[Ip-health] MSF response to ruling in Gilead sofosbuvir patent hearing at European Patent Office

Shailly GUPTA Shailly.GUPTA at geneva.msf.org
Tue Sep 18 02:18:44 PDT 2018


Dear All,

Sharing a bit belatedly about the patent opposition hearing that was held at European Patent Office last week for Sofosbuvir base compound. In a bid to contest Gilead’s unmerited patent on this drug in order to make the medicine more affordable in Europe, a legal challenge was filed in March 2017 by patient and treatment provider organisations from 17 European countries, including Médecins Sans Frontières (MSF); Médecins du Monde (MdM); the European Public Health Alliance (EU-wide); Salud Por Derecho (Spain); AIDES (France); Praksis (Greece); and Access to Medicines Ireland.

Unfortunately, EPO upheld Gilead’s patent with amended claims that still stays in the way to access more affordable generic versions in Europe. See below our statement in this regard. Also below is the press release issued before the hearing giving more details about the case and pricing of sofosbuvir in Europe.

MSF response to ruling in Gilead sofosbuvir patent hearing at European Patent Office
Munich, 13 September 2018 — Médecins Sans Frontières (MSF) is gravely disappointed with the European Patent Office’s decision today to uphold US pharmaceutical corporation Gilead Sciences’ patent related to the key hepatitis C drug sofosbuvir. In a bid to contest Gilead’s unmerited patent on this drug in order to make the medicine more affordable in Europe, a legal challenge was filed in March 2017 by patient and treatment provider organisations from 17 European countries, including Médecins Sans Frontières (MSF); Médecins du Monde (MdM); the European Public Health Alliance (EU-wide); Salud Por Derecho (Spain); AIDES (France); Praksis (Greece); and Access to Medicines Ireland.
The oral drug sofosbuvir, which forms the backbone of most hepatitis C combination treatments, has been priced by Gilead as high as €43,000 for a 12-week treatment course in Europe. In countries where MSF is treating people with hepatitis C, including Myanmar, Cambodia, India, Pakistan, Mozambique, Uganda and Kenya, sofosbuvir is currently being procured from generics manufacturers for €75 for the same treatment course. The exorbitant price of this drug and the resulting rationing of access has stirred an intense debate on the pricing of patented medicines in Europe. Following the oral proceedings in Munich today, the European Patent Office upheld the patent granted to Gilead in relation to sofosbuvir—with amendments. The decision allows Gilead to retain a patent on a pharmaceutically-inactive component that appears in the body during the synthesis of sofosbuvir. The result is that Gilead’s monopoly still stays in the way to access more affordable generic versions in Europe.
Gaelle Krikorian, Head of Policy, MSF Access Campaign
“Today’s decision is a clear illustration of how multinational pharmaceutical corporations like Gilead abuse the patent system so they can shut out any competition and continue unfettered to charge exorbitant prices. We will appeal today’s decision as we strongly believe that the European Patent Office should have revoked the patent.
Any patent granted in Europe not only affects access to medicines for Europeans, but also impacts people in many developing countries that lack the resources to perform careful patent examination, and instead follow the EPO’s decisions. This calls for extremely close scrutiny by EPO of any patent related to medicines.”

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Also see our previous press release:

Civil society groups call for end to Gilead’s unwarranted hepatitis C drug monopoly in Europe
Gilead’s price gouging for sofosbuvir blocks millions of people from getting treatment

Munich/Paris/New York, 11 September 2018 – This week in Munich, the European Patent Office is hearing a legal challenge filed by groups in 17 countries in March 2017 against an unmerited patent that allows US pharmaceutical corporation Gilead Sciences to charge exorbitant prices in Europe for the key hepatitis C drug sofosbuvir. The organisations Médecins du Monde (MdM), Médecins Sans Frontières (MSF) and Just Treatment are among the patient and treatment provider organizations* that challenged the validity of a Gilead patent on sofosbuvir on the grounds that it does not fulfill the requirements to be a patentable invention from a legal or scientific perspective. The groups today urged the European Patent Office (EPO) to rethink its decision that gives Gilead this monopoly. The EPO will hold a public hearing on 13 and 14 September to make a decision on the case.

If the patent challenge is successful, a major step will have been taken toward allowing the production and importation of affordable generic versions of sofosbuvir in Europe, thereby protecting health systems across Europe from illegitimate financial burden due to excessive corporate pricing of this drug. The extremely high prices in Europe of newer hepatitis C medicines—called direct-acting antivirals, or DAAs—has led civil society organisations to investigate and subsequently challenge the monopoly status and legitimacy of such patents.
“I have been through an extremely agonising wait for three long years to get access to the critical oral hepatitis C medicine sofosbuvir,” said Clare Groves, Just Treatment patient leader who was treated and cured of hepatitis C through the National Health Service in the United Kingdom, which was forced to ration supply of the medicine due to its high price. “I was repeatedly told by my doctor that I am sick, but not sick enough to qualify for the treatment under the public health program. I don’t want other people to be denied sofosbuvir because its price is exorbitant, so I will continue to fight for their access to this hepatitis C cure.”

The World Health Organization estimates that 15 million people in the European region—approximately one in 50 people—are chronically infected with hepatitis C, leading to approximately 112,500 deaths per year from related liver cancer and cirrhosis. The advent of DAA drugs, which offer a safer, shorter and more effective cure compared to older treatments, has marked a major breakthrough in the treatment of the disease, with cure rates higher than 90%, compared to around 50% previously. Sofosbuvir forms the backbone of most hepatitis C combination treatments, yet access to these newer treatments remains very limited globally because of high prices, with governments and treatment providers in many countries forced to ration treatment and limit access only to people with advanced forms of the disease.

Gilead charges as much as €43,000 for one person’s 12-week treatment of sofosbuvir in Europe. Meanwhile, in countries where the drug is not patented, competition among generic producers has driven the price of sofosbuvir to just €52 for the same treatment course. Studies have shown that it costs about €0.50 per daily pill to manufacture the drug.

“Financial barriers in access to medicines and healthcare have become a challenge for high-income countries in Europe, and because unmerited patents are the key driver for these excessive prices, it’s time to challenge unmerited patents in Europe,” said Olivier Maguet, of MdM’s drug pricing campaign.

While the high prices charged for medicines are a well-known problem in many parts of the world, the recent excessive pricing of DAAs has for the first time brought Europe’s attention to the impact that monopolies have both on health budgets and on people’s access to many other essential medicines. Legal challenges against patents on sofosbuvir and other DAAs have been filed in several countries, and key patents on sofosbuvir have already been rejected in Egypt, China and Ukraine. Decisions are pending in other countries, including Argentina, Brazil, India, Russia and Thailand.

“Every day, MSF witnesses firsthand how monopolies on medicines restrict people’s access to life-saving medicines,” said Gaelle Krikorian, Head of Policy at MSF’s Access Campaign. “MSF was only able to start scaling up treatment for people with hepatitis C in countries like Cambodia and India once more affordable quality-assured generics became readily available. It’s high time that the European Patent Office and patent offices around the world apply greater scrutiny when granting monopolies on medicines, recognizing the negative impact that unmerited patents have on people’s health. Revoking Gilead’s patent would end the corporation’s monopoly in Europe, and allow countries to access sofosbuvir from multiple generic manufacturers at affordable prices. It would also send a strong signal to other countries to challenge unmerited patents when people’s health and survival are at stake.”
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Shailly Gupta
Press & Communications Officer
MSF Access Campaign
Médecins Sans Frontières
Ph: +41 22 849 9334
M: +41 79 203 13 02
Skype: Shailly.17 |Twitter: @shaillytweeting






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