Supplementary protection certificates (SPC) for combination products. Ruling by ECJ November 24th 2011.
On 24th November 2011 the Court of Justice of the European Union released its important decisions in the two cases Medeva (Case C-322/10) and Georgetown (Case C-422/10).
Article 3(a) in the SPC regulation (Regulation No 469/2009 states that a prerequisite for granting an SPC, is that “the product is protected by a basic patent in force”. “Product” shall be understood as active pharmaceutical ingredient (API) or a combination of APIs.
According to the Medeva judgement, Article 3 (a) precludes the granting 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 SPC application”. Thus unless the patent claims specifies the combination of active ingredients, no SPC for a combination shall be granted. And if the claims specify the combination A+B, no certificate for A shall be granted based on that patent.
As can be seen from the term “specified in the wording of the claims”, the court does not use the infringement test for interpreting “protected by a basic patent” in article 3 (a). The infringement test has been used to a larger and larger extent by European national courts. What it takes for a product “to be specified in the wording of the claims” is likely to be the subject of future court cases. Also the fate of SPCs granted according to the infringement test is likely to end up in court after this decision from ECJ.
In Georgetown the court interprets Article 3 (b) of the regulation. This article states that a valid authorisation “to place the product on the market” has to be in place. (“Product” shall be understood the same way as in 3(a); API or combination of APIs.)
The court concludes that Article 3 (b) does not preclude the granting of an “SPC for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the MA is submitted is support of the SPC application contains not only that active ingredient but also other active ingredients.” In other words, if the patent specifies API A, while the MA specifies A+B, an SPC may be granted for A.
In Medeva, this latter point is repeated with respect to a patent specifying A+B, and the MA covering A+B+ other active ingredients. In such cases an SPC should be granted for A+B.
Since the product A+B+C will infringe an SPC for A or an SPC for A+B, there is a real protection against combination products also after Medeva and Georgetown.
However, the unfortunate mixture of the regulatory and patent world in the SPC regulation, will end up in ECJ also hereafter.
Contact person: Inga Kaasen Attorney-at-Law PhD (biotechnology)