The compulsory licence granted under the court ruling applies exclusively within Russia, including the use of the two Eurasian patents on Russian territory. It does not authorise the manufacture or sale of medicines in other countries where these patents are in force.

The licence will allow the manufacture and sale of cabotegravir-containing medicines for the remaining duration of the relevant patent rights, including any extensions. The court set combined annual royalties at 1.75% of sales revenue, with 1.17% payable to ViiV Healthcare and 0.58% to Shionogi.

However, authorisation to use the patents does not, in itself, mean that the relevant medicines have received regulatory approval or become available to patients. In August, the Promomed Group announced that its oral and injectable formulations of cabotegravir and rilpivirine had received marketing authorisations in Russia. The company also noted that the start of commercial sales remained subject to the fulfilment of the necessary legal requirements.

Pharmvestnik also cites information from Zdravresource, a Russian organisation working to improve access to treatment. According to the organisation, access to the originator long-acting injectable medicines has so far been largely limited to participation in clinical trials conducted at selected AIDS centres. Its representatives note that one of the remaining steps towards ensuring publicly funded access to these medicines is their inclusion in Russia’s List of Vital and Essential Medicines (ЖНВЛП).

We would also like to emphasise that the Russian court’s ruling does not, in itself, ensure access to cabotegravir in other countries of Eastern Europe and Central Asia (EECA). Its public health significance will depend on how it is implemented in Russia: whether affordable, quality-assured medicines are procured, whether reliable supplies can be ensured, and whether people who need these medicines will actually be able to access them.

Which Patents Are Covered by the Court Ruling?

The three patents protect different aspects of the medicine, ranging from chemical compounds to the injectable formulation and manufacturing processes.

1. EA014162B1 — Eurasian Patent Covering Chemical Compounds

This patent covers a specific class of polycyclic carbamoylpyridone compounds with inhibitory activity against HIV integrase. Its patent protection is relevant to several antiretroviral molecules, including cabotegravir and dolutegravir.

2. EA024924B1 — Eurasian Patent Covering an Injectable Formulation

This patent relates to a pharmaceutical composition for the injectable administration of cabotegravir. Protection of this formulation is relevant to the manufacture of long-acting medicines.

3. RU2527451C2 — Russian Patent Covering a Synthesis Process and an Intermediate Compound

This patent covers a specific chemical synthesis process for carbamoylpyridone HIV integrase inhibitors, including bromination, side-chain formation, ring formation, and removal of a benzyl protecting group. In addition, the patent protects a specific intermediate compound used in the synthesis process.The primary subject of the patent protection is the chemical manufacturing process rather than the finished injectable formulation.

The post Russian Court Grants Biokhimik a Licence to Manufacture and Supply Cabotegravir first appeared on ITPCru.

Before that, Humanitarian Action Charitable Foundation, a St. Petersburg-based NGO, with the technical support of Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru), filed an opposition against a patent for this drug. The next hearing in the Chamber for Patent Disputes is scheduled for September 9, 2020.

The combination of tenofovir and emtricitabine is part of the key recommended regimen for initiating antiretroviral therapy according to the World Health Organization and the Russian Association of Specialists in HIV Prevention, Diagnostics and Treatment. Currently, it is the only regimen approved in Russia for pre-exposure prophylaxis (PreP).

It is important to note that Gilead Sciences on several occasions have made it clear that the company has no plans to actively market Truvada in Russia, and that the company’s strategy would focus on the novel drugs instead.

The drug is not included in the Essential Medicines List (EML), and during one of the meetings with patient organizations the company stated explicitly that it was not planning to re-submit the dossier for inclusion of TDF/FTC into the EML. Due to the absence of TDF/FTC in the EML, the price of TDF/FTC in Russia is not regulated. The current price in the range of USD200 per month places the drug out of reach for most patients either as HIV pre-exposure prophylaxis (PreP) or as treatment. In 2019, only 10 people could access it as part of the antiretroviral therapy within the government HIV treatment programme in Russia.

PreP is not yet covered and provided by the government, and patients must purchase the drug themselves. According to a study about PreP carried out by one of the Russian patient organizations (Phoenix-PLUS), only 6% of the respondents are willing and able to buy the original version of TDF/FTC at approximately USD200 per month.

There are currently several generic versions of TDF/FTC registered in Russia, which could be marketed at considerably lower prices if there were no patent protection (registration in itself is not a patent violation). The global prices for generic TDF/FTC can be as low as 3 USD per month; in some countries of EU, the price of generic TDF/FTC is below 50 EUR. In the Netherlands, for example, the price of TDF/FTC has dropped from 344.28 Euro (Gilead’s Truvada) for a 30 day supply to 47.95 Euro for the generic version.

The activists believe that availability of generic versions of tenofovir and emtricitabine in Russia will enable to significantly decrease the costs of PreP and expand its availability, as well as improve access to recommended fixed-dose combinations of antiretroviral drugs. This, in its turn, will increase the effectiveness of therapy and the HIV response.

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