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A landmark case for second medical use patents in the UK

29 June 2015

News & Views
Author: Mike Snodin

On 28 May 2015, the UK Court of Appeal issued its judgement in an appeal by Warner-Lambert against a decision of the UK High Court that refused to grant a preliminary injunction aimed at preventing sales of a “skinny label” pregabalin product for which Actavis had sought a Marketing Authorisation.

Although largely positive, the decision of the UK Court of Appeal represents mixed news for innovators.

The good news relates to the standard for proving infringement that was adopted by the Court of Appeal, which now compares very favourably to the much stricter standard for proving anticipation of second medical use claims (which has since been confirmed by a decision of the UK High Court in a different case).

On the other hand, the less positive news relates to:
- the difficulties that are likely to be encountered in seeking preliminary injunctions against “skinny label” generic products; and
- the possibility that, even for innovative medicinal products that are marketed in the UK, freedom-to-operate issues may arise in respect of patents to indications that are not on the product label.

This article discusses these issues and more, including crucial questions that have not yet been answered.

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