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European Union (EU) - First Court of Justice Decision on Supplementary Protection Certificates for Pharmaceuticals

In the European Union (EU), extension of a period of protection given by a patent to compensate for delays in placing a pharmaceutical (and now also a plant protection product) on the market because of the need to obtain governmental marketing approval is effected by a Supplementary Protection Certificate. Such extension is restricted to products that have been granted marketing approval and does not provide for extension of protection for any other subject matter that might fall within the scope of the patent claims. The application for a supplementary protection certificate must be made within six months of the date on which marketing approval for the product in question is granted anywhere within the EU. Furthermore the relevant directive implies that 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 Biological SA decided on January 23, 1997, the European Court of Justice had to consider the issues that arose when there was more than one "basic" patent 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 protection certificate was requested. The product was a vaccine and the marketing authorization was held by a licensee of, inter alia, the owner of patents on DNA intermediates used in producing the vaccine. In its decision the Court held that:

(1) notwithstanding statements made previously by the Commission that there could only be one supplementary protection certificate per product, in appropriate cases more than one supplementary protection 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 Ladas & Parry - Posted 7/15/97
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