Globalization and Access to Drugs. Perspectives on the WTO/TRIPS Agreement - Health Economics and Drugs Series, No. 007 (Revised)
(1998; 97 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the document1. Speech of the WHO Director-General, Dr Gro Harlem Brundtland
View the document2. World Intellectual Property Organization (WIPO)
Open this folder and view contents3. World Trade Organization (WTO)
View the document4. South Centre
View the document5. Health Action International (HAI)
View the document6. International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
View the document7. International Generic Pharmaceutical Alliance (IGPA)
View the documentOther documents in the DAP - Health Economics and Drugs Series
View the documentBack cover

2. World Intellectual Property Organization (WIPO)

Speaker: Richard Wilder

WIPO’s Role and Activities in the Field of the Protection of Patents

Role and Activities of WIPO

The World Intellectual Property Organization (WIPO) is an intergovernmental organization with headquarters in Geneva, Switzerland. It is one of the 16 specialized agencies of the United Nations system of organizations. There are, as of September 21, 1998, 171 States which are members of the Convention establishing WIPO. WIPO is responsible for the promotion of the protection of intellectual property throughout the world through cooperation among States, and for the administration of various multilateral treaties dealing with the legal and administrative aspects of intellectual property. Its principal activities are the progressive development of norms in the field of intellectual property, administering certain treaties for global protection for intellectual property, in particular for patents, trademarks, industrial designs and development cooperation.

One of the main tasks of WIPO consists in cooperating with developing countries in their efforts for development as far as intellectual property is concerned. In the field of industrial property, the main objectives of WIPO’s cooperation with developing countries are:

(i) to encourage and increase, in quantity and importance, the creation of patentable inventions by their own nationals and in their own enterprises, and thereby to enhance their technological self-reliance and their competitiveness in international markets;

(ii) to improve the conditions of acquisition of foreign patented technology, that is, making those conditions more favourable to them than they are today;

(iii) to increase their competitiveness in international trade through a better protection of the trademarks and service marks of relevance in such trade and through a more effective use of trademarks and service marks in commerce;

(iv) to facilitate their access to the technological information contained in patent documents and its dissemination to potential users of such information.

In order to achieve those objectives, most developing countries are in need of enacting or modernizing domestic legislation, strengthening governmental institutions, acceding to international treaties, having more specialists in government, in industry and in the legal professions, and having better access to, and making better use of, industrial property information, particularly patent documents. WIPO provides training and technical assistance to developing countries in all of these areas and has been doing so for many years. Recently, at the request of the WIPO member states, these training and technical assistance activities have been expanded to include matters relating to the implementation of the TRIPS Agreement administered by the WTO.

Patent Protection and Procedures for Application and Legal Effect of Grant

Turning now specifically to patent protection, there are several key points to be borne in mind to best gauge the economic impact of the patent system. These points apply equally to patent protection for pharmaceutical processes and products. First, the patent system encourages people to invent. By granting exclusive rights in an invention, for a limited period of time, people, in particular those engaged in commercial enterprises, are more willing to invest in the resources necessary to make and commercialize the invention. The patent system also encourages people to disclose inventions, rather than retain them as trade secrets.

Applications for patent protection must be filed in every country (or regional offices, where they exist) where protection is desired. The decision of whether to file or not is a business decision based upon the cost of obtaining protection versus the value of that protection in a given country. It is rare that a person or company will file for patent protection in every country having a patent system. Further, many patent systems require the payment of fees to keep both applications and granted patents in force.

A patent, to be valid, must meet certain conditions. First, it must relate to subject matter that is not excluded from patent protection. A diminishing number of countries still exclude pharmaceutical products from patent protection. WIPO advice is not to exclude such subject matter. Further, the invention for which protection is sought must be novel and involve an inventive step. That is, it must not be an invention that is obvious to persons that are skilled in the area of technology with which the invention is concerned. Further, the invention must be useful or be applicable in some area of industry. In addition, the patent application must disclose the invention such that persons skilled in the relevant area of technology can also make and use the invention.

Many offices require that an application, once filed, be subject to a search and examination to determine if it meets the requirements for patentability. A search involves looking for “prior art” - that is, other prior patent documents or other literature that may be relevant to the invention. Following the search, the invention is examined to compare it to the “prior art” to determine if it meets the requirements of patentability. If the conditions for patentability are met, the patent is granted and will have effect for a limited period of time - at least 20 years from the filing date. There is no requirement that every patent office have all the resources necessary to do such a search and examination themselves. For example, many offices rely on the work that has already been done in respect of the same invention by other offices. Moreover, some offices grant protection without a search and examination having been performed. It should be noted that WIPO administers a program of assistance whereby searches and examinations can be performed for patent offices that do not have the facilities to do so themselves.

The patentee has the right to prevent others from using the invention without his permission. Thus, it is a “negative” right. The grant of a patent does not give the patentee a “positive” right to perform the patented invention. Thus, other laws, such as those for the protection of the environment or human or animal health may constrain the use to which the patentee may put the invention. Such constraints include, for example, the requirement in many countries to obtain marketing approval for pharmaceutical products from a health ministry. In respect of preventing others from using the invention, the patentee is limited to the scope of the “claim” contained in the patent. The “claim” is a formal part of the patent which clearly indicates the scope of the patent. It is the “claim” against which the patentability of an invention is judged and against which infringement by others of the patent is determined.

The exercise of the right to exclude others from using a patented invention may be subject to limitations in some countries, including by the right of the government to use the invention or by the grant of compulsory licenses. Moreover, countries may put in place legislation that specifies practices in the licensing of patents that have an anti-competitive effect.

A patent system, to function properly, should be balanced. On the one hand, the patentee must be granted effective protection for his or her invention to induce further research and encourage the disclosure of inventions to the public. On the other hand, national law may take cognizance of the constraints that may be imposed on the grant and exercise of the patent right.

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