MEDIA & PUBLICATIONS

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Pharmaceuticalssold in Brazil will be allowed to have labels with patented uses carved out,the country’s food and drug agency, ANVISA, determined last week. The unanimousdecision by the agency’s board of directors is a win for generics manufacturersoperating in the country, but has potentially negative repercussions forpharmaceutical patent owners. It is especially significant because Brazil isexpected to become the fifth largest pharmaceutical market in the world withinthe next ten years.

However, ANVISA is likely to have a fight on its handsto enforce its new policy. Many contest its right to introduce such aregulation without a change in the country’s federal legislation, which doesnot allow for generics to be sold with skinny labels. As such, the newregulation is expected to be challenged in court.

The intention behind the change is to improve publicaccess to healthcare by promoting greater competition. Currently, the Braziliandrug regulator requires generic drugs to be sold with labels identical to thoseof their reference drugs, meaning that IP owners are able to use a singlepatent-protected indication to prevent copycats from being launched at all(even if the drug compound patent has expired and there are indications forwhich the originator has no patent protection). The strategic advantage of thisfor branded pharma companies is significant.

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