The TRIPs Agreement and Pharmaceuticals. Report of an ASEAN Workshop on the TRIPs Agreement and its Impact on Pharmaceuticals. Jakarta, 2-4 May 2000
(2000; 91 pages) View the PDF document
Table of Contents
View the documentEXECUTIVE SUMMARY
View the documentI. INTRODUCTION
Open this folder and view contentsII. GENERAL ISSUES
Close this folderIII. TECHNICAL ISSUES
View the document3.1 General overview of the TRIPs Agreement
View the document3.2 Standards for patentability
View the document3.3 Compulsory license
View the document3.4 Parallel import
View the document3.5 Exceptions to the exclusive rights
View the document3.6 Enforcement
View the document3.7 Opposition procedures
View the document3.8 Increasing access to HIV/AIDS drugs - Thailand’s experience
View the document3.9 Undisclosed information
View the document3.10 Trademarks, public health and drugs
View the document3.11 State practice and WTO participation
View the document3.12 TRIPs Review
Open this folder and view contentsIV. SPECIAL ISSUES
View the documentVI. RECOMMENDATIONS
Open this folder and view contentsANNEXES

3.6 Enforcement

Enforcement is not discussed very much, but the rules related to enforcement can have significant implications. As mentioned before, sometimes patents may be granted without sufficient justification, they may in fact be invalid. However, once a patent has been granted, there is a presumption of validity. This may create serious problems if countries have strong provisional measures under their enforcement system, such as for instance provisions allowing the patent holder to stop potential infringements.

This can be illustrated with the example of fluconazole in Chili. Fluconazole was in the public domain, no patent was granted on the product in Chili. However one company obtained a process patent on fluconazole in Chili. In Chili, in case of a lawsuit, a patent owner can ask the judge for a provisional measure to prevent potential infringement and stop commercialization of the product. So when a local company started producing fluconazole, the patent owner, based on the process patent, started a lawsuit and asked for a provisional measure, as a result of which the local company had to stop production and commercialization. Litigations like this often take several years. In this case, after the local supply was stopped, the price for the consumer was significantly higher than before the suit was brought. Finally, after several years, the judge came to the conclusion that there was no infringement, that in fact the patented process was not applied for the production of fluconazole by the second company and this company was allowed to resume producing and selling the product. But the question now is: who will reimburse the consumers? How many people have in the meantime not been able to use the product because of the higher price?

So while it may look like a minor point, enforcement regulations may have important consequences. When preparing legislation, such practical cases should be considered. The law can contain very nice substantive rules, but if, at the level of the procedures and in particular the provisional measures, the public interest is not taken into account, unexpected problems may result.

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