European Court Rules on Supplementary Protection Certificates for Multivalent Vaccines

Supplementary Protection Certificates (SPCs) have been available in the European Union since 1992 for the purpose of extending the duration of patents for medicinal products.  This was deemed to be necessary to compensate the patentee for the years of patent term lost during the lengthy regulatory approval process that all new medicinal products must go through.  An SPC comes into force on the normal expiry date of the patent and has a maximum duration of 5 years with a further limitation that the patentee receives no more than 15 years of market exclusivity (post marketing approval).

The Court of Justice for the European Union (CJEU) have recently issued rulings on the interpretation of Article 3 of Regulation No 469/2009 concerning SPCs for medicinal products after references made during two cases in the UK Patents Court (C-322/10 and C-422/10).  The main issues the court considered were:

1. whether a patent claim which just covers one active ingredient can be used to support an SPC application to a product comprising the active ingredient in combination with one or more additional active ingredients; and
2. whether a marketing authorisation which relates to more than one active ingredient can be used to support an SPC application to a single active ingredient. 

Both cases relate to the Patent Office’s refusal of SPC applications directed to multivalent vaccines.  These are particularly problematic because the patent filings often relate to individual vaccines whereas the marketed products contain vaccines directed to a number of agents.

On the first issue, the CJEU reasoned that as an SPC confers the same rights as a patent it should have the same scope.  Therefore, an SPC should not be granted if it relates to active ingredients not ‘specified in the wording of the claims’ of the patent. 

On the second issue, the CJEU took into account the fact that vaccines are often developed as multivalent vaccines on the recommendation of the health authorities of the member states and that in such cases the basic patent would probably only cover some of the active ingredients included in the final product.  To deny the extra protection of an SPC in such cases would mean the protection conferred by the patent would be insufficient to cover the research investment necessary to develop the product and would tend to favour the development of monovalent medicinal products.  Both of which would be contrary to the interests of public health.

So in conclusion, the CJEU interpreted the SPC Regulation as requiring all of the active ingredients specified in the application to be ‘specified in the wording of the claims’ of the supporting patent while allowing the marketing approval to relate to a product containing additional active ingredients.  What exactly constitutes ‘specified’ will probably be the subject of further referrals to the CJEU.

Other issues that were discussed in the decisions were the question of infringement and the limitation of one SPC per patent.

On infringement, the court confirmed that an SPC for a single active ingredient could be infringed by the use of that ingredient in a combination, stating that an SPC confers ‘the same rights as were conferred by the basic patent in relation to the product’.

Less encouragingly for SPC applicants, the court stated that ‘where a patent protects a product… only one certificate may be granted for that basic patent’. This apparent limitation of one SPC per patent appears to be contrary to current practice in many member states.  It remains to be seen how this will be interpreted in cases where more than one product is covered by a patent.

For more information, click This e-mail address is being protected from spambots. You need JavaScript enabled to view it to contact Philip French, Head of Biotechnology.