The background

On 24 November 2011 the CJEU cleared up the ambiguities accumulating around the granting of SPCs. Companies investing in medical technology often suffer delays before they can put a medicinal product on the market. For example, delays result from having to clear the necessary safety hurdles before regulatory approval can be granted for the product. These delays eat away at the period of protection afforded by the patent system. SPCs were introduced under a specific European framework to redress the balance. They are not patent extensions, but can be applied for to protect a product protected by an underlying patent also held by the applicant.

Different countries have disagreed about the exact scope of protection afforded by SPCs, as well as the circumstances in which they may be granted. One of the key issues revolves around combination drugs involving multiple active ingredients–particularly applicable to vaccines. The essence of the Medeva reference was whether an SPC should be granted for a vaccine containing more active ingredients than were specified in the claims of the underlying patent. The essence of the Georgetown reference, which overlapped with some of the Medeva issues, was whether (where there is a valid authorisation to put the product on the market) an SPC can still be granted for an active ingredient specified in the patent if the authorised medicinal product contains that active ingredient but also other active ingredients.

The essence of the case

Medeva, which holds a European patent concerning the preparation of vaccine against whooping cough, sought to use it with other active ingredients to produce a multi-disease vaccine for children. The firm filed five SPC applications with the UK patent office, seeking supplementary protection for vaccines covering diphtheria, tetanus, whooping cough, poliomyelitis and meningitis. The office refused to grant the SPCs, stating that in four of the applications more active ingredients were specified than in the wording of the claims of the basic patent, and that the fifth related to medicinal products containing nine active ingredients, not all of which were specified in the SPC application and in the patent claim.

The importance of the judgement

The European Federation of Pharmaceutical Industries and Associations (EFPIA) agreed that the Court’s interpretation of the rules ‘takes us back to the original intent of the SPC scheme - patent protection to stimulate innovation.’

The European justices stated that an SPC can only be granted for the active ingredient(s) specified in the claims of the basic patent. They further ruled that an SPC can be obtained for two active ingredients that are specified in the claims of the patent where the medicinal product contains that combination of two active ingredients as well as other active ingredients. Moreover, where an SPC has been granted for a single active ingredient, that SPC will protect all presentations of the active ingredient, either alone or in combination with other active ingredients. In relation to Georgetown reference, an SPC can be granted for an active ingredient claimed in the patent where the medicinal product for which the marketing authorisation is granted contains that active ingredient as well as others. However only one SPC can be obtained per patent and an SPC cannot be granted solely for ingredients that are not covered by a patent.

The exact meaning of the judgment is now being studied by all concerned, but lawyers specialising in the field have welcomed the relatively broad protection granted and the clearer position of when an SPC may not be granted. The fundamental objective of the SPC Regulation was to ensure sufficient protection to encourage pharmaceutical research, a position upheld by the CJEU ruling.

This ruling could affect generics since SPCs give originator companies marketing exclusivity during which time generics cannot enter the market.

Related articles

EMA definitions of generics and biosimilars

Concerns of patent filing and approval date on market exclusivity