Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare
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1 W.I.P.O.J. 43 (2009)
This essay addresses the legitimacy of seizures by the customs authorities of some European Union member states of pharmaceutical products moving in transit through European ports and airports based on patents in force in the transit countries. Seizures have been directed to products off-patent in the countries of manufacture and destination. EU member state customs authorities have justified such seizures on the basis of a 2003 EU intellectual property border enforcement regulation. The seizures have generated intense controversy at the WTO and more widely among stakeholders interested in assuring affordable access to medicines. This essay argues that seizure of generic pharmaceutical products in transit contravenes GATT article V that obligates WTO Members to assure freedom of transit for goods passing through ports and airports, and obligates Members to refrain from imposing unreasonable regulations on such transit goods. It further argues that the seizures are fundamentally inconsistent with the Paris Convention principle of independence of patents that recognizes the sovereign right of states to adopt and implement patent protection as they consider appropriate, within the framework of a general set of rules. Rules permitting enforcement of transit country patents effectively deprives exporting and importing Paris Union and WTO Members of their right to make determinations regarding patents, and represents an overextension of patent jurisdiction by countries without a substantial interest in enforcement. Dutch court adoption of a manufacturing fiction to justify transit seizures – pretending that subject pharmaceuticals are manufactured in the Netherlands, when they clearly are not – represents a significant potential threat to the conduct of international trade. Each WTO Member might pretend that all manner of its domestic regulation – labor, environmental, social welfare – was violated in an exporting country when goods were manufactured, allowing the goods of that country to be seized in transit for a violation of transit country law. The international trading system could not function reasonably in such a fiction-laden environment. The seizure of generic pharmaceutical products in transit is inconsistent with the object and purpose of the Doha Declaration on the TRIPS Agreement and Public Health that promotes access to medicines for all.