The Court of Justice of the European Union (the “CJ”) has confirmed that the relevant date to be used when calculating the duration of an SPC is the date on which the decision to grant the MA is notified to the applicant.
The Court’s decision has put an end to the uncertainty faced by both the innovative and the generic pharmaceutical industries regarding the duration of the effective patent protection afforded to medicinal products.
The decision was made in the context of a dispute between Seattle Genetics and the Austrian patent office concerning SPC protection for orphan medicinal product ADCETRIS. Article 13 of Regulation 469/2009 (the “SPC Regulation”) provides that an SPC is to be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. In calculating the SPC term for ADCETRIS, the Austrian patent office used the date of the Commission’s decision to grant the MA. However, Seattle Genetics contested that the relevant date was five days later on the date on which the decision to grant the MA was notified to the MA holder, which would result in an extra five days patent protection.
Following a reference for preliminary ruling made by the Austrian Court,Seattle Genetics Inc. v Österreichisches Patentamt (Case C-471/14)1, the CJ ruled that the relevant date is the date on which the marketing authorisation holder is notified that the marketing authorisation (“MA”) has been granted. Agreeing with Advocate General Jääskinen, the CJ held that the question must be interpreted in light of the objective which the SPC Regulation seeks to attain. Since the EU legislature’s intention was the give the holder of an SPC adequate effective protection, “the calculation of the duration of supplementary protection cannot be carried out without taking into account the determination of the date from which the recipient of an SPC is in fact able to enjoy the benefit of his marketing authorisation by marketing his product”. Clearly, the MA holder cannot commercialise his product until he has been notified of the MA grant. In addition, the Court emphasised that “it cannot be accepted that procedural steps carried out between the decision granting marketing authorisation and the notification of that decision – the duration of which is not within the control of the SPC holder – reduce the period of validity of an SPC”.
What does this mean for the innovative pharmaceutical industry?
Not only has the CJ’s ruling put an end to the uncertainty faced by both the innovative and generic pharmaceutical industries regarding the duration of effective patent protection afforded to medicinal products, the additional two to five days typically seen between grant of an MA and notification to the applicant are of immense commercial value. This is particularly so as the market for a medicinal product will often reach its peak towards the end of the patent term. Taking this into consideration, the additional days per product, in every member state in which the product is marketed, multiplied by the number of products that an innovative company may have in its portfolio is far from insignificant!
Furthermore, although the SPC regime is harmonised throughout the EU, patents remain a national right and SPCs are granted by national patent offices. Following the CJ’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation of the SPC term allowing patent holders to be certain of a uniform SPC duration throughout the EU and, similarly, allowing competing generic companies certainty as to when patent protection will expire.