As was widely reported last week, Brazil and India have requested WTO consultations on the generic drug seizures issue. From Ravi Kanth of the Business Standard:
India and Brazil raised a trade dispute against the European Union (EU) before the World Trade Organization on Tuesday over seizure of generic drugs by EU member countries on high seas.
In two separate trade dispute complaints, India and Brazil have asked the EU and one of its member countries — the Netherlands — to enter into dispute settlement consultations over Brussels’ alleged violation of global rules by illegally confiscating generic drugs exported by Indian pharmaceutical companies to Brazil and other developing countries.“These seizures have wide-ranging implications for developing countries and they undermine the principle of universal access to medicines in poor countries and impose TRIPS+ obligations,” India’s trade envoy Ambassador Ujal Singh Bhatia told reporters.
“Despite raising our concern repeatedly over the European Union’s deeply flawed directive 1383 of 2003, Brussels has failed to bring its rules in compliance with global trade rules,” said Bhatia.
Brazil's request is here. India's request does not seem to be up on the WTO web site yet; I'll add it when they post it. [UPDATE: India's request is here.] For background, SpicyIP has a number of posts on the issue here; and on this blog, Bryan has a much commented on post here.
I'm not going to go through every aspect, but here are some key parts, from Brazil's request.
First, some details on the specific actions:
(A) A shipment of the generic drug Losartan Potassium, produced in India and destined to Brazil, was seized when in transit at Schipol Airport, in the Netherlands, in December 2008, and later returned to the country of origin. The Dutch authorities seized the shipment pursuant to the European Communities Council Regulation No 1383/2003 (EC Regulation No 1383/2003). Based on complaints of suspected infringement by alleged owners of patents (or supplementary protection certificates), over the last two years, customs authorities in the Netherlands have seized a substantial number of consignments of generic medicines from India in transit through the Netherlands, including the aforementioned shipment of Losartan Potassium destined to Brazil.
Then there's the underlying law itself:
(B) EC Regulation No 1383/2003 sets out rules for "customs actions against goods suspected of infringing intellectual property rights and the measures to be taken against goods found to have infringed such rights", including goods in transit through the territory of the European Union, and provides, among other actions, for the seizure of goods. The applicability of EC Regulation No 1383/2003 encompasses medicines in transit through the territory of the European Union that are suspected of infringing patent rights or are found to have infringed patent rights constituted according to the laws of the EC transit country, regardless of the patent status of such medicines in the countries of origin and destination.
The main legal provisions at issue are:
-- GATT Article V:1, V:2, V:3, V:4; V:5, V:7;
-- GATT Article X:3;
-- TRIPS Agreement Articles 1.1, 2, 28, 31, 41.1, 41.2, 42, 49, 50.3, 50.7, 50.8, 51, 52, 53.1, 53.2, 54, 55,
58(b), and 59, and Article 4bis of the Paris Convention of 1967.
Here's a recent journal article (not free, unfortunately) about the case:
Shashank P. Kumar, 'International Trade, Public Health, and Intellectual Property Maximalism: The Case of European Border Enforcement and Trade in Generic Pharmaceuticals' (2010) 5 Global Trade and Customs Journal pp. 155–169
Summary:
Even as the world witnesses another pandemic, industrialized nations and their industries continue their efforts to ‘rachet-up’ levels of intellectual property (IP) protection. Such a maximalist agenda drives another paradigm shift in the international IP regime today. While maximalists employ several methods to promote their agenda, this work seeks to study the case of European border enforcement law (Council Regulation (EC) No. 1383/2003 of 22 Jul. 2003, Concerning Customs Action Against Goods Suspected of Infringing Certain Intellectual Property Rights and the Measures to be Taken Against Goods Found to Have Infringed Such Rights [hereinafter ‘EC Regulation 1383’]) and its effects on international trade in generic drugs. Triggered by several incidents involving ‘seizure’ of in transit generic drugs by European customs, the issue continues to be ‘hotly debated’ on at the international level and is of immense contemporary relevance to larger issue of global justice. After a discussion on the evolution of European border enforcement law and its interpretation by European courts to determine its scope, this work seeks to study the effect of EC Regulation 1383 on international trade in generic pharmaceuticals by studying several instances of ‘seizure’ of generic pharmaceuticals in transit between developing nations and the international debate it has generated at the World Trade Organization (WTO). The discussion highlights the maximalist (and ‘TRIPS-Plus- Plus’) nature of the European law and raises important issues concerning the interpretation of Agreement on Trade-Related Aspect of IP Rights (TRIPS), public health, World Trade Organization, Ministerial Declaration of 14 Nov. 2001 (hereinafter ‘Doha Declaration’), and the possibility of a future WTO dispute. The discussion concludes with some comments on broader issues of global justice and the WTO that are raised by the European law and its enforcement affecting access to medicines in developing countries.
And here's a free one, from Fred Abbott.
ADDED: Here's another free one:
Freedom of Transit and Trade in Generic Pharmaceuticals: An Analysis of EU Border Enforcement Law and Implications for the International Intellectual Property Regime
Shashank Kumar
National Law University, JodhpurEuropean Intellectual Property Review, Forthcoming
Abstract:
A recent dispute involving the suspension of release of a consignment of generic drug in transit from India to Brazil by Dutch Customs raises some important issues for the future of the international intellectual property regime. The dispute is only too timely as some countries resort to bilateralism and Free Trade Agreements for extending intellectual property protection beyond the minimum contained in TRIPS. It provides a classic stage for studying the conflict of interests between developing and developed countries on the issues of access to medicine and standard of protection, and thus deserves closer and independent scrutiny of facts and law. On a cursory glance EC Regulation 1383, which provides for border enforcement of rights in cases of patent infringement, seems to be in consistence with the TRIPS Agreement. A closer analysis, however, reveals that the law, in providing for a TRIPS-Plus standard of protection, may run afoul of Part III, Section IV of the TRIPS Agreement. This conclusion, however, rests on a contextual interpretation, which as this work argues, is provided by the Doha Declaration on Public Health and TRIPS and the subsequent Decision to implement paragraph 6 of the Declaration.
The analysis deals with the interpretation of Articles 51 and 52 of the TRIPS Agreement besides addressing the possibility of using the language of the Agreement itself as providing "ceilings" for maximum protection. The work offers some policy and symptomatic recommendations, but, and perhaps more importantly, shows how the incident serves as another litmus test for testing the efficacy of the intellectual property regime under the TRIPS and the promise of a "balance" the Doha Declaration had promised.
And a short piece from the South Centre: http://www.southcentre.org/index.php?option=com_content&task=view&id=1073&Itemid=279
