Authors: Tim Powell and Rebecca Lawrence (Powell Gilbert LLP)
Joined Cases C322/10 Medeva and C422/10 Georgetown University, Court of Justice of the European Union, Advocate General's Opinion, 13 July 2011
Journal of Intellectual Property Law & Practice (2011) doi: 10.1093/jiplp/jpr158, first published online: November 4, 2011
The Advocate General has opined on the availability of Supplementary Protection Certificates (SPCs) for combination products, clarifying the interpretation of Articles 3(a) and 3(b) of Regulation 469/2009.
SPCs may be granted to patentees to extend the life of patent protection in relation to specific medicinal products. The availability of SPCs is prescribed by Regulation 469/2009, which aims to compensate patentees where the effective monopoly afforded by the patent has been eroded by a lengthy marketing authorization process.
In order to obtain an SPC, certain requirements prescribed by the Regulation must be met, including:
Article 3‘Product’ is defined in Article 1(b) as ‘the active ingredient or combination of active ingredients of a medicinal product’. ‘Basic patent’ is defined in Article 1(c) as ‘a patent which protects a product as such, a process to obtain a product or an application of a product … ’.
(a) the product must be protected by a basic patent in force;
(b) a valid authorization to place the product on the market as a medicinal product must have been granted;
(c) the product must have not already been the subject of an SPC;
(d) the authorization in (b) must be the first to place the product on the market.
Issues relating to SPCs for ‘combination products’ which contain two or more active ingredients have resulted in the recent referral of questions by the courts in England and Wales to the Court of Justice of the European Union (ECJ). Advocate General Trstenjak (‘the AG’) has now provided her Opinion in the first of those cases.
The facts in Medeva illustrate the relevant issues. Medeva had a patent relating to two antigens of the whooping cough virus Bordetella pertussis. However, the vaccines Medeva marketed additionally contained other active ingredients directed to diphtheria and tetanus and, in some vaccines, meningitis and polio. Medeva applied for five SPCs, four of which covered vaccines containing eight or nine active components and one (the '018 Application) which covered the two patented components.
The applications relating to eight or nine active components were rejected as not complying with Article 3(a) of the Regulation as a product containing a multiplicity of active ingredients was not considered to be ‘protected’ by a basic patent which only claimed a subset of those ingredients.
The '018 Application was rejected as not complying with Article 3(b) of the Regulation as the relevant marketing authorization contained a greater number of active ingredients than the product, so there was considered to be no valid authorization to place the product on the market.
The key questions in Medeva referred by the Court of Appeal to the ECJ can be summarized as follows:
1. What is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this?
2. Are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ for medicinal products comprising more than one active ingredient and, if so, what are those further or different criteria?
6. Does the Regulation and, in particular, Article 3(b), permit the grant of a supplementary protection certificate 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 Regulation; and
Questions 3–5 were specifically related to Article 3(a) as it applies to multi-disease vaccines and are of less general importance. The sole question referred in Georgetown University was the same as question 6 in Medeva.(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 marketing authorization?
The ECJ was faced with the challenge of including a partially patented multi-disease vaccine within the scope of the Regulation in a manner consistent with its objectives, without jeopardizing the balance achieved in that Regulation between the various interests at stake in the pharmaceutical sector.
Article 3(a): questions 1–5
Medeva argued that a combination of active ingredients is protected by a basic patent where at least one of its active ingredients is claimed in the patent, so that the whole combination would infringe the patent (the so-called infringement test). The UK government supported this approach, while the Commission submitted that the Court must establish which active ingredients are protected by a patent under national law, not which forms of commercial activity by third parties the patent proprietor can inhibit.
The AG considered that, on a literal reading of the Regulation, an SPC may be granted only in relation to the entire combination of active ingredients because, according to the wording of Article 1(b) of the Regulation, only the combination of active ingredients as such constitutes the ‘product’. Thus there should be no mismatch between the ‘product’ the subject of the SPC application and the ‘product’ the subject of the patent.
However, the AG recognized that such a literal interpretation would not be in accordance with the aims of the Regulation as it would lead to a rejection of SPCs on extremely important combination medicinal products. She therefore considered that a ‘teleological’ interpretation should be adopted taking into account the aims of the Regulation. By this approach, the definition of ‘product’ in Article 1(b) also included one or a subset of the authorized combination.
The AG then considered whether the widening of the concept of ‘product’ in this way upset the balance of interests envisaged by the legislature in adopting the Regulation. She was concerned about the risk of ‘evergreening’ whereby a manufacturer of medicinal products could develop a number of products with different combinations of active ingredients on the basis of one patented active ingredient and place those products on the market at different times, for the purpose of obtaining a variety of certificates of different durations.
The AG considered that the product within the meaning of Article 3(a) must be interpreted as meaning the product which forms the subject matter of a basic patent within the meaning of Article 1(c). Thus, whichever combination is marketed, the product is always the same. Subsequent authorizations with different combinations will not give rise to further SPC applications because the product will already have been the subject of an SPC (Article 3(c)) and the authorization will not be the first to place the product on the market (Article 3(d)). In other words, if the patent relates to a + b but the marketing authorization is for a + b + c + d, the patentee can apply for an SPC on a + b. If a + b + f + g is later authorized, no further SPC can be granted as a + b is already the subject of an SPC.
In light of this finding, it was unnecessary to apply the infringement test advanced by Medeva. The AG rejected the test and instead drew a distinction between the subject matter—or extent of protection—and the protective effect of the basic patent, considering that this followed from the requirements of Article 1(c) of the Regulation that sets out the definition of a ‘basic patent’ under which an SPC can be granted.
Article 3(b): question 6
In considering the question referred on the interpretation of Article 3(b) of the Regulation, the AG decided that it follows from the teleological interpretation adopted in respect of Article 3(a) that the marketing authorization under Article 3(b) can relate to a medicinal product which contains, in addition to the patented active ingredient/combination, one or more other active ingredients (provided that it is the first authorization to place the product on the market).
The AG has been prepared to interpret the Regulation in a teleological fashion, introducing flexibility into the requirements of Article 3 and allowing a ‘mismatch’ between the number of active ingredients included in the marketing authorization and the number in the patent. To this extent, this Opinion seems favourable to the research-based pharmaceutical industry in that the Regulation has been interpreted to avoid an unduly harsh refusal of SPC protection. The ECJ must decide whether to adopt the Opinion of the AG. However, the Opinion leaves open to interpretation the ‘subject matter’ of the basic patent. Also, in rejecting the infringement test, the AG did not go as far as many in the pharmaceutical industry would have liked in providing SPC protection for second generation combination patents.