Validity of patent considered at preliminary injunction stage

  • United Kingdom
  • 02/27/2019
  • CMS

Home eAlerts Validity of patent considered at preliminary injunction stage
Validity of patent considered at preliminary injunction stage
26.02.2019 United Kingdom
1. Introduction

In a recent judgment, the High Court considered the validity of a patent at the preliminary injunction stage, on the basis of a summary judgment application brought by Dr Reddy’s Laboratories (UK) Limited (“DRL”), a generic pharmaceutical company. DRL brought the application against Novartis Pharmaceuticals UK Limited (“Novartis”) on the basis that the Opposition Division of the European Patent Office (the “EPO”) had already held the patent to be invalid on ground of added matter.

2. Everolimus

The patent relates to the compound “40-O-(2-hydroxyethyl)-rapamycin”, more commonly known as everolimus and sold by Novartis as Afinitor. Novartis held a second medical use patent for the use of everolimus in combination with exemestane for use in breast cancer; “40-O-(2-hydroxyethyl)-rapamycin in combination with exemestane for use in the treatment of hormone receptor positive tumor, wherein in the hormone receptor positive tumor is a breast tumor” (the “Patent”).

Although the Supplementary Protection Certificate on everolimus per se expired on the 17 January 2019, protection was still provided by the Patent. This Patent prevented DRL, who had obtained a marketing authorisation for everolimus in July 2018, from launching its generic version of the drug after 17 January 2019.DRL could have launched a skinny label product directed at smaller indications (by “carving out” the treatment of breast cancer from its marketing authorisation), but opted not to (continue)

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