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Thursday 2 September 2010

Court of Justice says "no" to Kirin Amgen, "yes" to Member States' transitional discretion

The Court of Justice handed down its ruling this morning in Case C‑66/09, Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras, Amgen Europe BV, a reference for a preliminary ruling from the Lietuvos Aukščiausiasis Teismas (Lithuania) dating back to 10 February 2009.

What was this about? In short, Kirin Amgen owned a 1994 European patent for Aranesp, which was extended to Lithuania. In June 2001 Kirin Amgen obtained a Community marketing authorisation and then lodged an application for an SPC with the Lietuvos Respublikos valstybinis patentų biuras (the Lithuanian Patent Office), accompanying the application with its Community marketing authorisation. The SPC having been refused initially and on several appeals, Kirin Amgen maintained that the fact that it held a Community marketing authorisation was sufficient to obtain an SPC in Lithuania: it did not exceed the six-month period for lodging its application, because that period had to be calculated from 1 May 2004, the date upon which the Republic of Lithuania acceded to the European Union. The Lietuvos Aukščiausiasis Teismas (Supreme Court of Lithuania) stayed the proceedings before it and asked the Court of Justice for a preliminary ruling on the following questions:
‘(1) Is the date, referred to in Article 19(2) of Regulation No 1768/92, upon which that regulation enters into force to be understood for [the Republic of] Lithuania as the date of its accession to the European Union?

(2) Should the answer to the first question be in the affirmative, what is the relationship between Article 19 and Article 7 of Regulation No 1768/92 when calculating the six-month period and which of those articles is it necessary to apply in a case?

(3) Did an authorisation to place a product on the market in the European Community enter into force unconditionally in the Republic of Lithuania from the date of its accession to the European Union?

(4) Should the answer to the third question be in the affirmative, can the entry into force of the authorisation to place the product on the market be equated to its grant for the purposes of Article 3(b) of Regulation No 1768/92?’
Today the Court ruled as follows:
"Articles 7 and 19a(e) of Council Regulation ... 1768/92 ..., as amended by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic ..., must be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union, for the grant of a supplementary protection certificate where an authorisation to place that product on the market as a medicinal product was obtained more than six months before accession under Council Regulation ... 2309/93 ... laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, but the product did not obtain a marketing authorisation in Lithuania".
In its analysis of the legal position, the Court justified its position in the following terms:
"45 As regards the objective pursued by Regulation No 1768/92, it is admittedly true that the regulation establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State and by providing, in particular, for a uniform duration of protection (see, by analogy, Case C-350/92 Spain v Council [1995] ECR I-1985, paragraph 34, and Hässle, paragraph 37). As is apparent from the sixth recital in its preamble, that regulation seeks thereby to prevent the heterogeneous development of national laws leading to disparities likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.

46 Nevertheless, certain Member States wished, in accordance with the 10th recital in the preamble to that regulation, to safeguard for a longer period the achievement of other legitimate objectives, concerning their public-health policies, and, in particular, ensure the financial stability of their health system by supporting the generic medicinal product manufacturing industry (see, to this effect, Hässle, paragraph 38).

47 In order to take account of those differences in assessment, Articles 19 and 19a of Regulation No 1768/92 contain different relevant dates as a transitional measure. The setting of those dates according to the Member State thus appears to be justified inasmuch as each of them shows the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which vary from one Member State to the next (see, by analogy, Hässle, paragraphs 39 and 40).

48 It follows from the foregoing that the objective pursued by Regulation No 1768/92 of according uniform protection for a medicinal product throughout the European Union does not preclude transitional provisions, resulting from the accession negotiations, which may mean that it is not possible to apply for an SPC for certain medicinal products in certain Member States. This outcome, which may impede, even if only temporarily, that objective and the functioning of the internal market, is justified by the legitimate objectives concerning health policies, including, as the case may be, the financial stability of the health systems of the Member States (see, to this effect, Hässle, paragraph 46).

49 In the circumstances of the main proceedings, it would run counter to the outcome of the negotiations which led to the accession of the Republic of Lithuania to the European Union to accept that a holder of a Community marketing authorisation such as the holder in the main proceedings can rely on Article 7 of Regulation No 1768/92 to obtain an SPC in Lithuania. Article 19a(e) of that regulation provides for the possibility of applying to the competent Lithuanian authorities for grant of such an SPC only on the basis of a first marketing authorisation obtained in Lithuania before the accession of that State. As has been stated in paragraph 33 of the present judgment, that provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation.

50 Furthermore, if the entry into force of a Community marketing authorisation in a new Member State could be equated to its grant there, every Community marketing authorisation would confer entitlement to the grant of an SPC if it were applied for within six months of the accession of such a Member State to the European Union, even if the date of grant of that marketing authorisation were prior to the dates for the obtaining of an authorisation that are referred to in the transitional provisions of Regulation No 1768/92. This would also run counter to the outcome of the accession negotiations.

51 To give an example concerning another Member State, it would be possible, if the grant of a marketing authorisation were equated to its entry into force, for the holder of a Community marketing authorisation obtained before 1 May 2004 to apply in the Czech Republic for an SPC until 30 November 2004, although Article 19a(a)(ii) of Regulation No 1768/92 provides for the lodging of such an application, so far as concerns that Member State, only within six months of the date on which the first marketing authorisation was obtained.

52 Consequently, the wording and the context of Articles 3(b), 7 and 19a(e) of Regulation No 1768/92 as well as the objective of the latter, and in particular the objective pursued by its transitional provisions, preclude the entry into force of the Community marketing authorisation from being equated to its grant within the meaning of Article 3(b)".

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