Amsterdam, 26 July 2018
The European AIDS Treatment Group welcomes the landmark decision of the European Court of Justice confirming the invalidity of the patent extension (Supplementary Protection Certificate) of Truvada (TDF/emtricitabine) that was granted to Gilead Sciences in several European countries.
The ruling signifies the end of an additional market exclusivity that the company had kept within several countries after its patent expired in 2017. This patent extension which was deemed undue and the delay it caused in price competition in many countries continued burdening European health systems budgets and hindered the provision of the TDF/emtricitabine combination for Pre-Exposure Prophylaxis (PrEP) for persons at risk of HIV infections.
‘The introduction of generics is key to scaling up access to PrEP and treatment across Europe and we have been advocating towards regulators, policy makers and the industry for overcoming barriers to access’ says Koen Block, Executive Director of EATG. ‘We commend this decision as an important step in this direction’.
The invalidation of the Supplementary Protection Certificate (SPC) creates jurisprudence in the granting of SPCs. In this particular case, it opens the way to the introduction of generic versions of the TDF/emtricitabine combination. It will enable health systems to save costs, facilitate PrEP programmes introduction as well as their sustainability. It will enable persons at risk of HIV to access an additional effective tool in preventing HIV infection.
Being a strong promoter and supporter of PrEP research from the very beginning, EATG will continue collaboration at local and international levels to further scale up combination prevention, including PrEP.
You can download the press release here.