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2. Chapter Two : The International Response to Biopiracy and

2.6 A Critical Analysis of the Nagoya Protocol

2.6.7 Designated Checkpoints

Under the Nagoya Protocol, Contracting Parties are required to take measures, as appropriate, to monitor and enhance transparency regarding the utilization of genetic resources.195 As stated above, such monitoring measures must include one or more designated checkpoints.196 The monitoring provisions in Article 17 were left vague with regards to the appropriate checkpoints

190 Nijar, GS (n. 116) at 27.

191 Article 17.3, Nagoya Protocol.

192 Article 17.4 (f), Nagoya Protocol.

193 Nijar, GS (n. 116) at 27.

194 Kamau, EC, Fedder, B and Winter, G (n. 50) at 253.

195 Article 17.1, Nagoya Protocol.

196 Article 17.1(a), Nagoya Protocol.

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for collection of information. Although the Like-Minded Megadiverse Countries (LMMC) argued for the mandatory inclusion of patent offices as designated check-points in the Nagoya Protocol, these were not included in the adopted Protocol.197 Had they been included, this could have had the effect of mandating Parties to provide disclosure of origin requirements in national patent laws, which could assist in the mitigation of patent-related biopiracy.

Developing countries argued for the disclosure mechanism to be incorporated within the intellectual property system, as the registration of patents constitutes the point at which genetic resources are commercialized and benefits are generated.198 It was argued that the mandatory disclosure in patent applications would have the following benefits:

(a) Patent applicants would be obliged to comply with national ABS law;

(b) Patent offices would be encouraged to be more vigilant when examining patent applications pertaining to genetic resources and associated traditional knowledge;

(c) It would serve as an essential tool for user countries in monitoring applications based on genetic resources and associated traditional knowledge and in so doing, would assist provider countries in tracking suspicious patents applications.199

South Africa’s experience in the Pelargonium case is an example of what could have been avoided if the mandatory disclosure in patent applications were in place. In the Pelargonium case, a plant used as a herbal remedy known as Umckaloabo was part of a patenting dispute between the indigenous community from Alice in the Eastern Cape and the company Schwabe Pharmaceuticals from Germany. The community of Alice, together with certain NGOs, challenged the validity of patents registered with the European Patents Office, in favor of Schwabe Pharmaceuticals, on the basis that Schwabe Pharmaceuticals had registered patents based on an extraction method used to produce Umckaloabo, which had in fact been used by the community of Alice for centuries.200 Schwabe Pharmaceuticals failed to obtain the PIC of or to enter into BSAs with the community of Alice. One of the patents was ultimately revoked by the European Patents Office on the basis that the extractive method used by Schwabe Pharmaceuticals to produce Umckaloabo lacked an inventive step, as the community of Alice

197 Bavikatte, K and Robinson, DF (n. 30) at 48.

198 Jospeh, RK (n.10) at 82.

199 Ibid.

200 Rutert, B et al (n. 25) at 18.

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had used the same extraction method to produce Umckaloabo for centuries. The European Patents Office allows patents to be granted even if they rely on resources which were obtained in breach of a provider country’s ABS legislation and more stringent checkpoint provisions in the Nagoya Protocol, as advocated by the LMMCs, may have required a change in this regard.

Proposals concerning the mandatory disclosure in patent applications were strongly resisted by Japan, Australia, New Zealand, the European Union and Switzerland, which argued that such requirements would conflict with international intellectual property law.201 The developing countries proposed a compromise to the effect that if intellectual property offices were not specifically identified as checkpoints in the Nagoya Protocol, then alternate effective checkpoints should be identified.202 However, even this suggested compromise was refused by countries such as Canada, Japan and Australia and the Protocol fails to identify any specific checkpoints.203 Accordingly, the Contracting Parties have flexibility in designating checkpoints and the decision is theirs as to whether to specify their patent office as a checkpoint.204 The end result is that the adopted version of the Nagoya Protocol gives Parties substantial discretion with regards to the type of checkpoints to be designated, the type of information to be disclosed at such checkpoints and the measures to be taken in the event of non-compliance. Article 17 of the Nagoya Protocol simply requires that the appointed checkpoints be ‘effective’205 and the measures to address non- compliance be ‘appropriate, effective and proportionate’.206

Of further significance is that there is no obligation on the Contracting Parties to inform the Clearing House/Secretariat of their designated checkpoints, whereas provider countries are obligated to notify the Secretariat of their designated focal points, as well as their national competent authority.207 The compliance provisions in the Nagoya Protocol are therefore weak as no effective checkpoints have been identified and there is no mandatory requirement for users to disclose all relevant information relating to PIC, the source of the genetic resource, the establishment of MAT and/or the utilization of genetic resources, at checkpoints due to the

201 International Institute for Sustainable Development (IISD) Reporting Services ‘ABS-4 Highlights: Wednesday, 1 February 2006’ in Earth Negotiations Bulletin 9:342, 2 February 2006, 1 at 2. Available at http://www.iisd.ca/biodiv/abs-wg4/. Accessed on 18/03/13.

202 Jospeh, RK (n. 10) at 90.

203 Ibid at 91.

204 Ibid.

205 Article 17(1)(iv), Nagoya Protocol.

206 Article 17(1)(ii), Nagoya Protocol.

207 Articles 13 & 14, Nagoya Protocol.

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qualifier of ‘as appropriate and depending on the particular characteristics of a designated checkpoint’.208 Furthermore, the Protocol requires no specific sanctions to remedy the non- disclosure of designated checkpoints by user countries. Hence, it would appear that the Nagoya Protocol falls short in dealing with concerns relating to bio-piracy and intellectual property.