DESPITE US FTA, CHILE PATENT WORRIES CONTINUE
Chile's free trade agreement with the US is nearing its expected term for full compliance, but foreign firms complain that the new Industrial Property Law is failing to bring the country into line with its international obligations.
Specifically, the measure's definition of a new chemical entity applies only to compounds that have never been an active ingredient in any drug product previously authorised in Chile. On this basis, US trade association PhRMA argues that -- in common with many Latin American countries -- Chile does not fully allow for "second use" patents obtained from a new indication.
Furthermore, the law imposes a 12-month deadline within which companies must launch a new product after the date of first approval in any other market, or lose entitlement to five-year data protection. A period of one year is also the maximum permitted time between registration in Chile and a launch.
Unsurprisingly, US companies complain that such a narrow timeframe allows certain advantages to local copy drug firms, which remain able to exploit unreformed regulatory provisions in order to achieve product registrations, without reference to any data relating to an existing patented version. Meanwhile, it remains to be seen whether new regulations from Chile's Health Institute will improve matters.