New ECJ reference in relation to Supplementary Protection Certificates for Medicinal Products

20 December 2007

Trevor Cook

The latest reference to the ECJ under Council Regulation (EEC) No 1798/92 concerning the creation of a supplementary protection certificate for medicinal products, which establishes the scheme by which Supplementary Protection Certificates (SPCs) enable de facto patent term extension of up to 5 years to be secured for pharmaceuticals, concerns the time limit for filing an application for such an SPC. Where the basic patent that it is sought to “extend” by an SPC has already been granted Article 7(1) of the Regulation requires that such application be filed within six months of the grant, in or effective in the Member State where the SPC is sought, of the first authorisation to place a product on the market as a medicinal product.

This deadline can present problems for applicants who are not also the applicant for a marketing authorisation in seeking to file an SPC application within such deadline because in some Community Member States, such as the UK, marketing authorisations are not published until some time, and occasionally some months, after their nominal date of grant. However the UK Patent Office, in its Decision of 25 July 2002 in Abbot Laboratories SPC Application [2004] RPC 20, held that the relevant date was when the authorisation took effect under national law and, under such national law, rejected a submission that it was the date of publication of the grant that should count for such purposes.

The ECJ has now been asked by the German Federal Supreme Court to rule on the point. The reference, Case C-452/07, Health Research Inc. poses the following 2 questions:

  • Is the “date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted”, referred to in Article 7(1) of the Regulation determined according to Community law or does that rule refer to the date on which authorisation takes effect under the law of the Member State in question?

  • If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account for that purpose?

However, even if the effect of the ECJ decision once it is given, probably in 2009, is that the relevant date is that of the nominal grant of a marketing authorisation, and not for example that of its publication, an applicant that has not filed its application for an SPC within the time fixed by Article 7(1) may in certain Community jurisdictions still be allowed so to do so out of time in certain cases. Thus in the UK, in the Abbot Laboratories SPC Application case discussed above, the UK Patent Office in the exercise of its discretion allowed such an application to be filed out of time, where the late filing had occurred as a consequence of a corporate acquisition, the purchaser and the seller each reasonably believing that the other was attending to it, and where they had acted promptly as soon as they became aware of the irregularity. In that case the applicants also identified cases in France, The Netherlands, Sweden and Luxembourg where such late filings had also been allowed on the specific facts of those respective cases.