India rejected Gilead's patent request for Sofosbuvir, a new hepatitis C (HCV) drug therapy, on Wednesday, a move that will allow other manufacturers to produce generic forms of the medication.
Gilead has priced the oral drug at $84,000 for complete treatment course, amounting to $1,000 per pill.
After Liverpool University conducted a study confirming that a three-month treatment course could be manufactured for just $101, the pricing controversy sparked a global debate about the cost of patented medical treatments.
In November 2013 and March 2014, India’s Delhi Network of Positive Peopled (DNP+) and Initiative for Medicines, Access & Knowledge (I-MAKE) filed patent oppositions against Sofosbuvir.
Gilead signed voluntary license agreements with several Indian generic producers that forced many rules on the companies, such as which countries will be allowed to access the companies’ drugs.
Because of the Indian Patent Controller's rejection, the companies that did not sign the license agreement with Gilean now can produce generic versions of Sofosbuvir.
This will drastically reduce prices for the treatment, especially in countries that were omitted from the license agreement. As a result accessibility to the medicine by patients who cannot afford the $84,000 for a treatment course will greatly expand.
Doctors Without Borders, which says 185 million worldwide have Heptatis C, is currently negotiating with Gilead to provide Sofosbuvir treatments to patients in nine different countries.
"Sofosbuvir has proved to be a billion-dollar blockbuster drug and we hope today’s decision opens the floodgates for more open competition that could rapidly lower the price,” Dr. Manica Blasegaram, executive director of the Doctors Without Borders' MSF Access Campaign, said. “This drug makes hepatitis C treatment more effective and easier for patients and doctors, so broad access to affordable versions will allow treatment to be scaled up dramatically. ... Getting Sofosbuvir out of the stronghold of Gilead’s monopoly will be crucial to expanding treatment for people with hepatitis C globally.”