Initiative for Medicines, Access & Knowledge (I-MAK), a team of lawyers and scientists campaigning for global accessibility of medicines for hepatitis C and HIV patients, has challenged Gilead for seeking illegitimate patents for hepatitis C medicine sofosbuvir, blocking millions of people around the world from getting the treatment.
I-MAK and its partners, including Grupo de Trabalho sobre Propriedade Intelectual (GTPI), All-Ukrainian Network of People Living with HIV/AIDS, Treatment Preparedness Coalition and Fundacion Grupo Efecto Positivo (Fundacion GEP), have filed a series of new, coordinated patent challenges in recent weeks that has major implications for the global fight against an exploding hepatitis C epidemic that is killing 700,000 people every year.
I-MAK and its partners, including people with hepatitis C and patient advocates, have filed challenges in Argentina, Brazil, China, Russia and Ukraine detailing how Gilead is abusing patent laws by claiming existing public knowledge as its own-thereby preventing people with hepatitis C from getting treatment.
The challenges against Gilead's patent applications for sofosbuvir-marketed under the brand name Sovaldi -demonstrate that, despite its medical benefits, sofosbuvir was developed using previously published information and an existing compound. The filings build on patent challenges I-MAK filed last year in Europe with Medecins du Monde and in India with the Delhi Network of Positive People, where the patent for sofosbuvir is still pending. Following the challenges in India, Egypt in 2014 rejected the sofosbuvir patent. More than 59 million people are living with the hepatitis C virus in Argentina, Brazil, China, India, Russia and Ukraine.
"The global criteria for patents are clear: They are reserved for drugs that are proven to be novel, non-obvious and useful," said Mr Tahir Amin, I-MAK co-founder and director of intellectual property. "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."
"In the face of an escalating global public health crisis affecting 150 million people, illegitimate patents are blocking people with hepatitis C from the treatment they need to survive and get well, " said Ms Priti Radhakrishnan, I-MAK co-founder and director of treatment access. "By freeing sofosbuvir from unjustified patents, we can fight this deadly disease and get more people the medicine they need to live healthy, productive lives. Millions of lives are at stake-especially in middle income countries like Brazil, Argentina and Ukraine, where the disease is concentrated."
As part of the growing movement against Gilead's business practices that come at the expense of people's health, people with hepatitis C, their families and patient advocates held demonstrations in Bangkok, Thailand, protesting the company's abuse of an unjustified patents that block patients from getting care. Leading NGOs and public health leaders have also sent a petition to Gilead calling for an end to patent abuse, while the company faces a rising backlash against high drug prices in the United States.
In the United States, Gilead and Sovaldi are the subjects of growing outrage and scrutiny over the past year, with state governments and Congressional leaders calling for greater transparency into the company's high prices for sofosbuvir while Institutional Shareholder Services has advised the Board of Directors take steps to mitigate business risk due to prices few can afford. While Gilead brings in more than USD1 billion in profits each month, the company avoids billions of dollars in US taxes by storing USD2 trillion offshore.
"The only drug that offers benefit is a drug that patients can access," said Dr Jennifer Cohn, Access Campaign Medical Director for Doctors Without Borders/Medecins Sans Frontieres (MSF) which is scaling up treatment to people with hepatitis C in several countries. "It's deeply unsettling to see that the high price of hepatitis C treatment has led to treatment rationing. With millions of people in developing countries in need of treatment, there needs to be a concerted global effort to ensure effective medicines are available to as many people as possible, as soon as possible."
In 2009, I-MAK, along with civil society groups in India, won an important HIV patent challenge against Gilead's branded drug Viread. I-MAK selectively intervenes to block unjustified drug patents that are preventing people from getting the treatment they need.
