European Court of Justice clarifies scope of SPC protection

The Court of Justice of the European Union (CJEU) yesterday handed down a landmark judgment clarifying the scope of protection afforded by Supplementary Protection Certificates (SPCs) and the circumstances under which they can be granted. The ruling answers questions referred by the Court of Appeal of England and Wales in the cases of Medeva (a company bought by Celltech that, in turn, was taken over by Belgium’s UCB in 2004) and Georgetown University, USA.

“The fundamental objective” of the EU rules in question “is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health,” said the Luxembourg-based CJEU.

Explaining the decision handed down by the court, lawyers at Marks & Clerk, a leading intellectual property specialist, noted that companies investing in medical technology often suffer delays before they can put a medicinal product on the market. Specifically, delays result from having to clear the necessary safety hurdles before regulatory approval can be granted for the product. These delays eat away at the period of protection afforded by the patent system. SPCs were introduced under a specific European framework to redress the balance. They are not patent extensions per se, but can be applied for to protect a product protected by an underlying patent also held by the applicant.