• Supplementary Protection Certificates

    To compensate for the short effective patent life of pharmaceuticals, EU Council Regulation (EEC) No. 1768/92 provides for Supplementary Protection Certificates (SPCs) for Medicinal Products. According to this Regulation, where a medicinal product is first authorized to be put on the market more than 5 years after the date of the patent application for the product, an SPC can be granted that extends the protection conferred by the basic patent for up to 5 years beyond the normal term of the patent. The patent protection is extended only in respect of the product covered by the marketing authorization.

    The SPC Regulation entered into force on 2 January 1993, and was followed four years later by the entry into force of Regulation (EC) No. 1610/96 creating similar SPCs for Plant Protection Products.

    The conditions for obtaining a certificate are set out in Article 3 of both Regulations (see panel), and have been the subject of recent decisions and questions referred to the ECJ which are briefly reviewed above.

     

    Scope of protection of SPC extends to the product of the marketing authorisation in all its patented forms

    The terms “active ingredient” and “active substance” are not defined in the regulations. They have been held to cover, for example, new combinations and derivatives, such as salts or esters. As stated in Farmitalia Carlo Erba Srl’s SPC Application (C392/97), [2000] RPC 580, the SPC is capable of covering the product mentioned in the marketing authorisation “in any of the forms enjoying the protection of the basic patent”.

    However, in BASF AG v. Bureau Voor de Industriele Eigendom (C258/99) [2002] RPC 9, the ECJ held that a purer form of the product or the product in a different concentration could not be considered a new product in the context of an SPC application. In Draco AB’s SPC Application [1996] RPC 417, the English Patent Court refused a SPC for a new formulation.

     

    The product protected by the patent must be the product authorised

    The first and second conditions set out in Article 3 are that the product must be protected by a basic patent in force and must be the subject of a valid authorisation to place the product on the market. This has given rise to questions relating to combination products. In Centocor Inc’s SPC Application [1996] RPC 118 (Patent Office), an SPC for a combination of ingredients was refused on the grounds that, although the patent covered the combination, the marketing authorisation only related to one of the ingredients. In Takeda Chemical Industries Ltd’s SPC Applications (No.3) [2004] RPC 3, although the authorisation related to the combination, the patent only covered one ingredient, and the grant of the SPC was also refused. (In this latter case, it was also held that the issue of whether a patent for a product would cover its salts or esters is a matter of interpretation of the patent claims.)

     

    Must all the ingredients of a combination be independently active?

    Two cases concerning the definition of “product” have been referred to the ECJ and are still pending - Yissum Research and Development Company of the Hebrew University of Jerusalem (C-202/05) [2004] EWHC 2880 (Pat) and MIT v. Bundesgerichtshof (C431/04). These cases ask essentially the same questions, namely:

    1. does the term “combination of active ingredients/substances” (in Article 1b) mean that all the components of the combination must be active ingredients/substances with a therapeutic effect/pharmaceutical activity; and
    2. what if the second ingredient merely enables presentation of the first ingredient in a form having altered pharmaceutical activity (or renders possible a pharmaceutical form of the medicinal product that brings about a changed efficacy of the medicinal product)?

    Only a valid marketing authorisation in the Member State will suffice

    The marketing authorisation must have been granted in accordance with the relevant Directive (65/65/EEC or 81/851/EEC, for a medicinal product; or 91/414/EEC for a plant protection product). A letter issued by the Medical Control Agency is not a valid authorisation (British Technology Group Ltd’s SPC Application [1997] RPC 118 (Patent Office)). Similarly, marketing authorisation from another Member State than that in which the SPC is sought cannot be accepted (Yamanouchi Pharmaceuticals Co Ltd v. Comptroller-General of Patents, Designs and Trade Marks (C110/95) [1997] RPC 844; also confirmed in Novartis AG v. Comptroller-General of Patents, Designs and Trade Marks (C207/03) [2005] RPC 33).

     

    Only one SPC per medicinal product – multiples for agrochemicals

    According to Article 3(c) of Regulation No. 1768/92, the product must not have already been the subject of a certificate. In contrast, Regulation (EC) No. 1610/96 allowing for SPCs for plant protection products includes a provision to allow more than one SPC to be granted in respect of the same product, under Article 3(2).

    Indeed, where a product is protected by a number of basic patents in force, which might belong to a number of patent holders, each of those patents could be designated for the purpose of the procedure for the grant of an SPC (Biogen Inc v. SmithKline Beecham Biologicals SA (C181/95) [1997] R.P.C. 833; also confirmed in Chiron Corp’s and Novo Nordisk A/S’s SPC Application [2005] RPC 24). This also implies that a patent holder having more than one patent for the same product should not be able to obtain more than one certificate for that product.

     

    Only the first authorisation gives rise to an SPC

    The last condition, as set out in Article 3, is that the authorisation is the first authorisation to place the product on the market as a medicinal product or as a plant protection product. In Farmitalia, the applicant provided details of the first authorisation to place the product on the market, which was in respect of human use only. However, it was held that the duration of a SPC was determined by the date of the first authorisation in respect of the product, whether pharmaceutical or veterinary. The authorisation for human use was not the first authorisation to put the product on the market, because there had been an earlier authorisation for veterinary use.

     

    Comment

    It can be seen from the cases above that one of the contentious issues of the supplementary protection certificate is that of the identity of the “product”, which must be the same in both the patent and the marketing authorisation. Patent applicants are may wish to consider including in their patent applications claims to (or at least lists of) all the ingredients with which the patented substance is to be combined, so that the patent has at least one claim, or can be amended to have at least one claim, to the specific combination that is the subject of the marketing authorisation.

     

    Article 3 of Council Regulation (EEC) No. 1768/92

    A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and that at the date of that application:

    1. the product is protected by a basic patent in force;
    2. a valid authorization to place the product on the market [as a medicinal product] has been granted in accordance with Directive 65/65/EEC or Directive 81/851/ EEC, as appropriate;
    3. the product has not already been the subject of a certificate;
    4. the authorization referred to in b) is the first authorization to place the product on the market as a medicinal product.”

    The “product”, for which the SPC is sought, is defined in Article 1b as the “active ingredient or combination of active ingredients” for a medicinal product or the “active substance or combination of active substances” for a plant protection product.