In a November 3 2011 decision Barcelona Commercial Court No 7 dismissed a preliminary injunction motion filed by Roche against Mylan, Kern, Teva and Cinfa, which hold marketing authorisations for generic medicaments for the treatment of osteoporosis, which contain 150 milligrams (mg) of ibandronic acid and are to be administered orally once a month. Roche asked the court to prohibit the launch and sale of these generic medicaments.

Roche asserted European Patent EP1506041-B1, validated in Spain with translation ES2294277-T3, which claims the use of ibandronic acid for the preparation of a medicament for the prevention or treatment of osteoporosis which contains 50mg to 250mg of ibandronic acid and is orally administered once a month.

Previously, Roche had limited the EP1506041-B1 patent twice during opposition proceedings at the European Patent Office (EPO): in May 2009 in its reply to the oppositions, and later during the oral proceedings that took place in December 2010. By a first instance decision of February 1 2011 the Opposition Division of the EPO dismissed the oppositions and maintained the patent in amended form as requested by Roche. The opponents have appealed this decision before the EPO Board of Appeal.

In its infringement action and preliminary injunction motion, filed in late July 2011 and extended in early September 2011, Roche asserted EP1506041-B1 as originally granted by the EPO and translated in Spain (ES2294277-T3). This is the only effective version of the patent in force in Spain (Articles 65, 103 and 106 of the European Patent Convention (EPC) and Articles 7, 8 and 9 of Royal Decree 2424/1986 on the application of the EPC in Spain). However, Roche advanced from the outset that if the defendants argued the invalidity of the patent, in the main proceedings a limitation of the patent would be requested to put it in line with the amended form maintained in first instance by the EPO Opposition Division.

According to Roche, the legal basis for the limitation of the patent would be Article 138.3 of the EPC, which establishes that:

"In proceedings before the competent court or authority relating to the validity of the European patent, the proprietor of the patent shall have the right to limit the patent by amending the claims. The patent as thus limited shall form the basis for the proceedings."

The defendants argued that Roche lacked the necessary 'appearance of right' for a preliminary injunction to be granted, on the basis of the following considerations:

  • The patent as originally granted and in force in Spain is indisputably invalid as Roche had implicitly recognised twice during EPO opposition proceedings. Roche again implicitly admitted the invalidity of the patent as originally granted in its infringement action by advancing that it would not even try to defend its validity, but instead would request a limitation of the same.
  • The amended version of the patent as upheld at first instance by the EPO Opposition Division was ineffective and could not be asserted against third parties in Spain due to the suspensive effect of the pending appeals of the opponents and the lack of publication of a Spanish translation of the same (Articles 65, 103 and 106 of the EPC and Articles 7, 8 and 9 of Royal Decree 2424/1986).
  • The admissibility of the limitation of the patent within the main proceedings could not be taken for granted and would be disputed.
  • In any event, the amended version of the patent would be invalid.

In its decision the court dismissed Roche's preliminary injunction petition after realising that the amended version of the patent, as upheld at first instance by the EPO Opposition Division, lacked legal effect and could not be asserted against third parties in Spain. For this reason, the court concluded that Roche lacked the necessary appearance of right, and therefore a preliminary injunction was not justified.

Roche is expected to appeal this decision but in the meantime the main proceedings on the merits will continue.

For further information on this topic please contact Ana-Laura Morales at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email ([email protected]).