La metodología en el Diseño

The TRIPS Agreement imposes an obligation on all member states to offer adequate protection for confidential information submitted as prerequisites for gaining market approvals for new drugs. Article 39 of the TRIPS Agreement addresses this issue in the following terms:

11

C M Correa, Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement

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1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.

2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information:

a. is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;

b. has commercial value because it is secret; and

c. has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected.

An argument has been made that the initial wording of Article 39.1, ‘ensuring effective protection against unfair competition’, suggests that the protection afforded under Article 39 is founded on the rules relating to unfair competition as outlined in article 10bis of the Paris Convention.12 Such protection would therefore offer a safeguard against unfair commercial practices without giving rise to exclusive rights.13 On this basis, Article 39 does not create proprietary rights but only gives a de facto control to the owner of the undisclosed information.14Daniel Gervais has taken the view that the protection against unfair commercial

12 UNCTAD-ICTSD, above n 10, 527. 13 Ibid. 14 Ibid.

85 use is enough to satisfy the protection against non-disclosure.15Carlos Correa also maintains the position that the text of Article 39 is ‘unusually clear’ in showing that the obligation under the provision does not go beyond the requirement of protection against unfair commercial practice recognised in the Paris Convention.16 He further argues that not only does the language of Article 39 fall short of what could be recognised as data exclusivity or the creation of an independent proprietary right but also any interpretation of this Article requiring the establishment of exclusive rights (as constantly done by the US and the pharmaceutical industry) would be fundamentally at variance with the language of TRIPS.17 While the argument that Article 39 does not go beyond the requirement to protect against unfair commercial use (as provided for in the Paris Convention) does sound attractive, it does not necessarily sound convincing. It is important to note that obligations under the Paris Convention are already incorporated in the TRIPS Agreement by virtue of Article 2, which provides:

1. In respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19, of the Paris Convention (1967).

2. Nothing in Parts I to IV of this Agreement shall derogate from existing obligations that Members may have to each other under the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits.

Given the fact that obligations under the Paris Convention are already binding on parties, it would be unnecessary to reproduce Article 10bis of the Paris Convention in the text of the TRIPS Agreement. In addition, it is very obvious that Article 39 of TRIPS contains specific provisions that substantially differ from Article 10bis. Indeed, what the opening wording of Article 39 says is that Members, in the course of ensuring adequate protection against unfair competition, must protect undisclosed information in line with the further standards imposed by the provision. It is therefore submitted that the protection required under Article 39 is not just confined to the protection against unfair commercial use, as a number of eminent scholars in the field have argued, but also requires standards significantly higher than those

15

D Gervais, The TRIPS Agreement: Drafting History and Analysis (Sweet & Maxwell, Thomson Reuters 4th ed., 2012), 545.

16

Correa, above n 11, 367.

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86 available under the Paris Convention. Writing in a similar vein, Nuno Pires de Carvalho argues:

…the purpose of Article 39 is not to oblige WTO Members to provide for effective protection against unfair competition, but rather to clarify two issues relating to the protection trade secrets that the legislation of many countries had failed to address appropriately…18