On 24 November 2011, the European Union's Court of Justice ("CJ") announced its judgements in the cases of Medeva (Case C-322/10) and Georgetown et al. (Case C-422/10). Both cases are references for a preliminary ruling from the UK Courts on the interpretation of Article 3 of the Regulation (EC) 469/2009 regarding the requirements for grant of a supplementary protection certificate (in the following "SPC Regulation") for a partially patented combination product.

Background

Article 3 of the SPC Regulation sets out the conditions for the grant of an SPC. Article 3 (a) requires that the product for which the SPC is granted is "protected by a basic patent". Article 3 (b) requires that the product which is the subject of the SPC must have a "valid authorisation to place the product on the market as a medicinal product". With regard to Article 3 (a) there has been debate whether it is sufficient for granting an SPC for a combination product that the product infringes the basic patent ("the infringement test", which does not require that all active ingredients are claimed) or whether it is required that all active ingredients of the combination are claimed in the claim wording of the basic patent.

The UK courts had submitted a number of questions to the CJ asking for clarification regarding Art. 3 (a) and Art. 3 (b) SPC Regulation.

The Medeva and Georgetown cases

The first reference to the CJ (C-322/10) was made by the UK Court of Appeal in Medeva v. Comptroller-General of Patents, Designs and Trade Marks.

The Medeva case concerns a vaccine comprising multiple active ingredients of which only two are the subject of a combination patent. An SPC for this 'multi-component vaccine' as authorised was refused because the patent did not claim the additional active ingredients. SPC protection for a combination of the two active ingredients of the multi-component vaccine that were claimed in the patent was refused in the UK, because the marketing authorisation was granted not for a medicinal product only containing the combination of these two active ingredients, but for the multi-component vaccine that also comprises other active ingredients. In other words, in the case of all of Medeva's SPC applications there was a mismatch between the active ingredient protected by the patent and the active ingredients in the vaccine for which the relevant market authorisations had been given.

The Court of Appeal in the Medeva case referred to the CJ (according to the understanding of the CJ) the questions:

1. Whether Article 3(a) of Regulation No 469/2009 must be interpreted as precluding grant of an SPC where the specified active ingredients include active ingredients not mentioned in the wording of the claims of the basic patent.
2. Whether Article 3(b) of Regulation No 469/2009 may be interpreted as not precluding the grant of an SPC for a combination of two active ingredients, specified in the wording of the claims of the basic patent, where the medicinal product for which the marketing authorisation is submitted contains not only that combination of the two active ingredients but also other active ingredients.

The basic scenario in the Georgetown case (C-422/10), as referred from the UK High Court of Justice in Georgetown University et al. v. Comptroller-General of Patents, Designs and Trade Marks, is the same, i.e. the basic patent claims an antigen of a vaccine, whereas the marketing authorisation is for a multi-antigen vaccine, including additional antigens beyond the claimed ones. The SPC applications were refused in the UK for the same reasons as set out above for Medeva. In the Georgetown case the High Court referred the same question as the second Medeva question.

The opinion of Advocate General Trstenjak (delivered on 13 July 2011) had been the source of considerable confusion. It had remained unclear what was meant by the "subject-matter" test she had suggested to define the product protected by basic patent in accordance with Art. 3 (a) SPC Regulation. Further, she had stated that a basic patent can only support one SPC for a medicinal product containing the patented active ingredient(s), which SPC must be based on the first marketing authorisation for such product, which suggested that it may not be possible, e.g. to obtain SPCs for mono products and combination products on the same basic patent.

Summary of the CJ judgements

The CJ takes a more straight-forward approach than the Advocate General. It holds that:

1. Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to 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 certificate.
2. Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.  

With regard to the question when a product is protected by a basic patent in accordance with Art. 3 (a) SPC Regulation the Court dismisses the above-mentioned infringement test. The Court turns instead to the above-described second approach, i.e. requiring that an SPC may only be granted for such active ingredients which are "specified in the wording of the claims of the basic patent".

It argues that in the absence of European harmonisation of patent law, the question of SPC grant cannot be made dependent on the national view of the extent of patent protection as this would be contrary to the purpose of the SPC Regulation to provide a uniform solution at European Union level.

Further, the Court finds this approach specifically supported by the explanatory memorandum accompanying the precursor of the current SPC Regulation with its references to the wording of the claims. Additionally, the Court points to recital 14 in the preamble of Regulation (EC) No. 1610/96 concerning SPCs for plant protection products, which refers to the need for "products" to be "the subject of patents specifically covering them".

As support, the Court further cites to Art. 5 SPC Regulation, which provides that the SPC confers the same right as the basic patent. This reference remains opaque.

The Court's decision seems to be driven by its aim of establishing an approach which can be applied in a uniform way across Europe.

With regard to the requirement that the product must have a marketing authorisation according to Art. 3 (b) SPC Regulation, the Court takes the approach that the marketing authorisation may cover additional active ingredients beyond those for which the SPC is sought.

In this respect the Court refers to the wording of Art. 4 SPC Regulation according to which the product must be "covered" by the authorisation, which to the Court's understanding does not exclude that other additional ingredients are also covered. The Court states that the "product" under the SPC need not be identical with the "medicinal product" under the marketing authorisation.

The Court finds its approach further supported by the above-mentioned explanatory memorandum and its reference to a scenario where the authorised product consists of a combination of compound X (which is protected by the certificate) and another active ingredient.

The Court relies in this respect on the aim of the SPC Regulation being to encourage pharmaceutical research. This aim, so the Court says, would be undermined and the patent holder for an innovative active ingredient or combination of active ingredients would not be able to sufficiently cover his investment if it were refused an SPC on the grounds that the marketed product contains additional active ingredients. Additionally, the Court believes that requiring the SPC product to be identical to the authorised product would wrongly encourage the pharmaceutical industry to develop and market monovalent products which may not be in the best interest of public health.

In line with this thinking the Court declares that first marketing authorisation for the purposes of an SPC for a combination product is the marketing authorisation for a medicinal product comprising, among its active ingredients, the combination as identified in the wording of the claims of the patent. 

Finally, the Court very briefly, with a reference to the Biogen case states that where a patent protects a product in accordance with Art. 3 (c) SPC Regulation only one SPC may be granted for that basic patent, without addressing what the consequences are for a patent which protects a variety of products, e.g. one or more mono products and combination products.

Conclusion

It will remain to be seen whether the CJ's declared aim to establish an approach which can easily be applied in a uniform way across Europe, will be fulfilled. Areas of further dispute will surely be how specifically the active ingredients need to be included in the claim wording in order to be regarded as "specified" and whether several SPCs for different products can be granted under the same basic patent.

For more information on these cases please feel free to contact Ina vom Feld on ina.vom.feld@twobirds.com.

Case C-322/10, judgement available here curia.europa.eu/jurisp/cgi-bin/form.pl?lang=EN&Submit=Submit&numaff=C-322/10 .  Case C-422/10, judgement available here curia.europa.eu/jurisp/cgi-bin/form.pl?lang=EN&Submit=Submit&numaff=C-422/10