Clarification of requirements for an SPC
13th December 2011
The Court of Justice of the European Union (the CJEU) recently handed down its decisions in two cases relating to SPCs: C-322/10 (Medeva BV vs Comptroller) and C-422/10 (Georgetown University, University of Rochester, Loyola University of Chicago vs Comptroller).
During the often lengthy time a medicinal product takes to obtain marketing authorisation, the product cannot be sold and the patent owner is unable to exploit their exclusivity in the marketplace, sometimes for a significant portion of the life of the patent. In order to mitigate this, in European countries a Supplementary Protection Certificate (SPC) can be applied for to cover the product protected by the patent. The SPC comes into effect on expiry of the patent and lasts for up to five years.
Medeva had a patent relating to a whooping cough vaccine, the claimed preparation consisting of a combination of two active ingredients. Before the patent expired in April 2010, Medeva applied for five SPCs. The marketing authorisations which they relied on for these applications were for medicinal products containing between 8 and 11 active ingredients in addition to the two claimed in the patent.
The UKIPO refused all five applications, four on the grounds that more active ingredients were specified in the SPC than were identified in the patent claims, and the fifth because, though the product in the SPC was the same as the patent, the product in the marketing authorisation contained a number of additional active ingredients.
Medeva appealed to the High Court, unsuccessfully arguing that the requirement that the subject of the SPC must be “protected by a basic patent” covers any product containing the patented vaccine, regardless of whether it was sold as a single or combination vaccine. Medeva then appealed to the Court of Appeal, who referred a series of questions to the CJEU.
Similar issues were faced by Georgetown University, the University of Rochester and Loyola University of Chicago, who were also refused SPCs by the UKIPO on the grounds that the medicinal product for which the marketing authorisation was granted contained more active ingredients than the product for which the SPC was sought. All three applicants appealed to the Patents Court, which also referred a question to the CJEU. One of the key questions asked in both the Medeva and Georgetown cases was as follows:
Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’
The CJEU has now ruled that the regulations must be interpreted as “precluding the … 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…”. In other words, the SPC must relate to the same product as is claimed in the patent.
However, they went on to state that the regulations do not preclude the granting of an SPC for a combination of two active ingredients, where the product for which marketing authorisation was obtained contains additional active ingredients.
In summary, the product protected by the SPC must be the same as that claimed in the patent, but the product for which marketing authorisation was sought can contain additional active ingredients. The CJEU stated that the relevant test in this case should be whether the medicine covered by the marketing authorisation contains the active ingredients “specified” in the patent claims.
In addition to this ruling, the CJEU gave its opinion that infringement of an SPC should be determined in the same way as infringement of a patent. This means that a medicinal product containing the active ingredients specified in the SPC would infringe, regardless of what other active ingredients it also contained.
This decision is a boon for companies involved in making products that contain multiple active ingredients, such as vaccines; provided that the product covered by the marketing authorisation includes the active ingredients specified in the claims of the patent, an SPC can be obtained. With the CJEU’s comments on infringement, SPCs have also been given a broad scope of protection in relation to third party combination products.
However, it is not entirely clear what is meant by “specified” in the patent claims. For example, it is unclear whether this test enables an SPC to be obtained where a compound is claimed in the patent as part of a class of active ingredients (eg “an antibiotic”), and the product for which the SPC is sought contains a specific compound in that class (eg penicillin).
13 December 2011