Georgia’s civil society opposes patents for HIV medicines

Network TBPeople, MMA’s partner in Georgia, has made progress in the fight against patent monopolies for life-saving drugs.

Image © Gemma Taylor/Make Medicines Affordable/2018

Holy Trinity Cathedral of Tbilisi, Georgia.

On the December 9, 2021, Network TBPeople, with technical support from 100% Life in Ukraine and ITPC Global, submitted three patent oppositions for the HIV antiretroviral drugs islatravir and doravirine, against the following patents:

  • P20207190B – Islatravir for the treatment or prophylaxis of HIV (dosing regimen less frequent than once-daily);
  • P20217231B – Islatravir for the treatment or prophylaxis of HIV (dosing regimen less frequent than once-daily); and
  • P20156368B – Doravirine compound.

Doravirine (DOR) a nonnucleoside reverse transcriptase inhibitor (NNRTI) is an approved HIV antiretroviral, which is used in combination with other antiretrovirals. DOR is available as a stand-alone tablet and as part of a fixed-dose combination with tenofovir disoproxil fumarate and lamivudine.

Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), was being developed in oral, injectable and implant formulations for HIV treatment and prevention – with the potential for weekly. monthly and even annual dosing. However, islatravir was placed on clinical hold by the US FDA in December 2021, because some clinical trial participants who received the drug had decreases in their CD4 cell counts – especially those who got higher doses of the drug.  The mechanism responsible for this side effect is currently unknown – as is islatravir’s future.

Nonetheless, elimination of the patent barriers to islatravir and doravirine is an important step towards ensuring access to effective medicines. Network TBPeople hopes for a prompt and positive decision on islatravir and doravirine patent oppositions in Georgia.

“While we don’t know if islatravir will reach the market, this patent opposition is still an important step towards access to life-saving medicines.”, says Mari Chokheli, from Network TBPeople.


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