Life Lines

24 July 2019

Looking Ahead 

  • 8 July 2019 – Glaxo Wellcome UK Limited and another v Sandoz Limited – Trial ongoing
  • 19 July 2019 – (1) Samsung Bioepis UK Limited (2) Biogen IDEC Limited – Fresenius Kabi Deutschland GmbH – Trial floating

Ireland

  • 30 July 2019 – Merck Sharp & Dohme Corp -v- Clonmel Healthcare Ltd (McDonald J) Ezetimibe & Impastation combination. Resume hearing - Closing Submissions - 2d

Outstanding Decisions

  • Dr Reddy’s Labs & Ors v Napp Pharmaceuticals (HP 2016 000013)
  • Allergan Limited v Aspire Healthcare Limited (HP 2018 000001)
  • T-211/18 Vanda Pharmaceuticals v Commission – CJEU Appeal
  • Ranbaxy Laboratories & Ors v Commission (C-586/16)
  • Arrow Generics v Commission (C-601/16 P)
  • Generics UK v Commission (C-588/16 P)
  • Merck v Commission (C-614/16 P)
  • Xellia Pharmaceuticals and Alpharma v Commission (C-611/16 P)

Ireland

  • Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd Supreme Court 107/18 (Appeal interlocutory injunction decision) (Hearing 30 April 2019) (Inegy (Ezetimibe & Impastation combination))
  • Gilead Sciences inc & Anor -v- Mylan S A S & ORS 2017 05984 P
  • Genentech Inc v Amgen Inc & Anor (Injunction) (Costs) (Avastin/ Mvasi (Bevacizumab) Commercial List: 2019 01906 P
  • Teva Pharmaceuticals Industries Ltd -v- Mylan Teoranta & Anor Court of Appeal List: 2018 279 (Copazone)
  • Anthropharm (Europe) Limited v Health Products Regulatory Authority Court of Appeal 2018 1080 JR

Decisions

CJEU considers Polish parallel import licensing scheme for medicinal products

Delfarma v Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych [2019] C-387/18

In this case Delfarma had applied for a licence to parallel import a generic version of azithromycin from the UK to Poland, where the product had been authorised as a reference product under the brand name Sumamed®. The Polish health authorities refused to grant the licence on the basis that under the Polish parallel import licensing scheme the imported medicine and the medicine authorised in Poland must be either both generic products or both reference products. Delfarma challenged this decision before the Warsaw Administrative Court, arguing that such a requirement was purely formal and created a restriction to the free movement of goods prohibited by Art. 34 TFEU, as such restriction was not justified on grounds of public security (Art. 36 TFEU). The Polish health authorities, however, considered that this requirement was necessary in order to make sure that the imported product and the product authorised in Poland are essentially therapeutically similar, which they cannot confirm if the products have been the subject of different authorisation routes and based on different dossiers. The Polish health authorities also argued that removing such requirement would allow applicants to bypass the marketing authorisation procedure set out by Directive 2001/83, as they would obtain the same result with a parallel import licence but at lower cost and faster. The issue was referred to the CJEU. In its judgement of 3 July 2019, the CJEU found that the Polish legislation on parallel imports infringed Art. 34 and 36 TFEU. According to the CJEU, (i) the national authority cannot refuse to grant a parallel import licence based on a formal requirement without actually verifying, based on the data available, if the products are essentially similar, and (ii) if additional data (e.g. data from the dossier of the reference product authorised in the Member State of export) is necessary, the national authority must request such data from the applicant and/or through the cooperation between the national medicines agencies. The CJEU also considered that there is not a risk of applicants bypassing the requirements of Directive 2001/83 to obtain a market authorisation, as in each case the national authority still needs to verify that the imported product is essentially similar to the product authorised in the Member State of import.  Decision (not yet available in English).

 

Court of Appeal agrees unlawful interference claim fails in perindopril case

Secretary of State for Health and another v Servier Laboratories Ltd and others [2019] EWCA Civ 1160

The NHS's unlawful means tort claim was correctly struck out by Roth J in the present case, according to this recent decision of the Court of Appeal. It was correctly struck out because there is binding precedent that such a claim cannot succeed in the absence of interference with the dealings of the English Courts and the EPO with the NHS. The Supreme Court (then the House of Lords) in this previous case emphasised the need to confine the tort within "manageable and readily comprehensible limits". The Secretary of State for Health and the NHS Business Services Authority claimed that Servier is liable for interfering with the NHS's economic interests by unlawful means. Servier is alleged to have obtained a patent from the European Patent Office EPO and defended that patent in both the EPO and the English courts with representations about the novelty of the patent , which Servier knew to be false or which were made by Servier with reckless indifference to their truth. Servier also succeeded in obtaining an interlocutory injunction, which succeeded in delaying the introduction into the UK of a cheaper generic version of the drug, perindopril, causing the NHS to pay higher prices than would otherwise have been the case. So far as concerns the NHS's claimed losses in this case as a result of the interim injunction granted to Servier against Apotex in August 2006, it was open to the NHS to apply to the Court for Servier to be required to give the NHS an undertaking to pay damages which the NHS might suffer as a result of the interim injunction. Such a procedure has been advocated by the Courts on a number of occasions. In fact, the 2019 Patents Court Guide (in para. 10.1 drawing attention to paragraph 5.2 of Practice Direction 25A) states that, when a person seeks an interim injunction which would affect dealings in a pharmaceutical product or medical device purchased by the NHS, the court will consider whether the applicant should give an undertaking in favour of the NHS. The Guide requires the applicant to notify the Department of Health by email of the application when it is made and any order made following the application as soon as practicable.  Decision

 

Glycosylated antibody patent found to be invalid

Takeda UK Ltd v F Hoffmann-La Roche AG [2019] EWHC 1911 (Pat)

The UK Patent Court has held that Takeda’s Vedolizumab product (Entyvio) approved for ulcerative colitis and Crohn’s disease is an antibody within the claims of Roche’s European patent entitled ‘Glycosylated Antibodies’. However, the court also found that the patent ought to be revoked; all the relevant claims are invalid due to a lack of novelty, a lack of technical contribution and insufficiency. The issue of infringement turned on claim construction and questions of fact about the properties of vedolizumab.The case has a useful discussion on novelty. The issue in this case was around enablement. Roche contended that for anticipation what had to be enabled was the very thing disclosed in the prior art. Takeda did not agree and argued that as long as the prior art enabled the skilled person to produce something within the claim, the claim would be anticipated. The judge, Birss J, agreed with Takeda. In his opinion "the correct approach to prior use is as follows. The requirement of enablement is that whatever has been disclosed must be something the skilled person can use to produce a practical result." Decision

Brexit

Where are we:

There is the prospect once again of a possible no deal Brexit with the confirmation this week that Boris Johnson will take over as Prime Minister from Teresa May. He has previously indicated that he will take the UK out of the EU on 31st October “do or die”.

As we have noted before there is likely to be a hiatus in talks between the UK and EU over the summer for a number of reasons. The House of Commons rises for recess on 24th July. Parliament won't sit again until 4th September – but only for a few days before Party Conference season begins – and then not again until 9th October. On the EU side; a new Commission president is elected over the summer - and the process of electing a new Commission won't likely be complete until October. This could mean that it is not until October that the UK Parliament is able to look again at the Withdrawal Agreement – whether amended or not.

What's new?

UK consults on 'no deal' Brexit SPC waiver law

Generic and biosimilar medicines manufacturers will continue to benefit from existing qualified rights to make SPC-protected medicines in the UK for export or stockpiling in a 'no deal' Brexit scenario, the UK government has confirmed. More

OBR analysis highlights no-deal Brexit economic risk

Businesses which experience seasonal fluctuations in demand should step up their preparations for a potential no-deal Brexit in response to the latest economic analysis by the Office for Budget Responsibility (OBR). For industries that are exposed to a seasonal flow of goods a wintertime EU exit creates a more extreme economic risk compared to the original springtime date. More

Guidance on exporting active substance manufactured in the UK in a no deal scenario

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on exporting active substance manufactured in the UK if we leave the EU without a deal. The guidance covers the ‘Written Confirmation’ process for active substances manufactured in the UK and will apply from exit day.

Our Brexit resources

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

Biosimilars law in Germany draws legitimate criticism

A new law designed to support the use of biosimilar medicines in Germany has successfully passed the legislative procedures. The new law includes the future pharmacy-level substitution of biologics. It has been met with substantial criticism from industry bodies and physicians given the risk the plans present to the growth in use of biosimilars, to the business case for manufacturing biosimilar medicines in Germany, to the security of Germany's medicines supply and, potentially, patient safety. More

Creating the right framework to realise the benefits of health data

The Government's aim is to make the UK home to the latest data-driven scientific advances in healthcare and to better use data as a collaboration tool between the NHS and partners. For this reason, and to enable partnerships between the NHS and partners to thrive, the Department of Health and Social Care (DHSC) developed 5 guiding principles, the first draft of which were published in December 2018. An update of these principles has now been published following a period of engagement with key stakeholders and partners. These revised principles address a number of emerging ethical challenges associated with the use of data in developing and testing data-driven innovations in the NHS. The new guidance also sets out the core functions of the National Centre of Expertise which will oversee the policy framework, provide specialist commercial and legal advice to NHS organisations entering data agreements, develop standard contracts and guidance, and ensure that the advantages of scale in the NHS can deliver benefits for patients and the NHS. The Centre will sit in NHSX. The DHSC plans to publish the next iteration of the principles in a policy framework later this year. Updated guidance

Individuals advised to check whether they can still claim entrepreneurs' relief

The rules regarding when an individual can claim entrepreneurs' tax relief on a sale of shares have changed significantly over the past 12 months. Individuals hoping to benefit from the relief should carefully review their position before selling their shares. More

NHS health information available via voice assisted technology

The NHS and Amazon have entered a collaboration which will see Alexa, Amazon’s voice assisted technology, provide health information to patients from the NHS website. The aim is to enable access to NHS verified information for patients who are unable to access the internet through traditional means, while also reducing pressure on the NHS and GPs. The NHS also plans to explore ways of making other NHS services available to patients through digital technology, in line with its Long Term Plan Press release

Minister for Health confirms restructuring of health services in Ireland

Minister for Health Simon Harris TD on 17 July 2019 announced a major step towards restructuring the health services leading to the establishment of six new regional health areas. The new regional health areas are in line with recommendations made in the Oireachtas Committee on the Future of Healthcare Sláintecare Report (2017). The key provisions are that regional bodies will be responsible for the planning and delivery of integrated health and social care services. The proposed six regional health areas are based on population data including how people currently access health services, as well as a public consultation. Press release Map of the new regional health areasQ&A document

Data strategy call after copyright and algorithms ruling

A recent ruling by the High Court in London highlights why businesses should look into developing a comprehensive data strategy. Although the value of data has been recognised for many years in some sectors such as the advertising, gambling and insurance sectors, businesses in all sectors, including the life sciences sector, are becoming increasingly aware of what data they hold and its value, and inevitably some of those businesses will be looking to commoditise that data. It is becoming more common to hear business managers and their advisors talk about 'data ownership', but most legal systems do not recognise a general right of ownership over data, and businesses which do not consider and appreciate the limits of their legal rights may soon find their plans to turn data into revenue being challenged. More

Repurposing of established medicines discussed at 11th Meeting of STAMP Expert Group

The papers and other documents produced for the 11th Meeting of the the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) on 15 March 2019 are now available here. Amongst the topics discussed at this meeting was repurposing of established medicines/active substances including a framework to support not-for-profits organisations in drug repurposing and the Pilot of the STAMP repurposing pathway. STAMP Meeting papers

UK government called on to harness power of data

Leading figures from across the data industry have called on the UK government to ensure its forthcoming national data strategy delivers "transformative" and not "incremental" change in the way organisations use data. Given the huge data lakes the government is holding, and will build potentially exponentially in the future, the public need to see better use of, and have greater confidence in, how data are treated, shared and used. More

Regulatory

Ombudsman decision on how EMA's pre-submission activities

Strategic inquiry OI/7/2017/KR

Prior to submitting a marketing authorisation (MA) application, medicine developers may seek and receive scientific advice from the EMA. These ‘pre-submission activities’ entail experts designated by EMA providing advice to pharmaceutical companies on how best to design and carry out clinical trials on medicines. These ‘pre-submission activities’ may have some positive consequences for public health. However, it is important to avoid even the perception that the eventual opinions of EMA on medicines might be influenced by these earlier interactions. The Ombudsman recommends that the EMA should carefully manage the contacts its evaluators have with medicine developers during the pre-submission phase. She also found that EMA should provide greater transparency on its pre-submission activities, with the aim of maintaining public trust in its work. The Ombudsman has also made a number of suggestions for improvement to EMA. In the inquiry the Ombudsman focused solely on pre-submission activities in which the EMA provides medicine developers with scientific advice. The inquiry also looked more generally at the transparency of EMA’s work concerning the authorisation of medicines. Decision EMA response

EU-US MRA fully operational

The EU-US Mutual Recognition Agreement (MRA) has now been fully implemented following the US Food and Drug Administration’s (FDA's) recognition of the final EU member state, Slovakia, last week. The FDA has confirmed the capability of all 28 EU member states to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States. Press release

NHS pilots world's first ‘subscription’ style payment model to tackle AMR

The National Institute for Health and Care Excellence (NICE), NHS England and NHS Improvement will lead the trial for a new ‘subscription’ style model intended to address antimicrobial resistance (AMR) and encourage the development of new drugs for resistant infections. Pharmaceutical companies are currently paid by the volume of antibiotics sold so are reluctant to invest in the necessary research and clinical trials to develop new antibiotics, however this new payment system will pay pharmaceutical companies upfront for access to drugs based on their usefulness to the NHS. It is anticipated that this will incentivise pharmaceutical companies to invest in developing new drugs with the guarantee that they will be paid for the drug. Press release

European Commission medical device manufacturer’s incident report

Additional guidance has been issued by the European Commission on the Medical Device Vigilance System which is currently in operation under the EU’s Medical Devices Directive. The guidance introduces a new Manufacturer’s Incident Report (MIR) which will become mandatory for inclusion in device manufacturer’s databases from January 2020, as well as a template for a Field Safety Notice. It also clarifies existing definitions, differences between the EU National Competent Authority Report (NCAR) exchange and the International Medical Device Regulators Forum NCAR, and provides further detail on the coordination of vigilance issues among competent authorities. The most recent revisions of all forms are available on the European Commission website Guidance

WHO five-year action plan

Following survey results from the World Health Organization (WHO) highlighting that only 30% of national regulatory authorities (NRAs) in 2018 had the capacity to effectively and efficiently regulate medical products, the WHO has published a five-year action plan. The 2019-2023 plan aims to build effective and efficient regulatory systems and help NRAs solve capacity issues and other challenges. In particular, the plan sets out 4 strategic priorities; to strengthen country and regional regulatory systems in line with the drive towards universal health coverage, increase regulatory preparedness for public health emergencies, strengthen and expand WHO prequalification and product risk-assessment processes, and increase the scope and impact of WHO’s regulatory support activities. WHO five-year plan

Guidance to improve reporting of medicine shortages

Two guidance documents intended to improve and harmonise the EU’s approach to reporting and communication on medicine shortages have been published by the EU task force. One document provides guidance to marketing authorisation holders on reporting medicine shortages while the other provides guidance to the EU national competent authorities and the European Medicines Agency on communicating shortages to the public. Press release

EU invests €35 million to develop Artificial Intelligence solutions for cancer prevention and treatment

The European Commission recently pledged €35 million, as part of the Horizon 2020 research programme, to encourage the provision of data required to develop image recognition systems. Given the increasing demand and shortage of experts able to interpret scans, image recognition systems are becoming a more appealing option to quickly and accurately interpret scans. The development of image recognition systems would allow common forms of cancer to be diagnosed quicker and therefore refer patients for treatment sooner. Applicants for the funding must contribute by building a repository of “high quality, interoperable, anonymised or pseudo-anonymised data sets of annotated cases”. The deadline for applying is 13 November 2019. Press release Details Horizon 2020

MHRA on implementing the Falsified Medicines Directive

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on naming human medicines. The guidance covers selecting or constructing a product name, as well as Braille requirements on the product label. Guidance

Updated UK guidance on user testing information leaflets for parallel imported licences

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on preparing for implementation and compliance of the Safety Features Regulation, the final stage of the EU Falsified Medicines Directive. The update includes information on how to check FMD compliant stock in Italy and Greece, who are yet to implement the 2D barcode UI system. Guidance

Consultations

New consultations

ICO consultation on the draft data sharing code of practice 

As required by the Data Protection Act 2018, we are working on updating our data sharing code of practice, which was published in 2011. The updated draft code is now out for public consultation and will remain open until Monday 9 September 2019. Consultation

MHRA seeks views on engaging patients and the public 

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking views from patients, patient group representatives and healthcare professionals on the best approach to engage and involve patients in the MHRA’s work. It aims to adopt a systematic approach to involving patients when dealing with safety concerns relating to medicines and medical devices, as well as implement a communication stream between the Agency and the public. The consultation closes on 7 October 2019. Press release Consultation

UK consults on 'no deal' Brexit SPC waiver law

Following the introduction of the supplementary protection certificate (SPC) manufacturing waiver on 1 July 2019, reported in our previous issue of life lines, the Intellectual Property Office (IPO) has announced that changes are required to ensure that the waiver continues to work as UK law. The IPO has opened a consultation on proposed new UK regulations to address this point. The amendments introduce the concept of a new 'UK waiver' in the law of SPCs. It is intended that the proposed Patents (Amendment) (No.2) (EU Exit) Regulations 2019 would supplement the existing Patents (Amendment) (EU Exit) Regulations 2019 and make changes to areas of patent law, including in respect of SPCs. The consultation closes on 9 August 2019. More Consultation

Open consultations

ECHA consult on proposed restriction on intentionally added microplastics 

The European Chemicals Agency (ECHA) has launched a public consultation on its proposed restriction on intentionally added microplastics under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation 1907/2006 on the production and use of chemicals and their impact on health and the environment (which includes medicines, medical devices and in vitro diagnostics). In particular, it is proposed that microplastics shall not be placed on the market in a concentration equal to or greater than 0.1% w/w. Transition arrangements and derogations for different sectors are included in the proposed restriction. For example a transition period of two years is proposed for medical devices and in vitro diagnostics and paragraph 5 of the Restriction Report has derogation that is primarily intended to be applicable to professional uses of microplastics in medical devices and in vitro diagnostic medical devices (e.g. in hospitals and healthcare facilities) where the microplastics are contained or disposed of in the same way as hazardous waste. Table 27 and 28 of the Annex XV Restriction Report consider the socio economic impact of the restriction on the MedTech and Pharma sectors respectively. In medicinal products, microplastics are the backbone of many ‘controlled-release’ medicines and in medical devices microplastics are used as polymeric filters, adsorber and absorber granulates and in ultrasound devices. Page 26 of the restriction report has a useful table showing other countries initiatives in this area. The first deadline for comments is 20 May 2019 (second deadline 20 September 2019). Consultation

Revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation. The revisions reflect discussions regulators in the European Union, the United States and Japan have had over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The consultation closes on 19 July 2019. Revised guidelines Press release

IMDRF consultation on regulatory pathways for personalised medical devices

The International Medical Device Regulators Forum (IMDRF) personalised medical devices working group (WG) is seeking views on its proposed document on Regulatory Pathways for Personalised Medical Devices. The document applies to all personalised medical devices and recommends a harmonized approach for the application of existing regulatory pathways to any medical devices intended for a particular individual, outlining considerations and concepts that may be relevant in developing such an approach. The consultation closes on 24 July 2019. Consultation

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

This revised guideline replaces the previous guideline on the evaluation of medicinal products indicated for treatment of bacterial infections and amendments to it. The revisions reflect scientific advice given on the development of antibacterial agents, decisions taken during regulatory procedures and alignments on clinical trial requirements that have resulted from discussions between regulators in the EU, United States and Japan, including revised recommendations for primary endpoints, primary analysis populations and non-inferiority margins in trials to support certain infection site-specific indications for use. The consultation closes on 31 July 2019. Consultation

Consultation on draft key principles of electronic product information

A joint public consultation welcoming views on the proposed key principles of electronic product information (ePI) for human medicines has been launched by the European Medicines Agency (EMA), Heads of Medicines Agency (HMA) and the European Commission (EC). The draft principles are intended to form the basis of how the ePI system, which aims to provide available and up to date information to patients and healthcare professionals, will be developed and used in the EU. The consultation closes on 31 July 2019. press release Consultation

EMA consultation on ATMPs in clinical trials

The European Medicines Agency (EMA) has opened a consultation seeking comments on a new guideline for the quality, clinical and non-clinical requirements of investigational advanced therapy medicinal products in clinical trials. The consultation closes on 1 August 2019. Consultation

EMA's consults on draft guideline on quality requirements for medical devices in combination products

The European Medicines Agency (EMA) is seeking views on its draft guidance on quality requirements for medical devices in drug-device combinations. The guideline addresses new obligations under the Medical Device Regulations (MDR) and intends to increase transparency and consistency of information in regulatory submissions. The consultation closes on 31 August 2019. More Draft Guidelines

NICE consultation on the data and analytics statement of intent

NICE is seeking views on its data and analytics statement of intent, which outlines data that NICE currently uses and where it may broaden the sources of data used to develop guidance and evaluate its effect. The consultation closes on 13 September 2019. Consultation

HRA consults on research transparency mission

The Health Research Authority (HRA) has opened a public consultation seeking views on their research transparency mission. In order to give the public and research professionals more influence over the development of the final strategy, the HRA has developed the overall vision, as well as a mission and series of commitments in delivering that vision, and seeks views on how those commitments will work in practice and what are the right measures to bring about lasting change. The consultation closes on 6 September 2019. Consultation

Views sought on ICH guideline on the general considerations for clinical trials

The International Council for Harmonisation (ICH) has launched a public consultation seeking views on the revised version of its guideline E8(R1) on the general considerations for clinical trials. The document provides guidance on quality considerations and outlines accepted principles and practices in the design and conduct of clinical studies, as well as providing an overview of the types of clinical studies performed. The consultation closes on 30 September 2019. Consultation