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Role, Perspectives and Challenges of the Generic Pharmaceutical Industry in Latin America

The domestic pharmaceutical industry has adapted to the new rules set by the WTO Agreements since 1995, even if the TRIPS obligations became binding on developing countries only in 2000; and the obligation to grant product patent protection for pharmaceuticals will only commence in 2005. The patent protection for pharmaceutical products generated an unexpected scenario: the indiscriminate granting of trivial patents (polymorphs, isomers, second uses or combination of known products, formulations, etc) to foreign pharmaceutical companies. Patents granted according to a TRIPS-plus system of "pipeline" protection (see below for an explanation) jeopardize or exclude from the market medicines that have been in the public domain and marketed for a long time under the presumption of infringement. In some cases the exclusion is obtained through judicial provisional measures, in many cases without ground. After years of litigation, these law suits some times cannot prove the patent infringement, but serve the purpose of forcing competition out of the market.