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a prescription for infringement? Actavis and Warner-Lambert - intention, or foreseeability?

26 October 2016

The Court of Appeal has handed down its judgment on the long-running Pregabalin saga. The patent was found invalid, so the reasoning below is non-binding, but adds clarity to when a claim in a patent for an alternative use of a medicine (a.k.a. 'Swiss-Form Claims') is infringed by a product which is labelled for use for a different purpose to that in the patent.

Previously, to infringe, the company selling the non-patented product had to “foresee that the product would be intentionally administered [by a doctor or pharmacist] for the use which was patented”. Floyd LJ has now clarified that the test is whether the manufacturer can “foresee that there will be intentional use” which matches the patented use.

Manufacturers selling an 'alternative use' product will not be able to avoid liability by simply having the proposed use on the label (and not the patented use). To negate the 'foreseeability' of intentional use for the patented purpose, additional steps such as notifying those prescribing the product that it must not be prescribed for the patented purpose, or applying warnings to this effect should be considered.

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