The Spanish Parliament approved a new Patent Act on the 24 July 2015. This Act will enter into force on 1 April 2017. With over one and a half to go it is likely that some changes to the Act will be implemented in the long vacatio legis period (for instance if Spain joins the UPC system).
The new Act will affect litigation in Life Sciences matters in a number of ways:
On the patent prosecution side, the new system will involve the prior examination of the merits of the patent, so national patent applications will have to satisfy an examination in order to proceed to grant (currently examination is optional). Utility models are not permitted for chemical and pharmaceutical patents (as is the case under the existing law). Provisions relating to Supplementary Protection Certificates (SPCs) are included for the first time in the Spanish Patent Act, but these relate only to administrative aspects of SPCs, as substantive aspects are governed by EU law.
The scope of patent rights closely follows the existing law. The only difference is that the Act treats the experimental use and the Bolar provision as two different exceptions. However, this represents a change of detail, rather than of substance, with no obvious consequences. The scope of the Bolar provision (as under the previous Act) encompasses any preparatory act aimed at obtaining marketing authorisations in Spain and/or abroad.
The most important changes are in the field of patent litigation. Under the new Act, a patentee will be allowed to limit the scope of its patents by modifying its claims at any time during the life of the patent (including during the validity period of a supplementary protection certificate and during nullity proceedings). While this provision has not yet entered into force, the amendment of claims has already been allowed in some cases (in Granada and Barcelona Courts).
Protective letters are permitted for the first time in the Spanish Patent Act. While protective letters are already permitted by the practice of the Barcelona Courts, they are not by the Madrid Courts. There are some differences in the way protective letters will operate under the new Act compared to how they operate in other European jurisdictions that permit protective letters. Under the new Act the protective letter initiates a "reverse PI proceeding" and the owner of the patent is served with the a protective brief.
The new Act introduces specialist patents judges. Currently only the Barcelona Courts are specialized in this way, however the Madrid Courts have recently announced specialization for Courts 7 to 10. The key point is that only Courts with this specialization will be permitted to hear patent cases. This measure will avoid the current situation whereby courts located in 17 different Spanish cities have jurisdiction to hear patent matters. However, the Act does not introduce any specialization in the administrative courts. This limitation is expected to have a limited impact as in the past, the administrative courts rarely heard cases involving patent validity issues.
The Act provides that patent cases pending as at 1 April 2017 will be governed by the previous law. However, some courts have already introduced certain provisions of the Act (such as the limitation of patents and use of protective letters) which did not exist under the previous law.