The European Patent Office (EPO) Board of Appeal recently revoked Roche's European Patent EP1506041 after an oral hearing held on May 22 2012.

The patent, which protected the drug Bonviva (once-monthly ibandronate for the treatment of osteoporosis), was previously maintained in amended form by the Opposition Division (decision dated February 1 2011). However, the EPO Board of Appeal set aside that decision and revoked the patent due to added matter.

In parallel with the EPO proceedings, in Summer 2011 Roche, together with its Spanish subsidiary and co-marketer Laboratorios Beta, filed an infringement action and a preliminary injunction motion against seven generic companies in Spain. Roche alleged that the defendants had obtained marketing authorisations and price approvals for generic versions of Bonviva®, which would thus soon be launched on the market. Roche stated that there was a strong presumption as to the validity of the asserted patent, since it had been maintained (in amended form) by the EPO Opposition Division.

Some of the defendants undertook not to launch their generics until the EPO Board of Appeal had decided on the validity of the patent. In contrast, Teva, Mylan, Cinfa and Kern opposed the preliminary injunction motion, arguing as follows:

  • The amended form of the patent as maintained by the EPO Opposition Division was not effective in Spain because that decision was under appeal with suspensive effect (Article 106.1 of the European Patent Convention). Therefore, the amended patent had not been published by the EPO or translated into Spanish and published by the Spanish Patent Office (Articles 65 and 103 of the convention and Articles 7, 8 and 9 of Royal Decree 2424/1986 on the convention's application in Spain).
  • The patent as originally granted, which was the only effective version of the patent in Spain, lacked any presumption of validity because Roche had defended the amended form as a main request in the EPO opposition proceedings, and had maintained from the outset of the Spanish proceedings that if the defendants were to contest the patent's validity, then a limitation of the patent would be requested in the main proceedings (Article 138.3 of the convention) to amend it as maintained by the EPO Opposition Division.

An analogous argument (ie, that there was no presumption of validity of the patent because the holder itself was defending an amended form as a main request at the EPO) had previously been successfully raised in cases involving desmopressin, fluvastatin and drospirenone, in which preliminary injunctions were also dismissed.

Bearing these arguments in mind, in an October 27 2011 decision Barcelona Commercial Court 7 dismissed the preliminary injunction motion, holding that the decision should be based on the amended form of the patent, and that this amended form was ineffective in Spain.

This decision enabled Teva, Mylan, Cinfa and Kern to become the first companies to launch generics of Bonviva on the Spanish market, capturing a significant market share.

In the meantime, the main proceedings on the merits continued and Roche managed to limit the patent by application of Article 138.3 of the convention, so that the amended patent as maintained by the Opposition Division of the EPO became the basis of the litigation. Thus, when the court accepted this limitation of the patent in the main proceedings, Roche filed a second preliminary injunction motion arguing that the circumstances had changed and that the preliminary injunction should thus be granted. However, this petition was again rejected by the court in a decision issued on February 8 2012.

Finally, the recent decision of the EPO Board of Appeal to revoke EP1506041 will result in the termination of the Spanish litigation. Other companies will now also be able to launch generic versions of Bonviva; but thanks to their defence strategy, Teva, Mylan, Cinfa and Kern have already been commercialising their generics for several months.

For further information on this topic please contact Miguel Gil at Grau & Angulo by telephone (+34 91 353 3677), fax (+34 91 350 2664) or email ([email protected]).