New framework for Spanish patentees

Bolar provision

The Bolar provision included in the new patent law includes two main changes:

It has been separated from the exception relating to acts carried out for experimental purposes.

The term “generic” has been deleted.

We consider that this new Bolar provision reflects more clearly and precisely the intention and requirements of the European Directive 2004/27/CE from which the Bolar provision primarily derives.

Patentability of first and subsequent medical uses

In relation to first and subsequent medical uses, the wording of the new law is adapted to that of the European Patent Convention (EPC) 2000. Therefore, in the absence of examination guidelines, which have still to be issued by the Spanish Patent and Trademark Office (OEPM), it is foreseeable that the previous wording of the first and subsequent medical uses, in the Swiss-type claim, is modified to adapt the wording to that accepted by the European Patent Office (EPO) in accordance with EPC 2000.

The adaptation to the EPC 2000 in relation to the patentability of first and subsequent medical uses solves the current situation in which, by means of a direct Spanish patent application, claims are obtained with a wording different from those obtained before the EPO and validated in Spain and, therefore, having a different scope of protection.

In relation to this last issue, it will be interesting to see whether the Spanish courts share the opinion of the Boards of Appeal of the EPO in that the claims of first and subsequent medical uses drafted in accordance to EPC 2000 (purpose-limited product claims) provide a greater scope of protection than the Swiss-type claim (purpose-limited process claims).

Inventions relating to biological material

Modifications introduced in this area are minor and contribute to the creation of a clearer legal framework. Again, in many cases, they tend to adapt to current legislation before the EPO. Among them, we highlight:

With regard to the exhaustion of the patent right regarding biological matter, it is made clear that the limitation does not apply when there are legitimate reasons which justify that the holder of the patent opposes the subsequent marketing of the biological material.

In connection with biological deposits, the figure of the independent expert is defined.

Authorisation for foreign first filing

The new law introduces an interesting development since it expressly contemplates that, by filing the required prior documentation, the OEPM will authorise foreign first filing of an invention made in Spain.

In order to obtain this authorisation, a copy of the patent application as intended to be filed abroad, including description, claims and drawings, together with a translation of said documents into Spanish, must be filed before the OEPM under confidential conditions. Within one month, the OEPM will grant or reject the authorisation.