November 02-04 Tbilisi hosted a meeting dedicated to the issues of access to medicines in terms of the barriers associated with intellectual property. The meeting was attended by representatives from the following pharmaceutical companies: Pharmasyntez (Russia), Biocad (Russia), Cipla (India), Mylan (U.S.), Tatchempharm (Russia), and PharmEvo (Pakistan).
The following issues have been discussed at the meeting:
- The companies’ plans for authorization and the market launch of the second or third-line medicines for HIV infection treatment and antiviral drugs for hepatitis C virus treatment (lopinavir/ritonavir, atazanavir, darunavir (including darunavir generics (amorphous form of darunavir), which do not infringe the existing patent on this medicine), dolutegravir, sofosbuvir and combination therewith, daclatasvir).
- As far as access to darunavir is concerned, it has been emphasized that in the market there are several darunavir generics (amorphous form of darunavir), which do not infringe the existing patent on this medicine (including produced by Pharmasyntez and Hetero). Tatchempharm also announced that their medicines would not infringe a valid patent on darunavir. Subject to the completion of the WHO prequalification or obtaining an approval from FDA/EMA, these medicines can be delivered within the procurement carried out by international agencies.
- The necessity to challenge patents on such medicines as tenofovir/emtricitabine (Eurasian application No 15145), lopinavir/ritonavir, and sofosbuvir due to the weakness of these patents from the point of view of the experts.
- Abatement of the patent on entecavir in the Russian Federation by Pharmasyntez was announced (Eurasian patent on entecavir No 6181, granted pursuant to application No ЕА200200812, protecting the entecavir composition until 2021. The Rospatent official decision will be issued after November 20.
- Decisions on abatement of Eurasian patents in the Russian Federation may and must be used for the abatement of the respective patents in other countries.
- Compulsory licensing.
- The problem of preferences for domestic producers in public procurements.
- ARVs commercial market
Furthermore, one of the key discussion issues was the fact that the absence of patent protection does not automatically mean broad access to the medicine, and that it is required to work towards elimination of other barriers as well.
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