Article 13(1) of Regulation (EC) No 469/2009 concerning the SPC for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.Many thanks go to Axel Paul Ringelhann for being the first of our readers to spot the ruling.
And that is to the provision is to be interpreted as meaning the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.
An early press release from London-based law firm Bristows observes that the ruling will be welcomed by innovative (= patent-owning) pharmaceutical companies, explaining the decision like this:
The issue concerned the duration of supplementary patent protection afforded to the innovative pharmaceutical industry. EU legislation provides the possibility of a supplementary protection certificate (“SPC”) to compensate a patent holder for the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation (“MA”). In the EU, no medicinal product may be commercially exploited before the relevant authority has issued an MA.
However, there was confusion as to how the duration of an SPC should be calculated. EU legislation provides that the SPC is to be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”. But what constitutes the date of the first MA? Is it the date when the decision granting the MA is adopted by the relevant authority? Or, is it the date on which the applicant is notified of the decision?
Following a preliminary reference from Austria, the CJEU has cleared all confusion: the relevant date is the date on which the decision is notified to the applicant.
Why will the decision benefit the pharmaceutical industry?
Not only has the CJEU’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 can be of significant 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, potentially multiplied by several products is not insignificant!There follows a quick word from Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, who was clearly quite chuffed by the decision:
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 CJEU’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.
“The CJEU’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJEU on this matter”.Representing Seattle Genetics, Marie Manley (Partner and Head of Bristows' Regulatory Practice added:
“This is a decision of significant importance for the innovative pharmaceutical industry which invests millions in developing a medicinal product. As such, the duration of SPC protection is essential for their medicinal products. Importantly the decision provides certainty to both innovative and generic pharmaceutical companies by clarifying when SPCs expire”.
2 comments:
The decision is very much appreciated since it clarifies at least certain aspects of the SPC term calculation. Nevertheless room for discussions with Examiners remain. In particular, since the decision is based on the fact of a marketing authorisation under the centralised procedure which is effective upon notification of the addressee. What happens in cases in which the MA becomes effective upon publication in an official gazette, which typically is after the notification of the MA holder?
In "Seattle" the CJEU emphasizes (again) that the SPC systems aims at an "effective" system; procedural steps which are not under the control of the SPC holder, should not reduce the period of validity of an SPC. Hence this decisions opens up an argumentation in favour of an even longer SPC duration that the date of effect of the MA finally is decisive. This can be e.g. the date of notification (as in cases of an cetralised procedure) or the date of publication in an official gazette.
Is this decision can be applied retroactively or is it for future SPCs which will be granted after this decision?
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