CJEU adviser to give opinion on SPC term
An adviser at Europe’s highest court is expected to issue an opinion on whether the term of a supplementary protection certificate (SPC) begins once it is authorised or when the applicant has been notified about it.
Tomorrow, September 10, an advocate-general at the Court of Justice of the European Union (CJEU) is expected to issue an opinion on the issue.
At the centre of the dispute is biotechnology company Seattle Genetics’s SPC application called “Brentuximab vedotin or pharmaceutically acceptable salts thereof”, which the company applied for at the Austrian Patent Office (APO).
The dispute centres on divergences between national laws in EU member states regarding when the term of an SPC begins.
The APO authorised Seattle Genetics’s SPC on October 25, 2012 but it was not until October 30 that the company was notified of the approval.
According to the APO, the SPC, which is due to expire on October 25, 2027, is valid from the date of notification.
Seattle Genetics appealed against the APO’s decision at the Oberlandesgericht Wien (Higher Regional Court of Vienna) arguing that the term of protection should begin after the SPC owner is notified about the authorisation, the later date.
The biotech company said that the SPC term in the UK, Belgium, Slovenia and Portugal begins from the date of notification.
In October last year, the Vienna court referred two questions to the CJEU concerning the inconsistencies applied to SPC terms across the EU.
The court first asked the CJEU: “Is the date of the first authorisation to place the product on the market in the community under article 13(1) of regulation (EC) No 469/2009 … concerning the SPC for medicinal products determined under community law, or does the regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?”
Second, it asked: “If the CJEU affirms that the date under question one is determined under community law: which is the relevant date—that of the authorisation or that of the notification?”
While the AG’s opinion is not binding, the CJEU is thought to agree with the AG in around 80% of cases.
