Product definition in Swedish SPCs


Hampus Rystedt

Product definition in Swedish SPCs

There is a contradiction at the heart of product definition in Swedish supplementary protection certificates, says Hampus Rystedt.

A supplementary protection certificate (SPC) grants an extension in time to the protection conferred by a patent relating to certain products that require expensive and protracted procedures for marketing authorisation, most notably pharmaceuticals but also plant protection products. The legal basis for SPCs is provided by EU regulations 469/2009/EC, for pharmaceutical products, and 1610/96/EEC, for plant protection products. In order to get an SPC, there must be a basic patent covering the product authorised for marketing.

The SPC is not an extension of the basic patent itself, but rather a standalone protection. The protective scope conferred by an SPC is governed by Article 4 of 469/2009 and only extends to the product covered by the marketing authorisation. However, recitals 13 and 17 of 1610/96 further extend the protective scope by saying that the SPC gives the same rights as the basic patent and that when the basic patent covers an active ingredient and its derivatives (salts and esters), the SPC confers the same protection.

A key court decision on the scope of protection conferred by an SPC is European Court of Justice (ECJ) case C-392/97 (Farmitalia), where the court concluded that the applicant was entitled to an SPC that defined a product as the neutral form of the active ingredient and associated salts, while only one specific salt was actually authorised for sale as a pharmaceutical product.

Product definition, SPCs, Sweden, ECJ