Gareth advises life sciences clients on all exclusivity rights around pharmaceuticals and medical device products. Whether it is patents, SPCs or regulatory exclusivities, Gareth has decades of experience advising on these rights and has litigated in UK and EU courts.

Gareth's experience

  • Advising ROMA on the defence of IPEC infringement proceedings brought by Syri Limited and subsequent High Court proceedings brought claiming declarations of non-infringement.

  • Advising Sandoz AG on interim injunction proceedings, and patent revocation and infringement proceedings following the launch in the UK of its generic dapagliflozin product.

  • Advised Sandoz AG, a global generics and biosimilars manufacturer, on revocation proceedings before the UK Patents Court concerning a dosing regime patent for Rivaroxaban (Xarelto), and on the subsequent damages enquiry arising from a wrongly granted interim injunction.

  • Advised Dana Fabre, a pharmaceutical company, on its appeal against a UK IPO decision refusing a paediatric extension to its SPCs protecting Tecentriq and Bavencio.

  • Advising on two separate products for a global pharmaceutical company and a biotech firm, focusing on the preparation of submissions to the European Medicines Agency to secure orphan drug exclusivity at the final review stage.

  • Advising an international pharmaceutical company in due diligence on product acquisitions concerning the validity and enforceability of regulatory exclusivity rights.

  • Acting for an international clinical research organisation in developing a freedom to operate strategy in relation to patents protecting protein assay technology.

  • Represented CSL Behring, a leading biopharmaceutical company, in challenging the European Medicines Agency and the Commission's grant of a conditional marketing authorisation for a competitor gene therapy product to the CSL product marketed as Hemgenix.

  • Advising Sanodz in relation to proceedings seeking to revoke EP 1 893 196 and its SPC which relates to the major prostate cancer drug, enzalutamide (Xtandi).

  • Acted for Teva in cases concerning data, and market exclusivity on Tecfidera before national courts, the EU General Court and CJEU.

Credentials

  • 2021
    Joined Pinsent Masons
  • 2020
    Honorary Fellow of Faculty - Pharmaceutical Medicine
  • 2016
    Qualified - Ireland
  • 2001
    Bristol University - IP Law (Postgraduate)
  • 2000
    Qualified - England & Wales
  • 1996
    University of Oxford - Biochemistry (DPhil)
  • 1991
    University of Oxford - Biochemistry (MA)
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Out-Law / Insight by Gareth Morgan

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