| 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.