TIPO Granted The World’s First Compulsory Licensing on Tamiflu.

Taiwan granted compulsory licensing on the Tamiflu antiviral on 25 November 2005, which is the first in the world in the light of the threat of an avian flu pandemic.  The grant takes effect immediately and shall operate through 31 December 2007.  However, there is one prerequisite:  The Tamiflu antiviral made under the compulsory licensing shall be made for and only for stockpiling sufficient national inventory of the antiviral and must not be deployed until after the Tamiflu stock provided by Roche is fully drawn.

 

Department of Health, Executive Yuan (DOH) filed the compulsory licensing application with TIPO on 31 October 2005 in light of the threat of an avian flu outbreak.  According to Roche, the exclusive licensee of the patented active pharmaceutical ingredient (API) of the Tamiflu antiviral, Roche will supply Taiwan with the Tamiflu antiviral on a phased basis for Taiwan to stockpile an inventory sufficient for deployment to one tenth of the population (namely 2.3 million) by the end of June 2006.  However, to secure the national avian flu preparedness plan, DOH in its capacity as the central health authority considers it necessary to obtain grant of compulsory licensing on the antiviral to eliminate possible shortage in the stock of the Tamiflu antiviral due to an outbreak or Roche’s failure to timely supply the antiviral.

 

TIPO examined DOH’s application in consideration of both of the API patent holder’s right/interests and the national preparedness needs and decided to grant the compulsory licensing on these preconditions:  (1) the grant shall take effect immediately and operate through 31 December 2007 to meet the needs and only the needs of the national preparedness plan; (2) the antiviral made under the compulsory licensing must not be deployed until after the stock of the Tamiflu antiviral or API which DOH procured from Roche is drawn in full; (3) the compulsory licensing may be terminated upon an agreement between Roche and DOH on the licensing of the API patent.  TIPO recommends that Roche and DOH negotiate as soon as possible the compensation payable under the compulsory licensing.  (2005.11)

/EMA