February 10, 2016

Delhi/New York—A patient living with HIV in India has filed an application to try to block ViiV Healthcare from being granted patents on two new critical HIV drugs, the medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) announced today. The organization, which uses Indian generic medicines to treat many diseases and conditions, supports the patent opposition, which would help ensure that generic production of these medicines is possible and keep them affordable for people living with HIV.

The patent oppositions against ViiV Healthcare (a joint venture by Pfizer and GlazoSmithKline) were filed on the drug dolutegravir, which has been the first-line HIV treatment in the US for the past two years, and cabotegravir, which is still in clinical trial development.

"Many of us have now developed resistance to existing medicines and are in dire need of new drugs to stay alive,” said Anand Singh*, who is living with HIV and 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 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. The drug is not available from ViiV in India because the company has not applied for registration in the country, and does not  make the drug available under ‘compassionate use’ programs 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. The Medicines Patent Pool works with partners such as pharmaceutical manufacturers and patient groups to increase access to HIV, hepatitis C and tuberculosis drugs in low and middle-income countries. ViiV also has at least one other separate license outside of its agreement with the Medicines Patent Pool.

But due to its licensing conditions, dolutegravir is not available for public sale and ViiV has effectively blocked access to the drug by limiting its supply to public sector entities and NGOs in India with prior permission from the company. 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 program 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. MSF relies on affordable medicines made in India to treat more than 200,000 people around the world living with HIV, and uses Indian generic medicines to treat many other diseases and conditions, such as malaria and tuberculosis. “The only way people living with HIV in India and across the developing world will be able to access these new life saving HIV medicines is if unrestricted competition among generic producers can take place.”

*Name changed to maintain anonymity

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