‘Patent opposition’ seeks to ensure availability of affordable generics
New Delhi/Geneva, 10 February 2016 — People living with HIV have opposed patent applications in India for two important HIV medicines, dolutegravir and cabotegravir. Médecins Sans Frontières/ Doctors Without Borders (MSF) supports these ‘patent oppositions,’ which 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.
The company has so far failed to make dolutegravir available in India for people who have run out of other treatment options. Cabotegravir is still in the clinical trial phase of 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*, 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 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. 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
Dolutegravir (DTG), an integrase inhibitor, has been found to have a high barrier to development of drug resistance. For HIV+ patients who have failed treatment with most other antiretrovirals (ARV) and now require a third-line regimen, treatment with a DTG-containing regimen is useful since it has higher barrier to resistance than other options like raltegravir, which can develop resistance quickly. DTG is now recommended as an alternative first-line drug in the revised WHO guidelines for HIV treatment, as it is a well-tolerated once-daily ARV that reduces virus levels faster, has a high barrier to resistance and has few drug interactions.
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% equity in ViiV Healthcare. ViiV Healthcare is a company established in November 2009 by GlaxoSmithKline (GSK) and Pfizer.
ViiV Healthcare, under a licence 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 evergreening 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.