Court revokes combination SPC for telmisartan + hctz - International Law Office

On June 20 2012 Pamplona Commercial Court No 1 declared the invalidity of the supplementary protection certificate (SPC) granted for combination product telmisartan + hydrochlorothiazide (hctz), upholding a revocation action filed by Cinfa and Actavis against Boehringer.

Boehringer's patent (EP502314–ES2118095) claimed processes for the manufacture of hypertension treatment telmisartan. The patent expired on January 31 2012, but led to the granting of two SPCs:

• one for the product telmisartan (C009900021), valid until December 11 2013; and
• the other for the combination product telmisartan + hctz (C200200018), valid until January 31 2017.

The plaintiffs' main argument was that the SPC granted for telmisartan + hctz was invalid because the combination product was not protected by the basic patent, as the active ingredient hctz had not been specified in the wording of the claims (as stipulated in Article 3(a) of EU Regulation 469/2009); the patent claimed only telmisartan (processes for its manufacture).

Boehringer defended the validity of the combination SPC, arguing that although the combination product had not been claimed in the basic patent, this combination was included within its scope of protection.

During the preliminary hearing, both parties agreed that it would be prudent to wait for the European Court of Justice (ECJ) to issue its decision in the Medeva (C-322/10) and Daiichi (C-6/11) cases, in which the same issue was under dispute.

The court agreed with the parties and scheduled a hearing for May 23 2012, in order to give them the opportunity to make their final closing statement in light of the pending ECJ decisions.

On November 24 2011 the ECJ issued its judgment in the Medeva case, stating that:

"Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of May 6 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a member state from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate."

On November 25 2011 the ECJ issued its decision in the Daiichi case, establishing that the questions referred in the case by the High Court of Justice were, for all essential purposes, similar to those referred by the Court of Appeal (England and Wales) (Civil Division) in the Medeva case, which gave rise to the judgment of November 24 2011. The ECJ stated that: "Consequently, the answers and clarifications given by the court in that judgment are equally valid as regards the question raised by the referring court in the present case."

On May 23 2012, after the ECJ's decisions had been remitted to the Pamplona Commercial Court, the hearing proceeded and the parties made their closing statements.

On June 20 2012 Pamplona Commercial Court No 1 declared the invalidity and revocation of the SPC for telmisartan + hctz based on the ECJ case law laid down in the Medeva and Daiichi cases.

This is the first court decision in Spain regarding combination SPCs since the ECJ judgment in the Medeva case.

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 (l.morales@gba-ip.com).