ARTICLE
2 September 2021

Granting Of A Compulsory Licence For Pharmaceuticals

SV
Smit & Van Wyk
Contributor
Smit & Van Wyk logo
Smit & Van Wyk is a specialist Intellectual Property law firm that deals exclusively with IP law in South Africa and across Africa as a whole. Our attorneys have the knowledge, experience and resources to give expert legal advice regarding IP portfolio’s and can assist with the filing, registration, prosecution and enforcement thereof.
In particular, Section 56 of the South African Patents Act is applicable when applying for such a licence, based on a so-called "abuse of rights".
South Africa Intellectual Property
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In the event that an interested person discovers, through whatever means, a patented product that is still in force, and that person wishes to make use of that patent in South Africa, the person may approach the Patentee for the grant of a voluntary licence and/or a compulsory licence. When it comes to compulsory licensing, the South African Patents Act is largely compliant with the TRIPS Agreement and the Doha Declaration. In particular, Section 56 of the South African Patents Act is applicable when applying for such a licence, based on a so-called "abuse of rights". In terms of Section 56, at the request of any interested person, a compulsory licence may be granted if one of the following conditions, deemed an abuse of the patent, are met:

  • The patented invention is not being worked in the Republic on a commercial scale or to an adequate extent, after the expiry of a period of four years from the filing date of the patent application or three years from the date of grant of the patent, whichever period expires last, and there is no satisfactory reason therefor (in opinion of Commissioner of Patents).
  • The working of the patented invention does not meet the demand in the Republic to an adequate extent and on reasonable terms.
  • On account of refusal of the Patentee to grant a licence on reasonable terms and the establishment or development of trade and industry is being prejudiced and it is in the public interest to grant a licence.
  • The demand in the Republic is being met through importation and the price charged by the Patentee, his licencee or agent for the patented invention is excessive in relation to the price charged therefor in countries where the patented invention is manufactured by, or under licence from, the Patentee.

Although a Patentee has a Patent Certificate and the exclusive rights to the patented invention for the duration of the patent, a compulsory licence may be granted upon request and if one or more of the above requirements have been proven in court.  A compulsory licencee bears the same rights and obligations as any other licencee of the patent, subject to any conditions which may be imposed by the court. The compulsory licence provisions should not be seen as a threat to Patentees. These provisions merely aim to ensure that there is in fact exploitation of patented inventions in South Africa and that patent rights are not exercised in such a manner as to prejudice the development of the relevant industry. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

ARTICLE
2 September 2021

Granting Of A Compulsory Licence For Pharmaceuticals

South Africa Intellectual Property
Contributor
Smit & Van Wyk logo
Smit & Van Wyk is a specialist Intellectual Property law firm that deals exclusively with IP law in South Africa and across Africa as a whole. Our attorneys have the knowledge, experience and resources to give expert legal advice regarding IP portfolio’s and can assist with the filing, registration, prosecution and enforcement thereof.
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