Fresh from picking up a positive opinion in Europe for sofosbuvir, Gilead Sciences is facing a battle to get patent protection in India for its much-touted new hepatitis C drug.

The USA-based Initiative for Medicines, Access & Knowledge (I-MAK) group has filed a pre-grant opposition at India's Patent Office to stop Gilead getting protection for sofosbuvir, which has just been backed by the European Medicines Agency's Committee for Human Medicinal Products in combination with other medicines for HCV. It will be marketed as Sovaldi. 

Tahir Amin, lawyer and director at I-MAK, said that India’s patent law "doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it".

Drugs need to be 'simple and affordable': MSF

The move has been welcomed by Medecins Sans Frontieres and Simon Janes, its medical coordinator in India, said that if sofosbuvir is unaffordable, "the majority of the most vulnerable groups will remain untreated. We know from our experience providing HIV treatment over more than a decade in dozens of developing countries that treatment needs to be simple and affordable - preferably less than $500 to start with". Gilead is likely to get approval for the drug shortly in the USA and is expected to charge around $80,000 for a course of treatment.

Some 90% of HCV patients live in low-and middle-income countries and if the challenge is successful, it would allow Indian manufacturers to produce a cheap generic. To add to the pressure on Gilead with regards to pricing, Andrew Hill, a pharmacologist at Liverpool University, has published a study claiming that sofosbuvir could be produced for as little as $62-$134 for a 12-week treatment course. He notes that the HCV drugs coming out of the pipeline "are compounds that are relatively simple and cheap to make”, adding that their profit projections "are staggering and stand in no relation to what it costs to make these drugs".

The I-MAK challenge has also been welcomed by The Open Society Foundations. Els Torreele, director of the lather's Access to Essential Medicines initiative, argued that "sofosbuvir is not innovative enough at the molecular level to warrant a patent". He said that "this is a battle over whether profits or the lives of patients will drive the HCV response".

Gilead working with HCV community in poorer countries

Gilead told PharmaTimes that "providing treatment in resource-limited settings presents complex challenges and we understand the concerns that have been raised, but we are committed to working with the community to ensure our HCV medicines benefit as many patients as possible".

The company says that "as we did with our current HIV access programme, we are working very closely with advocates in the communities that are affected by HCV to develop an appropriate access and pricing strategy". Gilead added that "wW greatly value the input of these individuals and the communities they represent and will continue to engage them as we develop plans to ensure access to this significant therapeutic advance".
The California-based group concluded by saying that "we look forward to providing additional details about our programme in the near future".