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News Articles

Enforcement Of Second Medical Use Patents: Landmark Case Sets The Scene For Future Battles

08 December 2016

Author: Mike Snodin
Pink Sheet (17 November 2016)

This article was first published in the Pink Sheet (https://pink.pharmamedtechbi.com/). It discusses the October 2016 decision of the UK Court of Appeal in Warner-Lambert v Actavis, which relates to the alleged infringement of a second medical use patent by a "skinny label" generic product.

As well as highlighting aspects of the decision that will be welcomed by innovators, the article points to areas where important questions still remain unanswered. These include the following.

(1) Which specific actions must (not) be done by the manufacturer of a "skinny label" generic product in order to avoid infringing a claim directed to an indication that has been carved out of the label of that product?

(2) Could the tests proposed by the Court of Appeal for direct and indirect infringement lead to contradictory results (and/or to liability for infringement arising due to off-label use)?

(3) Which remedies are appropriate in cases where sale of a "skinny label" product is found to infringe a valid patent to a second medical use?

Finally, the article suggests some proactive, practical steps that innovators could take, with a view to minimising the chances of "skinny label" generic products being used in the treatment of patented indications.

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