Much has been said about the meaning of “specified in the wording of the claims”, a phrase which the Court of Justice of the European Union used when describing products which can be protected by a Supplementary Protection Certificate (“SPC”). The Court of Appeal of England and Wales recently had an opportunity to provide clarity to this phrase, when it applied the ruling of the Court of Justice1. So did they take this opportunity?
Before answering this question I should rewind to remind readers of the substantive matters creating the dispute which has provided fuel for yards of commentary over the past six months.
To obtain an SPC in a member state of the European Union an applicant must have three things: a product, a basic patent in force which protects it, and a valid authorisation to place that product on the market in the EU. The Medeva case concerned a mismatch between these three items and a resulting dispute about five rejected SPC applications.
In November 2009 the UK IPO refused Medeva’s SPC applications based upon a patent which claimed a method for the preparation of an acellular vaccine against Bordetella pertussis (the causative agent for whooping cough). The vaccine claimed in the patent consisted of a combination of two antigens, pertactin and filamentous haemagglutinin in such a ratio as to provide a synergistic effect on the potency of the vaccine.
The five applications filed by Medeva sought supplementary protection for vaccines against multiple conditions–diphtheria, tetanus, poliomyelitis and meningitis, in addition to whooping cough. The marketing authorisations (“MAs”) relied upon to obtain the SPCs were MAs for products which contained between 8 and 11 active ingredients, being the antigens necessary to vaccinate against these diseases. Clearly those vaccines contained more actives than were listed in the basic patent.
The UK IPO rejected four applications on the basis that more active components were listed in the SPC application that were identified in the wording of the claims of the basic patent. In respect of the fifth, whilst the SPC application specified the actives claimed in the basic patent, the MAs relied upon to support the application were for products comprising the two claimed actives in combination with other actives. In short, there was a mismatch between on the one hand what was claimed in the basic patent and on the other what was authorised under the MA and the protection sought by the SPC applications.
The UK High Court rejected Medeva’s appeal of the decision of the UK IPO examiner. Medeva appealed further and the Court of Appeal referred six questions for consideration by the CJ EU.
In respect of Article 3(a) of the SPC Regulation, the Court of Justice concluded that an SPC cannot be granted for active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate2.
So how did the English Court of Appeal interpret the Court of Justice’s ruling?
The first point that the court noted was that the infringement test had been clearly rejected by the CJ EU3. The question for the national court was therefore which actives are specified in the wording of the claims?
When considering the meaning of “specified” the Court of Appeal noted that this could range through express naming, description, necessary implication and reasonable interpretation. The Court did not pinpoint where on this scale the dividing line between what is allowable and what is not would sit, suggesting that further references in further cases would be required to clarify this. A prospect which may excite commentators, but not those trying to determine whether their own SPC or that of a competitor is liable to challenge.
In the particular circumstances before the Court of Appeal, it was clear that the active ingredients for vaccines against diphtheria, tetanus, meningitis and polio were excluded from the basic patent. The fact that, in drafting patent specifications, the word “comprising” is interpreted as not excluding other elements was deemed to be insufficient. The Court stated that “there must be some wording indicating that they are included in the claims”. However it did not go on to suggest what form such wording might take.
So all we know is that, to be “specified in the wording of the claims”, a product must be included by some form of wording. What form that wording should take still remains unclear, and whether this must be words or can be formulae is again still be clarified.