|Country||Recognizes Clinical Trial Exemption||Exemption Covers New Drugs as well as Generics/Biosimilars?4||Ability to Export Data for Authorization in Foreign Jurisdiction?2|
|Bulgaria||Yes||Not clear||Not clear|
|China||Yes6||Not clear||Not clear|
|Korea||Yes?8||Not clear||Not clear|
|New Zealand||Yes||Yes||Not clear|
|Poland||Yes||Yes||Probably limited to EU-member states|
|South Africa||Yes||Not clear||Not clear|
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. To view our past issues, as well as other firm newsletters, please click here.