20 min. read

Life Lines

6 November 2019

Looking Ahead

  • 7 November 2019 - EU Commission pharmaceutical committee meets - Agenda

  • 26 November 2019 - Flynn Pharma v CMA - Appeal fixed

  • 2 December 2019 – GSK v Merck Sharp & Dohme – settled

  • 10 December 2019 - Teva UK Limited and ors v Gilead Sciences Inc – Appeal fixed

  • 15 January 2020 – Glaxo v Vectura – Appeal fixed

Ireland

  • Anthropharm (Europe) Limited v Health Products Regulatory Authority Court of Appeal 2018 1080 JR Case ongoing

Decisions expected

  • Dr Reddy's Labs & Ors v Napp Pharmaceuticals (HP 2016 000013) – settled

  • Allergan Limited v Aspire Healthcare Limited (HP 2018 000001) – settled

Ireland

  • Merck Sharp & Dohme Corp -v- Clonmel Healthcare Ltd (McDonald, J) Ezetimibe & Impastation combination

Decisions

'Flood' of disclosure of clinical study reports curbed for now

C-175/18 PTC Therapeutics International v EMA and C-178/18 MSD Animal Health Innovation GmbH, Intervet international BV v EMA

As we discussed in Life-Lines on 10 October 2019 pharma industry concerns that commercially sensitive details from clinical trials they organise are subject to disclosure will ease if the EU's highest court follows the advice it has been given recently. The opinions of advocate general (AG) Gerald Hogan in the these two recent cases suggest that detailed clinical study reports (CSR) and other pre-clinical or clinical documents featuring know-how or details of expensive and time-consuming product safety testing will not be automatically subject to disclosure by the European Medicines Agency (EMA). Read our analysis of the cases here.

EU Courts entitled to consider behaviour of parties when considering if PI application is an abuse

C 688/17 Bayer Pharma AG v v Richter Gedeon & Exeltis Magyarország

This case considers the term 'appropriate compensation' in the Enforcement Directive (EU 2004/48/EC). In its decision, the Court of Justice of the European Union (CJEU) has confirmed that the national courts of the EU member states are not obliged to order an award of damages when an injunction is lifted automatically. In this case the CJEU found that the term ‘appropriate compensation’ in the Enforcement Directive did not preclude national legislation that deemed a party ineligible for damages when a preliminary injunction was issued as ‘a result of failure to behave as generally expected to avoid losses’. The generics firms in this case had launched at risk in the knowledge that a patent was pending. The CJEU ruled that, in these circumstances, Bayer’s application for a preliminary injunction was not unjustified even when the patent was subsequently found to be invalid. Decision

Brands can claim exclusive rights to a colour

Glaxo Wellcome UK Limited & Anor v Sandoz Limited & Ors [2019] EWHC 2545

A recent UK court ruling shows that businesses require strong evidence from customer surveys or expert witnesses to demonstrate the link between a colour and their brand to prevent rivals using the same colour to market their products. As we reported previously in Life-Lines pharmaceuticals business Glaxo lost a legal battle with generic medicines manufacturer Sandoz before the High Court in London over rights to market asthma inhalers coloured a particular shade of purple. The High Court's ruling has wider implications than for just the pharmaceutical sector. More

Court of Appeal confirms correct health and safety sentencing approach

BUPA Care Homes Limited v R. [2019] EWCA Crim 1691

A parent company's turnover will be largely irrelevant when considering the appropriate level of fine for a company found to be in breach of its health and safety obligations, according to the English Court of Appeal in this recent case. The mere fact that a company is a wholly owned subsidiary of a larger parent does not mean that the resources of the parent can be treated as either available to the subsidiary or as part of the subsidiary's turnover. More

Ireland

SPC for Truvada revoked

Gilead Sciences v Teva Pharmaceuticals and Mylan Dublin [2019] IEHC 683

The Irish High Court has dismissed allegations of infringement of a supplementary protection certificate (SPC) for HIV drug Truvada and ruled that the SPC in issue should be revoked. The Irish proceedings, originally scheduled for 2018, had been adjourned pending the outcome of a reference made by the High Court in England and Wales, in the course of similar proceeding in the UK, to the Court of Justice of the European Union (CJEU). The reference sought clarification of the interpretation of Article 3(a) of Regulation 469/2009 (the SPC Regulation). Decision

Brexit

Where we are

The EU has agreed to extend the date of the UK’s withdrawal from the EU until 31 January 2020. Whilst the extension will be a welcome relief to businesses as it avoids an imminent no-deal scenario, as our colleague Clare Francis says "the ‘flextension’ nature of the extension makes it challenging for businesses to plan". The ever-changing political environment means a swift Brexit could materialise at any time during the coming months. Therefore businesses will need to remain agile and be prepared for any situation. This takes time and resource and means critical decisions are likely to be placed on hold yet again while that much needed certainty of the future direction remains elusive. Some businesses may see the latest extension as simply ‘the boy that cried wolf’ and scale back no-deal contingency planning as Brexit paralysis takes hold. Given this is the third extension this response is understandable. However, this could lead to utter chaos for businesses should a swift exit from the EU materialise in the coming months. More

What's new?

International trade mark registrations after Brexit

International trade mark registrations protected in the EU under the Madrid Protocol will no longer enjoy protection in the UK after Brexit. The UKIPO have published new guidance. It confirms that on exit day, international trade mark rights will be immediately and automatically replaced by UK rights. Therefore if you own an existing right, you do not need to do anything at this stage. Guidance

Brexit resources

Withdrawal Agreement Briefing

This Briefing contains details of the key changes made to the Protocol on Ireland/Northern Ireland, the process for ratification, a summary of the key areas of consensus, and where appropriate suggests actions that businesses can take to manage risk now and to gain advantage. More

The life sciences sector and preparing for Brexit

This resource created by the Department for Business, Energy & Industrial Strategy (BEIS) collates guidance for preparing for a no deal EU Exit and can be viewed here.

Continuity of supply

The NHS England's website page regarding the continuity of supply of medical products can be viewed here.

No-deal handbook: A practical guide to preparing for a possible no-deal Brexit

Pinsent Masons' Brexit Advisory team have created a handbook to help businesses planning for a no-deal Brexit to understand what essential steps they should take to prepare for Exit Day, and how to mitigate the potential risks. Specific advice is available for sectors including Life Sciences. The handbook can be viewed here.

Report: How are the EU institutions and European countries preparing for Brexit?

Pinsent Masons' Brexit Advisory team have created a briefing to support businesses seeking to understand what specific changes to the law are currently being considered in light of Brexit. Insights have been gathered from our network of EU offices as well as from Belgium, France, Ireland, Italy, Germany, Spain and Switzerland. The briefing can be viewed here.

Pinsent Masons Brexit Hotline

Pinsent Masons has set up a Brexit Hotline to support clients to prepare their business for Brexit. GCs, in-house legal and operational teams can use this service to seek advice on specific Brexit-related issues or to identify the steps they could be taking now to prepare. The service can be accessed by email or phone:

E: Brexit Hotline T: +44 20 7490 6279

More information about our Brexit services can be found on our Brexit hub.

Other news

The UK Purdah rules explained and how it may impact your business

The UK parliament dissolved on 5 November for the General Election campaign and purdah rules now apply, placing limits on what Government Ministers and civil servants can do in the run-in to December 12th. Under purdah rules, Ministers remain in charge of their departments and the essential business of Government carries on, up to and including Election Day. However, during this time, Ministers must defer major decisions on policy, commercial contracts or senior public appointments, on which a new government might take a different view from the present administration. Additionally, during purdah civil servants must avoid activity which would distract from, or compete for attention with the General Election. A short briefing, produced by our Public Policy team, on purdah and how it may impact your business

WHO Digital Health Technical Advisory Group meets

The World Health Organization (WHO) Digital Health Technical Advisory Group met for the first time last week to discuss its plans over the next two years to "address the world’s most pressing health challenges". Topics discussed at the meeting included data governance and the ethical and equitable use of digital technologies. An action plan was agreed at the meeting which will enable the group to focus its activities and priorities while also "safeguarding the misuse of people’s data and protecting their health.” Press release

EC published the final reflections of RISE Group

The European Commission published on 25 October 2019 the final reflections of the Research, Innovation and Science Expert Group (RISE). Building on previous work, the report provides insights on science diplomacy, citizens’ engagement, disruptive technologies, procurement for innovation and mission-oriented policies. Amongst the key finding: disruptive technologies such as 5G, artificial intelligence (AI) and blockchain are key for EU competitiveness; transforming a traditional research-driven university into an innovation-driven entrepreneurial institution is a global — and not Europe-specific — challenge; and procurement is a potentially powerful instrument for driving innovation. Report

High-growth firms and intellectual property rights: the IPR profile of high-potential SMEs in Europe

This study, produced jointly by the EPO and the European Union Intellectual Property Office (EUIPO), looks at the use of IPR by high-growth SMEs and analyses how these firms shape their IPR strategies prior to experiencing high growth. Report Summary Key findings on patents

2019: Intellectual property rights intensive industries and economic performance in the EU – industry-level analysis reports

These studies analyse the contribution made by Intellectual Property Rights (IPR)-intensive sectors to the EU economy. They cover all major IP rights: patents, trade marks, designs, copyrights, geographical indications and plant varieties. They identify which industries make above-average use of those IP rights. Video 2019 Study

2019: Market success for inventions: Patent commercialisation scoreboard: European SMEs

This study by the Chief Economist analyses how small and medium-sized enterprises (SMEs) are successfully leveraging their inventions for commercial purposes. The report identifies a variety of approaches, with a focus on collaborations with a partner from another European country. The methodology is stratified across three main sectors including healthcare, biotechnology and chemistry (HBC). Scorecard Key findings

Producers to be made responsible for packaging waste under new legislation

The UK government has introduced legislation aimed at making producers more responsible for the packaging waste they produce. The government announced the Environment Bill in the Queen’s Speech. It has since published the draft legislation. Commons Library analysis of the Environment Bill More

CMA competition concerns on Illumina/Pacific Biosciences of California merger

As part of its Phase 2 investigation, the Competition and Markets Authority (CMA) has recommended that the acquisition by Ilumina of Pacific Biosciences of California is prohibited after provisionally finding that it is likely to result in a substantial lessening of competition (SLC). There are concerns that the merged entity would cause a significant loss of competition between the two companies, with few alternative providers of DNA sequencing systems remaining. Provisional findings

FRC sets out expectations on corporate reporting

Corporate reporting needs to improve to help build public trust in businesses, the Financial Reporting Council (FRC) has said. More

Boardroom Briefing November 2019

The November issue of Boardroom Briefing, our one page monthly update on corporate governance and related issues discusses: the FRC’s new Stewardship Code, aiming for more transparency as to the activities of institutional investors; an FRC Lab report with guidance for company disclosures on the sources and use of cash; a second FRC Lab report aiming to help companies with climate-related reporting; Investment Association guidelines on bringing directors’ pension contributions in line with those for the rest of the workforce; the use of paper and electronic proxy forms; and a webinar on 13 November previewing Grant Thornton’s 2019 Governance Review and talking about emerging governance practices. Boardroom briefing

Pinsent Masons' International White Collar & Corporate Crime Briefing October 2019

Our International White Collar & Corporate Crime Briefing is a round-up of white collar & corporate crime legal and business developments with analysis and commentary from the international white collar & corporate crime team at Pinsent Masons. Topics include: AML enforcement increase should prompt companies to review policies; and Pinsent Masons' Annual Business Crime & Compliance Conference on 14 November. White Collar & Corporate Crime Briefing

Digitisation of prescriptions

The electronic prescription service (EPS) will be rolled out nationally next month, and intends to make prescribing and dispensing medicines and collecting repeat prescriptions faster and easier by digitising all prescriptions. Patients will be given a unique prescription barcode, which they will be able to scan at any pharmacy to retrieve medication details. It is anticipated that the EPS will save the NHS £300 million by 2021. Press release

Dialogue with Chinese authorities on medicine regulation

In line with the ongoing EU-China regulatory dialogue on pharmaceuticals, the European Medicines Agency (EMA) recently met with the Deputy Commissioner of the Chinese National Medical Product Administration (NMPA). Discussions covered good manufacturing practice (GMP) standards for active pharmaceutical ingredients, good clinical practice (GCP) standards, and the Commission’s strategic approach to pharmaceuticals in the environment, as well as a common training curriculum focused on GMP and GCP standards. Press release

Patent Box offers tax savings on innovation

Many businesses are unaware of the tax savings they could make by electing innovative technologies they own patents for into the UK's Patent Box regime. The Patent Box regime allows companies "to pay tax on qualifying profits earned from its qualifying patents or patented inventions at just 10%". Businesses are urged to undertake an audit to understand what IP rights they hold and identify where protection is lacking. More

Regulatory

NHS England seeks views on draft NHS Commercial Framework for Medicines

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access committed NHS England to publishing a commercial framework, giving additional detail on the commercial arrangements it has with industry. The Voluntary Scheme outlined an increasing role for NHS England working alongside the National Institute for Health and Care Excellence (NICE) and industry to support the introduction of clinically and cost-effective medicines. The NHS Commercial Framework for Medicines (“the Framework”) aims to set out the NHS’ approach for commercial activity for branded medicines. The Framework, and the activity it will potentially enable, aims to support both NHS England and NICE’s ambition to deliver patient access to proven, affordable and transformative medicines in a financially sustainable way. For the pharmaceutical industry, it aims to encourage faster market entry for new treatments and support uptake and adoption where these medicines are priced fairly and responsibly. The draft Framework makes clear that confidential complex commercial arrangements are expected to be considered only for products which represent value at or below the lower end of the standard NICE threshold or other applicable thresholds. Engagement is a key element of the Framework and the schematic on page 14 outlines the opportunities for engagement with NICE and NHS England. Examples of the commercial options available to companies are set out in Section 5. NHS expects that the Framework will be expanded in the future to include, for example, information on the commercial approach for biosimilar and generic medicines. Section 3 will be of interest to all companies. There will be stakeholder engagement and two workshops (dates to be confirmed) over the next 10 weeks (to take account of UK purdah, closing on Friday 10th January 2020) and NHS England expects to publish a first edition in early 2020. Draft framework Overview

Clinical trial authorisation process fast-tracked in France

Pharmaceutical companies will be able to obtain speedier authorisation for clinical trials of new medicines in France under new plans outlined by the country's medicines regulator, following a successful pilot exercise. The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) provides two distinct routes for pharmaceutical companies depending on the nature of the product they wish to trial – the 'access to innovation' track and the 'support for development' track. A third fast-track route to support speedier authorisation of clinical trials concerning innovative therapies (gene and cell therapies) is also due to be introduced. More

First dual notified body designation

The European Commission (EC) has announced that the first dual Notified Body (NB) to be designated under the EU's In Vitro Diagnostic Regulation (IVDR) and the Medical Devices Regulation (MDR) is BSI Assurance UK Ltd. Updates on NB's can be viewed on the EC's New Approach Notified and Designated Organisations (Nando) Information System. Nando

MDCG guidance and work on medical device regulations

The European Commission Medical Device Coordination Group (MDCG) has published a document outlining its ongoing work and its plans to publish new guidance documents on the new medical device regulations (MDR and IVDR). The main focus is on notified bodies (NBs) and clinical investigations and evaluation (CIE). Guidance development

State of play of the implementation of EUDAMED

The new In Vitro Diagnostic Regulation (IVDR) and the Medical Devices Regulation (MDR) establish a much wider EUDAMED database than the existing one under the current directives. It is now anticipated that EUDAMED will be launched in May 2022 once all modules, including those on unique device identifiers, notified bodies and clinical investigations, are fully operational. Update

Good practice to assess GMO aspects for in-vivo gene therapy products

The European Commission has published a new document concerning good practice on the assessment of genetically modified organisms (GMO) related aspects in the context of clinical trials with Adeno-associated virus (AAV) clinical vectors. Guidance

EMA's guidance on testing for Nitrosamine Impurities

The European Medicines Agency (EMA) has issued guidance for marketing authorisation holders (MAH) on how to avoid the presence of potentially cancer-causing impurities which have been identified in some blood pressure and heartburn medicines. The guidance sets out a three step process for MAH's, including the requirement to conduct a risk evaluation of products at risk of N-nitrosamine formation by March 2020. Guidance

Events and webinars

  • 7 Nov 2019: Diversity & Inclusion: Your essential update - Register

  • 13 Nov 2019: Emerging governance practices - what can we learn from them? - Register

  • 14 Oct 2019: The future of the generics industry in the UK – what lies ahead? This is a joint breakfast event with the BGMA off the back of a recent report by economics consultancy Oxera, commissioned by the BGMA. Please register your interest to attend - here (places are limited)

  • 14 Nov 2019: Pinsent Masons' Annual Business Crime & Compliance Conference - Register

  • 28 Nov 2019: How to make data pay: the exploitation of intangible assets - Register

  • 12 Dec 2019: Competition Law Issues in Digital Markets - Register

Consultations

New consultations

Strategic Agenda for Innovation in Healthcare under Horizon Europe

In line with the proposed European Health Innovation Public-Private Partnership (PPP) under Horizon Europe, five industry associations are working closely to create a Strategic Agenda for Innovation in Healthcare. The associations (COCIR, EFPIA, MedTech Europe, EuropaBio and Vaccines Europe) are seeking comments from the public and stakeholders to contribute to the Strategic Agenda, which intends to guide research and innovation and address key European healthcare challenges. The consultation closes on 15 November 2019. Consultation

Open consultations

Enpr-EMA seeks views on draft framework for paediatric clinical trial preparedness

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has opened a consultation inviting comments on its draft framework for paediatric clinical trial preparedness. The framework outlines recommendations for discussions about paediatric clinical trial preparedness and intends to allow for smooth and timely conduct. The consultation closes on 15 November 2019. Consultation

Cybersecurity in medical device regulation

A consultation launched by the International Medical Device Regulators Forum (IMDRF) aims to strengthen cybersecurity in medical device regulation. The IMDRF invites responses to its draft guidance on the general principles and best practices of cybersecurity in regulation of medical devices, which includes recommendations for pre-market and post-market management of medical device cybersecurity. The consultation closes on 2 December 2019. Consultation

Consultation on revised draft guide on the manufacture of ATMPs and Biological Medicinal Substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) seeks comments from stakeholders on its revised draft Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use). Both annexes form part of the guide to good manufacturing practice (GMP) for medicinal products. The consultation closes on 20 December 2019. Consultation