Patent for hepatitis C treatment would cut access for millions, groups say

Activists charged the pharmaceutical company Gilead on Wednesday of seeking unjustified patents for a hepatitis C medication that would make the treatment prohibitively expensive for millions worldwide.

The Initiative for Medicines, Access and Knowledge (I-MAK), a legal advocacy group, announced patent challenges against Gilead in Argentina, Brazil, Russia and Ukraine. Similar filings against the company have already been made in India, Egypt and the European Union.

With its attempts to hold exclusive rights to sofosbuvir, which the company has branded Sovaldi, Gilead was “abusing patent laws by claiming existing public knowledge as its own,” Priti Radhakrishnan, a co-founder of I-MAK, said in a conference call. 

The treatment is not a Gilead innovation, Radhakrishnan said; rather the drug is an evolution of previously published information and existing compounds.

According to international patent law, a company must prove that a drug is novel, non-obvious and useful to obtain rights to a treatment, said Tahir Amin, an I-MAK co-founder and the group’s director of intellectual property.

Based on those criteria, Dr. Jennifer Cohn, the access campaign medical director for Doctors Without Borders, said Gilead does not deserve patents for sofosbuvir.

“Despite this medical advance, it doesn’t mean that it’s new or innovative science that makes it eligible for a patent,” Cohn said.

Radhakrishan said sofosbuvir costs around $1 a pill to manufacture. Gilead said in April 2014 that its new $1,000 hepatitis C pill generated record-breaking sales of $2.27 billion, helping to nearly triple the company's quarterly net profit. 

Advocates said Gilead is expected to demand anywhere between $2,000 and $15,000 for a 12-week sofosbuvir treatment in countries where some of the world’s poorest people live on less than $1.50 a day.

Gilead did not respond to Al Jazeera's request for comment. However, the company told NPR in Dec. 2013 that the high price is fully justified.

Gregg Alton, vice president at Gilead, said, “We didn't really say, ‘We want to charge $1,000 a pill.’ We're just looking at what we think was a fair price for the value that we're bringing into the health care system and to the patients.”

About 150 million people suffer from hepatitis C around the globe, leading the World Health Organization to call the disease a “viral time bomb.”

Hepatitis C is spread when the blood of an infected person enters the body of another person, most often by the sharing of needles or other equipment to inject drugs, according to the Centers for Disease Control and Prevention website.

Left untreated, the virus can lead to liver disease and liver cancer, which kills about 700,000 people each year, advocates said in the conference call.

But sofosbuvir could change that, if it’s widely accessible, activists said. 

The treatment has a 96 percent cure rate and few side effects, according to Dr. Rafael Ortega, director of treatment education program for New York-based National Aids Treatment Advocacy Project, which works with HIV and hepatitis C patients. 

Ortega called it a “really amazing medicine.” But for many suffering from hepatitis C, the prices charged for treatment by Gilead puts the cure out of reach, advocates said.

In Russia, the cost of sofosbuvier would effectively block “millions … from this life-saving treatment,” Sergey Golovin, senior advocacy manager for Russian advocacy group, Treatment Preparedness Coalition, said in the call.

Golovin’s organization said Wednesday it was launching a campaign to block Gilead’s attempt to receive a patent in Russia.

In Argentina, advocates filed a challenge last month against Gilead, who was attempting to gain a patent for the medicine there, according to Lorena Di Giano, executive director of Fundación Grupo Efecto Positivo (GEP).

Di Giano said she hoped his organization’s attempt to stop Gilead from gaining a patent in Argentina would “shine a light” on such predatory pharmaceutical practices.

In February, Médecins du Monde (MDM) filed its patent challenge in the European Union against Gilead, saying that although the use of sofosbuvir to treat hepatitis C was an “important step forward, the molecule itself is not sufficiently innovative to warrant a patent,” the group said in a press release. Gilead's patent in Europe is still pending.

The challenges to Gilead have a good chance of succeeding, I-MAK's Amin said in the call, citing statistics that showed 75 percent of challenged patents are overturned in the United States. And there is global precedent — in 2014 Egypt rejected Gilead’s sofosbuvir patent.

For Alex Freyre, who lives with hepatitis C and works with treatment advocates in Argentina and Latin America from GEP and RedLAM to remove barriers to treatment, the medicine represents hope.

“To live with hepatitis C before the discovery of this drug was basically living with the constant fear of dying from liver cancer,” Freyre said in the conference call. “It was also sadness — saying goodbye to old friends I knew who had the same virus and have been dying for the last few years.”