Some activists in other industrialized countries are leading a fight to void Gilead Science’s patents on its hepatitis C drug Solvadi (sofosbuvir), the New York Times reported. According to the Times, the New York-based legal group Initiative for Medicines, Access and Knowledge (I-MAK) announced patent challenges last week in Argentina, Brazil, China, Russia and Ukraine.
Gilead allows 11 Indian drug manufacturers to produce sofosbuvir and distribute to 91 developing countries around the world. But in middle or high income countries Gilead retains distribution rights. It has proposed $7,500 per treatment in countries like Brazil, and according to I-MAK, that would mean it would cost $270 billion to treat people with hepatitis C in the five countries in which it filed patent challenges.
I-MAK is challenging the patents with the claim that sofosbuvir is not “novel” compared with products in other applications. Priti Radhakrishnan, a founder and director with I-MAK, told the Times, “Despite sofosbuvir’s medical benefits, it’s really based on old science.”
Estimates for hepatitis C prevalence range from 150-180 million people worldwide.
Our Take: Gilead Sciences continues to make news for all the wrong reasons. Solvadi, and its newer combination drug Harvoni, is stressing state Medicaid budgets as people seek treatment for the first time. Last year, the company was asked to testify before Congress, with House Democrats asking the company to explain how it arrived at the $84,000 price of treatment.
Gilead is a remarkable success story. The company reported first quarter total revenues of $7.6 billion, compared to $5.0 billion in Q1 2014 and $2.5 billion in Q1 2013. Its market cap is $165 billion, about the same as Merck & Co. ($168 billion). It need not apologize for its success. But it should be careful how it plays its hand in the coming months, because the spotlight won’t be dimming any time soon.