Recent trends in the revision of European patent translations

During the period when the reservation to the patentability of pharmaceutical products set forth in Article 167.2(a) of the European Patent Convention (EPC) was in effect in Spain, most holders of European patents chose to apply for a double set of claims:

• One for those EPC member states in which no restriction existed concerning the patentability of pharmaceutical products.
• One for those countries which, like Spain, excluded patentability from these types of product.

Not all patent holders used the double set of claims option in the same way. Thus, while some simply excluded the Spanish set of product claims from the original set, others added their own claims from the Spanish set which were not included in the original set (mainly mixture or Swiss-type claims).

Once the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) came into effect in Spain, some patent holders raised before the courts the issue of the validity in Spain of the product claims of those European patents which had been applied for or granted before TRIPs came into effect, based on Articles 70.2 and 70.7 of TRIPs. It is well known that the Spanish courts have recognised this possibility, thus allowing for these product claims to be invoked in Spain even if they were not part of the set of claims submitted for Spain.

The issue stems from the method of implementing the protection of this type of claim in Spain. Thus, some patent holders invoked the product claims of the European patent, despite the fact that these did not form part of the set of claims filed with the Spanish Patent and Trademark Office (SPTO). This possibility was rejected by the Spanish courts (see Section 28 of Madrid Court of Appeals Decision 96/2009), arguing that the claims shall be enforceable against third parties once they have been incorporated, by the owner, into the set of claims published before the SPTO. In other words, this decision entailed an extra step for patent holders to take before being able to invoke the product claims in Spain.

However, other patent holders, turning to Article 70.4 of the EPC, chose to request a revision of the translation of the European patent originally applied for with the SPTO, including in the revised translation the product claims of the originally envisaged European patent. This approach was rejected first by the SPTO and then by the contentious-administrative courts, stating that Article 70.4 of the EPC was aimed at correcting material errors and that the intentions of the patent holders clearly surpassed this aim.

The Supreme Court has now issued four judgments (three on 4th November 2010 and one on 3rd March 2011) which protect this practice and establish the following:

• The scope of Article 70.4 of the EPC is broader than that intended by the SPTO, making the revision of the translation the appropriate way to incorporate the product claims.
• The SPTO should agree to revise the translation to the extent that it corresponds to the original version.
• The filing of the revision of the translation is subject to no legal timeframe, such that the patent holder may complete it at any time.

Even though these judgments resolve their respective cases only and do not set down a general rule, there is no doubt that the Supreme Court’s thesis must be followed by the SPTO with regard to any future requests for the revision of the translation of a European patent. This seems to be a peaceable solution at first glance, although questions arise in relation to other issues. Is the mere incorporation of the product claims included in the original set into the Spanish set sufficient, or must the entire Spanish set of claims be replaced with the original set of claims? This issue is relevant because in some cases the Spanish set of claims contained claims that were not present in the original set filed in other countries, which the patent holder must now perhaps “waive” if it intends the translation of its European patent to be revised. Even though no administrative or court decision has been issued regarding this matter, it seems that the SPTO will opt for the integral substitution of the claims, and that it will not allow the patent holder to perform any form of "claim picking”.

The second question is related to the content of Article 70.4(b) of the EPC, relative to the revision of the translation of the European patent, which has been implemented into Spanish law through Article 12 of Royal Decree 2424/1986. According to this rule, in the event that the translation of a European patent is revised, anyone who in good faith begins to exploit an invention or makes serious and effective preparations to do so without that exploitation constituting an infringement of the application or of the patent in accordance with the text of the initial translation may, without any compensation, continue with the exploitation.

This rule is undoubtedly the one which requires the most interpretative effort and the one from which future cases are most likely to arise. The following issues will need to be considered:

• Which party deserves the consideration of a good-faith third party must be assessed, especially in light of the knowledge that this third party may have of:
  • The contents of the original set of claims of the European patent (and the fact that the patent holder possessed protection for its pharmaceutical product in other countries).
  • The protection recognised by the Spanish courts based on TRIPs granted to patent holders for pharmaceutical products.
• The concept of the serious and effective preparation for exploitation must be interpreted, especially in light of the administrative steps that the laboratories must take before marketing their drugs. More specifically, if a generics company has begun the process of obtaining marketing authorisation for a specific drug before publication of the revision of the translation of the European patent, will it then be facing serious and effective preparations for exploitation of the invention?
• The scope of the concept of “exploitation” of the invention must be determined. Although it is true that Article 12 of Royal Decree 2424/1986 expressly refers to the concept of exploitation, the English version of Article 70.4(b) of the EPC (which bears witness in accordance to the provisions of Article 177.2 of the EPC) refers to the more limited concept of “use”. Thus, doubt arises as to whether a good-faith third party may simply use the patented product or may commercially exploit it. Similarly, it must be determined whether the needs of the company encompass its “commercial needs” – that is, if the commercial spirit of the patented product is part of the needs to which the rule refers.

Depending on the answers to these questions, the patent holder will have to demonstrate that the acts of exploitation of the invention carried out by the third party (or for which acts of serious and effective preparations have been made) already constituted patent infringement according to the earlier set of claims, in order to prevent the third party from continuing to exploit the invention without having to pay any compensation to the patent holder.