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The Medeva and Georgetown Cases - Combination Drugs and SPCs

On 24th November 2011, the European Court of Justice announced its judgements on two cases, Medeva (Case C-322/10) and Georgetown et al. (Case C-422/10). Both related to combination drugs, supplementary protection certificates (SPCs) and the interpretation of SPC regulations.

Summary

The Medeva case concerned a vaccine where there was a mismatch between the patent and the marketing authorisation. The relevant patent covered two active ingredients that formed a combination drug. Whereas, the relevant marketing authorisation was for a vaccine that incorporated multiple active ingredients, including the aforementioned patented combination.

In attempting to obtain a supplementary protection certificate ("SPC"), EC regulations presented a possible impasse. SPCs may only be granted on products that are protected by a basic product patent, they cannot be granted on products that do not have a basic patent. Meanwhile, it is also a requirement that there be a marketing authorisation. On the one hand, the combination drugs that were together patented did not have a marketing authorisation, on the other, the multiple active ingredients that did enjoy a marketing authorisation were together not covered by a patent.

The outcome of the case was that a SPC could be granted on the combination drugs that did have the basic product patent and they would refer to the marketing authorisation of the multiple active ingredients - even though those included additional active ingredients. Meanwhile, it would not be possible to gain a SPC on the multiple active ingredients, since although they benefitted from a marketing authorisation, there was no relevant basic patent.

The Relevant SPC Regulations

Article 3(a) of EC Regulation 469/2009 ("SPC Regulation") states that a SPC may only be granted on products that are protected by a basic patent.

Meanwhile, Article 3(b) of the SPC Regulation states a SPC may only be granted on a product for which there is a marketing authorisation.
 

The Medeva and Georgetown Cases

The Medeva case concerned a vaccine that contains multiple active ingredients, where:

- Two of the active ingredients were protected as a combination by a basic patent. Whereas, the combination of all the active ingredients was not protected by a basic patent.

- Marketing authorisation had been granted on the overall vaccine, comprising all the active ingredients in the product, rather than on the combination of the two patent protected drugs.

The first question concerned whether Article 3(a) of the SPC Regulation (requiring SPCs to only be granted on products protected by a basic patent) meant that no SPC could be granted on the product, as this contained active ingredients not specified in the basic patent.

The second question concerned whether Article 3(b) of the SPC Regulation (requiring a marketing authorisation on the product for which the SPC is being sought) prevented the SPC being granted on the product, as the marketing authorisation was in respect of all the active ingredients contained in the vaccine not just the two active ingredients for which there was a combination patent.

Similarly, in the Georgetown case, a basic patent had been granted for one antigen contained in a vaccine, whereas a marketing authorisation had granted in respect of a product containing multiple-antigens including the one that had been patented.
 

The European Union's Court of Justice Judgement

The court ruled that Article 3(a) of the SPC Regulation does prevent a SPC being granted on active ingredients which are not the subject of a basic patent.

However, the court also held that Article 3(b) of the SPC regulation does not prevent a SPC being granted on those combination of active ingredients on which there is a basic patent, even though the marketing authorisation applied to the combination of active ingredients including those that were not patented.

The marketing authorisation may cover additional active ingredients that are not part of the basic patent against which the SPC can be sought. The product stated in the SPC need not be identical to that of the marketing authorisation.
 

Conclusions 

In reaching the judgement, the court has strived to provide for a consistent approach across the EU. It aims to encourage innovation by allowing the SPC to be granted on the combination of actives that do have basic patent cover. Even though the relevant marketing authorisation incoporates additional active ingredients that were not specified in the original patent and that cannot themselves be covered by the SPC.

The court also noted that, as in the Biogen case, only one SPC may be granted against a patent. The issue, of whether multiples SPCs may nevertheless be granted against patents that protect more than one product (e.g. A single active, as well as combination), was not clarified. This is an issue that may yet need to be tested and is the subject of some debate.