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2 December 2011
The CJEU Rules on SPCs for Combination Products
On 24 November 2011, the Court of Justice of the European Union (CJEU) handed down its judgments in the cases of Medeva (C-322/10) and Georgetown (C-422/10), both of which were referred to the CJEU by the UK Courts.
BACKGROUND
Both Medeva and Georgetown had patents covering vaccines. In both cases, applications had been filed for supplementary protection certificates (SPCs) which effectively extend the life of the patent beyond its normal 20 year term in respect of particular products for which a marketing authorisation (MA) is obtained. The disputes in each case centred on the conditions under which SPCs should be available.
In the Medeva case, the patent claims were directed to a specific combination of active ingredients (e.g. a combination of two actives A+B), whereas the MAs authorised multi-active products having not only A+B but also other active ingredients C, D, E, etc. Medeva filed five SPC applications as follows:
(1) Four SPC applications were filed for multi-active vaccines, each corresponding to a particular combination of actives specified in a particular MA, i.e. of the type A+B+C+D+E. These applications were refused because more actives were specified in the SPC applications than were identified in the wording of the claims of the basic patent.
(2) A fifth SPC application was filed for a multi-active vaccine specifying only the two actives identified in the wording of the patent claims (i.e. A+B), but this was refused on the grounds that the MA relied on in support had been granted for a medicinal product containing additional actives (i.e. A+B+C+D+E).
These refusals and subsequent appeals resulted in a referral to the CJEU on the interpretation of Articles 3(a) and 3(b) of SPC Regulation No. 469/2009.
Article 3(a) requires that the product is protected by a basic patent in force. The key questions referred to the CJEU concerning Article 3(a), and relevant to the situation identified in (1) above, can be summarised as:
Whether Article 3(a) must be interpreted as precluding the grant of an SPC where the active ingredients specified in the SPC application include active ingredients not mentioned in the wording of the claims of the basic patent relied on in support of the SPC application.
Article 3(b) requires that a valid authorisation to place the product on the market as a medicinal product has been granted. The key question referred to the CJEU concerning Article 3(b), and relevant to the situation identified in (2) above, can be summarised as:
Whether Article 3(b) may be interpreted as not precluding the grant of an SPC 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 SPC application contains not only that combination of the two active ingredients but also other active ingredients.
The Georgetown case was similar in nature to the Medeva case, however with a referral to the CJEU relating to the question concerning Article 3(b) only.
CJEU JUDGMENTS
Article 3(a)
The CJEU has decided, as part of the Medeva judgment, that:
Article 3(a) must be interpreted as precluding the grant of an SPC 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.
Article 3(b)
The CJEU has decided, as part of both the Medeva and Georgetown judgments, that:
Article 3(b) does not preclude the grant of a supplementary protection certificate for an active ingredient [or for a combination of two active ingredients] 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 SPC application contains not only that active ingredient [or that combination of two active ingredients] but also other active ingredients.
IMPLICATIONS
Article 3(a)
The upshot of the judgment is that an SPC application covering e.g. actives A+B+C+D+E relying on the claims of the basic patent which only cover A+B, will not be granted, even though the MA is granted for a product having actives A+B+C+D+E.
Thus, the CJEU has taken a strict approach under Art. 3(a), which will not be welcomed by patent holders, shunning the "infringement test" previously favoured by some national courts. The infringement test took the approach that a product was "protected by a basic patent" if the patent would have been infringed by placing that product on the market.
The CJEU has instead adopted an approach more in line with the "disclosure test" previously favoured by other national courts, i.e. to be "protected by a basic patent", the active ingredients must be disclosed in combination in the patent.
However, even with this strict approach, which appears from the CJEU judgment to have been adopted with the aim of providing a harmonised approach to this question, all is not clear. Most notably is the requirement for the basic patent to "specify" in the wording of the claims, the actives covered in the SPC application. Exactly what form of patent claim "specifies" and therefore supports an SPC application for a combination of actives, remains to be seen.
For example, in the earlier Gilead decision, the basic patent claimed:
A pharmaceutical composition comprising [active A] together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
The Gilead SPC application covered a combination of active A with another specified active B. On appeal, the UK court decided that although the particular combination of actives was not disclosed in the specification of the basic patent, the claim’s mention of "other therapeutic ingredients" was sufficient for the SPC covering the combination of specific actives to be allowed. After this CJEU judgment, it would appear that such a claim would no longer support the grant of an SPC application for A+B, since B is not specified in the claim.
This CJEU judgment therefore raises questions for patent drafting, and thought should certainly be given to including in patent claims any specific combinations of actives of interest. Patent holders can only hope that this issue will gain clarity in time, hopefully sooner rather than later.
Article 3(b)
The upshot of the judgment is that an SPC application covering actives A+B, where the basic patent also covers A+B, which relies on a MA referring to e.g. A+B+C+D+E, should not be refused under Article 3(b).
This decision is far more clear-cut and less contentious than the decision concerning Article 3(a).
FURTHER POINTS OF INTEREST
A positive arising out of these judgments is that the CJEU has clarified that a granted SPC for a single active (e.g. "A") will be infringed by the sale of a combination product (e.g. "A+B"):
A SPC confers, upon expiry of the patent, the same rights as were conferred by the basic patent in relation to the product, within the limits of the protection conferred by the basic patent. Accordingly, if during the period in which the period was valid, the patent holder could oppose on the basis of his patent, all use or certain use of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product which were authorised before the expiry of the certificate.
Far more worryingly, the CJEU also commented on Article 3(c) – which sets as a condition for grant of an SPC that the product has not already been the subject of a certificate – as follows:
where a patent protects a product, in accordance with Article 3(c) of Regulation No. 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28).
In this regard, the CJEU refers to the earlier CJEU Biogen decision which also included this statement but which has since been loosely interpreted, with multiple SPCs continuing to be granted out of a single patent, e.g. where the patent covers a number of products. Patent holders must therefore hope that this point made by the CJEU will continue to be interpreted as it has been since the Biogen case. Otherwise, this observation made by the CJEU could have very damaging consequences to patent holders, in particular for those patents which cover not just a single product but a number of products.
