April 19, 2011

Gaps in Data Exclusivity under Trade Secrets Law

Asian-Counsel

In 2002, Thailand adopted the Trade Secrets Act which contains a provision intended to safeguard the confidentiality of marketing approval data submitted to the Thai Food and Drug Administration (FDA). However, the Patent Act clearly confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to seeking regulatory approval before a patent for a particular protected drug has expired (i.e., a Bolar provision). Based on this, the extent of data protection for the information submitted to the FDA by a drug originator is a key issue, as discussed in this article.

AUTHORS
Edward Kelly
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