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27 March 2017AmericasJosé Manuel González

New rules for SPCs in Spain

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

It is necessary to obtain authorisation to market these products in EU countries. The European Medicines Agency (EMA) grants marketing authorisations through a centralised 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 marketing authorisations.

SPCs are currently regulated in EU countries by Regulation (EC) No. 469/2009, covering SPCs for medicinal products, and Regulation (EC) No. 1610/96, which created SPC protection for phytosanitary products.

The 469/2009 regulation also covers paediatric extensions, which last for six months, for those medicinal products that have completed a paediatric investigation plan.

New legislation

Articles 45 to 47 and 184 of Spain’s new Law 24/2015 on patents address the application, prosecution and maintenance of SPCs. The final text of the regulation on the implementation of the law has still not been approved, but a draft of this text has been made public. In the draft, articles 54 to 57 refer to the filing of the SPC application (article 54), formal examination of the application and publication (article 55), substantive examination (article 56), and grant of the SPC (article 57).

This is the first time that the patent law and its implementing regulation define the application, prosecution 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, prosecution and maintenance

According to the new law, the SPTO establishes in article 46 that it will not investigate ex officio whether the marketing authorisation is first for a medicinal product or a phytosanitary product, as provided for in article 10.5 of the 469/2009 and 1610/96 regulations.

Articles 55 to 57 of the draft regulation describe the prosecution procedure. First, a formal examination is performed (article 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 examination has been completed, the SPC application will be published.

After publication, a substantive examination will be carried out (article 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 (article 57) or deny the SPC application (article 56). The applicant can file an appeal against the decision to deny (article 44.2 of the law will be applicable to SPCs).

“According to the new law, the SPTO establishes in article 46 that it will not investigate ex officio whether the marketing authorisation is first for a medicinal product or a phytosanitary product.”

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 granted before the patent expires. The period has changed with regard 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, 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.

Seattle Genetics

There have been some developments regarding corrections to the duration of SPCs. In October 2015, the SPTO changed its standard practice in calculating the duration of SPCs after the October 6, 2015 judgment by the Court of Justice of the European Union (CJEU) 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 authorisation to its holder, not based on the grant date that appears on the marketing authorisation. This means an additional two to four days, on average. The SPTO decided to apply this calculation to SPC applications under prosecution. 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 September 14, 2016, a Hungarian court requested a preliminary ruling from the CJEU(case C-492/16) in which it questioned whether the authority relating to IP in a member state (in Spain this authority is the SPTO) is required to rectify the expiration date of granted SPCs in order to adjust that date according to the ruling in Seattle Genetics.

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

José Manuel González is a consultant at  Clarke, Modet & Co. He can be contacted at: jmgonzalez@clarkemodet.com

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