On 3 October 2011, the Brussels Commercial Court (the “Court”) handed down its judgment in joined cases Ratiopharm GmbH and Ratiopharm Belgium NV (“Ratiopharm”) v. H. Lundbeck A/S (“Lundbeck”) and Alfred E. Tiefenbacker GmbH & C° KG (“Tiefenbacker”) v. Lundbeck regarding the validity of Lundbeck’s supplementary protection certificate (“SPC”) for Sipralexa®.
Lundbeck is a pharmaceutical company that commercialises two antidepressants, namely Cipramil® and Sipralexa®. Cipramil® is based on the active ingredient citalopram which is a so-called ‘racemate’. A racemate is a mixture of two enantiomers (an S-enantiomer and an R-enantiomer), i.e. two compositions of molecules that are each other’s mirror images and that are not identical. Lundbeck received the marketing authorisation in Belgium for Cipramil® in May 1990. Citalopram was protected by a Belgian patent that expired in January 1997. The patent protection of Cipramil® was prolonged by a SPC that expired in January 2002.
Sipralexa®, on the other hand, is based on the active ingredient escitalopram which is the S-enantiomer of citalopram. The marketing authorisation for Belgium for Sipralexa® was granted in July 2002. Escitalopram was protected by a European patent that expired in June 2009. An SPC for Sipralexa® was granted as well (the “Sipralexa SPC”). The Sipralexa SPC would expire in June 2014.
Ratiopharm and Tiefenbacker both market generic pharmaceuticals and wish to put on the market a generic pharmaceutical on the basis of escitalopram. However, such a product cannot be launched as long as escitalopram is protected by the Sipralexa SPC. In 2008, Ratiopharm and Tiefenbacker brought an action against Lundbeck claiming that the Sipralexa SPC should be declared invalid.
The action was based on Article 15.1(a) of Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”) which provides that an SPC is invalid if it was granted contrary to the provisions of Article 3 of the SPC Regulation. An SPC differs from a patent since it protects the product which is covered by a marketing authorisation, whereas a patent protects an invention as such. According to Ratiopharm and Tiefenbacker, Sipralexa® and Cipramil® are in fact the same ‘product’ within the meaning of the SPC Regulation. As a result, they argued that the Sipralexa SPC had been granted contrary to Article 3(c) of the SPC Regulation given that at the date of the application for the Sipralexa SPC, the product had already been the subject of an SPC in the guise of the SPC for Cipramil®.
Moreover, Ratiopharm and Tiefenbacker contended that the Sipralexa SPC had also been granted in violation of Article 3(d) of the SPC Regulation given that at the date of the application the marketing authorisation for Sipralexa® was not the first marketing authorisation for the product. Indeed, Lundbeck had already been the beneficiary of a marketing authorisation for Cipramil® in 1990.
The Court found in favour of the plaintiffs. The Court first considered that the interpretation of the definition of the term ‘product’ laid down in the SPC Regulation was crucial in order to decide on the validity of the Sipralexa SPC. More specifically, it had to decide whether Cipramil® and Sipralexa® should be considered as one and the same product.
The Court recalled that Article 1(b) of the SPC Regulation defines ‘product’ as “the active ingredient or combination of active ingredients of a medicinal product” and that the Court of Justice of the European Union (the “ECJ”) had decided in the MIT case (C-431/04) that this should be interpreted strictly. The Court continued, further relying on the ECJ’s decision in the MIT case, that the term ‘active ingredient’ refers to a substance which has a therapeutic effect of its own. According to the Court, it is not required for the grounds of invalidity laid down in Articles 3(c) and 3(d) of the SPC Regulation that two identical products are concerned, given that the active ingredient is key. On the basis of Lundbeck’s patent for Sipralexa®, several documents provided by Lundbeck and the report of the appointed experts, the Court concluded that the active ingredient for Cipramil® and that for Sipralexa® are the same and that, as a result, Cipramil® and Sipralexa® are one and the same product under the SPC Regulation.
The Court did not accept the arguments put forward by Lundbeck to demonstrate that Cipramil® and Sipralexa® are different products. First, the Court found that Lundbeck had failed to prove that citalopram and escitalopram are different active ingredients. The Court was not convinced by Lundbeck’s argument that the R-enantiomer of citalopram has its own effect and interacts with the S-enantiomer. Further, the Court held that the mere fact that different marketing authorisations were obtained for Cipramil® and Sipralexa® does not mean that they are different products within the meaning of the SPC Regulation.
Consequently, the Court declared the Sipralexa SPC invalid on the basis of Articles 3(c) and 3(d) of the SPC Regulation. The Court also declared its judgment provisionally enforceable in view of the supposed interest of patients to have access to generic pharmaceuticals on the basis of escitalopram.
