Following a preliminary reference made in the context of a dispute between Seattle Genetics and the Austrian patent office, Seattle Genetics Inc. v Österreichisches Patentamt (Case C-471/14), the Court of Justice of the European Union (the CJ) 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 CJ was asked to determine what is the relevant date to be used by national patent offices when calculating the duration of a supplementary protection certificate (SPC). Is it the date when the decision granting the marketing authorisation (MA) is adopted by the health authority, or the date in which the decision is notified to the applicant? Following the opinion of Advocate General Jääskinen, the CJ ruled that the relevant date is the date on which the MA holder is notified that the MA has been granted.
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 an MA. In the EU, no medicinal product may be commercially exploited before the relevant authority has issued an MA.
However, confusion lies in 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”. Yet, following the preliminary reference from Austria, the CJ has cleared all confusion: the relevant date is the date on which the decision is notified to the applicant.
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.
In addition, it is our view that the CJ’s decision will also provide authority that the date of notification of grant of an MA to an applicant is the relevant date for calculating the period of regulatory data protection for a medicinal product and the period of orphan market exclusivity for an orphan medicinal product.
This article was first published on Oxford University Press Blog, October 2015