Second medical use patent claims in the so-called “Swiss-type” form, i.e. claims formulated as “Use of a substance X in the manufacture of a medicament for the treatment of disease Y”, were deemed allowable by the Enlarged Board of Appeal of the European Patent Office (“EPO”) in decision G5/83 of 1984. However, for decades it has not been clear what scope of protection Swiss-type claims provide to patentees. For example, would a party infringe a patent with a valid Swiss-type claim following unauthorised manufacturing, selling, offering for sale, distributing and/or using the claimed substance if it is apparent that the substance would be, or has been, used for the indicated treatment? As summarised below, recent cases in the United Kingdom (UK) have started to review the meaning of and scope of protection afforded by Swiss-type claims. Unfortunately, it may be some time before we have answers.
By way of background, it is known that Swiss-type claims have been widely used to protect new and inventive second or further medical uses of known substances. Patents with Swiss-type claims have been granted not only in European countries but also in other jurisdictions around the world, especially where medical methods of treatment per se are not deemed to be patentable. Although Swiss-type claims are no longer permitted by the EPO for recently filed European patent applications (see Enlarged Board of Appeal decision G2/08), having been replaced under EPC2000 by second medical use claims in the form “Substance X for use in the treatment of disease Y”, the claims are widespread in granted European patents and other patents that could remain in force for many years.
A series of three related court cases involving Warner-Lambert Company (“Warner-Lambert”) as claimant and Actavis Group and others (“Actavis”) as defendants have been heard this year in the England and Wales High Court (Patents Court). In the first case ( EWHC 72 (Pat)) decided by Mr Justice Arnold on 21 January 2015, Warner-Lambert was refused an application for an interim injunction requiring Actavis to take a number of steps to prevent the drug pregabalin from being dispensed by pharmacies for the treatment of pain. Warner-Lambert asserted that their patent EP(UK)0934061 (“the Patent”) which included a Swiss-type claim directed to pregabalin for treating pain would otherwise be infringed by Actavis. Pregabalin is also used to treat epilepsy and generalised anxiety disorder, for which patent protection no longer exists in the UK. Actavis and another generic supplier had meanwhile brought proceedings in the UK to revoke the Patent, and Mr Justice Arnold ordered a full trial of the infringement and invalidity proceedings to be heard from 29 June 2015.
The reasons for Mr Justice Arnold’s refusal of the interim injunction in this first case were: (1) he considered there was no serious issue to be tried with regard to the infringement allegation; and (2) the balance of the risk of injustice favours refusal of the request. In coming to his decision on the first point, Mr Justice Arnold said it was common ground between the parties that the “for the treatment” wording in the Swiss-type claim under consideration means “suitable and intended for the treatment”. But what is meant by “intended” and whose intention is relevant? The judge said that because the Swiss-type claim is a directed to a process of manufacture, it is the intention of the manufacturer, rather than a person disposing of or offering to dispose of pregabalin, which is relevant. Furthermore, it must be demonstrated that the manufacturer had a subjective intention for pregabalin to be used for the treatment of pain. Since Warner-Lambert did not rely on any allegation of subjective intention on behalf of Actavis in the present case, the interim injunction was refused.
The same parties were back in the Patents Court to hear two further applications in the second case ( EWHC 223 (Pat)) decided by Mr Justice Arnold on 6 February 2015. Firstly, Actavis asked for the infringement claim by Warner-Lambert to be struck out or for a summary judgement dismissing the claim. Secondly, Warner-Lambert asked to amend its Particulars of Infringement to plead a case of subjective intention. The judge allowed Warner-Lambert’s application but refused Actavis’ application. Accordingly, the full infringement and invalidity proceedings trial will proceed in June 2015.
In a third related case in the Patents Court ( EWHC 485 (Pat)) decided by Mr Justice Arnold on 2 March 2015, Warner-Lambert obtained a court order mandating the National Health Service Commissioning Board (operating under the name “NHS England”) to issue guidance to all Clinical Commissioning Groups (“CCGs”) in England on the prescribing of pregabalin for treating pain. The order requires doctors in England to prescribe Warner-Lambert’s branded pregabalin (under the name “Lyrica®”), rather than generic versions of pregabalin, for treating pain. Warner-Lambert was obliged to give cross-undertakings in damages to the various parties involved who would be unjustly disadvantaged by the court order in the event that Warner-Lambert is unsuccessful at the full trial starting in June 2015.
We await the full Warner-Lambert vs Actavis full trial decision expected in July 2015 to obtain some clarity on the scope of protection afforded by Swiss-type claims in the United Kingdom. Even then, in view of the principles involved and the commercial importance of pregabalin for treating pain, it is reasonable to assume that the Patents Court full trial decision (whatever it is) will be appealed to the Court of Appeal and then potentially to the Supreme Court of England, Wales and Northern Ireland. Developments in other European countries where infringement involving Swiss-type claims is being decided upon should also contribute to our understanding of this important form of patent protection for medical developments.
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This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.