Posted by Laura Ercoli on Monday January 29th, 2018

If SPC term is not in line with Seattle Genetics, holder may request rectification

SIBprima February 2018

The Court of Justice of the European Union has ruled that the owner of a valid SPC may request the competent national office to rectify the SPC’s term in accordance with the criteria set forth by the Seattle Genetics decision even if the SPC was granted before that decision.

On 20 December 2017 the Court of Justice of the European Union  (CJEU) issued its ruling in Incyte Corporation (case C-492/16), which definitely brings good news for holders of Supplementary Protection Certificates (SPCs) in the European Union.

Facts in the case

Back in 2013 Incyte Corporation (Incyte), a pharmaceutical company based in the United States, applied with the Hungarian National Intellectual Property Office (the Office) for an SPC under Regulation 496/2009 concerning the supplementary protection certificate for medicinal products.

The application was based on the date of grant of the EU-wide marketing authorisation (MA) for the drug. The Office granted the SPC on 7 October 2014.

Almost exactly a year later, on 6 October 2015, the Court of Justice of the European Union issued its ruling in Seattle Genetics (case C-471/14), making it clear that the term of SPCs must be calculated from the date of notification to the applicant of the decision granting the MA – not from the date of grant of the MA itself. Usually notification takes place a few days after grant.

Incyte filed a request with the Office to rectify the SPC according to the Seattle Genetics ruling.

The Office rejected the request on the grounds that its decision granting the SPC did not contain any miscalculations or clerical errors.

The ensuing dispute reached the Budapest High Court which referred the case to the CJEU aiming essentially to establish whether the CJEU’s decision in Seattle Genetics is retroactive and whether national offices must rectify of their own motion the term of SPCs that are not in line with that decision.


Seattle Genetics decision is retroactive

The CJEU found that according to settled case law, the interpretation that the CJEU itself gives to a rule of EU law clarifies the meaning ad scope of that rule as it must be or ought to have been understood and applied from the date of its entry into force.

It follows that the rule as thus interpreted may and must be applied by the courts even to legal relationships established before the delivery of the judgement on the request for interpretation.

Therefore the correct date which should have been stated in Incyte’s SPC application, and should have been used by the Office to calculated the term of the SPC, is the date of notification, not the date of issue, of the MA.

The CJEU therefore held that the Seattle Genetics decision is, in this sense, retroactive.

SPC holders may file rectification requests with national offices

The CJEU declined to consider whether national offices must rectify ex officio SPC terms that are not in line with the Seattle Genetics decision, on the grounds that in the case at issue Incyte had already applied for rectification.

The CJEU held that Article 18 of EU Regulation 469/2009 must be interpreted as meaning that where the date of the first MA in the European Union, as stated in the application for the SPC, is incorrect, and as a result the duration of that SPC is also incorrect, the SPC holder may file a request for rectification directly with the authority that granted the SPC – as long as the SPC has not expired.

The Italian Patent and Trademark Office – along with the IP Offices of most other European Union member states- has not yet reacted to the CJEU’s ruling, but is expected to do so soon, so stay tuned for further developments.

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