There is new practice in Norway related to SPCs on combination products following recent Court of Justice decisions in Medeva and Georgetown University.
A prerequisite to obtain SPCs on combination products will be that a combination of active ingredients is protected by the basic patent (Article 3(a) of the SPC Regulation). The decisions further prescribe that the combination product must be specified in one of the claims of the basic patent.
An applicant in Norway will be entitled to two SPCs on the basis of a patent, one on the product and one on the combination product provided that two marketing authorisations have been issued. Additional SPCs can also be granted for combination products on the basis of a patent on the condition that further marketing authorisations have been issued and that these combination products can be deduced from the claims.
General conditions for obtaining SPCs must also be met, which is a granted patent and a marketing authorisation and that the SPC application is filed no later than six months after the grant of the patent or six months after the issue of the first Norwegian Marketing Authorisation for the product. 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 with the European Economic Area.
A consequence of the new decisions is that the combination product must be found 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 compounds even if the basis for patentability is found with the new compounds. 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 or biological assays.
Our advice is that an applicant evaluates its applications in view of possible future SPC-applications in Norway to ensure that combination products it wishes to pursue are found in the claims.
We have at present no information as to whether these decisions could have an effect on SPCs already granted in Norway.
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Arne Lund Kvernheim
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Arnhild Fiskaa
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Bryn Aarflot AS
Kongens gate 15
PO Box 449 Sentrum
NO-0104 Oslo, Norway
Tel: +47 46 90 30 00
Fax: +47 22 00 31 31
mailto@baa.no
www.brynaarflot.com