Inside U.S. Trade reports that the US government urged Chile “to strengthen the system by which patent owners can challenge the approval of allegedly infringing generic pharmaceuticals to be sold in that market, and its protection of test data used to demonstrate the safety and efficacy of drugs against use by generic companies.” The US discussed these matters at a meeting of the U.S.-Chile Free Trade Commission, a body established by the US-Chile FTA which has since been a forum for disputes over IP and medicines.
Industry sources cited in the article said they thought the current Presidential administration may be open to making these changes – as evidenced by the creation of an interagency committee on IPR last year – but that it may have trouble getting the opposition-controlled legislature to pass such measures.
The U.S. pharmaceutical industry has lobbied the U.S. government to advance these goals in Chile. In their 2010 comments to USTR for the Special 301 Report, PhRMA wrote:
Unfortunately, the Chilean Government has not yet taken concrete action to adopt the regulatory and other changes needed to establish a linkage system consistent with the obligations contained in the U.S.-Chile Free Trade Agreement. Regarding data protection, the current draft of the Health Ministry’s new regulation (which in December 2009 was under legal review by the General Controller of the Republic or CGR) would not provide adequate assurance that prior partial disclosures of data by foreign regulatory agencies could not be used to justify denial of data protection in Chile. In addition, the current draft would leave intact the objectionable provisions relating to data protection contained in Chile’s intellectual property law.
Chile remains on the Special 301 Priority Watch List, as the matter has not been resolved.
