European Court clarifies duration of effective patent protection for medicinal products
By Gabriel M. Lentner
In Seattle Genetics Inc. v Österreichisches Patentamt (Case C-471/14), the Court of Justice of the European Union (CJEU) clarified that the relevant date to be used by national patent offices when calculating the duration of a supplementary protection certificate (SPC) is the date when an applicant is notified of the decision granting a marketing authorization (MA).
Under EU law, no medicinal product may be commercially exploited before the relevant authority has issued a marketing authorization (MA). In order to compensate for the period that elapses between the filing of a patent application and obtaining an MA, a supplementary protection certificate (SPC) extends the period of effective patent protection. An SPC thus aims to offset the loss of patent protection for medicinal products that occurs due to the compulsory testing and clinical trials required for obtaining an MA.
These issues are governed by Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products. Article 13(1) of the Regulation provides that “[t]he certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of five years.”
Accordingly, the Regulation provides for an overall maximum of 15 years of protection from the moment the MA is first granted to the medicinal product in question.
The clarification of the Court was necessary since the Regulation does not further specify the relevant date for the protection to be calculated.
Aside from legal certainty, the ruling can be seen as a victory for the pharmaceutical industry in Europe. The few additional days of protection (the duration between the grant of an MA and notification of approval to the applicant) are of significant commercial value. Furthermore, the Court set an important precedent for similar issues regarding the calculation of the period of regulatory data protection for medicinal products and the period of orphan market exclusivity for orphan medicinal products.