ALP has undertaken to do a patent status search for select ARVs in Kenya with the Kenya Industrial Property Institute (KIPI) Patent office. KIPI is the body responsible for registering patent rights in the country. The nexus between a strict enforcement of IPR and accessibility of essential medicines is one that is now well appreciated. That a strict enforcement of intellectual Property Rights (IPR) would severely limit access to essential medicines. A recognition of this is manifested by the flexibilities provided for under the TRIPS agreement. Some of the big players in the pharmaceutical industry like Roche recognize this and on their website, announce that “Roche will not act against infringement of patents Roche holds on HIV/AIDS drugs in sub-Saharan Africa and UN defined Least Developed Countries, nor will Roche file patents on new or investigational HIV/AIDS medications in these countries.” Roche is just but one player, considering the wide field that is the pharmaceutical industry, this statement simply points to the great work yet to be done in ensuring that recognition and enforcement of patent rights does not limit access to ARVs which are life enhancing medication for PLHIVs. The new WHO Treatment Guidelines have proposed to increase the treatment threshold to CD4 <500 down from <350. This means that more patients will have to be enrolled on ARVs earlier and as such there will be a greater demand for the same medicines. As such, we are training our eyes on the patent status of ARVs to ensure that that IPRs do not infringe on the right to health, now so well guaranteed in Article 43 of the constitution of Kenya, 2010.
This information may particularly be important to organizations/individuals who may desire to institute patent litigation on the above ARVs. Patent litigation assists in ensuring compliance with patentability criteria under the national law, pressure on patent offices to do a thorough analysis of patent applications. Many patent applications are on new forms/improvements of known compounds; successful opposition can invalidate or reject such patents/applications, enabling access to affordable generic medicines and opposition proceedings can encourage voluntary licensing or withdrawal of patent applications. Currrently, the classes of ARV drugs being used in Kenya are as follows:
- Nucleoside reverse transcriptase inhibitors (NRTIs): Zidovudine (AZT), Didanosine (ddi); Lamivudine (3Tc); Tenofovir Disoproxil Fumarate (TDF); Abacavir (ABC); Emtricitabine (FTC); and Zalcitabine (ddc)
- Non-nucleoside reverse transcriptase inhibitors (NNRTIs): Nevirapine (NVP), Efavirenz (EFV); and Delaviraline (DLV)
- Protease inhibitors: Lopinavir/ Ritonavir (LPV/r); Nelfinavir (NFV); Ritonavir (RTV), Saquinavir (SQV); Indinavir (IDV); Atanazavir (ATV); Amrenavir (APV), Fasamprenavir (f-APV); and Tipranavir (TPV).
- Fusion Inhibitor (Entry inhibitors): Enfurvitide (T20)
The above are the initial focus of patent database which can be downloaded here. For any further information on the individual patent journals, you can contact us as provided in this website. Keep checking this for any emerging updates.