The European Court of Justice (ECJ) has ruled that only a granted marketing authorisation could be used to apply for a supplementary protection certificate.
The extension of patent protection for medicinal products is governed by the Supplementary Protection Certificate (SPC) Regulation (469/2009/EC) (2009 Regulation). One of the conditions for obtaining an SPC is that at the date of that application a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with the Medicinal Products Directive (2001/83/EC) (2001 Directive) or Directive 2001/82/EC (Article 3, 2009 Regulation) (Article 3).
Article 10(3) of the 2009 Regulation (Article 10(3) deals with corrections to a SPC application.
M owned a European patent for a drug which was used for the treatment of high cholesterol.
M filed applications for marketing authorisations in a number of EU member states, including Germany and the UK. M also filed an application for an SPC with the UK Intellectual Property Office (IPO) on the day before the patent expired, in 2014. At that time M did not have a UK marketing authorisation. M relied on an email from the German Medicine Products Agency described as the "end of procedure communication of approval", which was issued in accordance with Article 28(4) of the 2001 Directive (Article 28(4)) before the expiry of the basic patent.
The IPO refused the application on the ground that it did not comply with Article 3(b) because there was no UK marketing authorisation at the date of the application. M appealed.
The IPO referred to the ECJ.
The ECJ ruled that an end-of-procedure notice issued in accordance with Article 28(4) before the expiry of the basic patent may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b), with the result that an SPC may not be obtained on the basis of such a notice.
The adoption of the end-of-procedure notice under Article 28(4) represented an intermediate stage in the decentralised procedure and the notice did not have the same legal effects as a valid marketing authorisation, as the notice did not authorise M to place the medicinal product on a particular market. Unless it had been granted a marketing authorisation as a medicinal product, a patented product could not give rise to the grant of an SPC.
Article 10(3) could only cure irregularities in the application documents rather than the absence of an essential quality of the product, such as the grant of a marketing authorisation.
Unusually, a question referred to the ECJ on the 2009 Regulation has received a straightforward answer. The ECJ took a plain interpretation approach to the wording of the relevant provision of the 2009 Regulation in holding that "granted" in Article 3(b) means what it says and does not cover applications in the process towards grant, however close to that final step the process may have come.
Case: Merck Sharp & Dohme Corporation v Comptroller General of Patents, Designs and Trade Marks C-567/16.