News

Court of Appeal overturns cross jurisdiction award of DNIs to Actavis

27 July 2015

Last year we reported the decision of the UK High Court in the case of Actavis v Lilly, concerning the anti-cancer drug pemetrexed disodium (see here).

To recap briefly, the UK High Court ruled that Actavis’ pemetrexed dipotassium product did not infringe Lilly’s patent directed to pemetrexed disodium either under direct infringement, or under indirect infringement and Actavis were therefore entitled to a Declaration of Non-Infringement (DNI) not only under English law, but also in respect of the French, Italian and Spanish designations of the Patent.

The decision was appealed, and in the ensuing judgement of the Court of Appeal (see here) Lord Justice Floyd disagreed with the High Court on two main issues.

In the first instance, Arnold J considered the prosecution history to assist in ensuring that the patentee did not accept narrow claims during prosecution and subsequently argue for a broad construction of those claims for the purpose of infringement. This was rejected by Floyd LJ, stating that he would not have found it necessary to go to the prosecution history to arrive a conclusion when one can get there, straightforwardly, by reading the claims in light of the specification. The interesting possibility that the prosecution history might become important in UK patent litigation, analogous to “file wrapper estoppel” in the US, has therefore been overruled by the Court of Appeal.

Floyd LJ, following Arnold J’s reasoning, still found that there was no direct infringement. However, in relation to indirect infringement, the Court of Appeal reversed the decision of the High Court and ruled that the claim integer “pemetrexed disodium” could be construed under a non-literal interpretation to extend to other salts and that dealings in pemetrexed diacid, dipotassium and ditromethamine by Actavis would constitute indirect infringement because each of Actavis’ active ingredients would be dissolved and/or diluted in saline, which is a source of abundant sodium ions, before administration to the patient. The solution could be “pemetrexed disodium” even if the starting salt was not. Supply of, for example, pemetrexed dipotassium, to be made up in this way, would be “supply…of the means, relating to an essential element of the invention”, and therefore constitute indirect infringement under Section 60(2) of the Patents Act.

The Declarations of Non-Infringement sought by Actavis were therefore refused in respect of the UK as well as France, Italy and Spain, as it was considered that there is no detectable difference in their approach to contributory infringement.

Actavis filed numerous post-appeal submissions with one success. Actavis have proposed specifying that their product should be made up in dextrose solution rather than saline solution. The Court of Appeal has remitted the case back to the Patents Court to consider whether such a work around will avoid infringement, since it is conceivable that, despite their instructions, a medical professional may use saline instead. The saga is set to continue and it is not clear whether the further hearing will take place before the expiry of Eli Lilly’s SPC on 10 December 2015.

Kirsty Simpson
Life Sciences & Chemistry

If you require further information on anything covered in this briefing, please contact Kirsty Simpson (ksimpson@withersrogers.com; +44 20 7940 3600) or your usual contact at the firm.

This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.

© Withers & Rogers LLP, July 2015