MULTINATIONAL INTELLECTUAL PROPERTY RIGHTS THREATENED IN ARGENTINA
Recent cases involving multinational drug firms highlight the deteriorating intellectual property environment in Argentina's US$2bn drug market. Local media sources report that US-based Merck & Co and Schering-Plough, as well as Switzerland's Novartis, are to withdraw patented products. The decisions have been attributed to the country's poorly enforced patent rights, an indifferent government and the copy-producing local manufacturing sector.
Argentina has enforced a modern Patent Law since 2000, but as only eight pharmaceutical product patents have since been granted, concerns also focus on the country's data exclusivity rules. Foreign drugmakers argue that the relevant piece of legislation, Law 24.766, violates the national constitution as well as TRIPS.
The role of health regulator ANMAT is also critical in Argentina, as the agency has little direct linkage with the national patent office. In regulatory submissions, ANMAT only requests details of a drug's ingredients, manufacturing process, and clinical trial data, with no requirement to provide information on the product's patent status.
A key problem is protecting products for which patent applications have never been submitted in Argentina, with local firms attempting to obtain Argentine patents on many multinational-manufactured drugs. Multinationals report that local subsidiaries are unable to obtain patents, as local companies are often first to file.
Media sources say that a court ruling in June 2005 ordered five local manufacturers to cease production of a copy of leading high cholesterol drug. ANMAT then failed to implement the ruling, which also affected two leading cancer drugs, which had rival copies pending approval. However, the same judge overturned the decision two months later, purportedly on the basis of TRIPS, effectively allowing copies of all three foreign drug firms' products to continue. Meanwhile, it is reported that the health ministry has ordered the justice ministry to curtail the scope of cases involving exhaustion of rights.