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The duration of your SPCs may potentially be extended

02-02-2018

Important notice: The duration of your Supplemental Protection Certificates may potentially be extended by a few days.

The decision in Case C-492/16 Incyte Corporation follows a reference for a preliminary ruling on the interpretation of Regulation (EC) article No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning appeals before the national courts in the framework of the procedure for issuing Supplementary Protection Certificates (SPC) for medicinal products.

The reference for a preliminary ruling was made in the course of a dispute between Incyte Corporation and Szellemi Tulajdon Nemzeti Hivatala (Hungary’s National Intellectual Property Office) concerning its refusal to grant a request for rectification of the expiry date of a SPC for a drug formulated by Incyte.

As a reminder of the background here, under Regulation No 469/2009, the certificate shall have effect at the statutory term of the basic patent for a period equal to the period elapsing between the date of filing of the application for the basic patent and the date of the first Marketing Authorisation (MA) within the European Union, reduced by a period of five years. The duration of the SPC cannot exceed five years from the legal term of the basic patent.

Since the Seattle Genetics judgment of 6 October 2015 (Case C-471/14), it is clear that the date from which the expiry of a SPC must be calculated is the date on which the addressee was given notification of the decision on the MA.

By decision of 7 October 2014, the Hungarian Office issued a SPC to Incyte Corporation with an expiration date calculated from the granting date of the MA, and not from the notification.

The National Intellectual Property Office of Hungary rejected Incyte’s request for rectification on the ground that the decision granting the SPC at issue did not contain any miscalculations or clerical errors: the calculation was based on the date indicated in the initial SPC application, i.e. the granting date of the MA.

In its judgment of 20 December 2017 (C-492/16, Incyte Corporation), the CJEU considered that SPCs issued prior to the Seattle Genetics judgment should also be able to lodge an appeal for rectification of their expiration date. Thus, rectification can be requested for all SPCs still in force.

For France: in a press release of 15 January 2018, the INPI indicated that this rectification can be made through simple request from the holder of the SPC. To be admissible, the request must be accompanied by a copy of the publication in the Official Journal of the date of notification of the concerned MA. The request will be registered in the National Register of Patents of the INPI and will be mentioned in the Official Bulletin of Industrial Property. Once the admissible request for correction has been registered, the INPI website will also be modified in order to show the updated SPC expiration date.

For the United Kingdom: The UK IPO has already allowed such correction of SPCs post-grant, and therefore the date of expiry of the SPC, in light of the original Seattle Genetics decision. Such correction is available under Section 27 of the Patents Act 1977.  If the request is accepted, the decision will be published in the UK Patents Journal.

Your usual contacts at Novagraaf can of course carry out for you all necessary steps for these SPC rectifications before the national patent offices. For further information and support, contact us here.

Eric Enderlin is Director of the Chemistry and Life Sciences Department at Novagraaf in France