Two recent decisions of the European Court of Justice (ECJ)(1) have initiated a new practice in Norway related to supplementary protection certificates (SPCs) for medicinal products containing a combination of active ingredients – so-called 'combination products'. An SPC increases the duration of protection for certain patented products, extending the patentee's monopoly in respect of that product.
An SPC on combination products shall be granted if the combination of active ingredients is protected by a basic patent that is currently in force (Article 3(a) of the SPC Regulation). The ECJ decisions further prescribe that the combination product be specified in the wording of the claims of the basic patent.
A Norwegian applicant will be entitled to obtain more than one SPC on the basis of a patent, provided that each SPC is directed towards an active ingredient or a combination of active ingredients and provided that separate marketing authorisations have been issued. A requirement for obtaining SPCs on combination products is that these combination products can be deduced from the claims. Even if more than one SPC can be obtained on combination products, this will not be the case for SPCs in relation to medicinal products with separate marketing authorisations, where the products vary only in respect of different non-active ingredients, different doses, different salts or esters, different pharmaceutical forms, different uses or similar. Here, the first marketing authorisation will be a bar to obtaining more than one SPC.
General conditions for obtaining SPCs must also be met (ie, a granted patent and a marketing authorisation). Further, the SPC application must be filed no later than six months after the patent is granted or six months after the first Norwegian marketing authorisation for the product is issued. The marketing authorisation can comprise other active ingredients in addition to the product.
The patent term extension will be calculated based on the first marketing authorisation in the European Economic Area.
A consequence of the new decisions is that a combination product must be identified in the claims of the granted patent. Hence, it follows that the Norwegian Industrial Property Office will now allow claims directed to combination products together with claims directed to specific therapeutic compound(s), even if the basis for patentability is found with the new compound(s). If the patentable subject matter is the combination product as such or its use, the combination product and its use must be supported by examples/biological assays.
Applicants should evaluate their applications in view of possible future SPC applications in Norway to ensure that the combination products that they wish to pursue are specified in the claims.
It remains to be seen whether these ECJ decisions will effect SPCs that have already been granted in Norway.
For further information on this topic please contact Arne Lund Kvernheim or Arnhild Fiskaa at Bryn Aarflot AS by telephone (+47 46 90 30 00) or by fax (+47 22 00 31 31) or by email ([email protected] or [email protected]).
Endnotes
(1) Medeva (C-322/10) and Georgetown University (C-422/10).