June 25 2012
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:
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.
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