Life-Lines

10 October 2019

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Looking Ahead

  • 21 October 2019 - Unwired Planet v Huawei - Trial fixed
  • 31 October 2019 - UCB v Chugai - Appeal floating
  • 26 November 2019 - Flynn Pharma v CMA - Appeal fixed
  • 2 December 2019 - GSK v Merck Sharp & Dohme - Trial floating
  • 10 December 2019 - Teva UK Limited and ors v Gilead Sciences Inc - Appeal fixed
  • 15 January 2020 - Glaxo v Vectura - Appeal fixed

Ireland

  • 25 October 2019 - Genentech Inc v Amgen Inc & Anor (Injunction) (Costs) (Avastin/Mvasi (Bevacizumab)) Commercial List: 2019 01906 P - interim discovery motions and directions (no further details available)
  • 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)
  • Allergan Limited v Aspire Healthcare Limited (HP 2018 000001)

Ireland

  • Merck Sharp & Dohme Corp -v- Clonmel Healthcare Ltd (McDonald, J) Ezetimibe & Impastation combination
  • Gilead Sciences Inc & Anor -v- Mylan S A S & Ors (2017 05984 P)

Decisions

Purple inhalers: GSK's passing off claim dismissed

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

In a chunky judgment, Lord Justice Arnold has dismissed GSK's passing off claim against Sandoz and Vectura. The Judge seemed to accept that there were legitimate reasons for Sandoz and Vectura to choose the colour purple for their inhaler, including that many asthma/COPD patients need more than one inhaler and need to be able tell these apart. In addition, there was evidence of informal colour coding conventions and accordingly the use of purple would help to reassure patients that they are receiving the correct medication/using the correct inhaler. Decision

Opinion leaves open questions on SPCs in pharma patent claims

C-114/18 and C-650/17 Sandoz Ltd v G.D. Searle LLC and Royalty Pharma Collection Trust

The way in which active ingredients in pharmaceutical products should be protected by patents so that the products are eligible for supplementary protection certificates (SPCs) is unfortunately not completely clarified despite this new Opinion from the CJEU. The Opinion considers the interpretation of Article 3(a) of the SPC Regulation which requires the product that is the subject of the SPC to be 'protected by a basic patent'. Read more AG Opinion

CJEU agrees 'active substance' and 'medicinal product' are distinct concepts

C-359/18 EMA v Shire Pharmaceuticals Ireland Ltd

The Court of Justice has upheld the General Court's annulment of the European Medicine Agency's (EMA's) refusal to validate Shire's orphan designation on the basis that Shire's new product contains the same active substance as an existing orphan product for the same rare disease. Companies may now be eligible for separate periods of orphan exclusivity when new medicines are developed containing the same active substance, provided it can be demonstrated that the new therapy offers a 'significant benefit' (that is a clinically relevant advantage or a major contribution to patient care) to patients over existing medicinal products. The EMA's conclusion that two medicinal products are identical if they contain the same active substance and are for treating the same indication was rejected by the CJEU as too simplistic. Decision

CJEU rejects reference on SPC applications based on third-party MA

C‑239/19 Eli Lilly and Company v Genentech Inc

The Court of Justice has refused a request for a preliminary ruling on the interpretation of Article 3(b) of the SPC Regulation (Regulation 469/2009) because the referred question was 'hypothetical' as in this case the basic patent has been held invalid. The CJEU held that it is not sufficient to say that there may be an appeal down the line which may render the hypothetical scenario true. The referral request was made by the UK High Court in the case of Eli Lilly and Genentech ([2019] EWHC 388 (Pat)). The referral was concerned with whether the SPC Regulation precluded SPC applications for a product by patent holders based on third-party marketing authorisations (MAs) without the consent of the unrelated third party that has developed that product and obtained the necessary MA for it. Decision

AG considers presumption of confidentiality in two of the access to document cases

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

Advocate General Hogan has in these cases held that the General Court erred in law in its conclusions that (a) there was no general presumption of confidentiality and (b) access to the study reports submitted in a marketing authorisation application dossier at issue would not compromise the applicants' commercial interests. AG Hogan found that the General Court had applied the wrong test, thus reaching the wrong conclusion on whether a general presumption of confidentiality should be recognised with respect to the documents in issue. Another case on this issue is pending (Intercept Pharmaceuticals v EMA, (Case, C-576/19)). AG Opinion C‑178/18 P AG Opinion C-175/18 P

UK Patent Court refuses stay pending outcome of proceedings before EPO

Coloplast A/S v Salts Healthcare Ltd [2019] EWHC 1979 (Pat)

The court ruled in this case that the default position of a stay under the IPCom guidance (the roadmap for the court when exercising its discretion to grant or withhold a stay) is displaced. Coloplast had demonstrated that there were other factors that displaced the default option, one being that it had offered an undertaking that if the proceedings are not stayed; it would repay any damages awarded by the UK court if the EPO later revoked the Patent. Decision

Trade mark use in clinical trials may not prevent revocation for non-use

C-668/17 Viridis Pharmaceuticals Ltd

This case highlights the need to carefully consider the timing of trade mark applications as part of the regulatory and commercial strategies for a medicinal product so as to reduce the risk of revocation for non-use. Decision (not available in English)

Ireland

Irish Supreme Court clarifies patent injunction test

Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd [2019] IESC 65

Holders of patent-like rights in the medicines market are not automatically barred from winning injunctions to prevent generics launching rival products when there is an ongoing dispute over the validity of their rights even if it is possible to compensate them for the loss of their monopoly with damages in the event validity is subsequently proven. Ireland's Supreme Court confirmed the position when considering the legal test for determining when applications for interlocutory injunctions should be granted in cases where there is a dispute over the validity of supplementary protection certificates (SPCs). Decision Read more

Brexit

What's new?

Irish medical device manufacturers facing Brexit challenges

The Health Products Regulatory Authority (HPRA) has announced that some medical device manufacturers in Ireland are not yet ready to comply with EU regulations regarding device safety post-Brexit. Many medical device manufacturers currently rely on UK-based notified bodies to issue a CE marking for their devices; however post-Brexit UK notified bodies will no longer be able to perform this role. The HPRA and other EU authorities are working together to develop a European approach to help manufacturers and manage UK certificates that have not transitioned by the deadline. Details

Brexit and the threat of supply chain failure

Many products and services in the UK depend fundamentally on fast, efficient supply chains. A no-deal Brexit has the potential to disrupt supply chains through border delays and escalating tariffs and costs. You can prepare for the effects of this, though, and companies should make sure they have plans in place to protect their supply chains. Read more

Changes to SPC and patent law in the event of Brexit without a withdrawal agreement

Updated guidance has been published on changes to Supplementary Protection Certificates (SPCs) and patent law in the event of a no-deal Brexit. The guidance explains any changes required to SPC and patent law and their impact on UK right holders, businesses, and other organisations, but also outlines the areas of SPC and patent law which are not affected. Updated guidance

Update on the DHSC's plans to support the continuity of supply of medical products

The Health Secretary, Matt Hancock, recently issued a parliamentary statement providing an update on the Department of Health and Social Care's (DHSC's) plans to support the continuity of supply of medicines and medical products into the UK if we leave the EU without a deal on 31 October. The statement covers: improving trader readiness for new border arrangements; building up buffer stocks; procuring extra warehousing space for stockpiled medicines; securing freight capacity; changing or clarifying regulatory requirements; and strengthening the processes and resources used to deal with shortages. Statement

Brexit impact on UPC project acknowledged by Germany

The German government has officially acknowledged that Brexit plays "an important role" in the implementation of the Unified Patent Court (UPC) project. In a recent letter to members of the Bundestag, Germany's parliament, the Federal Ministry of Justice confirmed that a Europe-wide examination of the implications of the UK's planned withdrawal from EU membership on the proposed UPC reforms has still to be completed, citing factors which it said are yet unknown regarding Brexit as the reason. Read more

Trade with the EU in a no-deal scenario

In a no deal scenario, the UK will trade with the EU as a most-favoured-nation under World Trade Organization (WTO) terms. Businesses should consider what changes this might have on how they trade with the EU and what impact it may have on their supply chains. Examples of actions the UK Government are suggesting include: registering for a UK and/or EU Economic Operator Registration and Identification (EORI) number; preparing for different requirements at the border; registering for simplified customs processes; and checking tariff rates under the UK temporary tariff regime and the EU Common Customs Tariff. HMRC has published a helpful mythbuster about EORI numbers and are hosting a series of webinars to provide an overview for UK businesses involved in the movement of goods between the EU and the UK. Details can be found here. The Department for International Trade is also working to negotiate agreements to replace EU trade agreements after Brexit. The latest list of agreed trade agreements can be found here.

NAO on Brexit preparations for health and social care

A report analysing the Department of Health and Social Cares (DHSC's) Brexit preparations, specifically the Continuity of Supply Programme, has been released by the National Audit Office (NAO). The NAO highlighted in its report that while the DHSC has done a great deal of work in the lead up to Brexit there is still significant work to do, including securing cross-government freight capacity. Press release

MHRA guidance on converting CAP's

Three additional letters to industry have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) on converting Centrally Authorised Products (CAPs) in a no-deal Brexit. The MHRA is reminding marketing authorisation holders of the required action to ensure that Community Marketing Authorisations (CMAs) are automatically converted into UK Marketing Authorisations (MAs). Letters to industry

Guidance on regulating medical devices in a no-deal Brexit

Updated guidance concerning regulating medical devices in the event of a no-deal Brexit has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Included in the update is a new section on a 'UK Responsible Person' who is able to carry out tasks in relation to a manufacturer's obligations where the manufacturer has been established outside the UK. The guidance covers how a UK responsible person can be certified, the criteria for one, and their responsibilities. Guidance

UK government launches "Get ready for Brexit" campaign

A 'Get Ready for Brexit' campaign has been launched by the UK government in the lead up to Brexit to guarantee that the UK is ready to leave the EU on 31 October 2019. The government has published a wide range of information regarding Brexit and is hosting a variety of 'Get ready for Brexit' events for businesses and organisations. A checker has also been published which allows businesses to identify actions required in preparation for Brexit. Campaign

MHRA sets out exceptions to good pharmacovigilance practices guidance post-Brexit

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance highlighting the exceptions and modifications to good pharmacovigilance practices (GVP) in a no-deal Brexit scenario. The guidance sets out the aspects of the GVP guidance that will no longer apply to the MHRA or UK marketing authorisation holders (MAH) in a no-deal Brexit or are to be read subject to modification. Guidance

UK Government Border Delivery Group advice for EU businesses trading with or via the UK

The UK Government Border Delivery Group (BDG) is running a series of webinars outlining the steps EU businesses trading with the UK may need to take before 31 October. According to the website, presentations will include information on border preparedness and customs procedures at the border and a Q&A session. You can register for the webinars here. Links for later webinars will be released in due course. The next life sciences webinars will be held on 17 October and 24 October from 8:00 - 9:30.

Brexit resources

The life sciences sector and preparing for Brexit

This resource created by the Department for Business, Energy & Industrial Strategy 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: [email protected] T: +44 20 7490 6279
More information about our Brexit services can be found on our Brexit hub.

Other news

UK Government publishes new guidance on the parallel export and hoarding of restricted medicines

The UK government has restricted the parallel export and hoarding of some medicines. The new guidance includes a list of medicines that cannot be parallel exported from the UK or hoarded. The list is being reviewed and updated regularly. The guidance also outlines the consequences of breaching the restrictions. Guidance Read more

UK embarks on new genome sequencing project

Anonymised human genomes stored by the UK Biobank are to be sequenced by health researchers in a project part-funded by pharmaceutical companies in a move aimed at supporting the development of personalised treatments for diseases. Read more

Germany to supplement EU medical device laws

Medical device laws in Germany are to be updated to supplement EU regulations that will take effect as early as next year. One of the main changes proposed is a move to strengthen the existing powers of the Federal Institute for Drugs and Medical Devices (BfArM) to intervene in cases where it has concerns about risks medical devices on the market pose to patient safety. The draft legislation, which was reportedly presented to German government departments earlier this summer, would centralise the powers to prohibit the use of certain medical devices in Germany with the BfArM. More

EU MDR/IVDR: US raise concerns and urges EU to delay implementation

In a recent statement to the WTO Committee on Technical Barriers to Trade (Document G/TBT/W/679), the US raised two particular concerns about the implementation of the MDR and IVDR. One is the insufficient number of Notified Bodies to perform certification activities under the MDR/IVDR (currently 5 are certified) and two, that the EU has drafted an insufficient number of the implementing acts needed to provide details about how industry can ensure that their products comply with the new product standards. The US is urging the EU to delay implementation by three years to allow for US exporters to adapt to new requirements or alternatively to allow for legacy products that are currently deemed safe to be sold on the market until 2024 and to ask Notified Bodies to provide new products, which require testing for the first time, with priority access to testing and CE marking certification over products being re-certified to the new requirements. US statement 

WTO Panel established to review Turkish pharmaceutical measures 

World Trade Organization (WTO) members agreed at a meeting of the Dispute Settlement Body (DSB) on 30 September to a request from the European Union for a dispute panel to review various measures concerning the production, importation and marketing of pharmaceutical products in Turkey. Full details of the EU's concerns are outlined here and include measures that encourage localisation of production. Dispute summary

ICO approves DeepMind's Streams app for patient data sharing trial at NHS Royal Free Trust

The Information Commissioner's Office (ICO) in a recent statement confirms that the Royal Free Trust is complying with its data protection requirements and that it has no outstanding concerns regarding the current processing of personal data within Streams. Whilst common law matters fall outside of the ICO's regulatory purview, the ICO says in the Statement that it is very aware that clinicians and developers are seeking regulatory clarity on the interplay between the duty of confidence and the data protection framework and will work with other bodies including the National Data Guardian and Health Research Authority, to improve guidance so that healthcare organisations like NHS Trusts can implement data-driven technology solutions safely and legally. In July 2017, following reports concerning the use of Google DeepMind's Streams application at the Royal Free NHS Foundation Trust, the ICO found that the processing of personal data within Streams was not compliant with UK data protection legislation. The Trust was asked to complete a number of actions including establishing a proper legal basis for future processing, making sure future developments also comply with the common law duty of confidence, completing a privacy impact assessment as well as commissioning an independent audit into the processing of patient data that had occurred during the implementation of Streams. ICO statement

CMA merger: Issues statement in Illumina, Inc./Pacific Biosciences of California, Inc

The Competition and Markets Authority (CMA) recently published the issues statement as part of its in-depth phase 2 investigation of the anticipated acquisition of Pacific Biosciences of California, Inc by Illumina, Inc. The deadline for the CMA's final decision is 11 December 2019. Issues statement

Assessing the kingmakers in an age of extremes

With a General Election on the horizon and recent polls showing that neither the Conservatives nor Labour party are looking likely to win a majority of seats in the UK parliament, businesses are well advised to consider the possible outcomes of this election. In the event of another hung parliament, any future government may struggle to deliver against policy pledges on which it will have stood for election. Making sense of the current situation is not straightforward as the balance of power in a hung parliament could rest with parties such as the Liberal Democrats and SNP, and sharp differences in views makes a formal coalition government unlikely. Instead, businesses might find themselves engaging with a parliament and a legislative agenda driven by informal agreements. More

UK R&D tax credits

Companies that incur expenditure on research and development (R&D) may be able to claim enhanced UK corporation tax relief. Small or medium sized enterprises (SMEs) may be able to obtain an enhanced 230% deduction or, if loss making, a payable tax credit of 14.5% of the enhanced deduction. Read more

No patents on naturally obtained plants and seeds

The European Parliament has passed a non-legislative resolution that states that fruit, vegetables or animals derived from conventional breeding processes, such as crossing, must be patent-free. In the resolution, the European Parliament has asked the EU Commission to persuade the European Patent Office (EPO) to halt the granting of patents to products obtained from essentially biological processes and clarify the law in this area. The resolution has been adopted before the 1 October 2019 deadline for the submission of statements on the patentability of naturally obtained plants to the Enlarged Board of Appeal at the EPO. Resolution

Spanish authorities back plans to promote patent-free medicines

Competition authorities in Spain have backed plans to introduce more generic and biosimilar medicines with the aim of increasing competitiveness in the pharmaceuticals market. In a recent report, the National Commission on Markets and Competition (CNMC) has endorsed an action plan published by the Spanish Ministry of Health in April. It has, however, made several recommendations to improve the Ministry of Health's proposals, with a particular focus on improving competition in the market as a whole, with greater involvement from patients and civil society as well as healthcare personnel. More

Boardroom Briefing October 2019

The October issue of Boardroom Briefing discusses: a warning from the FCA on access to inside information and insider lists following a three year prison sentence for a compliance officer; a report on the skillset of non-executive directors in smaller companies; Law Commission confirmation of the validity of e-signatures; directors' duties and climate change; and FCA guidance on culture and customers. Boardroom briefing

CMA issues statement of objections in fludrocortisone case

The Competition and Markets Authority (CMA) has issued a statement of objections to Aspen, Amilco and Tiofarma. The statement of objections follows Aspens’s admission (and settlement offer), on 14 August 2019, that it took part in an anti-competitive market sharing arrangement. The CMA has provisionally found that Amilco and Tiofarma colluded with Aspen by agreeing to stay out of the market, which enabled Aspen to maintain its position as the sole UK supplier of fludrocortisone. Aspen has agreed to a penalty of £2.1m. In addition, the CMA has formally accepted Aspen's settlement offer of commitments, made in August 2019. These commitments include offering to pay the NHS £8m and ensuring that, in the future, there will be at least two suppliers of fludrocortisone in the UK. Press release Settlement press release

GPhC takes action on unsafe supply of high-risk medicines by some online pharmacies

The General Pharmaceutical Council (GPhC) is taking action after identifying significant patient safety concerns in relation to supply of high-risk medicines online. Press release

DHSC announce investment in National Artificial Intelligence Lab

The Department of Health and Social Care (DHSC) has announced the development of a National Artificial Intelligence Lab as part of the NHSX, the new organisation that will oversee the digitisation of the health and care system. The AI Lab aims to tackle some of the biggest challenges in health and care by providing earlier cancer detection and more personalised care for patients. Press release

Pharmacies ready for enhanced role in health sector

The move to fund heart check-ups at hundreds of community pharmacies in England is to be welcomed given the "untapped potential" of those pharmacies to "take a more active role in primary care". Read more

Principles for genome editing developed

Gene editing technology is not yet ready to be used to pass genetic changes down to future generations, according to a number of biotech companies. Thirteen businesses that use gene editing technologies confirmed their view on the topic as they endorsed a new "bioethical framework for the use of gene editing in therapeutic applications". The statement of principles was developed under the umbrella of international lobby group The Alliance for Regenerative Medicine. Read more

Regulatory

Update in relation to the licensing status of bevacizumab

The Medicines and Healthcare products Regulatory Agency (MHRA) has published an update on the licensing status of bevacizumab when intended for intravitreal administration. The MHRA clarification draws a distinction between the functions regulated in the European scheme of medicines regulation, and the clinical use of products within that marketplace. The MHRA accepts that when prescribed and/or used by a healthcare professional, the compounding of bevacizumab for ophthalmic use does not create an unlicensed medicine but falls under the scope of 'off-label' use. However, if placed on the market, the product would require a new or extended marketing authorisation, or an exemption from the need for one. Press release

European Commission publishes UDI FAQs

A FAQ document regarding the Unique Device Identifier (UDI) system has been published by the European Commission. The document outlines the basic principles of the UDI system as well as stakeholders' responsibilities under the UDI system, which will be implemented in line with the EU Medical Device Regulations (MDR and IVDR). FAQ document

MDCG issue guidance on summaries of safety and clinical performance

The EU Medical Device Coordination Group (MDCG) has issued guidance for manufacturers and notified bodies on summaries of safety and clinical performance (SSCP) in accordance with Regulation (EU) 2017/745 on medical devices. The SSCP is intended to provide the public with an updated summary of clinical data and other relevant information. Guidance

FDA guidance for developers of digital health tools

The US Food and Drug Administration (FDA) has published a collection of guidance documents to assist developers of digital health tools. Press release

Guidance to ensure novel analytic methods are fit for decision-making

In an article published in Clinical Pharmacology & Therapeutics, regulators and academics explain how proper methodological validation can ensure the credibility of novel data sources and allow authorities to rely on them to draw reliable scientific conclusions. The European Medicines Agency (EMA) has recommended medicine developers and clinical trial authorities use its 'Qualification of novel methodologies for medicine development' procedure to validate methodologies suggested by data sources. Press release

Health care regulation must keep up with online providers

The Care Quality Commission (CQC) in a recently published response has expressed concern over the safety of online primary care, saying that some providers 'are configuring services in ways that take them out of scope of some or all UK regulators'. The CQC has made a number of recommendations. Response

Medicinal cannabis

The Government has published its response to the Health and Social Care Select Committee report on drugs policy. Response

Consultations

New 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. This consultation closes on 2 December 2019. Consultation