Pharmaceutical industry patent holders to benefit from ruling in the EU
Seattle Genetics Inc. v Österreichisches Patentamt(Court of Justice of the European Union, October 10, 2015)
A ruling yesterday by the Court of Justice of the European Union clarifies the duration of supplementary patent protection afforded to patent holders in the pharmaceutical industry, and represents an opportunity for the patent holders to extend the value of their patents by a few days.In the European Union, a marketing authorization (“MA”) has to be issued before a medicinal product may be commercialized. As compensation for the wait the patent holder may have to endure before being authorized to market such a product, a patent holder is afforded the possibility to obtain a supplementary protection certificate (“SPC”). The law provides that the SPC is to be calculated based on “the date of first authorization to place the product on the market in the Community”. However, until now, what constitutes the first day of the MA was unclear. Yesterday’s ruling by Court of Justice of the European Union in favor of Seattle Genetics (Case C-471/14, Seattle Genetics Inc. v Österreichisches Patentamt) clarified that the relevant date is the date on which the decision is notified to the applicant, and not the date of when the decision granting the MA is adopted by the relevant authority, which is an earlier date.This clarification represents a difference of approximately two to five days, which, if is multiplied per product, and per every member state in which the product is commercialized, may amount to a significant commercial benefit for the patent holders.Moreover, yesterday’s ruling brings uniformity to the SPC duration throughout the European Union, and provides certainty to patent holders and other parties in regards to when the SPCs expire.
//Isabel Cantallops Fiol