Brazil’s New Patent Agreement Is “Real and Concrete Threat” To IP
An agreement between Brazil’s medicines regulator, ANVISA, and the National Institute of Industrial Property, INPI, aimed at clearly defining their respective roles in the patent application process could pose a threat to the patent system, say IPR experts.
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Brazilian drug regulator Anvisa has made some changes over the years, but still restricts companies with approved Rx products from licensing them to another company.
Joint ordinance signed by Anvisa and INPI hopes to resolve a 16-year impasse between the two agencies and bring predictability to patent application process; Anvisa will be relegated to analyzing public health matters, while INPI will make final patentability determinations.
Brazil could soon be manufacturing its own generic version of Gilead’s Sovaldi if opposition to the company’s patent application is upheld by the patent office.