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Worldwide Bolar-type Provisions*

Worldwide Bolar-type Provisions

Country

Recognizes Clinical Trial Exemption

Exemption Covers New Drugs as well as Generics/Biosimilars?1

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.

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

© 2019 Sterne Kessler

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About this Author

Paul Calvo, Intellectual Property Attorney, Sterne Kessler Law Firm
Ph.D. Director

Dr. Calvo, a director in the Biotechnology/Chemical Group, represents a diverse group of U.S. and international companies innovating in the biotechnology and pharmaceuticals industries.  He provides counsel with regard to global patent portfolio strategy, licensing, patent validity, infringement, and design around strategies.  Dr. Calvo is experienced in U.S. and international patent procurement and enforcement matters (particularly patent prosecution and oppositions), FDA/ANDA practice, technology transfer, invalidity, noninfringement, freedom-to-operate and patentability opinions, and...

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