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

*This document is based on information provided by local counsel in various countries. It does not constitute a legal opinion. Prior to commencing activities in any country, a legal opinion should be obtained from the relevant local associate based on the specific facts.

This article appeared in the December 2017 issue of Global Patent Prosecution Newsletter.