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Hepatitis C: Gilead Patent on Sofosbuvir Partially Maintained Following MdM Patent Opposition

Paris, 5 October 2016

European Patent Office (EPO) has taken its decision following Doctors of the World - Médecins du Monde (MdM) patent opposition on Gilead Sciences’ Sofosbuvir. MdM applauds EPO’s decision to revoke partially the patent.

MdM has filled an opposition on the patent granted to Gilead Sciences for Sofosbuvir (Sovaldi®) on February 10th, 2015. A patent opposition is a legal procedure by means of which the validity of a patent can be challenged because the drug patented does not fulfil the patentability criteria as defined by the European Patent Convention (EPC). Therefore, pharmaceutical companies rely on intellectual property associated to patent to request unjustified prices for their drugs. Sofosbuvir is a genuine example of this diversion of patent principles while the 12-weeks treatment course being priced 41,680 euros to French Social Security whereas the Indian generic version is sold 220 euros. "So, this is a flawed patent that has been used by the pharmaceutical company to impose a huge pressure on States, that have accepted exorbitant prices leading to treatment restrictions for patients in many European countries!" explains Dr Françoise Sivignon, President of MdM.

Following a two days-public hearing at the EPO headquarter in Munich, Germany, Gilead Sciences arguments to uphold its patent on Sofosbuvir have not been totally accepted by EPO opposition division. The EPO has decided that Gilead’s patent extended beyond the content of the patent application as filed. Technically, the EPO’s decision means that sofosbuvir in itself is not protected by a patent any more. "This EPO decision supports the global fight to denounce the diversion of the spirit and principles of patentability by pharmaceutical industry in order to set up dominant positions. Countries such as China, Ukraine and Egypt have been clear in fully rejecting Gilead’s patent" outlines Tahir Amin from I-MAK. "This goes to show that we need more rigorous patent examination to protect public health".

The Court has explained that the patent was not so strong at it was supposed to be. This shows that the quality of the patent was weak, and that public intervention in the patent system matters. But in maintaining the patent – even partially – this decision is not enough to reverse the balance of power toward the benefit of the health of population and the financial equilibrium of health insurance systems. "From this first breach we wait now for a strong public action from governments in Europe" declares Yannick Le Bihan, head of MdM domestic programs. Actually there is a legal tool they may use to immediately provide hepatitis C treatment widely and at a reasonnable price: the compulsory licence (CL). CL gives a legal basis to market generic versions of patented drug. "Up to now, we were explained by governments that compulsory licence was a « weak legal tool » to justify the fact they were not willing to use it – despite it has been endorsed by national laws and WTO rules; well, what we know today is that it is the patent that was weak. Governments have to take immediatly their responsabilities!" declares Olivier Maguet, MdM drug pricing campaign manager.

Alongside the launch of the “Price of Life” campaign in Europe [1], this EPO decision supports MdM’s fight for new rules in setting the price of medicines and for the establishment of an alternative model to patents for financing therapeutic innovation.

Read the Q&A on patent opposition

[1] To date, campaign has been launched in Germany, Spain and Belgium. In France, petition to Ministry of Public Health has been signed by more than 225,000 persons.