Life-Lines

Looking Ahead

UK Courts

• 11 – 12 February – Regeneron v Kymab – Supreme Court hearing Our comment
• 2 March 2020 – Akebia & GSK v Fibrogen – trial floating in 5 day window
• 1 April 2020 – Regen Lab SA v Estar Medical Limited – Appeal
• 28 – 29 April 2020 – Flynn Pharma v CMA – Appeal (costs)
• 29 June 2020 – Wyeth LLC v Merck Sharp & Dohme – trial floating in 5 day window
• 20 July 2020 – Edwards Life Sciences v Meril – trial fixed

EU

• 12 March 2020 – T-594/18 Pharma Mar v Commission – CJEU hearing

EPO

• 24 March 2020 – EP 2 215 124 PCSK9 inhibitors (Kexin Type 9) – BoA hearing

New Life Sciences cases

UK courts

• HP-2020-000004 Ceva Sante Animale SA v Bayer Intellectual Property GMBH
• HP-2014-000048 Alcon Research Limited & Anr v Aspire Pharma Limited & Anr
• LM-2020-000020 NAPP Pharmaceuticals Limited v Pharmaceuticals Direct Limited & Anr
• QB-2020-000470 AstraZeneca UK Limited & Anr v [[Defendant]]

Decisions expected

UK courts

• Flynn Pharma v CMA – Appeal
• Evalve v Edwards Life Sciences

EU

• 12 March 2020 – C-586/16 P Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission – listed for an Opinion

Decisions

Reverse payment settlement agreements under scrutiny

C‑307/18 Generics UK Ltd & Ors v CMA

Competition authorities across Europe are likely to enhance their scrutiny of reverse payment settlement agreements in pharmaceuticals markets in light of a ruling issued by the EU's highest court. The Court of Justice of the EU (CJEU) provided some clarification on when reverse payment settlement agreements will constitute agreements that restrict competition by object, restrict competition by effect and/or breach rules on the abuse of a dominant market position. The ruling lowers the bar for antitrust enforcement involving reverse payment settlement agreements and will have significant implications for pharma companies who are considering the settlement of a dispute or litigation. Decision More

Free samples of medicinal products can be distributed only to persons qualified to prescribe them advises AG

C-786/18 Ratiopharm v Novartis Consumer Health GmbH

The Advocate General (AG) advises that EU pharmaceutical legislation (Directive 2001/83 on the Community code relating to medicinal products for human use) does not preclude pharmaceutical companies from distributing free samples if they are distributed according to the conditions laid down in Article 96(1) of that Directive, and they are distributed only to persons qualified to prescribe them. Novartis Consumer Health, by an action in the German courts, sought to prevent Ratiopharm from supplying samples of a generic of one of its medicines 'for demonstration purposes' to pharmacists. The German Bundesgerichtshof (BGH) seeks the advice of the Court of Justice of the EU (CJEU) on whether EU rules governing the supply of medicine samples to physicians, as defined by Article 96 of Directive 2001/83/EC on the Community Code relating to medicinal products for human use, could also be extended to pharmacists. Opinion

Patents: bid to name machine as inventor rejected by EPO

An attempt to register a machine as an inventor has been rejected by the European Patent Office (EPO). US-based applicant Stephen Thaler had applied to the EPO seeking registration of two European patents for inventions that he claimed derived from a machine called 'DABUS', which Thaler described as "a type of connectionist artificial intelligence". The EPO said that the applications did not conform to the requirements of the European Patent Convention (EPC). Decision More

Brexit

Where are we?

The UK entered a transition period on 1 February. It lasts until 31 December 2020 while the UK and EU negotiate additional arrangements. The transition period can be extended by the Joint Committee established under the Withdrawal Agreement adopting, before 1 July 2020, a single decision extending the transition period for up to 1 or 2 years. However, the UK Government has said that it will not extend the Implementation Period beyond December 2020.

The UK will continue to stay aligned to EU law during the transition period. Any new EU legislation that enters into force during the transition period will become part of the EU ‘Acquis Communautaire’, with which the UK is expected to comply during the transition period e.g. the EU Medical Devices Regulation (EUMDR 2017/745) (MDR) that is due to enter into force on the 26th May 2020.

What's new?

Call for post-Brexit medicines regulation guidance

Guidance is needed to help pharmaceutical businesses understand what they can do to ensure new medicines before the European Medicines Agency (EMA) for approval can be sold in the UK after the Brexit transition period expires on 31 December 2020. Despite the EMA's recent publication of new Brexit 'Q&A' guidance, it is not clear what further steps manufacturers that submit their applications to the EMA during the Brexit transition period will be required to undertake in order to continue to sell medicines in both the EU and the UK after 31 December 2020. More

Supply and safety of medicines post Brexit

The European Medicines Agency (EMA) has issued new Brexit 'Q&A' guidance on preventing medicine shortages as a result of Brexit. The guidance outlines the changes that companies must make to comply with EU law, the risk to the supply of medicines during the implementation period, the medicines at risk of shortages and whether the safety of medicines will be impacted post Brexit. Q&A

Pharmaceutical regulation and legislation during the transition period

The European Medicines Agency (EMA) has confirmed that EU pharmaceutical laws set out in the ‘Acquis Communautaire’ will be applicable in the UK during the transition period. In order to ensure that authorised medicines comply with EU law and remain on the EU market post Brexit, companies must make the necessary changes by 31 December 2020 – see Q&A guidance and our comment above. Press release

Medical device regulation and legislation during the transition period

The UK will continue to stay aligned to EU law during the transition period. Any new EU legislation that enters into force during the transition period will become part of the EU ‘Acquis Communautaire’, with which the UK is expected to comply during the transition period e.g. the EU Medical Devices Regulation (EUMDR 2017/745) (MDR) that is due to enter into force on the 26th May 2020.

Effectively, during the transition period, everything remains as before (subject of course to any changes that might be required to comply with the MDR). CE Certificates issued by UK Notified Bodies, for example the BSI, continue to be valid for both EU and UK markets and UK Notified Bodies can continue to conduct conformity assessments for medical devices being placed on the EU and UK markets. UK-based manufacturers do not require an EU Authorized Representative based in an EU member state to place their medical devices on the EU market. Manufacturers outside of the UK and EU whose existing EU Authorized Representative is based in the UK or EU can continue with this arrangement until the end of the transition period.

Quality and safety of human blood and blood products

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on what blood establishments, blood banks and manufacturers of blood products need to do to ensure the safety and quality of blood and blood products during the transition period. The guidance confirms that from 1 January 2021, the UK will maintain the existing quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components. Guidance

UK data protection divergence post Brexit

The Information Commissioners Office (ICO) has announced that data protection laws, including the General Data Protection Regulation (GDPR), will continue to apply in the UK until the transition period expires on 31 December 2020. However, the Prime Minister has highlighted the UKs intention to diverge from EU data protection laws post Brexit. In a written statement the Prime Minister suggested that the UK "will in future develop separate and independent policies" in certain areas, including data protection. ICO statement Prime Ministers Written statement

IPO guidance on IP rights

The Intellectual Property Office (IPO) has released updated Brexit guidance in preparation for the changes which will come into effect at the end of the implementation period. The series of guidance covers SPC and patent law, as well as unregistered community designs, international designs, EU trade mark protection and international trade marks.

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

Guidance on what the implementation period means for the life science sector

This guidance document published in August 2018 sets out what the agreement on the terms of an implementation period would mean for the life sciences sector. Guidance

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.

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.

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 and updates

Concept of sufficiency comes before UK Supreme Court in Regeneron patent case

A hearing is underway before the UK Supreme Court in a case that could provide clarification on one of the grounds for invalidating patents in UK law. Regeneron and Kymab are in dispute over the validity of patents owned by Regeneron. The hearings before the Supreme Court, scheduled for 11 and 12 February, will consider the concept of 'sufficiency' under UK patent law. More

Workshops on the sharing of personal data in the health sector

The first of a series of workshops which will contribute to a legal study in view of the future establishment of a European Health Data Space (EHDS) have begun. The aim is to identify gaps in the sharing of health data between Member States by analysing the application of national and EU rules on the processing of health data. The EHDS will support the primary use of data (used for healthcare delivery) and secondary use of data (used for research, policymaking and development of private services in the field of health). Press release

IR35: only services provided after 6 April 2020 will be subject to new rules

The changes to the IR35 off-payroll working rules will only apply to payments made for services provided from 6 April 2020, HM Revenue and Customs (HMRC) has confirmed. More

NHS tech drive welcomed

Plans to drive technological change in the NHS will be welcomed by NHS trusts and medical technology developers alike. At a recent conference hosted by the Healthtech Alliance, the health secretary in England outlined a range of measures aimed at promoting tech-driven innovation in the NHS, including new funding for testing health technologies, plans for improved data infrastructure, and a drive to boost digital skills and understanding within NHS trust boards. Hancock said he wants the NHS to be a place where cutting-edge innovation in areas such as genomics and artificial intelligence (AI) can be implemented. More Health secretary speech

Electronic product information in the EU

Key principles outlining a harmonised implementation of electronic product information (ePI) for human medicines across the EU have been published by the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission (EC). The ePI aims to support the digital transformation of healthcare across the EU by making the information found on the package leaflet and the summary of product characteristics electronically accessible. EMA press release Key principles

Health agencies contribution to fighting coronavirus

Following the World Health Organization’s (WHO) announcement last week that the spread of the novel coronavirus is a public health emergency, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and WHO have taken various precautions and prepared for new medicines, vaccines and in vitro diagnostics (IVDs). The EMA has highlighted its commitment to provide support with regulatory tools to advance the development of measures to fight and prevent the spread of the virus. Press release

Managing the business impact of the coronavirus

Business operations managers should continue to monitor the impact of the coronavirus outbreak on their employees, facilities and supply chains as decisions may need to be made quickly to take account of what is a fast-changing situation. Our comment

Medical devices: Latest Notified Body designations

The European Commission (EC) has announced Norwegian DNV GL Presafe AS as the latest Notified Body (NB) to be designated under the EU's Medical Devices Regulation (MDR). Updates on NB's can be viewed on the EC's New Approach Notified and Designated Organisations (Nando) Information System. Nando

CMA tasked with reporting on state of competition

The UK's Competition and Markets Authority (CMA) is to produce regular 'state of competition' reports in a global first for competition regulators. The UK government has said that the reports should inform policy making and regulatory intervention in UK markets. The first 'state of competition' report from the CMA is to be published this summer. More

European Commission Work Programme for 2020

The European Commission has released its Work Programme for 2020, announcing digital transition as an ambition for the year. The Work Programme highlights the European Commission's intention to establish a new European Data Strategy and put forward a White Paper on Artificial Intelligence (AI) to support and promote a safe digital environment. Press release Work Programme

Regulatory

EMA pre-authorisation procedural advice

The European Medicines Agency (EMA) has issued updated pre-authorisation procedural guidance for users of the centralised procedure which addresses questions that users may have and provides an overview of the EMA's position on specific issues. In particular, the document contains guidance on what applicants should submit when their medicinal products contain or consist of genetically modified organisms (GMOs). Guidance

Grace period for manufacturers if scope of designation of the current Notified Body changes

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance regarding Notified Bodies for medical devices. The update outlines how manufacturers will be allowed a grace period to continue placing products on the EU market while they transition to a new Notified Body if the scope of designation of the current Notified Body changes. There are no specific provisions under current legislation for the ongoing validity of CE certificates in such a scenario. Guidance

CHMP meeting highlights

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 15 medicines for approval at its first meeting of 2020. Eight new medicines and six generic and hybrid applications were recommended, as well as Pfizer’s biosimilar Ruxience (rituximab). CHMP meeting highlights

Events and webinars

• 12 March 2020: Trade Secrets & Personal Data
• 18 March 2020: Annual Competition Law Conference

Consultations

New consultations

No new consultations.

Open consultations

Community pharmacies promoting health and wellbeing - NICE draft quality standard

The National Institute for Health and Care Excellence (NICE) seeks comments on its draft quality standard published recently. NICE proposes in the draft quality standard that community pharmacy teams should be more involved in health promotion and prevention by being included in existing care and referral pathways. The consultation closes on 14 February 2020. Consultation Press release Briefing paper

Consultation on the statutory scheme for branded medicines

The Department for Health and Social Care (DHSC) is seeking comments on the proposed adjustments to the payment percentages under the statutory scheme to control the costs of branded medicines. The consultation closes on 17 February 2020. Consultation

Draft policy on designating regulators as WHO Listed Authorities

The World Health Organization (WHO) is welcoming feedback on its draft policy for evaluating and designating Regulators as WHO Listed Authorities. The policy provides a framework to ensure that medicine regulators can be globally recognised as meeting WHO and other internationally recognised standards and practices, with the aim of strengthening medicinal products' regulatory systems. The WHO aims to assist countries in reaching a level of regulatory oversight that is effective, efficient and transparent. The consultation closes on 28 February 2020. Draft policy

EMA reflection paper on GMP and MAH's

The European Medicines Agency (EMA) recently published a draft reflection paper for consultation on good manufacturing practice (GMP) which applies to marketing authorisation holder (MAH) companies. The paper aims to provide clarity as to the various responsibilities of MAH's outlined in the European Commission's GMP guide. The deadline for comments is 17 April 2020. Draft reflection paper