Worldwide Bolar-type Provisions

 _{¹ This column addresses whether the clinical trial exemption is limited to abbreviated generic/biosimilar trials which rely on an innovator's data, or whether trials conducted on new drugs are exempt as well.}

_{² This column addresses whether the exemption is available in a first jurisdiction if the clinical trial is conducted in the first jurisdiction and the data generated is exported to a foreign jurisdiction for authorization in the foreign jurisdiction.}

_{³  Exemption only recognized for non-commercial experimentation}

_{⁴  Is arguable but not specifically addressed by statute}

_{⁵ MENA requirements}

_{⁶ Based on judicially-created law.  A statutorily created provision went into effect on October 1, 2009.}

_{⁷ Pursuant to the EU directive, a new law on pharmaceuticals was introduced, however it did not contain the Bolar provision of Article 10(6).  The provision was to be introduced into a revised Danish Patents Act.}

_{⁸ Korean law is largely modeled on Japanese law which judicially recognizes a clinical trial exemption.  However, as of December 19, 2008 there is no Korean case law on point.}

_{⁹ Exemption in UK extended to brand pharmaceuticals}

_{¹⁰ Provided the activity is objectively related to generating information for the US FDA}

_{¹¹ Taiwan is working on a proposed amendment to their Patent Act that would provide an exemption for clinical trials}