India grants GILEAD a patent for sofosbuvir
Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of medical tourism?
Gilead Sciences was seeking a patent for sofosbuvir since 2014, and had already seen their application rejected by India’s patent office in January 2015. After the rejection appeal, India was forced to reverse the course. The patent for sofosbuvir, the direct-action antiviral treatment for hepatitis C and the active component of the scandalously priced Sovaldi™ was now granted to Gilead.
The Indian Patent Office of New Delhi claimed this Monday that sofosbuvir was “novel” and “inventive”. Surprisingly, just 16 months ago the same patent office said the drug represented only minor changes to a previous formulation, and thus lacked the patent requirements.
Gilead announced that this decision would have no impact on availability of the compound, which is already licensed to several generic manufacturers in India. Despite Gilead’s statement, there are rising concerns that this move can stop affordable copies of antiviral treatment for hepatitis C or significantly limit its availability.
|If the patent was not granted, the non-license companies could have entered the hepatitis C market, forcing the price to go down. Most importantly, these companies, not limited by license agreements, could have supplied to the “restricted” middle-income countries.|
Patent for sofosbuvir, hepatitis C $1000-per-pill treatment: the end of generic hepatitis C treatment?
Licensing agreements between Gilead and seven Indian companies were signed as early as September 2014. The number of the licensees has now increased to 13. Eight of these companies (Hetero, Natco, Mylan and Cipla, among others) have launched sales in India and other licensed territories. The license allows the distribution of new hepatitis C drug in 101 developing countries. The goal of this voluntary licensing program and “partnership” with Indian manufacturers, according to Gilead, is to enable access to antiviral treatment for hepatitis C for as many people as possible, as quickly as possible.
The major complication is that these licensed territories are so-called “resource-challenged countries”; the middle and high-income countries are excluded from the scope. This leaves approximately 50 million of people suffering from hepatitis C without access to the affordable treatment. With the price that Gilead is charging for its original, branded drug, it is out of question that the “middle-income” patients can afford the treatment.
|Sovaldi™ was launched in the US at a list price of $28,000 for a 28-tablet bottle, or $1,000 a pill.
The generic version is sold in India at about $14 per pill.
The cost of the hepatitis C 12-week treatment course is around $84,000 in US, $50,000 in France and $1200 in India.