Gilead Releases Statement on EPO’s Sovaldi Decision

Continuing our coverage on the recent Sovaldi patent decision by the European Patent Office (EPO), Gilead sent us a statement clarifying certain details. I reproduce it below:

“On October 5, 2016, the EPO’s Opposition Division upheld the European patent (EP 2203462) covering sofosbuvir in amended form. The opposition division reached this considered decision following two days of hearings where the opponents to the granting of this patent were given an opportunity to present all of their arguments contesting its validity. While the opposition division rejected certain of our patent claims for technicalities, the remaining claims cover sofosbuvir and were determined to be valid. The patent will be amended accordingly. We believe this decision recognizes the extraordinary innovation involved in the development of sofosbuvir.”

Gilead contends that the Patent – EP 2203462 was not revoked, partially or otherwise. The EPO held the Patent to be valid, but in an amended form; and recognised that the claims covered sofosbuvir. EPO Opposition Procedure provides three grounds under Article 100 of the European Patent Convention upon which Opposition Proceedings can be based: That the subject matter of the patent is not patentable, that the invention is not disclosed clearly and completely for a person skilled in the art to carry it out, and what  was claimed in this case – that the patent’s subject matter extends beyond the content of the application as filed. The EPO also identifies three possible outcomes at the end of opposition proceedings: That the opposition is rejected and the patent maintained as granted, that the patent is maintained in an amended form – which needs a new patent specification, and that the patent is revoked. It is therefore the second conclusion that the EPO arrived at in this decision.

Gilead also sent us the Statement made by the EPO on the Order, which is as follows:

 Munich, 5 October 2016 – The European Patent Office (EPO) has maintained in an amended form European patent EP 2203462, granted to Gilead Pharmasset LLC in respect of a drug for the treatment of hepatitis CThe decision was announced today at the end of public oral proceedings in the opposition procedure before the EPO. The patent had been contested by ten parties, including the NGO Médecins du Monde, pharmaceutical companies and IP law firms. It covers drug compounds and especially the active chemical agent Sofosbuvir marketed under various brand names.

After hearing the parties present, the EPO’s Opposition Division (a body consisting of three experts in the relevant technical field and a patent law expert) came to the conclusion that after deletion of claims to single compounds, European patent EP 2203462 could be maintained‎ in an amended form.

The grounds for decision will be published on the EPO website in due course. The decision can be appealed by the parties before the EPO’s second-instance judiciary, the Boards of Appeal.

 The patent application was filed at the EPO on 26 March 2008, and the European patent granted to Gilead on 21 May 2014. Oppositions were filed with the EPO in February 2015 by ten parties. The opponents had requested revocation of the patent in its entirety for reasons of non-compliance with legal provisions of European patent law including novelty of the invention and the inventive step applied. The patent owner had requested that the patent be maintained.”


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