Following the oral proceedings, unfortunately EPO has maintained the Gilead’s patent with amendments that continue to block generic competition.
Please see below our response to this decision.
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.”