Background
ECJ decision
Commercial court decision
Comment
On April 26 2012 Pamplona Commercial Court No 1 declared the invalidity of the supplementary protection certificate (SPC) granted for memantine, pursuant to a petition filed by Cinfa against Merz. The commercial court awaited the European Court of Justice's (ECJ) judgment on the matter before making a decision (for further details please see "European Court of Justice holds SPCs for old medicinal products invalid").
Memantine is an active ingredient which was marketed by Merz in Germany from 1976 to 2002 for the treatment of Parkinson's and other diseases (Akatinol®). Merz sold this medicine on the basis of a marketing authorisation granted under the 1961 German Medicament Law, which did not require testing for safety and efficacy.
In 1989 Merz filed a European patent application for the use of memantine in a drug for the treatment of Alzheimer's. The patent was granted in 1993.
In May 2002 the European Medicines Agency (EMEA) authorised memantine for the treatment of Alzheimer's, and since then memantine has been marketed in different EU countries for this purpose.
In November 2002 Merz filed SPC applications in different EU countries on the basis of its European patent on the use of memantine for the treatment of Alzheimer's; it cited the EMEA marketing authorisation of May 2002 as the first authorisation for the marketing of memantine as a drug in the European Union.
Cinfa, the plaintiff, argued that memantine should be held outside the scope of the EU SPC Regulation according to Article 2 of the regulation, because memantine had been sold as a medicine in the European Union (ie, in Germany) since 1976 without previously being subject to an administrative authorisation procedure as required under EU Directive 65/65/EEC, and thus without testing for safety and efficacy.
Merz defended the validity of its SPC, arguing that:
- the grounds for invalidation of an SPC are established in Article 15, not Article 2, which thus does not constitute legal grounds for revoking an SPC; and
- Article 2 should be interpreted as requiring that the first marketing authorisation in the country for which an SPC is filed – not in the European Union – be an authorisation according to EU Directive 65/65/EEC.
At the same time, two petitions for a preliminary ruling to the ECJ were filed by the UK courts (where generic manufacturers had challenged the validity of the SPC for memantine).
Merz requested the suspension of the proceedings, stressing the impact that the pending ECJ judgment could have on the proceedings.
The commercial court decided to await the ECJ's judgment before issuing its decision.
On July 28 2011 the ECJ ruled that the SPC granted for memantine was invalid. It concluded that the first element to be considered was the aim of the SPC Regulation, which is to promote research through the creation of SPCs in order to extend the life of patents that protect active ingredients, given the lengthy period that usually elapses between filing a patent application for a new active ingredient and the granting of authorisation to release the drug onto the market. The ECJ pointed out that it would contravene this objective to grant SPCs that extended the life of patents protecting active ingredients which were already sold as medicines in the European Union without being subject to an authorisation procedure in accordance with EU Directive 65/65/EEC, including testing for safety and efficacy.
In the ECJ's view, Article 2 of the regulation should thus be interpreted as establishing that:
"only a product which is protected by a valid patent in the territory of the Member State concerned and which obtained a marketing authorisation after being subject, prior to being placed on the market in the Community as a medicinal product, to an administrative authorisation procedure as laid down in Directive 65/65, which included safety and efficacy testing, could be the subject of an SPC."
Commercial court decision
After the remittal of the ECJ's judgment to the commercial court, Merz consented to the revocation of its SPC.
In its judgment revoking the SPC, the commercial court reiterated that the ECJ's interpretation of the SPC Regulation is binding for national courts from a material perspective.
For further information on this topic please contact Ana-Laura Morales at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email ([email protected]).