Intellectual Property Advisory: Patentability of Dosage Regimens at the EPO and in the UK

It has long been established that second (and further) medical uses of a known medicament may be patented at the European Patent Office (EPO) and in the UK, provided that appropriate claim formats are used, including those now specified under the EPC 2000. What has been more controversial is where no new disease/condition is being treated and the distinguishing feature of the invention lies in a novel and inventive treatment regime (e.g., in the method, timing, frequency, or dosage of administration of the medicament). The UK courts have in the past found against the patentability of such claims whereas the EPO has generally (but not uniformly) adopted a more permissive position to such subject matter.

A recent decision of the English Court of Appeal (the second highest court in England and Wales) has, however, indicated a shift in the UK approach, whilst a referral to the EPO?s Enlarged Board of Appeal seeks to obtain clarification and a more uniform approach on the correct position to be taken at the EPO.

Please see full advisory for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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