Medeva BV v Comptroller General of Patents

For Article 3(a) of Council Regulation (EC) No 469/2009, an SPC cannot be granted for active ingredients that are not specified in the wording of the basic patent claims. The relevant inquiry is not whether the medicinal product would infringe the patent under national infringement law. “Specified” may involve express naming, description, necessary implication or reasonable interpretation. The precise boundary depends on the claim wording and facts. A drafting convention that “comprising” permits additional elements does not itself specify those ingredients in the claims.

Medeva filed five applications for supplementary protection certificates relating to combination vaccines. The marketing authorisations covered antigens which were not identified in the claims of the basic patent. A hearing officer rejected the applications, and Kitchin J dismissed Medeva’s appeal in the Patents Court: (2010) EWHC 68 (Pat).

The Court of Appeal referred five questions concerning Article 3(a) to the Court of Justice. A sixth question concerning Article 3(b) ceased to arise after the fifth application was withdrawn. Following the Court of Justice’s ruling, the issues were whether the ruling required the certificates to be granted or a further reference to be made, and whether the additional vaccine antigens were specified in the patent claims.

The appeal was unanimously dismissed. The Chancellor delivered the judgment, with which Lord Justice Etherton and Lord Justice Elias agreed.

1. Applicable test. The formulation in Farmitalia, requiring the extent of patent protection to be determined under the non-Community rules governing patents, was insufficiently clear where national law admitted competing approaches. The Court of Justice had rejected the infringement test. Article 3(a) instead required the national court to identify which active ingredients were specified in the wording of the basic patent claims.
2. Meaning of specified. The relevant wording might range from express naming through description, necessary implication and reasonable interpretation. The Court of Appeal did not fix the precise dividing line, recognising that further references might be required on the facts of future cases.
3. Application to the claims. The patent claim expressly identified two antigens of Bordetella pertussis and used the word “comprising”. Although that drafting term permits additional elements, it did not itself indicate that the antigens against diphtheria, tetanus, meningitis and polio were included in the claims. Treating it as sufficient would reintroduce the infringement test excluded by the Court of Justice.
4. Disposition. The additional active ingredients were not specified in the claims. The hearing officer and Kitchin J had therefore correctly applied Article 3(a). No further reference was necessary.

1. Court of Appeal (Civil Division): after referring questions to the Court of Justice and receiving its ruling, dismissed Medeva’s appeal on 3 May 2012: [2012] EWCA Civ 523.
2. High Court of Justice, Chancery Division, Patents Court: Kitchin J dismissed Medeva’s appeal from the hearing officer’s rejection of the SPC applications: (2010) EWHC 68 (Pat).