Patents - Allergan v Aspire Pharma

Jane Lambert

Patents Court (Mr Justice Atnold)  Allergan, Inc and another v Aspire Pharma Ltd [2019] EWHC 1085 (Pat) (3 May 2019) 

Allergan Inc is the proprietor of European patent EP1753434 for an enhanced bimatoprost ophthalmic solution which its English subsidiary, Allergan Ltd. exploits by marketing a product containing 0.1 mg/ml (0.01%) bimatoprost for ophthalmic administration for the treatment of glaucoma under the trade mark Lumigan 01 mg/ml. Aspire Pharma Ltd and Accord Healthcare Ltd have obtained marketing authorizations to market generic versions of Lumigan 0.1 mg/ml which they do not dispute would infringe the patent. They contend that the patent is invalid on the ground of obviousness or, alternatively insufficiency.

S.72 (1) of the Patents Act 1977 provides that the Patents or Intellectual Property Enterprise Court or the Comptroller-General of Patents, Designs and Trade Marks may revoke a patent for an invention on the ground that the invention is not a patentable invention or the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.  S.1 (1) (b) further provides that an invention is not patentable unless it involves an inventive step.  S,3 adds that "an invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above).  The "state of the art" is in the case of an invention taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way."

The invention for which the patent was granted relates to pharmaceutical compositions comprising bimatoprost, which is described as a prostamide marketed commercially for the treatment of glaucoma and ocular hypertension. The specification discloses a number of formulations of bimatoprost in combination with benzalkonium chloride and other compounds. Claim 1, for instance, claims a "composition comprising from 0.005% to 0.02% bimatoprost by weight and from 100 ppm to 250 ppm benzalkonium chloride, wherein said composition is an aqueous liquid which is formulated for ophthalmic administration."

The question of whether an invention was or was not obvious to a person skilled in the art having regard to any matter forming part of the state of the art was considered by the Supreme Court in Actavis Group PTC EHF and others v ICOS Corporation and another [2019] UKSC 15, [2019] Bus LR 1318, I discussed the appeal in The Cialis Dosing Appeal - Actavis Group PTC EHF and Others v ICOS Corporation and another 31 March 2019,  Mr Justice Arnold considered Lord Hodge's judgment between paragraphs [97] and [102] of his own:

"[97] First, at [60] and [93]-[96] Lord Hodge endorsed, while not mandating, the use of the structured approach set out in Windsurfing International Inc v Tabur Marine (Great Britain Ltd [1985] RPC 59 as reformulated in Pozzoli SPA v BDMO SA [2007] EWCA Civ 588, [20007] FSR 37 at [33].
[98] Secondly, at [63] Lord Hodge endorsed, while emphasising that it was not exhaustive, the statement of Kitchin J (as he then was) in Generics (UK) Ltd v H Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] RPC 32 at [72]:

'The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.'

[98] Thirdly, at [65] Lord Hodge agreed that it was relevant to consider whether something was 'obvious to try', saying that '[i]n many cases the consideration that there is a likelihood of success which is sufficient to warrant an actual trial is an important pointer to obviousness'. He nevertheless endorsed the observation of Birss J at first instance that 'some experiments which are undertaken without any particular expectation as to result are obvious.'
[99] Fourthly, at [69] Lord Hodge said that "the existence of alternative or multiple paths of research will often be an indicator that the invention … was not obvious", but nevertheless endorsed the statement of Laddie J in Brugger v Medic-Aid Ltd (No 2) [1996] RPC 645 at 661:
[100] "[I]f a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well."
[101] Although Lord Hodge did not explicitly make the point, it is implicit in his endorsement of this statement that it remains the law that what matters is whether the claimed invention is obvious from a technical point of view, not whether it would be commercially obvious to implement it.
[102]  Fifthly, at [70] Lord Hodge confirmed that the motive of the skilled person was a relevant consideration. As he put it:

'The notional skilled person is not assumed to undertake technical trials for the sake of doing so but rather because he or she has some end in mind. It is not sufficient that a skilled person could undertake a particular trial; one may wish to ask whether in the circumstances he or she would be motivated to do so. The absence of a motive to take the allegedly inventive step makes an argument of obviousness more difficult.'"

The prior art relied on was a paper by R A Laibovitz and others entitled Comparison of the ocular hypotensive lipid AGN 192024 with timolol: dosing, efficacy, and safety evaluation of a novel compound for glaucoma management Arch. Ophthalmol., 119 (7), 994-1000 (2001).  The defendants contended that the invention was obvious from Laibovitz's paper.  The claimants responded by seeking leave to introduce a new claim:

"A composition comprising 0.01% bimatoprost, 0.02% benzalkonium chloride, 0.0268% sodium phosphate dibasic heptahydrate, 0.014% citric acid monohydrate, 0.81% sodium chloride, and water, wherein the pH is 7.3."

Much of the argument focused on whether that new claim was obvious in the light of Laibovitz's paper and his lordship found that it was. So, too, were the other claims.  That was enough to dispose of the case.  As insufficiency was relied on only to the extent that the defendants would have argued that if the invention was not obvious the specification was implausible, the learned judge did not deal with that point.

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