Patent Attorney and Partner, Michael Best & Friedrich , 2 Prudential Plaza, 180 North Stetson Avenue, Suite 2000, Chicago, IL 60601 , USA +1 312 596 5812 ; +1 312 222 0818 ;
Expert Opin Ther Pat. 2014 Jan;24(1):1-4. doi: 10.1517/13543776.2014.854773. Epub 2013 Nov 9.
Pharmaceutical manufacturers who seek new markets for expansion are particularly attracted to Brazil given its potential for growth and the expectation that it will be the fifth largest drug market by 2015. Given the significance of Brazil in the marketplace, strong patent protection for pharmaceutical products and processes is critical. In April 2013, a new workflow came into effect in Brazil which allows the National Sanitary Vigilance Agency (ANVISA), a government agency whose function is to protect public health, to examine and reject any patent application that claims a pharmaceutical product or process before any examination of the application by the Brazilian Patent Office. If a patent application is rejected by ANVISA, the application is returned to the Brazilian Patent Office and filed away, without any further examination, for an unknown period of time. Therefore, the examination of pharmaceutical product and process applications under this new workflow is problematic for local and global pharmaceutical manufacturers for multiple reasons.
制药商寻求新的市场扩张，尤其被巴西的增长潜力所吸引，预计到 2015 年，巴西将成为第五大药品市场。鉴于巴西在市场中的重要性，对药品和工艺的强有力的专利保护至关重要。2013 年 4 月，巴西出台了一项新的工作流程，允许国家卫生监督局（ANVISA）——一个负责保护公众健康的政府机构——在巴西专利局对专利申请进行审查之前，对声称药品或工艺的任何专利申请进行审查和拒绝。如果专利申请被 ANVISA 拒绝，该申请将被退回巴西专利局，并在未知的时间内被归档，不再进行进一步审查。因此，由于多种原因，这种新工作流程下的药品和工艺申请的审查对当地和全球的制药商来说都是一个问题。
