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Intellectual Property

The last shots of the TRIPS battle against patents that resist becoming what they are not

The Supreme Court issued, a few months ago, an important ruling concerning the incorporation of pharmaceutical product claims to a Spanish translation of a European patent granted to Spain with process claims and applied for before October 7, 1992, that is, while the reservation to art. 167 EPC was in force. We refer to the Judgment of the Supreme Court (Civil Chamber) no. 568/2017 of October 20, 2017.

Art. 167 CPE provided that any State could make a reservation to foresee that European patents would not have effects or could be annulled in that State if they were aimed at protecting pharmaceutical products (art. 167.2.a EPC). In addition, the effects of the reservation would subsist throughout the duration of these patents (art. 167.5 EPC).

The holders of patent rights understood that the continued effects of the reservation had been repealed by the TRIPS based on its arts. 27 and 70.

Because of this, many of them submitted requests for reviewing Spanish translations of European patents granted by the European Patent Office (EPO) with different sets of claims. For Spain, these patents had only been granted with process claims while for other countries, which had not made reservation to art. 167 EPC, had been granted with product claims. In this way, through the review of the translation mechanism, they intended to introduce, in the Spanish validation of the European patent, the patent claims granted by the EPO to other countries, that is, the set of claims that included product claims.

This was the case of the patent concerned in the Supreme Court Judgment we are commenting. The claim was denied to the owner of the patent in administrative and contentious-administrative judicial proceedings, in first and second instance. However, the Contentious-Administrative Chamber of the Supreme Court, in the Judgment of September 16, 2011, agreed to revoke the decision of the Spanish Patent and Trademark Office (SPTO) that had denied the claim to incorporate the product claims granted by the EPO in other States to the Spanish validation of the patent.

In the opinion of the Contentious-Administrative Chamber of the Supreme Court, the continuing effects of the reservation to art. 167 CPEs had been repealed by the TRIPS Agreement.

That ruling led the SPTO to publish a version of the Spanish translation of the European patent incorporating the product claims granted by the EPO in other States, that is, not for Spain.

As a result of the above, the patent owner initiated infringement patent proceedings against a series of pharmaceutical companies that were already marketing their medicaments. The product claims of the European patent were invoked in the proceedings, even though the Spanish patent did not contain a single product claim.

In the first instance, the Commercial Court No. 4 of Barcelona, ​​in its Judgment of January 10, 2013, dismissed the claim in its entirety because it understood that the revised translation of the patent that included the product claims extended the protection of the European patent, since, for Spain, the EPO had not granted any product claim. The Court noted an insurmountable contradiction between the translation of the patent and the European patent that should be resolved in favor of this second, decreeing the ineffectiveness of the product claims of the translation of the patent based on arts. 70.1, 70.3 CPE and art. 12 of Royal Decree 2424/86.

After the plaintiff had appealed this ruling, Section 15 of the Barcelona Court of Appeals again rejected its claims in the Judgment of October 22, 2014. Moreover, it relied on three resolutions handed down during the course of that proceeding by the Court of Justice of the European Union: the Judgment of July 18, 2013 in the Daiichi Sankyo / Demo case and the two Orders of January 30, 2014 (cases Warner Lambert / Minerva and Warner Lambert / Siegerpharma). Said resolutions stated that art. 70 TRIPS could not be used to “attribute to a patent effects that it never had”. And this, according to the Court of Appeals, applies not only to the patents applied for and granted before the entry into force of the TRIPS, but also to those patents previously applied for, but granted afterwards. The latter was the case of the patent, so it concluded that it was not possible to extend its scope of protection with the product claims. As the product claims the holder intended to introduce with the review of the translation mechanism were ineffective, the patent infringement action was again dismissed (Legal Ground 17th).

The Supreme Court, in the judgment we comment, further denied the appeal filed by the patent holder, indicating that the aforementioned CJEU doctrine was fully applicable to the case, especially taking into account that the holder had not requested the incorporation of product claims while the granting of the patent was still pending. Having been granted only with process claims, the product claims introduced through the revision of the translation mechanism became ineffective (Legal Ground 5th). As a result, the patent infringement actions were completely dismissed.

However, the Judgment contains a statement that, since it is not relevant to the case, should be interpreted as an obiter dicta and, therefore, should not be considered as case law of the Supreme Court. In this regard, the Judgment states: “art. 70.7 TRIPS, in relation to the patents affected by the validity of the reservation at the time of its request, allowed to modify the patent application before its granting, not that after the concession and validation in Spain with the process claims this patent passed to protect the invention of the pharmaceutical product“. We understand this statement does not match the case law of the CJEU discussed above, but in the event that a Spanish Court, in the future, could consider it applicable to a case of a patent applied for while the reservation of art. 167 EPC was in force, we understand it should refer a preliminary ruling to the CJEU.