CSOs launch Europe-wide patent challenge on hepatitis C drug

European civil society organizations are disputing a patent on a hepatitis C drug which has restricted affordable access to this life-saving treatment.

by Kanaga Raja

GENEVA: The international medical humanitarian organization Medecins Sans Frontieres (MSF) has joined a number of other civil society organizations from 17 European countries in simultaneously filing patent challenges with the European Patent Office on the hepatitis C drug sofosbuvir.

In a press release, MSF said that the patent challenges were filed on 27 March on the pharmaceutical corporation Gilead’s monopoly on sofosbuvir, in a bid to remove the barriers that prevent millions of people receiving treatment for hepatitis C.

“With an estimated 80 million people worldwide living with hepatitis C, treatment should be available to everyone who needs it, no matter where they live – including in Europe,” said Isaac Chikwanha, Hepatitis C Medical Advisor for MSF’s Access Campaign.

“The price of sofosbuvir is keeping treatment out of reach for millions of people who need it, and treatment is being rationed or is just unavailable across the globe, including in many of the countries where MSF works, such as Russia, and many other middle-income countries including Thailand and Brazil. A drug that cures doesn’t do any good if the people who need it can’t afford it,” he added.

According to the MSF press release, sofosbuvir forms the backbone of most hepatitis C combination treatments for people, one of a range of oral “direct-acting antivirals (DAA)” to come to market within the last four years that has caused cure rates to skyrocket.

In Europe, Gilead charges as much as $59,000 per 12-week sofosbuvir treatment. In the United States, Gilead initially set the price at $84,000, or a staggering $1,000 per pill.

Meanwhile, studies have shown that it costs less than $1 per pill to produce the drug, said MSF.

“Gilead’s patent monopolies on sofosbuvir are blocking access to affordable hepatitis C treatment, including generic versions, in many countries including those in Europe,” said Alienor Devaliere, EU Policy Advisor for MSF’s Access Campaign. “This patent can – and should – be challenged; the science behind sofosbuvir isn’t new.”

According to MSF, access to affordable medicines has become a global challenge. Countries where Gilead retains monopoly control over sofosbuvir cannot import or produce generic versions. For many people living in some middle-income countries, Gilead’s restrictive voluntary licensing agreements still keep sofosbuvir out of reach for people and their governments, said MSF.

It pointed out that patent challenges – or patent oppositions – can remove or shorten the length of a patent and enable the robust generic competition needed to dramatically reduce prices.

Key patents on sofosbuvir have already been revoked in China and Ukraine, and decisions are pending in other countries, including Argentina, India, Brazil, Russia and Thailand, it said.

“Successful patent oppositions have created access to life-saving drugs for millions of people in the past, and are now being employed as a legal measure to improve access to hepatitis C treatment,” said Yuanquiong Hu, Legal Advisor for MSF’s Access Campaign.

“MSF has filed or supported patent challenges in many countries. People all over the world, and in the projects where MSF works, need affordable access to life-saving medicines.”

MSF underlined that if the patent challenge is successful, it could accelerate the availability of affordable generic versions of sofosbuvir in Europe.

It would also encourage all countries to take measures to open up access to affordable generic versions of sofosbuvir by either negotiating better deals with Gilead right now, and/or taking actions including issuing compulsory licences to import or manufacture more affordable generics.

In a separate press release also issued on 27 March, the European Public Health Alliance (EPHA), which is among the 30 civil society organizations from the 17 European countries simultaneously filing patent challenges on sofosbuvir, said that the development of highly effective new treatments for hepatitis C has been accompanied by outcry from patients and governments against exorbitant prices charged by the drug makers.

“With this filing, we are questioning the grounds on which the patent was granted and we emphasize the possible non-compliance with the current patentability criteria. It is no longer off-limits to discuss these matters in Europe, particularly given the gravity of the access to medicines problems Europeans face today,” said Yannis Natsis, head of EPHA’s Access to Affordable Medicines Campaign.

High disease burden

The World Health Organization (WHO), in its first ever Global Report on Access to Hepatitis C Treatment released last October, said that worldwide, approximately 80 million people are living with chronic hepatitis C virus (HCV) and millions more are newly infected each year. Annually, 700,000 people die from HCV-related complications, including cirrhosis and hepatocellular carcinoma.

Despite the scope and severity of the epidemic caused by HCV, until recently, the global response to reduce the burden of this disease has been very limited and the available treatment was expensive, poorly tolerated and had low cure rates, said WHO.

In 2013, the treatment of HCV was transformed by the introduction of a new class of medicines called direct-acting antivirals. An 8-12-week course of these medicines can cure more than 90% of persons with chronic HCV infection.

In 2015, 275,000 people living in low- and middle-income countries (LMICs) had received hepatitis C treatment based on the new DAAs. In September 2016, additional data reported from other countries brought the overall estimated number of people treated with DAAs in LMICs to over 1 million.

According to the WHO report, one of the main barriers in middle- and high-income countries is the lack of funding and the high prices of the new medicines. Initial prices of DAAs in high-income countries were extremely high, and have continued to remain high in many countries. For example, sofosbuvir, which was introduced in late 2013, was priced at $1,000 per pill in the US and sofosbuvir/ledipasvir at $1,125 per pill. This even triggered the attention of the US Congress that investigated the pricing of sofosbuvir.

High prices and limited funding can force countries to ration or only gradually upscale HCV treatment, said WHO. For example, in Brazil, people with no or mild fibrosis are not eligible for treatment, while Switzerland initially rationed access to treatment, excluding patients with mild or no liver damage because of high prices, and expanded access only after the country negotiated slight price reductions from originator companies. In the US, patients in California and Washington states filed lawsuits against a private insurance company and private payers for restricting access to HCV treatment.

Many middle-income countries have a high disease burden of hepatitis C. Affordable prices are a prerequisite for these countries to be able to increase treatment coverage, WHO underlined.

It was estimated that sofosbuvir, the backbone of most HCV treatment regimens, could be mass-produced for just over $1 per pill, which could bring the cost for mass production of generic sofosbuvir to $29 for a 28-day supply.

According to the WHO report, countries that are not able to procure from generic sources have to engage in price negotiations unless they use flexibilities under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Successful price negotiations require market intelligence, in particular, on what other countries and buyers are paying.

“Lessons learnt from the HIV field, however, show that while differential pricing can result in lower prices of medicines, generic competition is more effective in driving down prices,” said WHO. (SUNS8432)                                           

Third World Economics, Issue No. 635, 16-28 February 2017, pp10-11, 16