The problem of multi-ingredient medicines

In a recent decision of the UK Intellectual Property Office, five applications for supplementary protection certificates (SPC’s) were rejected as being for products which were either not protected by a basic patent, or not covered by a valid marketing authorisation.

In the European Union, an SPC can extend the period of protection of a patent relating to a new drug by up to five years. The extension is based on the length of time that it takes to obtain regulatory approval to market the product and is intended to compensate the patent holder for the erosion of effective patent term during the pre-approval period. An SPC can only be obtained for a medicinal product if:

a. the product is protected by a patent, known as the “basic”patent;and
b. the product is the first to receive a marketing authorisation for the particular “active ingredient or combination of active ingredients” contained therein. 

Medeva B.V.  are the owners of European patent number EP(UK) 1666057 B1, due to expire in April 2010.  This patent protects its Pertussis family of vaccines - four vaccines in total - each of which contains several active ingredients, including Peractin and filamentous haemagglutinin.

The patent claims methods of making vaccines containing Peractin and filamentous haemagglutinin.  As patent expiry approached, Medeva B.V. filed five SPC applications with the UK Intellectual Property Office in order to extend the term of protection for these vaccines.

In this case, Medeva B.V. had defined the “product” for the purposes of the first SPC application as the combination of Peractin and filamentous haemagglutinin only; the remaining four applications carried a product definition which required the presence of Peractin and filamentous haemagglutinin and further active ingredients.

The key questions to be answered were:
1. Does the patent protect the product as defined in each SPC application?
2. Is a valid marketing authorisation in place to cover the product defined in each SPC application?

In this case, it was found that only the SPC application in which the product definition permitted only Peractin and filamentous haemagglutinin to be present defined a product protected by the patent.  This is because the patent was found not to protect formulations where more than just these two actives were present.  As such, four of the five applications fell at this hurdle.  It is important to note that, for the purposes of the SPC requirements, the ultimate scope of the patent claims is not determinative when considering whether a combination product is ‘protected’.  Even if the patent claims would actually embrace the product in question (as was the case here), an SPC will not be granted unless the claims actually define a combination product.

The remaining application was found to be lacking as all of the marketing authorisations in place for the Pertussis vaccines required the presence of additional active ingredients.  There were no marketing authorisations in place for a vaccine containing only Peractin and filamentous haemagglutinin.  All five SPC applications were therefore rejected.

The problems encountered by Medeva B.V. with this family of applications serve to highlight the importance of considering at every stage whether there are patents present which directly reflect the commercial product, and which correspond to the marketing authorisations likely to be obtained for that product.  Had the basic patent included claims specifying the presence of additional active ingredients, it seems likely that SPC protection would have been available for the Pertussis products.  Omissions of this type are potentially very costly for any pharmaceutical patent holder.

Update - 27 January 2010 - Medeva's appeal of the UK IPO's decision has now been dismissed by the UK High Court.  The UK IPO's position is therefore confirmed.

Jonna Westwood.
Associate