Synthon BV v Merz Pharma GmbH & Co KGaA (Rev 2)

The court referred questions concerning the interpretation of the supplementary protection certificate regime to the Court of Justice. Its provisional view was that an authorisation granted under national legislation implementing Council Directive 65/65/EEC should be treated as compliant, without investigating whether the national authority properly assessed the safety and efficacy data. It also considered that earlier non-compliant authorisations might count as the first authorisation for calculating duration and transitional eligibility. More fundamentally, a product placed on the Community market without needing a Directive 65/65 procedure might fall outside the scope of Council Regulation No. 1768/92. The answers were potentially determinative of the SPC’s validity and term.

Merz owned an SPC for memantine, based on a 2002 EU-wide marketing authorisation. Memantine had previously been marketed in Germany and Luxembourg under arrangements which did not involve an independent safety and efficacy assessment under Council Directive 65/65/EEC. Synthon sought revocation of the SPC or a declaration that its term was zero.

The court considered whether the Luxembourg authorisation was granted in accordance with Directive 65/65, whether earlier non-compliant authorisations counted under Articles 13 and 19 of Council Regulation No. 1768/92, and whether a product first placed on the Community market without a Directive 65/65 procedure fell outside Article 2. The answers were treated as questions of Community law requiring reference.

1. Reference made. The court exercised its discretion to refer four questions on the interpretation of Council Regulation No. 1768/92 to the Court of Justice. The questions were closely related, potentially determinative of the action, insufficiently clear, and of wider importance.
2. Question 1. The judge’s provisional view was that an authorisation granted under national legislation implementing Directive 65/65 was an authorisation in accordance with that Directive, unless the product was specifically excluded from the Directive procedure by law. The SPC authority should make a legislative assessment by examining the legal provision under which the authorisation was granted, rather than investigating whether another Member State’s authority had fully performed the required factual assessment.
3. Questions 2 and 3. The judge considered that the Court of Justice’s reasoning in Hässle v Ratiopharm suggested that “authorisation to place the product on the market” should not receive different meanings in different provisions. The judge nevertheless referred the questions because Novartis v Comptroller and the conflicting national decisions left the position uncertain.
4. Question 4. The judge provisionally preferred the construction that Article 2 excluded products which could first be placed on the Community market without any Directive 65/65 authorisation procedure. Otherwise the Regulation could compensate a patentee where no regulatory delay had caused loss of patent protection, and could permit an excessive period of exclusivity.
5. The parties were invited to make submissions on the wording of the reference. The order directing the reference was to follow.