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...Since the status of a patent (application) is not included in the grounds set out in the Regulation and in the Directive, it cannot be used as an argument for refusing, suspending or revoking Marketing approval (MA).

....patent-linkage is considered unlawful under Regulation (EC) No 726/2004 and Directive (EC)No.2001/83."

(Ref.http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf accessed on 12-7-2009).

It is also a matter of concern that such patent linkage would have the following undesirable results: