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 22 October 2010

Medeva note in latest BioSLR

The Bio-Science Law Review, published six times a year by Lawtext Publishing Ltd, often carries features relating to SPCs. The current issue -- volume 11, issue 1 -- is no exception. It carries a case comment by Sangeeta Puran (Mayer Brown International LLP) entitled "Reference to ECJ in Medeva BV v The Controller General of Patents concerning the conditions to be satisfied for the extension of patent term of patents for medicinal products in the EU". The abstract of this case comment reads as follows:
"In the EU, the term of a national patent or a European patent for drug products is extended through the grant of a supplementary protection certificate. This is governed by Council Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.

The system recognises that significant periods of the 20 year patent term are lost due to the time it takes to obtain marketing authorisation for a new drug. The Court of Appeal has recently referred to the ECJ questions concerning the conditions that must be satisfied for the grant of a supplementary protection certificate, including whether it can be granted in relation to a patent which does not disclose all the active substances or components in the marketed drug. The current UK approach precludes an extension in such a case because the patent cannot be construed to "protect" the product as required by the regulation, even where the product and patent pass the "infringement test", that is the manufacture or supply of the product would infringe the patent. Other Member States, however, have adopted the infringement test, resulting in an important divergence in the approaches within the EU in respect of the same application for supplementary protection and resulting in dicta repeatedly calling for clarification by the higher court. This case note considers the issues that have led to the current reference to the ECJ and the diverging constructions that will be considered by it when determining the correct approach for patent term extension in the EU".
This piece features two useful figures, one being an example of a project lifecycle curve viewed from a cash flow perspective, the other being a graphic representation of the active ingredients/substances in the Medeva proceedings as they relate to the basic patent. marketing authorisations and SPC products.

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