Patient challenges patent on two key HIV drugs

MUMBAI: A patient suffering with HIV has opposed patent applications for two important HIV medicines, dolutegravir and cabotegravir, thwarting an attempt by ViiV Healthcare (a joint venture by Pfizer and GlaxoSmithKline) to obtain monopoly rights on the drugs, in India.
International medical humanitarian organisation, Médecins Sans Frontières (MSF) supports these patent oppositions, it said in a statement, adding the company has so far failed to make dolutegravir available in India for patients who have run out of other treatment options.Cabotegravir is still in clinical trials.
ViiV Healthcare acquired exclusive global rights to several integrase inhibitor compounds, including dolutegravir from a Japanese company, Shionogi. The patent application filed jointly by GSK and Shionogi, is at a critical stage of examination before the Kolkata Patent Office. Shionogi receives ongoing royalties and has 10% equity in ViiV Healthcare.
“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,” Leena Menghaney, head MSF’s Access Campaign in South Asia, said.
“Many of us have now developed resistance to existing medicines and are in dire need of new drugs to stay alive,” said Anand Singh (name changed to maintain anonymity), living with HIV who filed the patent opposition. “Affordable generic medicines from India have been one of the cornerstones for being able to put nearly 16 million people on HIV treatment in developing countries.”
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 here, MSF said in a statement.
ViiV licensed dolutegravir to several domestic generic companies in 2014 under a voluntary licence signed between ViiV and 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, it adds.
“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+), adding 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 is still under development. Clinical trials are on 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.