"Long-Felt Want” soothes Leo’s irritation and helps psoriasis patent to be found inventive

July 2015

The Court of Appeal in Teva UK Ltd & Anor v Leo Pharma A/S [2015] EWCA Civ 779 (28 July 2015) has reversed a 2014 High Court decision.   The Court of Appeal, with a leading judgement by Sir Robin Jacob, concluded that Leo’s two patents were not obvious, and also agreed with the conclusions of the European Patent Office (EPO) Opposition Division.

The case relates to Leo’s two patents: EP 1 178 808 and EP 2 455 083  concerning the treatment of psoriasis using an ointment comprising a combination of a corticosteroid such as betamethasone and a vitamin D analogue such as calcipotriol.  This has been successfully marketed as Dovobet Ointment in the UK.   

Prior to the ointment being marketed by Leo, both of the active ingredients were known in the treatment of psoriasis. However, the two actives were thought to be incompatible (or at least could not be presented together) and so patients had to use two different prescribed products - one containing calcipotriol and the other betamethasone.   For lots of patients this led to issues of compliance. Due to these well-known compliance issues, clinicians had expressed the need for a treatment containing both active ingredients.  

Leo found a solution to this problem by using a suitable solvent - Arlamol E.

When Dovobet, came onto the market in 2002, it was a success and its sales substantial.  Teva wished to sell a generic version of that ointment, which Leo said would infringe their patents.  Teva contended that both patents were invalid on three grounds: obviousness, insufficiency and added matter. 

Before the High Court, Judge Birss found the patents to indeed be invalid as they lacked inventive step.  This finding focused on Arlamol E being disclosed in a patent published in 1978 – ‘the Turi patent’. The basis for Birss J’s conclusion on obviousness was founded on the belief that the Arlamol E would have provided a suitable starting point to conduct a trial-and-error analysis which would not have been too burdensome to the skilled person.

On appeal, the point of obviousness was revisited in full.  Interestingly, the Court of Appeal looked even further back than the priority date of the patents (April 1999), to conclude that there had been a desire for a dual active product since at least 1995.  Although ‘the Turi patent’ proposed Arlamol E as a solvent for an anti-inflammatory steroid, in the real world, Arlamol E was not used for ointments and had nothing to say about compositions comprising two active substances.  The Court of Appeal disagreed with the conclusion that it would have been “an obvious choice to try”.  There had been “no reasonably optimistic expectation” that it would work – any suitable solvent may have worked – so finding that it really did was therefore a true invention and an advance in human knowledge. 

Experts on both sides agreed that Dovobet marketed in 2002 was a significant advance in the treatment of patients with psoriasis, and that this was because the product allowed for much better patient compliance.  The Court of Appeal felt Judge Birss had missed an important point in that he failed to consider why, in the face of a long-felt want, there was no satisfactory explanation of why that solution was not achieved previously.  The combination product was therefore not obvious, and the High Court decision reversed.  This also agreed with the conclusions of the EPO Opposition Division, which rejected Teva’s opposition and concluded ‘the Turi patent’ did not have the same purpose as the invention by Leo.

This update was prepared by Dr Chris Moore, Partner in our Birmingham office. 

If you would like further advice on this or any other matter, please contact Chris at cmoore@hgf.com (Tel: +44(0) 121 644 4960), or your usual HGF representative or visit our Contact Page to get in touch with your nearest HGF office.