A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 29 January 2010

More on adjuvants - from the Netherlands and France

Martijn de Lange sends us the following summary of a decision by the Rechtbank ‘s;Gravenhage in the Netherlands on whether an adjuvant is an active ingredient:

"Stallergenes filed an application for an SPC on the basis of a marketing authorization for Grazax which contains as the active ingredient a standardised extract of grass pollen allergen from Timothy grass. However earlier marketing authorizations existed for medicinal products containing the same active ingredient and in addition aluminium hydroxide, which is a well known adjuvant used for boosting the effectiveness of allergen products (and also vaccines). Stallergenes argued that because this adjuvant induces certain physiological responses it should be considered an active ingredient. Therefore the earlier marketing authorizations were issued for a combination of active ingredients, and thus a product different from that of Grazax. The Netherlands Patent Office rejected this interpretation and pointed to the fact that the earlier marketing authorizations clearly list, in accordance with directive 2001/83, the adjuvant aluminium hydroxide under the excipients. The application was therefore refused in view of article 3(d). On appeal the Court of The Hague (Rechtbank ‘s;Gravenhage, 4 november 2009) upheld this decision. The court noted, with reference to ECJ C-431/04 ‘MIT’, that in this particular situation aluminium hydroxide did not have any therapeutic effect on its own. A formal appeal was filed to the appellate court but was withdrawn last week."

A copy of the decision in Dutch is available here.

"In France where the equivalent SPC was granted, ALK-Abelló, the manufacturer of Grazax, challenged the validity of the SPC and the court (Tribunal de Grande Instance, 7 october 2009) came to the same conclusion that a substance cannot be considered to be an active substance if it has no therapeutic effect on its own and for the particular indication. It therefore annulled the SPC. This decision was published last month in Propriété industrielle - Bulletin documentaire (PIBD) No. 909 (2009) III, pages 9-14."

Thanks Martijn!

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