日期: 16 April 2013
With their Decision of 24th November 2011, the Court of Justice of the European Union has provided some important clarifications on the circumstances under which Supplementary protection Certificates can be granted. In particular, it was found that an active ingredient that is "specified in the wording of the claims" of a patent may be the subject of an SPC, as long as the active ingredient has been the subject of a marketing authorisation as a medicinal product, either on its own or in combination with other active ingredients.
Supplementary Protection Certificates - Background
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.
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:
a. the product is protected by a basic patent in force;
b. 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;
c. the product has not already been the subject of a certificate;
d. 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.
Medeva and Georgetown University cases - Background
Current public health policies require that vaccines contain a combination of active ingredients directed to a number of different diseases so that multiple immunisations can be achieved via a single injection.
Medeva and Georgetown University had patents relating to individual vaccines. The SPC Regulation requires that the active ingredient to be both "protected by a basic patent" and the subject of a marketing authorisation (see above). Both Medeva and Georgetown University were refused SPCs on the basis that the patent protected the active ingredient but the marketing authorisation was directed to a combination of active ingredients.
The case was referred to the Court of Appeal by Medeva, which argued that the words "product protected by a basic patent" should be interpreted to cover any product containing the patented active ingredient, regardless of whether it was sold as a single vaccine or as a combination of vaccines.
The Court of Appeal referred these cases to the Court of Justice of the European Union (CJEU).
Two issues were discussed by the CJEU, namely the meaning of the words "product protected by a basic patent" in Article 3(a) of the Council Regulation and whether a marketing authorisation for a combination of products could be used as the marketing authorisation in Article 3(b) to support an application for an SPC for a single product of that combination.
1. What does "product protected by a basic patent" mean?
According to Article 5 of the Council Regulation, the SPC confers "the same rights as conferred by the basic patent". Therefore, the CJEU found that Article 3(a) of the Regulation "precludes the grant of an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent", i.e. an SPC should not be granted which covers active ingredients which are not specified in the claims of the patent.
It was also clarified that if a patent claims that a product is composed of two active ingredients, but does not claim either active ingredient on its own, then an SPC cannot be granted on the basis of the patent for the one active ingredient considered in isolation.
2. What if the marketing authorisation is directed to a combination of products?
The CJEU found that if the SPC was refused on the ground that the marketing authorisation covers the active ingredient in combination with other ingredients, then this would undermine the objective of the SPC Regulation to encourage pharmaceutical research. In addition, it was pointed out that Article 3(a) of the Regulation does not rule out the possibility of the marketing authorisation covering a combination with further active ingredients.
It was therefore concluded that an SPC can be obtained for an active ingredient specified in the wording of the claims of a patent, even if it co-exists with other active ingredients in the medicinal product covered by the marketing authorisation.
Saturday, November 26, 2011