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25 October 2010
The European Court of Justice (ECJ) has issued a decision concerning the granting of a supplementary protection certificate for a medicinal product in Kirin Amgen Inc v State Patent Bureau of the Republic of Lithuania.(1)
This is the first ECJ patent law case in which a judgment has been made on the basis of a reference for a preliminary ruling from a Lithuanian court. The Supreme Court sought a preliminary ruling on the interpretation of Articles 7 and 19 of EU Regulation 1768/92 regarding the granting of a supplementary protection certificate for a medicinal product.
The reference was made in proceedings between Kirin Amgen Inc and the State Patent Bureau, which arose from the latter's refusal to grant the former a supplementary protection certificate for a medicinal product called Aranesp.
Kirin Amgen holds a European patent for Aranesp. It applied for the patent on August 16 1994 and the patent's effects have been extended to Lithuania. On June 8 2001 Kirin Amgen obtained a marketing authorisation for the product under EU Regulation 2309/93. On October 29 2004 it lodged an application for an supplementary protection certificate with the bureau, submitting its Community marketing authorisation with the application. The application was refused and two appeals against the decision before the lower Lithuanian courts were unsuccessful.
Kirin Amgen asserted that the marketing authorisation entitled it to a supplementary protection certificate in Lithuania, and that it had not exceeded the six-month period for lodging its application (as referred to in Articles 7 and 19 of Regulation 1768/92) because the period was to be calculated from May 1 2004 (ie, the date on which Lithuania acceded to the European Union).
The Supreme Court referred the following questions to the ECJ:
The ECJ decided that it was appropriate to examine the questions together. In essence, the referral should be understood as asking whether one or other of Articles 7 and 19(a)(e) allowed the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities within six months of Lithuania's accession to the European Union for the grant of a supplementary protection certificate where a Community authorisation to place the product on the market as a medicinal product - but not a national marketing authorisation in Lithuania - was obtained more than six months before that date.
The ECJ confirmed that the period for requests from holders of Community marketing authorisations issued before May 1 2004 for supplementary protection certificates in Lithuania should be calculated from the date on which the Community marketing authorisation was granted, not from the date of the entry into force of the relevant marketing authorisation in Lithuania.
In giving reasons for its judgment, the ECJ observed that according to case law, the derogations laid down by acts of accession must be interpreted strictly. The objective of the regulation - that is, to provide equal protection for medicinal products throughout the European Union - should not obstruct the application of transitional provisions resulting from accession negotiations, which might prevent a request for supplementary protection for certain medicinal products in certain member states. This outcome, which may impede the regulation's objective and the functioning of the internal market, if only temporarily, is justified by legitimate objectives in respect of health policies, potentially including the financial stability of a member state's health system.
The ECJ emphasised that Article 19(a) of the regulation is only a part of the transitional provisions and applies only to the new member states that acceded to the European Union on May 1 2004, whereas Article 19 applies to those states that were members at the time of the regulation's entry into force or acceded during the expansion of January 1 1995. The court noted that the provision in Article 19(a)(e) applies only to holders of national marketing authorisations, and that holders of Community marketing authorisations issued before May 1 2004 are not entitled to invoke it. The judgment also underlines that the granting of a marketing authorisation for a medicinal product must not be equated with its entry into force in a new member state.
The ECJ applied a strict position regarding the issuing of supplementary protection certificates in a new member state. This case demonstrates the potential consequences of EU accession for the medicinal product's patent protection.
For further information on this topic please contact Edita Ivanauskienė at Lideika, Petrauskas Valiunas ir partneriai LAWIN by telephone (+370 5 268 1888), fax (+370 5 212 5591) or email (firstname.lastname@example.org).
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