Posted: May 15th, 2019
Allergan, Inc and another v Aspire Pharma Limited and Accord Healthcare Limited v Allergan, Inc, High Court, London, UK, 3 May 2019, Neutral Citation Number:  EWHC 1085 (Pat)
In this judgment, Arnold J applied for the first time the UK Supreme Court’s decision in Actavis v ICOS  UKSC 15 on inventive step.
Allergan is the proprietor of EP (UK) 1 753 434 (“EP 434”) and markets a product which exploits that patent under the brand name Lumigan 0.1mg/ml. The invention in EP 434 is a formulation of a lower concentration (0.01%) of the active ingredient, bimatoprost, than had been made available in an earlier product for the treatment of glaucoma (Lumigan 0.3mg/ml), but formulated in combination with a higher concentration (0.02%) of the preservative benzalkonium chloride (“BAK”) than had been in that earlier product.
Aspire and Accord have marketing authorisations to market generic versions of Lumigan 0.1mg/ml which they agreed would infringe EP 434, if valid. However, Aspire and Accord alleged that EP 434 was invalid for obviousness, over a prior art document known as “Laibovitz”.
Allergan had applied unconditionally to amend the patent to add a new claim 18. This claim became the focus of the judgment.
Laibovitz describes a Phase II dose-ranging study conducted on bimatoprost at doses of 0.003%, 0.01% and 0.03%. Laibovitz explains that the formulations used did not include any preservative as no preserved formulations were available at the time the study was conducted.
The experts agreed that:
(i) the quality of data in Laibovitz was poor as the methodology did not accord with best practice and the number of patients (100) was not high; and
(ii) an obvious course was to repeat the Laibovitz study with a better methodology and more patients.
Arnold J therefore held that the key question was whether, when repeating the study, the inclusion of BAK would have been obvious or not. The quantity of BAK which would be included was also a point of contention.
In deciding the question of obviousness, Arnold J noted that “the overall tenor” of the judgment of Lord Hodge in Actavis v ICOS was to confirm the previous approach to obviousness. For the purposes of the present case, he picked out five main points from Lord Hodge’s judgment as follows:
1. The endorsement (but not mandating) of the Pozzoli approach.
2. The endorsement of the statement of Kitchin J (as he then was) in Generics v Lundbeck, that the question of obviousness must be considered on the facts of each case, that the Court must consider the weight to be attached to any particular factor, and that relevant factors can include motive, number and extent of possible avenues, and expectation of success, amongst other things.
3. That it is relevant to consider whether something was obvious to try with an expectation of success, whilst noting that “some experiments which are undertaken without any particular expectation as to result are obvious”.
4. That the existence of alternative or multiple paths of research will often be an indicator that the invention was not obvious, but also endorsing the statement of Laddie J in Brugger v Medic-Aid Ltd (No 2) that if a particular route is an obvious one to try, it is not rendered any less obvious because there are a large number of other obvious routes.
5. That the motive of the skilled person is a relevant consideration.
Arnold J also noted that Lord Hodge had implicitly endorsed the position that what matters is whether the claimed invention is obvious from a technical point of view, and not from a commercial i.e., financial point of view.
Arnold J noted that the only reason that preserved formulations were not used in the original Laibovitz study is because they were not available – it was not a deliberate decision for any scientific reason. On the facts, Arnold J concluded that it would be obvious to use a preserved formulation if repeating Laibowitz and, since BAK was the most commonly used preservative, “it would be an obvious choice”.
Additionally, including BAK at any of the concentrations used in relevant commercially available eye drops would have been obvious to try. In particular, the relevant range of concentrations from the common general knowledge was 0.005% to 0.02%, thus including the claimed 0.02% concentration of BAK.
Arnold J stated that even if it was not obvious to include 0.02% BAK purely as a preservative, it would have been obvious to include this quantity in the 0.01% dose formulation for other reasons. In particular, Laibovitz teaches that the 0.01% dose of bimatoprost is less efficacious than the 0.03% dose, but it was common general knowledge that BAK was a corneal penetration enhancer and would, therefore, increase the bioavailability of bimatoprost. The addition of the higher dose of BAK would therefore improve the efficacy of the lower dose of bimatoprost without impacting safety.
Arnold J concluded that EP 434 is invalid for lack of inventive step.
A copy of the judgment can be found here.
Headnote by Emma Muncey, Bristows LLP