One of the main changes set out in the new Law 24/2015 on Patents, which will enter into force on 1 April 2016, is the definition of the application, processing and maintenance procedures for Supplementary Protection Certificates (SPC) in Spain.  This, in and of itself, does not represent a true change in the current procedure; however, it is an important step that better organizes this process, which had not been set out in the former Law

Supplementary Protection Certificates (SPC) in the European Union (EU)

Supplementary Protection Certificates (SPC) were created in the European Union to offer supplementary protection to medicinal patents for human and veterinary use and for phytosanitary products, products that are used to fight infections and pests that affect plants. This supplementary protection extends the protection conferred by the base patent to the product covered by the marketing authorization for a specific period of time, which shall be a maximum of five years.

It is necessary to obtain authorization to market these products (medicinal and phytosanitary products) in European Union countries (marketing authorization). The European Medicines Agency (EMA) grants these marketing authorizations through a centralized procedure. In Spain, the Spanish Agency for Medicinal Products and Medical Devices and the Ministry of Agriculture and Fisheries, Food and Environment (the latter for phytosanitary products) are entities with the power to grant these marketing authorizations in Spain.

SPCs are currently regulated in EU countries by Regulation (EC) No. 469/2009, related to the supplementary protection certificate for medicinal products and Regulation (EC) No. 1610/96, which created a supplementary protection certificate for phytosanitary products. Regulation (CE) No. 469/2009 also regulates pediatric extensions, for a period of six months, for those medicinal products that have completed a pediatric research plan.

 

Law 24/2015 on Patents and the draft of the Regulation on the implementation of the Law

Articles 45-47 and 184 of Law 24/2015 on Patents address the application, processing and maintenance of SPCs. The final text of the Regulation on the implementation of the Law has still not been approved; however, a draft of this text has been made public. In the draft, Articles 54-57 refer to the filing of the SPC application (Art. 54) formal review of the application and publication (Art. 55) in-depth examination (Art. 56) and grant of the SPC (Art. 57).

This is the first time that the Law on Patents and its implementing Regulation define the application, processing and maintenance procedures for SPCs in Spain. These procedures are in line with the practices carried out by the Spanish Patent and Trademark Office (SPTO) to implement the Community Regulations in Spain. An analysis of these procedures and the new developments related to current practice are discussed below.

 

Application, processing and maintenance of SPCs

The SPTO invokes the proceedings without examination provided for in Article 10.5 of Regulation (EC) No. 469/2009 and of Regulation (EC) No. 1610/96, and it establishes in Article 46 of the Law that it will not investigate ex officio whether the marketing authorization is first for a medicinal product or for a phytosanitary product.

Articles 55-57 of the draft of the Regulation describe the processing procedure. Firstly, a formal review is performed (Art. 55) and if the SPTO considers that there is a formal defect, the applicant will be given a period of one month to reply. Once this formal review has been completed, the SPC application will be published.

After publication, an in-depth examination will be carried out (Art. 56 of the draft of the Regulation). If the SPTO considers that there is an in-depth defect, the applicant will be given a period of two months to reply. There will be no more opportunities to resolve the defects claimed by the SPTO after this response, and the SPTO will decide to grant (Art. 57 of the draft of the Regulation) or deny the SPC application (Art. 56 of the draft of the Regulation). The applicant can file an appeal against the decision to deny (Art. 44.2 of the Law will be applicable to the SPCs).

Article 184 establishes the payment period of the SPC maintenance fee, which is a one-time fee for the entire duration of the SPC. This period is for three months from the date of the entry into force of the SPC, after the expiration of the patent. This is the most common case, in which the SPC is given time before the patent expires. The period has changed with regards to current practice, where the payment period of the SPC maintenance fee has the same duration, but begins three months before the date of the entry into force of the SPC, and not on the date of its entry into force.

For less common cases in which the SPC is granted after the patent expires, the payment period of the SPC maintenance fee is three months from the date of publication of the grant.

 

SPC duration - The Seattle Genetics case

In recent months, there have been developments regarding corrections to the duration of SPCs. In October 2015, the SPTO changed its standard practice in calculating the duration of supplementary protection certificates (SPC) after the 6 October 2015 judgment of the Court of Justice of the European Union in the Seattle Genetics case (C-471/14) was made public.

The SPTO began to calculate the duration of SPCs based on the notification date of the marketing authorization to its holder and not based on the grant date that appears on the marketing authorization. This means an additional 2 to 4 days, on average. The SPTO decided to apply this calculation to SPC applications that were being processed. If an SPC has been granted and the period to appeal the grant decision has expired, it is not possible to correct the duration of the SPC granted.

On 14 September 2016, a Hungarian court requested a preliminary ruling from the Court of Justice of the European Union (case C-492/16), in which it questioned whether the authority related to industrial property in a member state (this authority in Spain is the SPTO) is required to rectify the expiration date of the SPCs granted in order to adjust it according to the legal ruling of the Seattle Genetics case.

If, over the next few months, the Court of Justice of the European Union concludes that the SPTO is required to rectify the expiration date of the SPCs granted, there will be a new change of practice in Spain and it will be possible to correct the duration of the SPCs granted in Spain. There is a great deal of expectation surrounding the Court’s decision.