Medicinal product assessment: a new defence to patent infringement in Ireland and the UK

The Intellectual Property (Miscellaneous Provisions) Bill 2014 and the Legislative Reform (Patents) Order 2014 have each now been published and will affect the scope of patent infringement in Ireland and the United Kingdom, respectively.  The research exemption in the legislation is to be enhanced, benefitting companies engaged in the pharmaceutical sector.  The Irish Association of Patent and Trademark Attorneys pressed the Government for this change to Irish law.

These pieces of legislation provide legal certainty by ensuring that anything done in, or for the purposes, of a medicinal product assessment, which would otherwise constitute an infringement of a patent for an invention, is to be regarded as having been done for experimental purposes relating to the subject matter of the invention.  In other words, critical research and clinical trials carried out in order to obtain the necessary marketing authorisation for new or generic versions of medical and veterinary products to be placed on the market for sale will be immune from patent infringement.

No date has yet been set for when the Intellectual Property (Miscellaneous Provisions) Bill 2014 will be effective in Ireland.  However, the Legislative Reform (Patents) Order 2014 will come into force in the UK from 1st October 2014.  We will post again when the law comes into force in Ireland.

Isabel Meenan

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