On 13 July 2011, Advocate General Verica Trstenjak delivered her Opinion in the joined cases of Medeva (Case C-322/10) and Georgetown et al. (Case C-422/10) before the European Unions Court of Justice ("CJ"). Both cases are references for a preliminary ruling from the UK Courts on the interpretation of Article 3 of the SPC Regulation (EC Regulation 469/2009) regarding the requirements for grant of a supplementary protection certificate ("SPC") for a partially patented combination product.
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 components are claimed) or whether it is required that all parts of the combination are claimed in the basic patent.
The UK courts have 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 deals with a multi-component vaccine of which only two components are the subject of a combination patent. An SPC for the multi-component vaccine as authorized was refused because the patent did not claim the additional components. An SPC for the two components of the multi-component vaccine which were claimed in the patent was refused in the UK, because the marketing authorisation was granted not for the two claimed components but for the multi-component vaccine which includes additional components. 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 the questions:
- what in the absence of a Community patent law, is the test is for determining whether the "product is protected by a basic patent in force" under Art. 3 (a) SPC Regulation, whether there may be specific criteria for products comprising several active ingredients and more specifically whether a vaccine containing multiple antigens is protected by a basic patent, if the patent protects one of the antigens;
- whether Art. 3 (b) SPC Regulation allows grant of the SPC for a patented active ingredient or combination of active ingredients if the marketing authorisation was granted for a product which includes active ingredients beyond the ingredients claimed in the patent.
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 set out above.
Summary of the Opinion of the Advocate General
In very short summary the opinion of the Advocate General states, that
- it is possible to obtain an SPC for a product containing a combination of active ingredients if at least one of the active ingredients is the subject matter of a basic patent, but 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.
The Advocate General starts out with a literal interpretation of the SPC Regulation. She refers to Art. 1 (b) SPC Regulation defining the "product" as "the active ingredient or combination of active ingredients of a medicinal product", and concludes that only the combination of all the active ingredients constitutes the "product", so that Art. 3 (a) SPC Regulation requires that this combination is protected by a basic patent. Further, she deduces from Art. 1 (c) SPC Regulation (the definition of basic patent) that the decisive test for the question whether the combination is protected by the basic patent is the subject matter of the patent (i.e. whether the combination is claimed by the patent) and not whether the patent's protective effect extends to such combination (i.e. whether the combination would infringe the patent). This leads her to conclude that based on such literal interpretation it would not be possible to grant an SPC in case of a medicinal product in which the combination of active ingredients is only partially patented.
As a next step, she, however, argues that such result would not be compatible with the objectives of the SPC Regulation in particular taking into consideration that manufacturers may find themselves obliged to place active ingredients on the market in combination with other active ingredients, but would (absent a patent on the combination) not be able to obtain an SPC for this combination. She tries to resolve this by way of teleological interpretation of Art. 1 (b) SPC Regulation to the effect that the term product can include also "an" active ingredient or "a" combination of active ingredients of the medicinal product. Accordingly it would be sufficient under Art. 3 (a) SPC Regulation that one of the active ingredients or part of the combination of active ingredients in the medicinal product is the subject matter of the patent, i.e. claimed in the patent.
She then examines whether in practice this may lead to a strategy of optimizing protection by strategically placing different combinations on the market with a time-lag to obtain various SPCs with different time-lines. She concludes that this will not be possible due to the application of Art. 3 (c) SPC Regulation according to which only one SPC may be granted per product. She concludes that under her teleological interpretation of Art. 1 (b) SPC Regulation, where the product can be a single active ingredient or partial combination of active ingredients of the medicinal product, only one certificate can be granted for a product containing the active ingredient or combination, so that the patentee must carefully choose for which product containing the active ingredient or combination he wishes to seek the SPC.
In this context the Advocate General, further points out that the patentee cannot hold off making this choice, as in accordance with Art. 3 (d) SPC Regulation he must apply for the SPC based on the first marketing authorisation for the "product", which under her interpretation of Art. 1 (b) SPC Regulation means the first marketing authorisation for a product containing the active ingredient or combination of active ingredients. She concludes that this result of one SPC per product with the same active ingredient, leads to adequate results as the patentee can by relating the SPC application to the central active ingredient or combination of active ingredients which can be expected to be contained also in future medicinal products, ensure that within the limits of the basic patent and during the term of the SPC also these subsequent products enjoy protection.
If followed by the CJ, the impact on pharma lifecycle strategies will be significant, as the first marketing authorisation for a product containing the patented active ingredient will determine which SPC can be obtained. If the active ingredient is initially marketed as mono product, a further SPC for a combination product containing this active ingredient would not be possible on the same basic patent. Whether the SPC for the mono product can be enforced against the combination product is (contrary to the Advocate General's assumption) not a foregone conclusion but instead the subject of litigation in the various Member States. Finally, it would be interesting to see what effect all this shall have on already granted SPCs, where based on the same basic patent SPCs have been granted on single active ingredients and combinations containing this active ingredient.