The ECJ judgment in AHP Manufacturing BV v Bureau voor de Industriële Eigendom (Case C-482/07), following a reference by the Dutch Courts, clarifies the scope of Article 3(c) of the SPC Regulations (previously, and at the time of referral to the ECJ, Regulation 1768/92 but now Regulation 469/2009). In its response to the five questions raised in the AHP case, the ECJ has mirrored the conclusions of the Patent Office's (now UK-IPO) decision in Chiron Corp's and Novo Nordisk A/S's SPC Application [2005] R.P.C. 24.

Business Impact

  • The ECJ judgment confirms that an SPC can be granted to an applicant irrespective of an existing SPC that has been granted to another patentee for the same 'product'.
  • Whilst this decision should not alter the UK-IPO's approach, it should result in it being easier to obtain an SPC in other member states in situations where several patentees wish to apply for an SPC for the same 'product' (e.g. where companies are collaborating on the development of a new drug).

Background

Article 3(c) of the SPC Regulations provides that 'A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application… the product has not already been the subject of a certificate' (with Article 1(b) of the SPC Regulations defining a 'product' as 'the active ingredient or combination of active ingredients of a medicinal product').

Consequently, a literal interpretation of Article 3(c) would appear to preclude the grant of an SPC if an SPC had been previously granted for that 'product' . This could, for example, result in only one party involved in a collaborative effort to develop a new drug being granted an SPC with the others involved in this process not receiving any reward for their input in the R&D process (even though they have suffered the delay in exploiting their inventions caused by obtaining a marketing authorisation).

ECJ Judgment

The ECJ clarified that Article 3(c) of the SPC Regulations should be interpreted in such a way that it does not prohibit the grant of an SPC to the owner of a 'basic patent' (i.e. the product, process or use patent on which the SPC is based) for a 'product' for which at the time of the SPC application one or more SPCs had already been granted to one or more other owners of one or more other 'basic patents'. The purpose of Article 3(c) being to prevent any single entity holding a variety of patents covering the same 'product' from obtaining a series of successive SPCs which would have the effect of extending its market exclusivity over that 'product'.

In reaching this view, the ECJ highlighted that a literal interpretation of Article 3(c) of the SPC Regulations would entail the risk that one or more patentees would be prevented from benefiting from SPC protection which would enable them to recoup their R&D costs. In addition, a construction of the SPC Regulations in light of Article 3(2) of the Plant Protection Regulation ((Regulation 1610/96) which applies mutatis mutandis to SPCs), which would only permit more than one SPC to be granted if the two SPC applications were co-pending could also establish a preference or priority between the various patent holders (which, as highlighted by the UK-IPO in Chiron, would be arbitrary). This interpretation could also result in the fate of an SPC application depending on fortuitous events outside the control of the applicant, including the relative speed by which the competent authority in each member state processed an earlier SPC application: the shorter the time period within which the first SPC application is processed, the less opportunity there would be for a second applicant to file a co-pending SPC application. As highlighted by AHP Manufacturing to the ECJ, the relevant Dutch authority must process an application as soon as possible and in any event within 6 months, whereas, other member states do not consider SPC applications until the near expiry of the underlying 'basic patent'. The ECJ concluded that this differing approach of the relevant national authorities could result in differing numbers of SPC being granted in each member state (also potentially to different parties) and cause fragmentation of the EU market.