Beyond the matter of sufficiency in the Warner-Lambert pregabalin case, the UK Supreme Court unanimously decided that there would have been no infringement had the claims in question been valid.

The judges, however, had differing views on the grounds for the finding, leaving the test for infringement unclear with regard to Swiss-form claims (claims relating to use of a compound in the manufacture of a product for an indicated medical purpose).

The question of infringement arose when Warner-Lambert, the proprietor of patent EP0934061, brought proceedings against Actavis for marketing a generic version of the patented product pregabalin.  Although the generic pregabalin is marketed for the treatment of epilepsy and generalised anxiety disorder, Warner-Lambert held the view that it would be foreseeable for a manufacturer of the generic pregabalin that, in due course, product would also be used for the treatment of neuropathic pain, as covered in the patent.

Prior to the Supreme Court hearing, the lower courts construed that Swiss-form claims are purpose-limited process claims and hence involve a mental element test when considering the issue of infringement. The question which arises from this construction is whether the test of the manufacturer’s intention is subjective or objective.  Subjective intention may extend liability to a person such as a pharmacist/physician, who could be found to infringe a purpose-limited patent by virtue not of his/her own intentions but due to those of someone else (such as a generic manufacturer). On the other hand, considering objective intention could effectively give a patentee a de facto term extension for an expired patent for an original use, i.e. until the expiry of a patent for a new use.

Two of the five Supreme Court judges found both the subjective and the objective tests irrelevant for the purpose of considering infringement, however, and instead advocated the “outward presentation” test. According to the outward presentation test the only important factor is the physical nature of the product as it emerges from the manufacturing process (including its formulation and dosage, packaging and labelling, and the patient information leaflet which will identify the use of the product).

In contrast, another two of the judges found the “subjective intent” test fair and more reliable. They found that the purpose limitation of a Swiss-form claim would necessarily relate to a mental element on the part of the manufacturer and, in order to strike a fair balance between competing policy objectives, a person’s intention should be tested. Such intention could be shown objectively as well as by considering downstream marketing.

The last of the judges remained doubtful regarding the tests discussed above and held that the objective appearance and characteristics of the end-product, in terms of its preparation, presentation, and marketing, should not be viewed in isolation in certain situations (for example when considering the intent of the end-user).

Although it was ruled that there was no infringement in the pregabalin case, the Supreme Court judges acknowledge that the various tests are far from perfect.


Khushbu Solanki

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