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Healthcare & Life Sciences

25 March 2020
Katie Lee Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness

Canada - Smart & Biggar

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.

Authors: Katie Lee, Urszula Wojtyra
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Riccardo Fruscalzo AIFA guidance on management of clinical trials during COVID-19 emergency

Italy - Hogan Lovells

Due to the COVID-19 emergency and the consequent lockdown that is affecting most non-essential services in Italy, including some healthcare services, the Italian Medicines Agency recently issued guidance for sponsors, non-profit organisations and contract research organisations involved in clinical trials. The guidance tackles urgent needs that sponsors are experiencing in clinical trials due to restrictions on patients' access to trial sites.

Authors: Riccardo Fruscalzo, Carlotta Busani
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Andreas Wildi Swiss health study commenced

Switzerland - Walder Wyss

The Lausanne University Centre for General Medicine and Public Health, in close cooperation with the Swiss Biobanking Platform, recently commenced the pilot phase of the so-called 'Swiss health study', which aims to determine which chemicals accumulate in the human body. The pilot phase is supported by the Federal Office of Public Health.

Author: Andreas Wildi
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Catherine Drew COVID-19 crisis: clinical trials and cross-border collaboration

United Kingdom - Pinsent Masons

The current circumstances are unsettling for many reasons, not least because there is still no approved vaccination or treatment for the novel coronavirus (COVID-19). Reflecting the collaborative approach recently called for by the European Medicines Agency, the UK Medicines and Healthcare Products Regulatory Agency has indicated that it stands ready to support researchers, manufacturers and other regulators to develop medicinal products to fight and prevent the spread of COVID-19.

Author: Catherine Drew
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Recent updates

Anne-Sophie Raxhon DPA approves draft act prohibiting life and health insurers from processing health tracker data

Belgium - ALTIUS

Authors: Anne-Sophie Raxhon, Jan Clinck
Andreas Wildi Indirect counterproposal to nursing care initiative

Switzerland - Walder Wyss

Author: Andreas Wildi
Urszula Wojtyra New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases

Canada - Smart & Biggar

Author: Urszula Wojtyra
Rainer Herzig Leucopenia medicine and reimbursement code

Austria - Preslmayr Attorneys at Law

Author: Rainer Herzig