Activists Challenge Gilead’s Patents on Costly Hepatitis C Drug Sovaldi

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Joel Roth, 65, of San Rafael, California, is a long-suffering hepatitis C patient who is taking Sovaldi, which costs $1,000 per pill, or $84,000 for a 12-week treatment course. Roth got financial assistance to pay his $11,600 share of the bill. Bob Ecker/MCT/Getty

A group of doctors and patient advocates are putting pressure on Gilead Sciences—maker of Sovaldi, the $1,000-a-day drug for hepatitis C—to release its patents. The Initiative for Medicines, Access & Knowledge (I-MAK), a U.S. nonprofit advocating for improved access to affordable medications, has filed challenges this week against the company in Argentina, Brazil, China, Russia and Ukraine. The organization had previously filed similar patent challenges in Europe and China.

In a statement posted Wednesday on its website, I-MAK said Gilead’s move toward worldwide patents for sofosbuvir (the generic term for Sovaldi) would prevent millions of people from getting the treatment. A full course of the drug for one patient can cost up to $84,000 over 12 weeks of treatment.

“The global criteria for patents are clear: They are reserved for drugs that are proven to be novel, non-obvious and useful,” said Tahir Amin, I-MAK’s co-founder and director of intellectual property, in a press statement. “By seeking exclusivity on science that is already in the public domain, Gilead is acting like a landlord charging exorbitant rent for property it doesn’t legitimately own.”

The organization argues that the cost of the drug, approved by the U.S. Food and Drug Administration in December 2013, is prohibitive to most patients. Additionally, I-MAK says Gilead’s bid for patents is unwarranted because the base drug compound had already been disclosed in a 2005 new drug application made by Cardiff University as a cancer treatment. I-MAK added that the company hasn’t provided any background research that proves its drug compounds are more effective than other forms.

Sovaldi is used to treat chronic hepatitis C virus (HCV) infections, a viral disease that causes inflammation and severe damage to the liver. Over time the chronic condition causes a number of serious complications, including bleeding, jaundice, fluid accumulation in the abdomen, infections and liver cancer. HCV is primarily associated with a history of intravenous drug use but can be acquired in numerous other ways as well.

The World Health Organization estimates 150 million people worldwide live with a chronic form of the disease, which most commonly afflicts the poor, uninsured and incarcerated.

According the U.S. Centers for Disease Control and Prevention, as much as 40 percent of inmates have at some point been infected with HCV and as much as 35 percent are chronically infected, compared with less than 2 percent of the general U.S. population. In the U.S., the rate of hepatitis C is also high for veterans. A recent government report found that in 2013 the Veterans Health Administration provided care to 170,000 veterans with HCV.

This week, U.S. Senator Bernie Sanders of Vermont called on the secretary of veteran affairs to use an existing law in order to force Gilead to break the patents on the drug. The law allows the federal government to override patents for a product when a need for the product is urgent.

In a letter to Secretary of Veteran Affairs Robert A. McDonald, Sanders suggested that the federal government put pressure on Gilead to simply provide the drug to veterans at no cost, which he says the company currently already does in other parts of the world where HCV rates are high. In March 2014, for example, the company reached an agreement with Egypt’s health ministry to supply the drug at 99 percent off the U.S. cost.  

“Our nation’s veterans cannot, and should not, be denied treatment while drug companies rake in billions of dollars in profits,” Sanders wrote.