issue <strong>of</strong> whe<strong>the</strong>r <strong>the</strong> requirement would also apply when<br />

<strong>the</strong> <strong>in</strong>vention for which <strong>the</strong> application is filed concerns<br />

syn<strong>the</strong>sized substances that were isolated or derived from<br />

active compounds <strong>of</strong> an accessed genetic resource and, if<br />

so, what <strong>the</strong> def<strong>in</strong>ition <strong>of</strong> “derived” is. The study stresses<br />

<strong>the</strong> need for fur<strong>the</strong>r work on <strong>the</strong> nature <strong>of</strong> disclosure<br />

requirements, not<strong>in</strong>g that a requirement can concern<br />

disclosure per se, or be used as an effective mechanism to<br />

prevent secur<strong>in</strong>g a patent if certa<strong>in</strong> preconditions are not<br />

met. 382 The study identifies several possible legal bases for<br />

disclosure requirements, some <strong>of</strong> which are particularly<br />

<strong>in</strong>terest<strong>in</strong>g consider<strong>in</strong>g <strong>the</strong> status <strong>of</strong> deep seabed genetic<br />

resources. Those are:<br />

• compliance with laws govern<strong>in</strong>g access to genetic<br />

resources;<br />

42

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