The Pharmaceutical Intellectual Property and Competition Law Review: United Kingdom
The pharmaceutical industry is and has been for many years an important sector in the UK. It has a vibrant research and development community within universities, hospitals and companies, from the largest multinationals to start-ups, and it continues to have significant manufacturing activity (although there is a move to bring more drug manufacturing within the UK to reduce the risk of shortages that have been experienced during the covid-19 pandemic and in anticipation of a 'no-deal' Brexit).
As well as the innovator manufacturers in the UK, there are a significant number of generic manufacturers. Many commentators would say that the there is a healthy balance (or even a virtuous circle) between the incentives and stimulus to the originators to maintain their research based activities and the activities of the generic manufacturers to secure access to reasonably priced medicines.
The UK government has expressed its support for the sector in 'The Life Sciences Sector Deals', which were designed to help ensure that new pioneering treatments and medical technologies are produced in the UK and to drive economic growth. The deals involve substantial investment from private and charitable sectors, and significant commitments in research and development from the government.
Notwithstanding the current buoyancy of the sector, to some extent its future is a little uncertain in the light of Brexit; the UK exited the EU on 31 January 2020 but EU law will continue to apply in the UK until the 31 December 2020. Thereafter, the EU treaties, EU free movement rights (including the access to the single market) and the general principles of EU law will cease to apply in relation to the UK, and prior EU regulations will only continue to apply in domestic law if not already revoked or amended by the UK. The effects of Brexit on the life sciences sector are likely to be substantial. This is because, as a third party to the EU, the UK will no longer have access to the benefits of the EU Single Market, such as the centralised procedure for marketing authorisations, the EU portal for clinical trials and the pharmacovigilance database. The loss of the free movement of goods, in the absence of a 'deal' is likely to affect trade between the EU and UK, which may cause delays (because of enhanced quality and safety, and import and export checks) and in a worst case scenario may result in shortages of medicines not only in the UK but throughout Europe as so many medicines are manufactured at least in part in the UK.
Competition (antitrust) law is implemented by the UK Competition and Markets Authority (CMA) – its activities are considered in more detail below. Recent cases have dealt with unlawful market2 and information3 sharing activity, excessive pricing4 and investigations in to 'pay-for-delay' cases where the innovator company pays a generic competitor to delay or give up completely its plans to enter the market.5
In this chapter, we set out the pharmaceutical legislative and regulatory framework – which is in some state of flux awaiting the outcome of Brexit negotiations – how to bring a product to market, the use and challenge in using patent litigation for product launch and then an overview of the competition law environment in the UK, including a review of unlawful activities, merger control and an assessment of case law.
Legislative and regulatory framework
In the UK, pharmaceutical products and medicines are regulated in accordance with the Human Medicines Regulations 20126 (UK HMR), which implement Directive 2001/83/EC7 and other key EU legislation, and consolidate relevant UK laws.
i Patent duration
Patent protection is governed by the Patents Act 1977. Patents have a maximum duration of 20 years from their filing date, subject to payment of renewal fees and remaining valid.8 Under Regulation (EC) No. 469/2009,9 a supplementary protection certificate (SPC) may be granted in certain circumstances to extend the duration of a patent relating to a medicinal product.10
ii Marketing authorisation
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is the competent enforcement authority for the regulation of pharmaceutical products. As an executive agency of the Department of Health and Social Care (DHSC), the MHRA is responsible for managing licences and marketing authorisations (MAs) under the UK HMR.
The European Medicines Agency (EMA) regulates pharmaceutical products on a pan-European level. This includes evaluating applications and providing recommendations to the European Commission for the grant of an MA through a centralised European procedure. Applications are assessed on the principles of safety, quality and efficacy set out in the Medicines Regulations, Community Code and Regulation (EC) No. 726/2004.11
The DHSC manages the pricing and reimbursement of medicines in the National Health Service (NHS), on the guidance and advice of the National Institute for Health and Care Excellence (NICE). Companies typically consult the DHSC before setting a reimbursement price, which is published in the Drug Tariff. NICE analyses the cost and potential benefit of a new drug to decide whether it should be recommended for use in the NHS.
The Voluntary Pricing and Access Scheme (VPAS) is a non-contractual agreement between the DHSC and the Association of the British Pharmaceutical Industry. Under VPAS, NHS spending on branded medicines is capped at 2 per cent growth of the total annual bill, with spending above this cap being paid back by members as a percentage of product sales. To encourage innovation, exemptions are available for products containing new active substances and for small- and medium-sized companies.
Companies not participating in VPAS are subject to the statutory scheme, governed by the National Health Service Act 2006 and the Branded Health Service Medicines (Costs) Regulations 2018.12 Under this scheme, companies pay rebates based on a percentage of their UK revenues.
iv Public purchasing
Medicines are procured using collective purchasing and framework agreements, governed by the Public Contracts Regulations 2015.13 The Commercial Medicines Unit of NHS England is responsible for awarding and managing frameworks across regional pharmacy purchasing groups, while hospital trusts are responsible for implementing the contracts awarded. In Wales, the contract process is managed by the NHS Wales Shared Services Partnership, while the All Wales Drug Contracting Committee acts as the awarding body and ensures compliance with legal and governance requirements.14
v Competition laws
For the time being, two sets of competition rules apply in parallel in the UK. UK-specific legislation comprises the Competition Act 1998 (Chapters I and II), which prohibits anticompetitive agreements and abuse of dominance that may affect trade within the UK, and the Enterprise Act 2002. Anticompetitive agreements that extend beyond the UK to other EU Member States are prohibited by Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU).
Each law essentially prohibits two main types of anticompetitive activities:
- anticompetitive agreements (the Chapter I and Article 101 prohibitions); and
- abuse of a dominant market position (the Chapter II and Article 102 prohibitions).
Even after the Brexit transition period, UK companies whose activities may affect trade within the EU, will still remain subject to EU competition law. The government has stated that it has no plans significantly to amend the UK competition laws.
New drugs and biologics – approval, incentives and rights
i Overview of the marketing authorisation pathways
Generally, prior to placing a new medicine on the UK market, irrespective of whether it is an innovative medicine, biological medicine, generic or biosimilar, an MA must be obtained. Depending on the circumstances, in accordance with Directive 2001/83/EC, as implemented in the UK by the UK HMR, there are four potential pathways to follow for purposes of obtaining an MA in respect of a medicine in the UK, namely:15
- the decentralised procedure, which is relevant where it is intended that a medicine shall be marketed in the UK16 and other named EU countries. One EU Member State, being the reference Member State) will lead the assessment of the application. Under normal circumstances, this procedure takes approximately 210 days. Once the application is approved, the UK (as a concerned Member State) shall issue a national licence within 30 days;
- the mutual recognition procedure, which is relevant where the applicant already has a national licence in at least one EU country, but wishes to market such medicine in other EU countries.17 The application takes up to 90 days. Once the application is approved, the UK (as a concerned Member State) shall issue a national licence within 30 days;
- the national procedure, which applies where an applicant only wishes to market the medicine in one country. In the case of the UK, for first-time applicants, the MHRA should be contacted via e-mail18 to obtain a company number. The applicant should also contact the MHRA for purposes of obtaining a product licence number prior to submitting an application. The application takes up to 210 days. National procedure applications are accepted by the MHRA at any time; and
- the centralised procedure,19 which is relevant where the medicine is to be marketed throughout the EU as well as Iceland, Liechtenstein and Norway. There are certain medicines that must have a centralised licence, such as orphan drugs, recombinant DNA-based products and monoclonal antibodies.20 A centralised MA, automatically valid throughout the EU, is issued by the EMA.
The majority of MAs in Europe are applied for under the decentralised procedure or the centralised procedure. Following Brexit, the UK will no longer be part of the EEA and has therefore established a new system for independent MA approval through the MHRA. The MHRA will carry out all functions currently done at the EU level, including the making of decisions on applications, variations and renewals.
Companies whose presence and activities are principally in the UK risk losing their MAs granted through the centralised procedure, unless action has been taken to transfer key operations and activities to an EU Member State. Conversely, companies will also need to consider UK activities and presence if they are currently based in the non-UK EU and EEA. Separate UK MAs will need to be applied for post-Brexit, although existing MAs on centrally authorised products will, pursuant to the Human Medicines Regulations (Amendment etc.)(EU Exit) Regulations 2019, be converted from EU to UK MAs, as if they were granted on the date the corresponding EU MA was granted. The MHRA will, however, require the provision of essential baseline data to be submitted electronically.
The MHRA will also take over the renewal process for MAs granted through mutual recognition or decentralised procedures that are underway at the end of the transition period.
ii New medicines and biological medicines
With regard to new innovative medicines (including biological medicines), Article 8(3) of Directive 2001/83/EC contains the basic requirements for an application for an MA in respect of such medicines (regardless of the pathway to be followed).21
Fees payable to the MHRA depend on the type and pathway of application.22 As at the time of writing, the fees for 'licence applications: marketing authorisations (including extension applications)' are, for example, £92,753 for the national procedure pathway.
Expedited approvals for new or innovative medicines
Applications may be expedited where it can be shown that there is compelling evidence that a medicine could provide a major breakthrough in the treatment of certain conditions, such as: chronic, debilitating, life-threatening or sever diseases for which available treatments are ineffective or otherwise inadequate; the emergence of a disease with wide-spread resistance to treatment with currently available treatments; or the emergence of a new disease entity that has severe or life-threatening effects and for which currently available treatments are ineffective or inadequate. Applications may, subject to the approval of the DHSC, also be expedited if there is shortage of supply of essential medicines.23 More recently, with the outbreak of the covid-19 pandemic and the unprecedented conditions it has resulted in, the MHRA has put in place certain measures to expedite the applications of any medicines aimed at the prevention or treatment of covid-19.24 From a practical perspective, for an application to be fast-tracked, the applicant must contact the MHRA via e-mail25 and provide a short letter that includes a brief description of: the relevant disease category; the major clinical properties of the product; and evidence supporting the claimed benefits of the product for the proposed indication or indications. The fast-tracking of an application is free of charge.
The UK HMR implements the EU concept of regulatory data protection and data exclusivity in the UK. For generally 1026 years after the granting of the first MA in the EEA for the product, applications for MAs for generic versions of the product cannot be granted because, according to legislative provisions defining the 'regulatory data protection' period, for the first eight years of that period, the originator company's MA dossier data cannot be cross-referred to by generic competitors. The data protection period runs concurrently with any patent or SPC protection.
Authorised orphan-designated drugs (to treat rare diseases) also qualify for a period of market exclusivity. The basic period is 10 years from the date of MA (extended to 12 years if approved paediatric studies have been completed – in which case the SPC paediatric extension referred to above is not available). This market exclusivity is different in scope from regulatory data protection. Subject to certain exceptions (notably, if a competitor develops a clinically superior medicine), market exclusivity prevents authorisation of any other 'similar' product for the same therapeutic indication, notwithstanding full independent development of that alternative product. As with regulatory data protection, market exclusivity runs concurrently with any patent (or SPC) protection, and runs concurrently with any remaining regulatory data protection for the product. The UK government has said that as far as possible it will replicate this incentive after Brexit.
iii Generics and biosimilars
As mentioned above, with regard to new generic medicines (and biosimilars) being placed on the market, Article 10 of Directive 2001/83/EC contains the basic requirements for an application for an MA in respect of such medicines (regardless of the pathway to be followed).
As regards generics, Articles 10(1) and 10(3) of Directive 2001/83/EC, read with Regulation 51 of the UK HMR, provide the legal framework for obtaining an MA for generic products by reference to an originator's product registration dossier, which essentially results in the MA application process being an abridged form of the 'full' Article 8 process mentioned above.
With reference to biosimilars, due to the nature of these medicines, Article 10(4) of Directive 2001/83/EC, read with Regulation 53 of the UK HMR, states that where a biological medicinal product that is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the similar biological medicinal product and the reference biological medicinal product, the results of appropriate preclinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I of Directive 2001/83/EC and related detailed guidelines.
As was the case above, fees payable to the MHRA depend on the type and pathway of the abridged application.27 As at the time of writing, the fees for 'licence applications: marketing authorisations (including extension applications)' are, for example, £9,403 for abridged (standard) applications via the national procedure pathway, etc.
Expedited approvals for generics and biosimilars
The fast-tracking process mentioned above in the context of new medicines and biological medicines shall also apply to MA applications pertaining to generics and biosimilars.
Unlike in the United States where an exclusivity period of a certain period of time may be obtained for the first-approved generic or biosimilar, there are currently no specific regulatory incentives in the UK to encourage generics and biosimilar manufacturers to bring their product to market.
In England and Wales, patents may be challenged in court or in the UK Intellectual Property Office (UK-IPO). The majority of patent revocation actions commence in the High Court, which has a division for patent disputes staffed by specialist judges. A minority of patent disputes, mostly relating to mechanical or other simpler kinds of technologies, commence in the IP Enterprise Court. The latter is a specialist forum for IP disputes, staffed by specialists, but designed for lower-value and more straightforward disputes, for example, involving SMEs. Very few patent revocation actions are commenced in the UK-IPO since there is no clear cost saving in using that forum. These three forums are each exclusive of the other28 meaning that a challenger must choose which to proceed in.
During the opposition period – nine months following grant – European patents validated in the UK may also be challenged by opposition in the European Patent Office (EPO). This forum, where available, operates in parallel to the three above, meaning that a patent challenger may potentially have two chances of revoking the patent. If successful in the EPO, the revocation will have European-wide effect whereas if successful in the English courts the decision will, formally, only have effect in the UK, although the reasons for the decision may be persuasive in other European countries in some cases.
Revocation actions are neither dependent upon nor are they formally linked to MAs for medicinal products. There is no specific procedural link between the forums discussed above and the process for obtaining marketing approval. However, English courts operate under a doctrine known as 'clearing the path' in the medicinal products sector. The effect of this is that a person wishing to launch a product (whether this is a generic pharmaceutical or a biosimilar) must revoke the relevant patent or patents or seek other relief from the courts such as a declaration of non-infringement (DNI) prior to launching their product or they will in most cases be subject to an interim injunction restraining the launch. The clearing the path doctrine applies up to at least the first appellate level: product launches for products protected by patents must be planned a significant time in advance since the usual time to trial is approximately 1–1.5 years and a similar time until appeal. Expedited trials or appeals, or both, may be ordered in certain cases to speed up this process.
In addition to revocation and a DNI, the High Court has jurisdiction to grant declarations that serve a useful commercial purpose. One now-recognised form is the 'Arrow' declaration intended to provide commercial certainty in the face of pending patents. Such a declaration, if available, will be to the effect that a certain product or process was known or obvious at a particular date, for example, the priority date of known pending patents. The product or process the subject of the declaration will be that of the third party seeking to launch, thereby giving an indirect defence to that third party against future infringement on the basis that any patent that it would putatively infringe would be invalid.
Patents may be revoked in the English courts, UK-IPO and EPO on essentially the same grounds, although the differing procedures in the English courts, UK-IPO and EPO make some bases better suited to one than the other. The main grounds are:
- the patent is not novel;
- the patent does not involve an inventive step, (i.e., it is obvious);
- the patent is not capable of industrial application;
- the patent is not disclosed sufficiently;
- the patent has been amended in an impermissible way (e.g., to extend its subject matter or to add matter not comprised in the application as filed); and
- the patent claims excluded subject matter.
This last category includes inventions the exploitation of which would be contrary to public policy or morality and inventions falling within certain defined categories. These categories include, among other things, methods of treatment or diagnoses. However, use-limited therapeutic claims have been permitted to give novelty for second medical uses of known medicinal products. In particular, 'Swiss-form' claims to use of X in the manufacture of a medicament for the treatment of Y were permitted until legislative changes at the end of 2007 abolished such claims, with prospective effect only, and introduced instead 'EPC 2000' claims to X for use in the treatment of Y. The change from the Swiss-form to the EPC-2000 form changed these claims from a process to a product with potential knock-on effects on infringement that are yet to be explored.
The UK left the EU on 31 January 2020, but will continue to be treated for most purposes as if it was still an EU Member State during the Brexit transition period until 31 December 2020, and most EU law will continue to apply to the UK during that period. This means the continued participation of the UK in the EU Customs Union and Single Market, the continued application of the four freedoms and the continued application of the usual EU supervisory, judiciary and enforcement mechanisms, until the end of 2020.
ii The CMA
The CMA is the main UK national competition authority and is the investigation and enforcement authority. The CMA's antitrust law powers are set out in the Competition Act 1998 and its merger control powers are set out in the Enterprise Act 2002.
The CMA has been very active in enforcing the Competition Act in the pharmaceuticals sector. It is actively engaged in several excessive pricing (abuse of dominance) cases. It is reinvestigating certain patent settlement agreements of GSK's following a European Court ruling in a pay-for-delay generics case, and is defending an appeal against its March 2020 nortriptyline decision finding an information sharing agreement in the sector to infringe the Act.
There is no requirement to pre-notify or obtain prior clearance for mergers under UK law, the pre-notification regime being voluntary. However, the CMA has the power to intervene and investigate mergers, including those that have not been notified or that have been completed, or both, and it frequently does so. Where the CMA reaches an adverse competition assessment following a second-phase investigation, it can prohibit an anticipated merger or impose remedial measures for a completed merger, including divestment requirements.
The acquisition of material influence, not just the acquisition of control, is subject to the UK merger control regime. For most sectors, including pharmaceuticals, the thresholds for a transaction qualifying for investigation are the target having a UK turnover of over £70 million or the parties having an overlapping share of supplies of 25 per cent or more in the UK (or a substantial part of the UK).
The CMA's investigation and enforcement powers apply to foreign-to-foreign mergers where the parties (and especially the target) supply (or supplies) the UK market and the relevant criteria for investigation are met. The definition of 'supply' is broad. For example, in the pharmaceuticals sector, in 2019 the CMA investigated, on its own initiative, the acquisition by Roche Holdings, Inc, a subsidiary of the Swiss-based Roche group, of Spark Therapeutics, Inc, a US biotechnology company active in developing gene therapy treatments. Roche was supplying the relevant UK market, but Spark's relevant products were still in clinical development. The ultimate test in UK merger control is whether the merger is likely to result in a substantial lessening of competition in the UK. The CMA concluded that there would not be in this case.
i UK Competition Act 1998 Chapter I – Restrictive Agreements
Reverse payment agreements (pay-for-delay)
Under specific circumstances, it is clear that a settlement agreement between a holder of a pharmaceutical patent and a manufacturer of generic medicines can be contrary to UK competition law. In 2016, the CMA adopted its first decision on reverse payment agreements. GSK and various generic medicines manufacturers concluded patent settlement agreements whereby the generics suppliers agreed to refrain from entering the market with their own generic medicines, in return for payments and supply by GSK of specified volumes of generic paroxetine tablets for resale on the UK market. The CMA found that the agreements in question infringed the prohibition of restrictive agreements under Article 101 of the TFEU and its UK equivalent (Chapter I of the Competition Act 1998) and constituted an abuse of GSK's dominant position in the relevant market on the basis of Chapter II of the UK Competition Act.
The CJEU formulated general principles to be applied to reverse payment agreements, on fundamental issues relating to the application of potential competition, object, effect, definition of the relevant market and abuse. The Court held that GSK's reverse payment settlement agreements may be considered as 'by object' infringements of competition law, thus breaching antitrust rules by their very nature, without needing proof of the effects that the conduct has had on the market.
Following the CJEU's preliminary ruling on GSK on 30 January 2020, the CAT will apply the ruling to the facts of the four referred cases.31
ii Ongoing CMA Chapter I investigations
In a decision on 4 March 2020, the CMA found that four drug makers, including Lexon, were involved in the exchange of commercially sensitive information – including about prices, volumes and entry plans – to try to keep the price of nortriptyline high. The companies were collectively fined £3.4 million. Lexon has appealed this decision to the CAT, which is due to hear the case in October 2020.
On 1 June 2020, the CMA announced that it secured a legally binding disqualification undertaking from Mr Amit Patel, a former director of Auden Mckenzie (Pharma Division) Limited and Auden Mckenzie Holdings Limited. Mr Patel was given a disqualification undertaking not to act as a director of any UK company for five years from 13 July 2020.
Nitrofurantoin and prochlorperazine
On 7 April 2020, the CMA announced a pause in two investigations, concerning alleged anticompetitive agreements in the supply of prochlorperazine and nitrofurantoin respectively to reallocate resources to enable the CMA to focus on urgent work during the covid-19 pandemic. Each of these investigations was the subject of statements of objections issued in 2019.
iii UK Competition Act 1998 Chapter II – Abuse of Dominance
UK Court of Appeal clarifies the legal test to be applied in excessive pricing cases
Phenytoin sodium – Pfizer/Flynn
In December 2016, the CMA imposed a record fine of £84.2 million on Pfizer Limited and £5.2 million on Flynn Pharma Limited for charging excessive prices and abuse of dominance in the market for the manufacture and distribution of phenytoin sodium capsules. The UK Competition Appeal Tribunal quashed the CMA's decision (June 2018) finding that the CMA had misapplied the legal test for excessive pricing, not properly applied the evidence adduced by the companies by not taking sufficient account of the prices of comparable products (phenytoin sodium tablets in particular) and not properly considered the economic value of phenytoin sodium capsules. The CMA appealed the CAT judgment to the Court of Appeal (supported by the European Commission) and on 20 March 2020, the Court of Appeal broadly upheld the CAT's ruling.
Competition cases are generally fought on specific facts and evidence. Here, Pfizer supplied a prescription anti-epilepsy drug in capsule form under the brand name Epanutin in the UK. In 2012, it transferred to Flynn the marketing authorisation for the capsule form that it continued to manufacture for Flynn, which in turn supplied it to the NSH. Flynn de-branded Epanutin and supplied it as a generic. As a consequence of this de-branding, the capsule form was no longer subject to price regulation. Pfizer increased its manufacturing price to Flynn for capsules by between 783 per cent and 1,615 per cent. Flynn raised its price to the NHS by an eyebrow-raising 2,387 per cent to 2,656 per cent.
The Court of Appeal considered the dispute concerning the legal test for excessive pricing established by the CJEU in its seminal United Brands judgment. Here, the Court stated that the excessive nature of a price could be determined inter alia through the application of a two-limb test:32
- the price must be excessive when the difference between the cost of production and the selling price of the product is excessive; (the excessive limb), and
- the price must be unfair either in itself or when compared to competing products (the unfair limb).
However, the Court of Appeal said that this two-limbed test is not the only method and that the CMA has a margin of manoeuvre or appreciation in deciding which methodology to use and which evidence to rely upon.
On 8 June 2020, the CMA announced the timetable for its investigation in the Pfizer/Flynn excessive pricing case, following remittal of issues by the CAT and by the Court of Appeal judgment. The initial re-investigation will be carried out between June and October 2020.
The CMA investigation relates to suspected unfair and excessive pricing by Advanz Pharma (formerly Concordia International RX (UK) Limited) in the supply of liothyronine tablets, including to the NHS).
The CMA's case, contained in two statements of objections, alleges that Advanz Pharma/Concordia abused its dominant position in breach of the Chapter II prohibition of the Competition Act and Article 102 of the TFEU, by charging excessive and unfair prices to the NHS.
Liothyronine tablets are primarily used to treat hypothyroidism. Until 2017, Concordia was the only supplier. The CMA has found that the amount that the price that the NHS paid per pack of this drug rose from around £4.46 before it was de-branded in 2007 to £258.19 by July 2017, an increase of almost 6,000 per cent, while production costs remained broadly stable.
On 12 February 2020, the CMA joined together three separate investigations into alleged excessive and unfair pricing, anticompetitive agreements and abusive conduct in relation to the supply of hydrocortisone tablets in the UK. The CMA issued statements of objections between December 2016 and February 2019.33
iv Market definition in abuse cases
In its GSK preliminary ruling, the CJEU provided guidance on the key issue of market definition, in the context of abuse of dominance, which will have wider implications for the pharmaceutical industry than patent settlement agreements alone. The guidance from the CJEU is that if the generic medicines are as a matter of fact (to be determined by the national court) in a position to enter within a short period with sufficient strength to compete with the originator, they are to be considered as being within the relevant market.
The Court also stated that it is for the national court to determine whether the strategy to conclude settlement agreements with the object or effect of delaying generic entry, has the capacity to restrict competition and, in particular, to have exclusionary effects, going beyond the specific anticompetitive effects of each of the settlement agreements that are part of that strategy.
Outlook and conclusions
We have referred numerous times to the issues raised by the implementation of Brexit – the relationship not only with the EU but with any other major economies, including US and Japan, will affect considerably how the sector looks 12 months hence. There remains optimism in the sector, and the continued investments made in research and development facilities by both UK-based companies and others demonstrate this optimism. The UK is seen favourably as a place for entrepreneurs in this sector, too, and while they, as well as the government as promised, and big pharma, continue to invest, talent will be attracted and IP created. The competition regime is unlikely to change in any significant way, but it will be interesting to see whether the independence of the MHRA results in a deviation from established EMA standards, or whether the UK becomes a 'white label' territory.
1 Sally Shorthose and Richard Eccles are partners, and Chris de Mauny, Pieter Erasmus and Bróna Heenan are associates at Bird & Bird LLP.
2 e.g., nitrofurantoin tablets (case 50511-1) and prescription-only prochlorperazine tablets (case 50511-2).
3 e.g, nortriptyline tablets.
4 e.g., hydrocortisone tablets (case 50277-1).
5 e.g., fludrocortisone acetate tablets (case 50455).
6 The Human Medicines Regulations 2012 (SI 2012/1916), as amended.
7 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended.
8 Section 25 of the Patents Act 1977, as amended.
9 Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, as amended.
10 The post-Brexit regime is yet to be determined.
11 Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended.
12 Branded Health Service Medicines (Costs) Regulations 2018 (SI 2018/345), as amended.
13 Public Contracts Regulations 2015 (SI 2015/102), as amended.
14 Guide to medicine procurement in the UK (Updated September 2018), by the NHS Specialist Pharmacy Service.
15 See further at www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk (last accessed 19 June 2020).
16 The UK can only be a concerned Member State during the Brexit transition period, which is set to expire on 31 December 2020.
17 As above, the UK can only be a concerned Member State during the Brexit transition period, which is set to expire on 31 December 2020.
19 See further Regulation (EC) 726/2004.
20 See Annex I of Regulation (EC) 726/2004 for details of medicines that must have a centralised licence.
21 Articles 10 (generics/biosimilars applications, see further below), 10a (well-established use applications), 10b (fixed combination application) and 10c (informed consent application) of Directive 2001/83/EC cover specific types of abridged applications where the dossier requirements may not be as extensive as that of a 'full application' as specified in Article 8(3), or (in the case of Article 10a) where the data required may be provided by way of reference to published scientific studies.
22 See further at www.gov.uk/government/publications/mhra-fees as well as the fees calculator available at www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk (last accessed 19 June 2020).
26 For the first eight years, no generic MA application may be filed using the data in the innovator's MA dossier. For a further two years, any generic MA application may not be granted. The overall 10-year period may be extended to 11 years if, during the first eight years, the same product is authorised for a new therapeutic indication with significant clinical benefits compared to pre-existing therapies.
27 See further at www.gov.uk/government/publications/mhra-fees as well as the fees calculator available at www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk (last accessed 19 June 2020).
28 There is a mechanism of transfer between the High Court and the IP Enterprise Court but a claim cannot be maintained in more than one of these forums in respect of the same patent or patents.
29 GlaxoSmithKline PLC v. Competition and Markets Authority, Case 1252/1/12/16.
30 Generics (UK) Ltd and Others v. Competition and Markets Authority, Case C-307/18, 30 January 2020, ECLI:EU:C:2020:52
311251/1/12/16 Generics UK Limited v. Competition and Markets Authority; 1252/1/12/16 GlaxoSmithKline PLC v. Competition and Markets Authority; 1253/1/12/16 (1) Xellia Pharmaceuticals APS (2) Alpharma LLC v. Competition and Markets Authority; 1255/1/12/16 Merck KGaA v. Competition and Markets Authority.
32 EU:C:1978:22, United Brands Company and United Brands Continentaal BV v. Commission, paras 251 and 252.
33 August 2017 (Case 50277-1), March 2017 (Case 50277-2) and February 2019 (Case 50277-3).