Medilink NOE News Summer 2020 Summer 2020

EXPERT VIEW JAMES LAWFORD-DAVIES PARTNER HILL DICKINSON JANET KNOWLES PARTNER HGF QUANTUMDX ATTAINS CE-IVD MARKING FOR ITS SARS-COV-2 TEST AND ANNOUNCES EXPANSION LEAVING THE EU - IMPLICATIONS FOR THE LIFE SCIENCES AND MEDICAL TECHNOLOGY INDUSTRY If no trade agreement is reached by 31 December 2020, there could be disruptive consequences for the life sciences industry. Businesses should prepare for the eventuality of the UK trading with the EU on World Trade Organisation terms. Bad News: Disruption • Prepare for potential difficulties trading or obtaining new contracts whatever the deal with the EU • Expect a decline in stability for contracts binding for EU and UK businesses, due to the unknown impact on many economic factors • Without a satisfactory trade deal, protections guaranteed by the GDPR regarding international transfers of data are uncertain Good News: Regulatory Revisions • The UK has already transposed EU legislation into national law, creating a temporary patchwork of applicable legislation and preventing significant disruption. • The UK has already communicated its intention to align, where possible, to the EU Clinical Trials Regulation 536/2014 (CTR). • The UK MDR 2002 has been amended to reflect the upcoming EU Medical Devices Regulation and the EU In Vitro Diagnostic Medical Devices Regulation. Our advice to business • Audit current contracts with EU businesses for likely changes. Preventive measures should be included in contracts, either through amendments or by adding Brexit-related termination clauses. • For new contracts, consider opting for short-term agreements and consider issues like delivery, payment, etc. • Examine the implications of trading with EU-based companies and the ability to meet contractual obligations, for example, supply chain issues due to customs disruption. Brexit will not relieve businesses from their contractual obligations Conclusion The UK will have to recreate its own legal order to some extent. We can expect the emergence of an ‘a la carte’ regulatory regime, which will increase the uncertainty of contract law and business relationships. However, businesses can count on the UK government’s intention to adjust rapidly to beneficial EU legislation. We are a corporate partner of Medilink UK and the exclusively recommended provider of legal services to Medilink’s North of England members. View James Lawford Davies’ webinar on the legal implications of Brexit for the life sciences and healthtech sector. AI AND IP - A NEW FRONTIER AI (Artificial Intelligence) has become the new buzzword in the sector. Even now, AI - machines that can become better at a task typically performed by humans with limited or no human intervention – is moving to ML (Machine Learning) - an AI process that uses algorithms and statistical models to allow computers to make decisions, without having to explicitly program it to perform the task. The FDA has already approved a diagnostic device powered by a deep learning algorithm trained on extensive set of images annotated by experts. We also have ML tools carrying out some of the science and conceiving inventions. So, what does this all mean for the patent landscape? Who is the inventor of any AI/ML conceived invention? The EPO recently explained that it had refused two patent applications naming the machine DABUS as an inventor because an inventor must be a natural person and various national courts have issued decisions to this effect. The applicant, DABUS’s owner could also not have had ownership transferred to him because DABUS has no legal personality and so cannot hold property. Will this be challenged? When is an AI/ML invention obvious because the use of AI/ML is obvious in itself? We are probably already there in some instances. An invention also has to be sufficiently disclosed. However, sometimes we don’t fully understand ML inventions – we can see the effect but not always how it works. AI/ML clearly needs big data. Yet none of the six regions of Health Data Research UK is located in the North. So, the North will rely on its Digital Health workforce. We have almost 30% of the country’s total Digital Health workforce - a force to be reckoned with. Please note - the views being expressed are those of the author and not necessarily Medilink. LR DAME SARAH STOREY, PROF ROB COPELAND, DAN JARVIS MP SHEFFIELD HALLAM LAUNCHES £14M WORLD-LEADING RESEARCH CENTRE FOR PHYSICAL ACTIVITY Sheffield Hallam University has opened the most advanced research centre in the world for developing innovations that will increase physical activity and improve population’s health. The new multi-million Advanced Wellbeing Research Centre (AWRC), supported by £14million funding from the Department of Health and Social Care and £905k investment from the European Regional Development Fund, has been officially opened by the Active Travel Commissioner for Sheffield City Region and Britain’s most successful female Paralympian, Dame Sarah Storey. As the centrepiece of the Sheffield Olympic Legacy Park, the AWRC is dedicated to improving the health and wellbeing of the population through innovations that help people move. Its mission is to prevent and treat chronic disease through codesigned research into physical activity, while attracting new jobs and investment to the region. The Centre is supported by several partners including: Canon Medical Systems, Westfield Health, EXOS, the National Centre for Sport and Exercise Medicine in Sheffield, Sheffield Children’s Hospital Charity, Ingesport and parkrun. Dame Sarah Storey said: “It is fantastic that innovation into helping people live more healthy and active lives is taking place here in the Sheffield City Region. Physical activity can improve both physical and mental health for people of all ages and abilities, and it’s important that everybody is given the opportunity to be active. “Our vision includes creating a 2040 Active Travel network which is safe and suitable for all, to allow everybody to start building physical activity into their everyday lives.” Mayor Dan Jarvis, Mayor of the Sheffield City Region, said: “I am delighted that the Advanced Wellbeing Research Centre will bring jobs and investment to the region, whilst driving new research into the health of populations across the world, as well as our own communities. “South Yorkshire is now home to the world’s most advanced research centre in the world for wellbeing research, the Advanced Manufacturing Research Centre, and National Centre for Excellence in Food Engineering.” The AWRC features indoor and outdoor facilities for multidisciplinary researchers to carry out world-leading research on health and physical activity in collaboration with the private sector, charities and the community. QuantuMDx Group Limited, a UK-based life sciences company developing transformational point-of-care molecular diagnostics and Medilink member, has received CE-IVD marking for its SARS-CoV-2 test under the In Vitro Diagnostics Detective (98/79/EC), which will enable the use of the device within the EU. The company has registered the test with the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA). The company has also applied to the US Food and Drug Administration (FDA) for Emergency Use Authorisation. The assay has been designed with the most upto-date sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences. Working with a British manufacturing partner, Biofortuna Limited, the company has increased the production capability up to 2 million tests a week with the potential to scale up to 3 million tests per week. Jonathan O’Halloran, Chief Executive of QuantuMDx, said: “Gaining CE-IVD marking now enables us to sell our SARS-CoV-2 detection assay directly into the European Union, as well as other territories worldwide that adhere to its regulations. This is another exciting step forward for QuantuMDx as we commercialise, join the international testing effort and support governments in their test, track and trace strategies.” QuantuMDx has also announced the appointments of Jonathan O’Halloran as Chief Executive Officer and Neil Butler as Chairman of the Board. Jonathan O’Halloran is the company’s Co-founder, former Chief Scientific Officer and inventor of many of its proprietary technologies. Neil Butler was appointed to the Board as Non-Executive Director last summer and is a seasoned IVD specialist. The board changes coincide with QuantuMDx’s transition towards commercialisation and the launch of its Q-POC™ high risk HPV genotyping assay in early 2021 10 LEGAL INTERNATIONAL PAYMENTS INSURANCE IP 11

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