Supplementary Protection Certificates For New Uses - ECJ Clarifies 'First Authorization Of The Product'

On July 19, 20120 the European Court of Justice (ECJ) rendered it decision in Case C-130/11 dealing with the availability of Supplementary Protection Certificates (SPCs) for new uses. The matter involved Neurim Pharmaceuticals' UK SPC application for its melatonin product (CIRCADIN) and European Patent Application 0 518 468.

Briefly, the objective of the SPC Regulation (469/2009) is to ensure sufficient protection to encourage pharmaceutical research. SPCs are intended to compensate the patentee for the reduced effective patent protection for the period between the filing of a patent application and the authorization to place the product on the market ("MA"). The maximum term of the SPC is limited to 5 years (extendable to 5.5 years if certain pediatric studies are conducted) and combined patent and SPC term cannot exceed 15 years (extendable to 15.5 years if certain pediatric studies are conducted). The conditions for obtaining a SPC are set out in Article 3 of the SPC Regulation, which provides:

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or 2011/82/EC , as appropriate;

(c) the product has not already been the subject of a certificate;

(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product

Background

In June 2007, Neurim received a MA for its melatonin product for human use for the short term treatment of primary insomnia characterized by poor quality sleep in patients 55 years old or older. On the basis of the CIRCADIN MA, Neurim applied to the UK IPO for a SPC for the '468 Patent on the basis that the MA for CIRCADIN was the first authorization to place the product on the market as a medicinal product. The UK IPO objected to the application on the basis that CIRCADIN was not the first authorisation to place the product on the market as a medicinal product - REGULIN, a melatonin product regulating the seasonal activity of sheep was previously approved in 2001.

The UK IPO's decision was initially upheld by Justice Arnold of the English High Court of Justice ([2010] EWHC 976 (Pat)), holding that article 3(d) requires the authorization in Article 3(b) to be the first...