The international medical humanitarian organisation Médecins Sans Frontières (MSF) has expressed solidarity with the people living with HIV who are opposing the patent applications in India for two important HIV medicines, dolutegravir and cabotegravir. These ‘patent oppositions’ have been filed to challenge an attempt by ViiV Healthcare (a joint venture by Pfizer and GlaxoSmithKline) to obtain monopoly rights in India while several of its patent claims are questionable according to Indian patentability criteria.

Dolutegravir has been available for use in the US and Europe for more than two years, and is now part of first-line HIV treatment in the US as it reduces virus levels faster, is very well tolerated and has a high barrier to resistance. In developing countries, it is urgently needed for some patients who have developed resistance to available first- and second-line medicines. However, the drug is not available from ViiV in India as the company has neither applied for registration in the country, nor makes the drug available under ‘compassionate use’ programmes for dying patients in India.

ViiV licensed dolutegravir to several Indian generic companies in 2014 under a voluntary licence signed between ViiV and the Medicines Patent Pool, as well as at least one bilateral licence outside of the Medicines Patent Pool. Yet, ViiV has effectively blocked access to the drug through licence conditions that limit its supply to public sector entities and NGOs in India with prior permission from the company – and not through private sales. If ViiV now gets a patent for dolutegravir in India, open generic competition among Indian producers would be blocked, keeping the drug out of reach of patients who desperately need immediate access.

“People with HIV in India have had to deal with long delays and it has taken years for new HIV drugs and monitoring tools to be introduced in the treatment programme by the National AIDS Control Organisation (NACO),” said Loon Gangte of the Delhi Network of Positive People (DNP+).

“Without access to dolutegravir in the private sector, people living with HIV who have developed resistance to existing HIV medicines will not be able to get effective treatment they need to stay alive. The irony is that the drug will be produced in India and exported to Africa, but won’t be available to Indian patients who need it.”

The second drug, cabotegravir, with a similar structure as dolutegravir, is still under development by ViiV. Clinical trials are on-going to evaluate this compound, which is being developed as an oral tablet but also as a long-acting injectable formulation, which could make new treatment options available for people living with HIV.

“Patents for these drugs would mean complete monopoly status for a company which has already restricted the availability of an important HIV drug in India,” said Leena Menghaney, head of MSF’s Access Campaign in South Asia.

The patent application in question (3865/KOLNP/2007) filed jointly by the pharmaceutical companies, GSK and Shionogi is at a critical stage of examination before the Kolkata Patent Office.

ViiV Healthcare acquired exclusive global rights to several integrase inhibitor compounds, including dolutegravir from a Japanese pharmaceutical company, Shionogi & Co. Ltd. Shionogi receives ongoing royalties and has 10 per cent equity in ViiV Healthcare. ViiV Healthcare is a company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer.

ViiV Healthcare, under a license to the Medicines Patent Pool (MPP), has placed India on a list of royalty countries where the drug can be supplied by generic companies (sub-licensees) but only to Indian public sector entities and NGOs, with the prior approval from the company. Generic companies like Aurobindo are now manufacturing the drug in India, but only for export to other countries as it is not yet registered in India.

In 2013, the Delhi Network of Positive People (DNP+) filed the first opposition against the grant of the application that claimed a vast number of integrase inhibitor compounds – an important class of HIV medicines. A markush claim is a common form of ever-greening by companies that claim millions of compounds in a single patent application without disclosing which exact medicine they are planning to put into development and production.