- Keywords > compulsory licences
- Keywords > intellectual property laws
- Keywords > intellectual property protection (IPP)
- Keywords > parallel importation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > pharmaceutical legislation
- Keywords > public health
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2000; 140 pages) [French] [Spanish]
VIII. EXAMINATION AND OBSERVATION PROCEDURES
Patent offices in developing countries are likely to receive a large and growing number of applications claiming protection for pharmaceutical processes, second uses of known products and formulation of products already in the market. Many of these applications will not satisfy the patentability requirements, but there is a real danger of many developing countries improperly granting patents in such cases. Most developing country patent offices lack the capacity to conduct a thorough technical examination of applications for patents. They may be further encumbered by laws and regulations that do not establish patentability criteria with sufficient specificity. Moreover, in some countries, patents are granted without prior examination. Though patents so granted can be revoked, the burden of proof lies with the third parties that challenge the patent’s validity.
Developing countries may ease the examination burden by accessing foreign applications and grants (including the reports of foreign patent offices) corresponding to a national application142. The TRIPs Agreement expressly allows Member countries to request such information (article 29.2). But local examiners should not rely uncritically on evaluations made in industrialized countries, especially because many of the latter will apply different patentability criteria.
142 The application of Chapter I of the Patent Co-operation Treaty administered by WIPO may also be considered in order to improve the examination made at the national level.
Many countries have established and actively use an opposition or observation system to patent applications in order to curtail the granting of improper patents. Such systems provide for the right of a third party to file an opposition to the grant of a patent or to submit observations on the patentability of the invention, after publication of the application143 and before granting144.
143 Such a system requires the publication of the application before granting, which is the current practice in most countries. The United States has recently adopted this rule (Public Law No. 106-113, of 29.11.99), but only for inventors who filed abroad before applying in the United States.
144 This procedure is currently provided for in some laws, such as in Argentina and in Decision 344 of the Andean Group countries.
Alternatively, the law may establish the possibility of challenging a patent before the patent office, at any time or145 within a certain period after the date of the grant146. This approach enables third parties to challenge patents without initiating more costly judicial procedures.
145 In the USA, for instance, the patent holder can request the re-examination of a patent by the Patent Office, before or during an infringement lawsuit, in order to determine whether prior art newly called to its attention invalidates one or more of the patent claims (33 USC 302).
146 A post-grant opposition procedure may be followed before the European Patent Office. “An opposition to an European patent may be filed within nine months from the publication of the grant” (article 99, European Patent Convention).
Opposition procedure may help prevent the granting of improper patents in the health-related sector and other fields of technology, while also strengthening finally granted patents.