UK Court grants cross border declaration of non-infringement

May 2014

The UK high court has granted a declaration of non-infringement (DNI) in respect of the UK, French, Italian and Spanish designations of a European Patent. 

This is a significant judgement as it confirms that the UK courts will hear non-infringement actions in relation to multiple European jurisdictions in a single court action. This has clear benefits in terms of cost savings for parties wishing to “clear the way” before launch of a product.  The judgement also provides a useful summary of the approach to claim construction in different European jurisdictions and the use of prosecution history in UK courts as an aid to claim construction.

The case, Actavis UK Ltd & Others v Eli Lilly & Company [2014] EWHC 1511 (Pat) (15 May 2014) (link to full judgement), concerned pemetrexed disodium as a cancer treatment marketed by Eli Lilly under the brand name Alimta since 2004. Pemetrexed and its pharmaceutically acceptable salts were protected by a now expired European Patent, which was subsequently extended by Supplementary Protection Certificates (“the SPCs”) which will expire on 10 December 2015. Lilly also owned a further European Patent (“the Patent”), which will not expire until June 2021, for the use of pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof and optionally a folic protein binding agent.

Actavis planned to launch a generic pemetrexed product, the active ingredient in which will be either pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine.  Actavis intended to obtain regulatory approval for their product by reference to Alimta. 

Actavis argued that dealings in their product will not infringe the Patent. This was disputed by Lilly.  In order to enter the market without fear of infringement proceedings on expiry of the SPCs, Activis sought a declaration of non-infringement not only for the UK designation of the Patent but also for the French, German, Italian and Spanish designations.

Both parties agreed that the Actavis product was not within the scope of the claims of the Patent on a literal interpretation. The issue was whether there was infringement of the Patent applying the Protocol on the Interpretation of Article 69 of the EPC. The judge concluded that neither pemetrexed diacid, nor pemetrexed dipotassium nor pemetrexed ditromethamine fall within the scope of the claims 1 or 12 of the Patent. In doing so he gave a very detailed and useful review of the approach to claim construction in the UK. The judge, with help from expert witnesses, then analysed the approach to claim construction in France, Spain and Italy and also concluded that the Actavis products did not infringe these designations of the Patent.

In reaching his conclusion the judge placed reliance on the prosecution history of the Patent and amendments made to the Patent during prosecution. Traditionally the UK courts have been reluctant to rely on the prosecution history as an aid to construction. However, in this case the judge decided that there are situations where there is no good reason why the court should “shut its eyes” to the story told in the prosecution history. This is a recognition of how “in the real world” the prosecution history is often used by patent lawyers to ascertain the scope of a patent.

In a final twist, the German designation of the Patent was not included in the declaration of non-infringement as in April 2014 the Dusseldorf Regional Court held that the Activis product did fall within the claims of the Patent. This decision by the German court was criticised by the UK court as not taking the correct approach to interpretation and treating the claims of the Patent as “mere guidelines”.

This update was prepared by Martyn Fish: mfish@hgf-law.com Partner of HGF Law, Leeds http://www.hgf-law.com/contact.asp.  Tel:  +44(0) 113 233 0148

If you would like further advice on this or any other patent matter, please contact Martyn Fish at mfish@hgf-law.com  or your usual HGF representative or visit our Contact Page to get in touch with your nearest HGF office.