ECJ clears the way for generic marketing of Alzheimer’s drug

08/08/11

Generics (UK) Ltd v Synaptech Inc. Case C-427/09

On 28 July 2011 the ECJ delivered judgment in a preliminary reference concerning the duration of a supplementary protection certificate ("SPC") granted to the company Synaptech for the product galantamine, used to treat Alzheimer's disease. The SPC had extended the patent protection for galantamine to January 2012. In proceedings before the Patents Court, and subsequently the Court of Appeal, the duration of that SPC had been challenged by Generics (UK), on the basis that galantamine was an old product that had been marketed in various parts of the EU since the 1960s.

The ECJ ruled that a product such as galantamine, which had been placed on the market in the EU as a medicinal product for human use before it had obtained a marketing authorisation under the provisions of Directive 65/65, and without undergoing any safety and efficacy testing, was not eligible for an SPC under Regulation 1768/92. It reached the same conclusion in another judgment, given on the same day, in a parallel preliminary reference from the Patents Court in proceedings between Synthon and Merz Pharma, concerning the product memantine.

The two judgments will have significant implications for the generic marketing not only of galantamine and memantine themselves, but also a number of other old medicinal products that were placed on the market in the EU before they obtained marketing authorisations under the provisions of Directive 65/65.

The judgment in Generics (UK) is here.

The judgment in Synthon BV v Merz Pharma GmbH & Co. KGaA, Case C-195/09 is here.