In Janssen Pharmaceutica N.V. against Greek pharmaceutical companies (Decision no. 342/2020, January 16, 2020) the Athens Court of Appeal confirmed the validity of Janssen’s Supplementary protection certificate (SPC) for paliperidone palmitate.

Janssen Pharmaceutica N.V. (Janssen) is owner of a Supplementary Protection Certificate (SPC) for paliperidone palmitate, which was granted in relation to its product Xeplion®. This SPC was granted in addition to Janssen’s prior SPC for paliperidone and its Invega product.

Greek pharmaceutical companies, all belonging to the same Group, initiated a nullity action against said SPC, arguing that the SPC was granted in contrast to article 3 (c) of EU regulation 469/2009. According to Article 3 (c) of EU regulation 469/2009, a certificate shall be granted only if “the product has not already been the subject of a certificate”. The Greek pharmaceutical companies argued that paliperidone and paliperidone palmitate are the same products within the meaning of Article 3 (c) of EU regulation 469/2009 and therefore the SPC for Xeplion® – paliperidone palmitate should not have been granted.

In 2018, the Athens Court of First Instance rejected the nullity action with decision no. 4001/2018, holding that paliperidone and paliperidone palmitate are different products within the meaning of Article 3 (c) of EU regulation 469/2009.

The Court of Appeal has now upheld this first Instance decision and confirmed the validity of Janssen’s paliperidone palmitate SPC.

The Court clarified that paliperidone palmitate is a fatty acid ester of paliperidone. Paliperidone is the active substance of the medicinal product “Invega”, while paliperidone palmitate is the active substance of medicinal product “Xeplion®”. Paliperidone palmitate is a different chemical compound and differs significantly from paliperidone as to its safety and efficacy.  These compounds constitute the subject of two different inventions which were protected by two different European Patents. In accordance with Article 1(b) of the EU regulation 469/2009, paliperidone palmitate constitutes the “product”, the active substance of the medicinal product “Xeplion®”. The Court of Appeal therefore agrees with the First Instant decision and concludes that paliperidone and paliperidone palmitate are different products within the meaning of Article 3 (c) of EU regulation 469/2009.

Furthermore, the Court of Appeal also decided that, in the appeal proceeding, the claimant is not entitled to change the basis of the lawsuit. Argumentations which were based on new facts of the case and were not included in the first instance proceedings cannot be brought in the Appeal proceeding. The Court of Appeal therefore rejected the appeal filed by the Greek Pharmaceutical Companies.

This is one of the rare cases in the Greek pharmaceutical sector which dealt with the validity of a SPC. The decision offers detailed guidelines on the interpretation of EU regulation 469/2009.

Decision no. 342/2020 can be appealed by the Greek pharmaceutical companies before the Supreme Court, the case is therefore still pending.