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Extension of patent term - Phillips Ormonde Fitzpatrick

Extension of patent term



The following table provides a snapshot of some key countries' approach to patent term extension

Country



Extension of patent term provision


Springboarding exemption *


Data exclusivity **


Australia
Yes
Section 70 (Patents Act 1990 (Cth))
Yes
Section 119A (Patents Act 1990 (Cth))
Yes
5 years
(s25A Therapeutic Goods Act (Cth))
Brazil
No
No
Yes
5 or 10 years
(Regulatory Law 10,603 of Dec 17 2002)
Canada
No
Yes
Article 55.2(2)
Yes
5 years
(Food & Drug Regulations, Section C.08.004.1)
China
No
No
Yes
6 years
(Article 35 of the Implementing Regulations of the Drug Administration Law of 4 August 2002)
EU
Yes
Article 69 (SPC)
Yes
Directive 2004/27/EC & 2004/28/EC
Yes
10 years
(Article 10 of Directive 2001/83/EC)
Japan
Yes
Article 67(2) of the Japanese Patents Act
Yes
Article 69(1) of the Japanese Patents Act
Yes
4-10 years
(Japanese Drug Regulation Article 18-3)
Korea
Yes
Article 89 of the Korean Patents Act
Yes
Article 96(1) of the Korean Patents Act
Yes
4 or 6 years
(Article 26-2 of the PAL: Article 5, Paragraph 11 of the KFDA Regulations Regarding the Safety and Efficacy Examination of Drug Products)
Mexico
No
Extension of term provision repealed in 1994
No
Article 22 of the Mexican Law of Industrial Property of 1991 is an experimental use provision only
Yes
5 years
(Article 1711 Trade Secrets, NAFTA)
New Zealand
No
New Patents Act due 2009/2010 will not include an extension of term provision
Yes
s68B of New Zealand Patents Act 1953 (a similar provision will appear in the new Patents Act)
Yes
5 years
(Medicines Amendment Act 1994 (NZ))
Russia
Yes
Article 10 of the Patent Law 1992
Yes
Article 11 of the Patent Law 1992
Yes
Not specified
(Article 39 - Civil Code - Business or Commercial Secret)
South Africa
No
No
Yes
Not specified
(Medicines Control Act 101 of 1995, Section 34)
UK
Yes
Section 123(1) of the Patents Act 1977
Yes
Section 60(5) of the Patents Act 1977
Yes
10 years
USA
Yes
Articles 155, 156 35 U.S.C.
Yes
Article 271(e)(1) 35 U.S.C
Yes
3 or 5 years
(Drug Price Competition and Patent Term Restoration Act, commonly known as the "Hatch-Waxman Act")

* Springboarding is an exception to patent infringement and in some jurisdictions, it is known as a 'Bolar‘, 'regulatory review' or ‘Hatch-Waxman’ exception.

Springboarding refers to the use of the subject matter of a patent for the purpose of obtaining regulatory approval of a generic version of the patented product while the patent is still in force.

In the absence of any permitted springboarding, such conduct during the term of a patent would amount to infringement of the patent.

** Data exclusivity is the period during which the relevant pharmaceutical regulatory agency (eg FDA or TGA) cannot access or use research data provided by the original applicant for permission to market a drug when considering an application by a generic manufacturer.

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