01 januari 1970

A FEW MORE DAYS OF PATENT PROTECTION FOR PHARMACEUTICALS

The lengthy procedure for obtaining a regulatory approval to introduce a new drug on the European market significantly affects the effective duration of patent protection for these drugs. In order to compensate for that loss and to stimulate innovation in the pharmaceutical field, the European Union provides Supplementary Protection Certificates (SPCs). These extend patent protection with a maximum of 5 years, while an addition half year is available for paediatric medicines.

To calculate the term of supplementary protection, one takes the time lapsed between the date of filing of the corresponding patent and the date of the first Marketing Authorization (MA) in the European Economic Area. This period is reduced with 5 years, taking into account that the maximum SPC term is 5 years.

While the calculation looks straightforward, it is complicated by the fact that there are two dates associated with the first Marketing Authorization. One is the date of the decision of the MA and the other is the date of notification of that decision. This led to a diverging practice across Europe. For example, the patent offices of Belgium, the UK, Slovenia and Portugal used the date of notification, while many other patent offices used the earlier date of the decision. Although there are generally only two to five days between the decision and its notification, these few days may have a significant commercial impact, especially since medicines often reach the highest sale towards the end of the term of protection.

The case underlying the current decision concerned EP1545613, a European patent of Seattle Genetics on Auristatin conjugates. The patent was applied for in 2003. In 2011, Seattle Genetics’ licensee Takeda applied for a conditional MA for Adcetris. By a decision of 25 October 2012, Takeda was granted a marketing authorization and Takeda was notified of the decision on 30 October 2012. Shortly thereafter, Seattle Genetics applied for an SPC at the Austrian patent on the basis of EP1545613 and the MA for Adcetris. The Austrian patent office calculated the term based on the date of the decision, i.e. 25 October 2012 and fixed the expiry date of the SPC as 25 October 2017. Seattle Genetics was of the opinion that the SPC should be calculated using the later date of the notification, leading to an SPC expiry of 30 October 2017 instead and started court proceedings. Taking into account the diverging practice of the national patent courts in Europe, the Austrian court applied for a preliminary ruling of the Court of Justice of the European Union (CJEU).

On 6 October 2015, the CJEU decided (C-471/14) that it is indeed the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision is the date to be used for calculating the SPC term.

In practice, this will mean a few more days of patent protection for innovative medicinal products in the European countries that previously applied the date of the decision to calculate the SPC term. In addition, the decision will end the current diverging practice that resulted in different SPC durations throughout the European Union and provide certainty on patent term expiry for patent holders as well as for generic pharmaceutical companies.


Stijn Lagaert

European
Patent Attorney



Background:

LC Patents provides a wide range of patent and other IP services, in particular in the pharmaceutical and biotech field. We are experienced in filing requests for SPCs in Belgium as well as in coordinating SPC requests throughout the European Union. Do not hesitate to contact us for more information on Supplementary Protection Certificates, this particular decision of the CJEU or pharmaceutical patent protection in general.


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