An SPC relating to active ingredients not specified in the wording of the claims of the basic patent cannot be granted. However, the application for a SPC for a combination of two active ingredients which conform to the wording of the claims of the basic patent, may be granted where the authorised medicinal product contains not only that combination of the two active ingredients but also other active ingredients.
Medeva is holder of a patent which protects a combination of two antigens, to be applied as a vaccine. However as a result of public health policies, the multi-disease vaccines for which Medeva had a marketing authorisation ("MA") contained 9 active ingredients. Medeva applied for five supplementary protection certificates ("SPCs") relating to five different multi-disease vaccines with different numbers of active ingredients for which a valid patent exists in respect of one or more of the active ingredients used in the combination.
The UK Patent Office refused to grant the SPCs because, in the case of four of the applications, more active ingredients were specified in the applications than were identified in the wording of the claims of the basic patent and, therefore, they were not protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009 ("the SPC Regulation"). Regarding the fifth SPC application the Patent Office concluded that, although the active ingredients identified in the patent were the same as those specified in the SPC application, the MA submitted in support of that application did not comply with Article 3(b) because it related to medicinal products containing nine active ingredients. Medeva appealed the decision and ultimately the matter was referred to the Court of Justice of the European Union ("CJEU").
Georgetown University faced very similar issues as Medeva and therefore both cases were heared together, although the CJEU issued separate final judgments.
Questions and answers
Protected by the basic patent
The CJEU was asked whether Article 3(a) of the SPC Regulation must be interpreted as precluding the granting of an SPC where the active ingredients specified in the application include active ingredients not mentioned in the claims of the basic patent.
The CJEU held that since the SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and obligations, an SPC cannot be granted if it relates to active ingredients that are not specified in the basic patent. By way of comparison, the CJEU explains that if a patent claims that a product is composed of two active ingredients but does not make any claim in relation to one of those active ingredients individually, a SPC cannot be granted on the basis of such a patent for the one active ingredient considered in isolation.
According to the Court, this finding is confirmed by paragraph 20 of the explanatory memorandum to the proposal for the SPC Regulation, which, as far as it concerns what is 'protected by the basic patent', expressly and solely refers to the wording of the claims of the basic patent. Therefore, Article 3(a) of the SPC Regulation 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.
Valid marketing authorisation for the product
The CJEU was also asked whether Article 3(b) of the SPC Regulation may be interpreted as not precluding the grant of an SPC for a combination of two active ingredients (which conform to those specified in the wording of the claims of the basic patent) where the medicinal product for which the MA is submitted, also contains other active ingredients.
The CJEU first refers to the fundamental objective of the SPC regulation, namely to ensure sufficient protection, in order to encourage pharmaceutical research and to improve healthcare. This fundamental objective could be undermined if an SPC would be refused in case of medicinal products containing more ingredients than specified in the basic patent, because then the patent holder would enjoy only the period of protection conferred by the basic patent. Moreover, such an approach would tend to favour the development of single-ingredient medicinal products which would certainly not be compatible with the fundamental objectives pursued by the SPC Regulation.
Therefore the CJEU rules that if the other requirements of Article 3 are also met, Article 3(b) does not preclude the granting of a SPC for a combination of two active ingredients which conform to that specified in the wording of the claims of the basic patent relied on, where the medicinal product specified in the MA contains not only that combination of the two active ingredients but also other active ingredients.
In the opinion of the Advocate General it was also suggested that only one SPC per basic patent may be granted, which is contrary to the current practice. However, in these judgments the CJEU basically repeats what it said in the Biogen case, and therefore it does not rule out the possibility of multiple SPCs per basic patent where one patent covers more than one product. As long as there is no clarity on this issue, patent holders may choose to enhance their chances to get a valid SPC by filing divisional for individual products contained in their patent application.
The CJEU has clarified that it is possible to obtain an SPC for a product that is marketed as part of a larger combination of active ingredients. This is may especially benefit manufactures of multi-disease vaccines.
The approach taken by the CJEU in this case suggests that it should be possible to enforce an SPC for one or two active ingredients against a medicinal products containing more active ingredients. However, whether this interpretation is correct will hopefully be clarified by the judgment in a new CJEU referral on SPCs for combination products (Novartis v. Actavis, C-442/11). To be continued.
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