Tracey is an intellectual property litigator in the life sciences sector, who studied Natural Sciences specialising in pathology. Tracey's principal expertise is in leading high-profile, multi-jurisdictional patent cases where she coordinates litigation strategy across Europe and worldwide, acting for both innovator and generic/biosimilar clients.

Tracey's experience

  • Coordinated litigation in the UK, Italy, Switzerland, the Netherlands and at the EPO for the European-wide launch of a generic company product for iron overload.

  • Advised Teva Pharmaceutical Ltd in their patent litigation against BioMarin in respect of the product sapropterin, a life-changing drug for PKU sufferers. A campaign by a cross party group of MPs and the Daily Express to make this drug available shone a light on its importance for patients.

  • Advised a large biotech company on a potential preliminary injunction action in the Netherlands to facilitate market access for their rheumatoid arthritis and ulcerative colitis biosimilar.

  • Advised Teva Pharmaceutical Industries Ltd in their successful 2022 trial against Novartis in respect of their deferasirox product. The case considered important legal question about numerical limits in respect of the Doctrine of Equivalents and the role of the Skilled Team.

  • Acted for Teva Pharmaceutical Industries Ltd in respect of their mirabegron product, co-counselling alongside Sandoz, in a case that considered key issues of plausibility at the UK trial.

  • Advised a large biopharmaceutical biosimilar manufacturer on orphan drug exclusivities in respect of the launch of their biosimilar for treatment of blood disorders.

  • Acted in patent proceedings for Teva Industries Ltd against Chiesi in respect of a combination of beclomethasone dipropionate and formoterol fumarate to treat asthma and COPD. This led to a precedent setting UK ruling on the threshold for a threat of patent infringement.

  • Acted for Roche in defence of a UK invalidity action of a patent (concerning the glycosylation of antibodies) brought by Takeda and a counterclaim for infringement in respect of Takeda’s monoclonal antibody vedolizumab (Entyvio) for the treatment of ulcerative colitis and Crohn's disease.

  • Coordinated parallel proceedings for Amgen in their PCSK9 case against Sanofi in the EPO, France and Germany.

  • Acted for Amgen in an infringement claim against Sanofi and Regeneron for the sale of their monoclonal antibody alirocumab (Praluent), which inhibits PCSK9 (a molecule involved in the regulation of low-density lipoprotein (LDL) receptors) and a counterclaim for revocation of Amgen’s patent for antibodies to PCSK9.

Credentials

  • 2023
    Made Partner at Pinsent Masons
  • 2020
    Admitted to the Irish Roll of Solicitors
  • 2019
    Joined Pinsent Masons
  • 2015
    Oxford University - Post Graduate Diploma in Intellectual Property Law
  • 2013
    Marks & Clerk Solicitors LLP - Associate
  • 2012
    Linklaters LLP - Associate
  • 2012
    Qualified, England & Wales
  • 2010
    Linklaters LLP - Trainee
  • 2009
    College of Law - Legal Practice Course
  • 2008
    College of Law - Postgraduate Diploma in Law
  • 2007
    University of Cambridge - MA (Cantab) Natural Sciences
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Out-Law / Insight by Tracey Roberts

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