Testing the boundaries of subjectivity: Infringement of Swiss-type claims in Warner-Lambert v Actavis

The IPKat has previously presented the court’s reasoning with regards to plausibility of second medical indication claims. Time to turn to the issue of what constitutes infringement.

The protection conferred by means of Swiss-type claims as well as the nature of the claims is of growing importance. This is the case despite  the fact that Swiss-type claims have been replaced by purpose-limited product claims under 54(5) of the EPC2000 and the Abbott ruling (G 0002/08 (Dosage regime/ABBOTT RESPIRATORY) of 19.2.2010).

Infringement of Claim 3

The  focus of the infringement ruling is Claim 3, stating  --

“use of pregabalin for the preparation of a pharmaceutical composition for treating neuropathic pain”.

The claim in question is a purpose-limited process claim. It is a process claim since it concerns the preparation of the substance pregabalin, and it is a purpose-limited claim since it only covers the process if undertaken in order to treat neuropathic pain  Although the Court unanimously holds that if Claims 1 and 3 had been valid, they would not have been infringed by Actavis, the justification of the ruling differs substantially between the Lords .

Warner-Lambert pursued its infringement case under section 60(1)(c) and separately, under section 60(2). Section 60 (1) provides:

“60.(1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say -
(a) where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise;
(b) where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent;
(c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise."

The central point  of  difference  between the Lords was the role that the “mental element” in the acts of the alleged infringer is to play in order to prove infringement under section 60(1)(c).

Lord Sumption and Lord Reed

 Lord Sumption and Lord Reed consider that the intention of the alleged infringer, whether subjective or objective, is irrelevant and that the sole criterion of infringement is whether the product as it emerges from the manufacturing process, including any labelling or accompanying leaflet, is presented as suitable for the uses which enjoy patent protection – the “outward presentation” test. The “outward presentation” test, contrary to the “foreseeability” test, avoids having to take into consideration the “internal cogitations” of the manufacturer, and it is based mainly on the patient information leaflet, which also constitutes the main line of communication between the manufacturer and the end user. 

In this particular case, it is not disputed that Lecaent was sold with labels and patient information to the effect that it was for the treatment of seizure disorders and general anxiety disorder. According to Lord Sumption, any other approach would in fact unnecessarily expose to liability not only the generics manufacturer but also the pharmacist who handles his product.

Lord Mance

Taking into consideration the fact that a generics manufacturer does not have any contractual relationship to the physician or  the apothecary, and is thus in no position  to dictate the use of the substance, it should be considered enough if the manufacturer makes it clear that the product is not meant for the patented use. That being said, he underlines the importance of allowing for another (and thus broader) interpretation, by which elements may be taken into consideration in “other extreme cases”., For example,f“cases where a generic manufacturer were to produce and supply quantities of the pharmaceutical composition for a distributor in a context which only made sense if they were destined for the patent-protected use”.

 Lord Mance seems to be reluctant to give clear and rigid interpretations to the issue at stake.

Lord Briggs and Lord Hodge

Lord Briggs and Lord Hodge prefer the view of Arnold J ,  whereby  the test is whether the alleged infringer subjectively intended to target the patent-protected market. Lord Briggs proposes a compromise, focusing  on h,  all “forensic means”  that could assist in clarifying the intention of the manufacturer to use the substance for the patented use. including but not limited to  packaging. In this regard, any documents recording the manufacturer’s decision-making process, or any other proof made available even under targeted disclosure, could be used to support the “subjective element” of intent.

Lord Briggs considers the German “only packaging will do” approach to be far too limited, even if he also concludes that in the test he proposes, packaging, labeling and patient instruction leaflets, will provide the most substantial source of information. Lord Hodge concludes that the approach of  Lord Briggs  provides for more satisfactory protection for the holder of a purpose-limited patent.

How objective should the “subjective element” be?

Introducing the requirement of proof of a “mental element” in the determination of infringement would of course entail a considerable burden for those wishing to make use of generics, where certain uses are still covered by purpose-limited patents. As all the Lords pinpoint, dealers and dispensers of pregabalin would not have the possibility to know whether the steps taken by the manufacturer to prevent leakage will be considered reasonable or not in a forthcoming infringement procedure, and they could in fact prefer not to make  use of the generic alternative at all.