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Patents / Biotechnology / EPO Biotechnology Practice / Supplementary Protection Certificates

Chemical and Biochemical Practice at the EPO

Supplementary Protection Certificates

Extension to agrichemicals

On February 8,1997 a new Regulation[1] came into effect providing for supplementary protection certificates for plant protection products such as insecticides, fungicides and herbicides that are also subject to regulatory approval before they can be marketed. The provisions are analogous to those that already exist for pharmaceutical products. The maximum possible additional protection will be for five years.

The problem of multiple "basic" patents

The extension of protection effected by the supplementary certificate is restricted to products that have been granted marketing approval and do not provide for extension of protection for any other subject matter that might fall within the scope of the patent claims.[2] The application must be made within six months of the date on which marketing approval for the product in question is granted anywhere within the EEC. Furthermore a supplementary protection certificate can be granted only in respect of the "basic" patent covering the product in question. In the case of Biogen Inc. v Smithkline Beecham Biologicals SA[3], the European Court of Justice had to consider the issues that arose when there was more than one "basic" patents covering a particular product and where the owner of the marketing authorization was different from the owner of the patent in respect of which the supplementary certificate was requested.[4] In its decision the court held that 1) in appropriate cases more than one supplementary certificate could be granted in respect of the same product if more than one "basic" patent covered it and 2) if the owner of the marketing authorization would not cooperate in supplying a copy of that authorization to assist an owner of one of the basic patents in applying for a supplementary protection certificate (submission of a copy of that authorization is one of the formalities required to secure an extension), it could not be compelled to do so but the application for the supplementary protection certificate should not be refused on that ground alone. The Court envisaged that "[b]y simple cooperation, the national authority granting the certificate can obtain a copy of the marketing authorization from the national authority which issued it".

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© Copyright 1997 John Richards - Posted 11/29/97 v2
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