Legal Issues relating to Compulsory Licensing

Though the TRIPS agreement addresses some specific issues relating to the compulsory licensing, it may not offer a higher degree of legal certainty which creates larger risks of legal battles in the developing countries who are the WTO members. Since compulsory licensing intends to provide the producer or importer a right to produce or import a product without the express agreement or consent from the original patent holder it involves a number of legal issues relating to such licensing. Hence it becomes important that:

Clear domestic laws are framed to provide the necessary conditions and circumstances under which compulsory licensing can be resorted to. Prior to the granting of the compulsory license the government may have to enter in to negotiations with the rights holders on the terms and conditions and also the time limit for the use of the rights. This will give rise to several legal issues in drafting the terms and conditions of the contract, determination of the time period as well as the compensation payable for the licensing.

According to Article 1 of the TRIPS Agreement the member nations are left to choose their own means of implementing the requirements of the TRIPS Agreement. As such with a view to facilitating the adoption of the legal protection prescribed under Chapter 3 of the TRIPs Agreement, the member countries can formulate a multilateral system of notification and registration that would enable the countries to administer and implement substantive obligations which extend beyond the existing requirements of TRIPS agreements to provide the producers and consumers a full legal protection. Under Article 63.2 of TRIPS each WTO member is required to notify the proposed measures for framing various legal frameworks in the respective countries pertaining to the framework and administration of the protection in respect of each class of intellectual property covered TRIPS.

Such notification should comprise of: The principal regulations governing the intellectual property and Subsidiary rules and provisions pertaining to IP rights. The notifications generally take two forms namely the ‘Main Laws and Regulations’ and ‘Other Laws and Regulations’. Each part was further subdivided in to various parts comprising of specific intellectual property classes.

These classes of regulations deal with the different intellectual property rights pertaining to that particular class. Generally the following are considered as the legal materials that are relevant to the notification of main laws and regulations: The formulation of primary national legal frameworks that deal with the protection of Intellectual Property Rights. These measures may take the forms of Acts, Codes or laws. The forming of subordinate laws in the form of  regulations, orders or decrees that have a direct relevance to the implementation of the primary national laws on IPRs

Measures to amend existing legislation in the form of primary and sub-ordinate laws that exist to protect the IPRs. Formulation of primary and subordinate laws with a view to bring in to bring the provisions of international agreements on IPRs. There is the provision of relating such legislation to common law provisions of different countries. Drafting of provisions relating to miscellaneous laws that provide detailed descriptions relating to procedures for administering the legal provisions, development of industries and the inventions from employees.

Even though the laws created are not covering the protection of the IPRs in their entirety they do have relevance to the total IP system of the countries. . In some cases notifications were made to notify the laws as ‘other laws’. Under the category of ‘other laws and regulations’ member nations usually incorporate a wide range of laws notifying a wide range of laws and other legal instruments even though they had only remote relationship with the intellectual property rights but could be construed as having relevance to Article 63. 2.

The laws covered under other laws are: “Ratification of international/regional agreements on IPRs. Procedural aspects of domestic administration and enforcement of IPR rights. Unfair competition and market regulation. Notifications of ‘other laws’ also included the following: Civil law countries declared their Penal and Civil Codes (referring to the basic legal rules contained therein) Australia declared its 1963 bilateral Agreement with the Government of the Republic of India regarding the mutual protection of priority on inventions

Ireland declared its primary and sub-ordinate legislation on plant variety protection” According to Daniel Gervais former Head of Section World Intellectual Property Organization (WIPO) after the Doha round of Ministerial Declaration the protection of traditional knowledge has increasingly been attained significance in the global discussions concerning the protection of intellectual property rights and other related issues.

The major reason for the increased importance of ‘traditional knowledge’ is that large number of countries is under the impression that though they possesses rich genetic resources and folklore they have not been used to beneficially. A proper exploitation of these resources is envisaged by major companies. The expression ‘traditional knowledge’ includes ‘traditional knowledge, innovations and practices’. Traditional knowledge covers a wide range of issues from traditional ways of doing agriculture, bio-diversity related pharmaceutical ideas and also folklore.

Professor Graham Dutfield defines traditional knowledge as: “It is recorded and transmitted through oral tradition; it is based on diachronic data, whereas western science is largely based on synchronic data; It is rooted in a social context that sees the world in terms of social and spiritual relations between all life-forms. In contrast, western science is hierarchically organized and vertically compartmentalized.