Alcon Research LLC and another v Pharmathen SA and Aspire Pharma Limited, Court of Appeal, London, UK, 28 June 2022, [2022] EWCA Civ 845

The English Court of Appeal (Lord Justice Arnold giving the leading judgment with whom Lady Justice King and Lord Justice Nugee agreed) has rejected an appeal by Aspire Pharma Limited (“Aspire”) upholding Mr Justice Meade’s first instance ruling that EP 1 920 764 (“EP 764”) and its associated SPC was valid.

Background

EP 764, which expired in 2014, concerned the use of the prostaglandin analogue prodrug, fluprostenol isopropyl ester (“FIE”), for the treatment of glaucoma and ocular hypertension. The corresponding SPC expired in 2017. Somewhat unusually, in 2020 invalidity proceedings were brought in the UK by two generics, Aspire and Accord, in an attempt to claim damages under historic cross-undertakings which had been agreed as part of interim injunction proceedings in 2014/2015.

First instance

To recap on the first instance judgment, in April 2021, Meade J found the patent and SPC valid. Having held that the skilled person would be a specialist working in prostaglandins for the treatment of glaucoma with the corresponding CGK as the generics had argued, he still rejected the generics’ obviousness case. The generics had sought to argue that the prior art disclosed the receptor profile of a particularly promising compound which would motivate the skilled person would look for other compounds in the literature with the same receptor profile, including fluprostenol (which was used at the priority date as a veterinary treatment to regulate fertility in horses).

However, the prior art made no reference to fluprostenol or FIE, and Meade J found that the skilled team would choose to develop analogues of the compounds mentioned in the prior art rather than locating and experimenting with another compound which could only be identified by means of a separate literature search.

Overall, he felt the generics’ analysis was too simplistic and that it failed to explain how the skilled team would think of fluprostenol in the first place. As a result, the Judge concluded that even if the skilled team did think of fluprostenol, the prospects of success (having regard to efficacy and side effects) would be very uncertain.

In relation to insufficiency, Meade J held that for FIE to be “suitable for the treatment of glaucoma”, it had to have reduced levels of the known side effects of related prostaglandins, namely ocular irritation and conjunctival hyperaemia. While EP 764 did not have any data on the level of ocular irritation caused by FIE (EP 764 only contained data on reduced hyperaemia), Meade J had held that this was not relevant as Alcon had not relied on a reduction in ocular irritation as part of the technical contribution of EP 764 when considering inventive step.

Aspire (and not Accord) appealed Meade J’s findings on obviousness and insufficiency.

The appeal

The Court of Appeal dismissed Aspire’s appeal on inventive step finding that Meade J had cogent reasons for rejecting the obviousness attack advanced by the generics, citing specifically the Judge’s finding that the skilled team would not without invention have turned its mind to fluprostenol as a possible glaucoma treatment in the first place.

On insufficiency (which the generics had pleaded as a squeeze on inventive step), the Court of Appeal accepted Aspire’s submission that the Judge was wrong to dismiss its insufficiency attack on the aforementioned basis as “the technical contribution of a patent is not a matter which depends on the patentee’s case, it is an objective question for determination by the court in the light of all the relevant evidence” (at [95]).

This appears to be contrary to existing case law in both the UK and the EPO where the patentee is permitted to reformulate its technical contribution in light of the prior art (as recently considered by Meade J in Sandoz & Teva v BMS [2022] EWHC 822 (Pat), [63]-[68], drawing on Generics v Yeda [2013] EWCA Civ 925, T939/92 AgrEvo and T 0116/18 Sumitomo).

However, the Court of Appeal nonetheless dismissed Aspire’s appeal on insufficiency as the squeeze as pleaded did not arise on the facts and, if it had been pleaded as a free standing insufficiency attack, the Court of Appeal accepted that Alcon would have led evidence at first instance including on what level of ocular irritation was acceptable when conjunctival hyperaemia was reduced.

A copy of the judgment can be found here.

Headnote by Florence Plisner and Jonathan Ross, Bristows LLP