EU Court Clarifies When Drug Patents Expire

A ruling by the Court of Justice of the European Union has clarified when drug patents expire, in a decision that could prove lucrative for drugmakers even though it adds only a few days of patent protection.

The case, Seattle Genetics Inc. v. Austrian Patent Office, deals with a specific aspect of European patent law known as a supplementary protection certificate, which extends the duration of certain rights associated with a patent. SPCs take effect after the general patent expires and typically last for five years. The combined exclusivity from the patent and SPC is normally capped at 15 years from the time the product first receives marketing authorization.

The Austrian Patent Office granted an SPC to Seattle Genetics on Oct. 25, 2012, and set the expiration date as Oct. 25, 2027. Seattle Genetics challenged that date, arguing the 15 years of protection should start when the company was notified of the authorization, thereby pushing back the expiration until Oct. 30, 2027.

In its Oct. 6 ruling, the CJEU agreed with the drugmaker, saying the term of an SPC begins on the date when the innovator is notified of marketing authorization, not the date when authorities decided to grant that authorization.

The case involved Seattle Genetics’ lymphoma therapy Adcetris (brentuximab vedotin).

Read the ruling here: www.fdanews.com/10-15-CJEU-SPC.pdf. — Jonathon Shacat