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
Argentina No3 n/a n/a
Australia Yes Yes Yes
Austria Yes Arguable4 Arguable4
Belgium Yes No No
Brazil Yes Yes Yes
Bulgaria Yes Not clear Not clear
Canada Yes Yes Yes
Chile No n/a n/a
China Yes6 Not clear Not clear
Croatia Yes Yes Not clear
Czech Republic Yes Yes Yes
Denmark Not yet7
Egypt5 Yes Yes Unclear
France Yes Arguable4 Arguable4
Germany Yes Yes Yes
Hong Kong No n/a n/a
Hungary Yes Arguable4 Not clear
India Yes Yes Yes
Iran5 Yes Yes Unclear
Ireland Yes No No
Israel Yes Yes Not clear
Italy Yes Arguable4 Yes
Jordan5 Yes Yes Unclear
Korea Yes?8 Not clear Not clear
Latvia Yes Yes Yes
Lebanon5 Yes Yes Unclear
Mexico Yes Yes Yes
Morocco5 Yes Yes Unclear
Netherlands Yes Arguable4 No
New Zealand Yes Yes Not clear
Philippines Yes Arguable4 Yes
Poland Yes Yes Probably limited to EU-member states
Portugal Yes No No
Romania Yes Yes Yes
Russia Yes Yes Not clear
Saudi Arabia5 Yes Yes Unclear
Singapore Yes Yes Not clear
Slovakia Yes Yes Yes
South Africa Yes Not clear Not clear
Spain Yes Yes Yes
Sweden Yes No No
Switzerland Yes Yes Yes
Taiwan3,11 No n/a n/a
Turkey Yes Yes Yes
UAE5 Yes Yes Unclear
Ukraine No n/a n/a
United Kingdom Yes Yes9 No
United States Yes Yes Yes10

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.