Decisión de la Oficina de Patentes Europea en relación a la patente del Sofosbuvir de Gilead Sciences

In February 2015, Médecins du Monde (MdM), an independent organisation to promote universal access to healthcare, filed an opposition to the patent on sofosbuvir granted to Gilead Sciences. Sofosbuvir is a direct acting antiviral used for the treatment of hepatitis C which, combined with other drugs, has high cure rates.

The opposition is a legal procedure by which the validity of a patent can be challenged when a drug patented does not fulfil the patentability criteria as defined by the European Patent Convention (EPC).

As a result of an opposition procedure, the patent can be granted with amendments or can be finally revoked; in this case, the drug could enter into competition with generic versions, which would considerably reduce its price.

On October 5, 2016, the European Patent Office (EPO) has decided on the opposition filed by MdM. The decision, which still has not been made available to the public, could partially limit the protection of the drug, as interpreted by the organization MdM. The Company, for its part, considers that the patent remains in force and is not revoked.

Despite the different versions in regard to the content of the decision of the EPO, what does seem certain is that the patent includes amendments with respect to the originally granted version, but they are not as deep as MdM has pointed out. These modifications, as well as the final scope of the patent protection, will only be known when said decision is made available to the public.

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