Cross Border DNIs Denied on Appeal

July 2015

The Court of Appeal has set aside a declaration of non-infringement (DNI) in respect of the UK, French, Italian and Spanish designations of a European Patent which the UK High Court granted last May, Actavis UK Ltd & Others v Eli Lilly & Company [2015] EWCA Civ 555 (25 June 2015).

The original judgement was significant as it confirmed that the UK courts will hear non-infringement actions in relation to multiple European jurisdictions in a single court action.  This jurisdictional aspect of the judgement has not been set aside.

The appeal raised both issues of substantive patent law; particularly regarding claim construction and the application of the UK law of contributory infringement and further legal issues about whether the English court must apply the corresponding foreign laws governing the conditions for applying for DNIs in foreign jurisdictions.

The case 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 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. 

At first instance, the judge placed reliance on the prosecution history of the Patent and amendments made to the Patent during prosecution.  Furthermore with help from expert witnesses, he 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.

However, on appeal, Floyd J, stated he would not have found it necessary to go to the prosecution history to arrive at a conclusion when one can get there, straightforwardly, by reading the claims in the light of the specification.  And, although there would have been no direct infringement by Actavis, he would have refused Actavis their DNIs on the ground of contributory infringement, and it followed on that the DNIs should also be refused in respect of the stated countries.

The case has now been remitted back to the High Court specifically on whether the supply or offer to supply of the Actavis active ingredients when recommended for reconstitution in dextrose rather than saline solution would infringe the Patent.  

Click here to read our detailed review of the case.

This update was prepared by Martyn Fish, Partner of HGF Law, Leeds.  Tel:  +44(0) 113 233 0148

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