“An ingenious attempt to exploit a loophole”: High Court rejects generic manufacturer’s JR of marketing authorisation refusal

R (Teva B.V.) v Secretary of State for Health [2018] EWHC 228 (Admin)

Biogen Idec Ltd was an interested party

Overview

On 13 February 2018, the High Court (Jay J) dismissed the application of Teva BV (“Teva”) for judicial review of the decision of the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) not to grant Teva a marketing authorisation (“MA”) for its generic version of Tecfidera, a drug used to treat multiple sclerosis.

Teva’s argument that the MHRA was not bound by a conclusion, appearing in a recital to the Commission Decision granting an MA to the reference product, as to the applicable period of data exclusivity for that reference product was found to be “ingenious” ([152]) but ultimately unsuccessful.

The judgment has important implications for pharmaceutical regulation, both now and post-Brexit. The High Court made key rulings about the role of national licensing authorities, including the requirement that they give effect to the package of rights emanating from the grant of a marketing authorisation by the Commission.

Please click here to read the full case note.

Anneli Howard and Anneliese Blackwood were instructed by the Government Legal Department for the Defendant.

The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

 

What does ‘fail’ mean anyway? MLS (Overseas) Limited v The Secretary of State for Defence

Summary

Just before Christmas, the High Court (Mrs Justice O’Farrell) delivered judgment in MLS (Overseas) Limited v The Secretary of State for Defence [2017] EWHC 3389 (TCC). There had been some anticipation that, as the first post-Energy Solutions ¹ case in which allegations of manifest error formed a central part of the argument, the judgment might shed some light on what approach a court would take to the higher degree of scrutiny arguably indicated by Energy Solutions. In the end, however, not much could be gleaned from the court’s judgment in this respect. The more interesting findings concerned transparency and the implications of any vagueness in an ITT’s description of the evaluation process. The MoD’s ITT had failed to spell out the consequence of failing a certain pass/fail criterion, which the court found ultimately invalidated the rejection of MLS’ tender on that basis. In that respect, the judgment joins a line of cases highlighting to contracting authorities the pitfalls of a lack of clarity in an ITT. For bidders, however, the message is perhaps less clear. The court rejected an argument that because the ITT itself had not been challenged (and a challenge would now have been out of time) it was not open to MLS to challenge the award on the basis of an ambiguity in the ITT. This seems to at least leave room for the question whether it is always best to challenge an ITT promptly, or whether in some cases it may well be opportune to retain some vagueness as a source of a potential future challenge to the award decision.

Please click here to read the full case note.

Philip Moser QC and Daisy Mackersie acted for MLS (Overseas) Limited.

Alan Bates and Michael Armitage acted for the Secretary of State for Defence.

The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

ING Intermediate Holdings Limited v HMRC [2017] EWCA Civ 2111

The Court of Appeal’s decision in this case, handed down on 13 December 2017, deals with fundamental concepts of VAT, namely whether there was a supply of services, and if so, whether it was ‘for consideration’, and if so, whether the consideration could be expressed in monetary form.  The case concerns deposit accounts provided by two members of the appellant’s VAT group referred to as “IDUK” and the ability of the group to recover input tax.

Peter Mantle acted for the Respondents, instructed by HMRC.

The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

To read the full case note please click here.

Sainsbury’s Supermarkets Ltd v (1) Visa Europe Services LLC (2) Visa Europe Ltd and (3) Visa UK Ltd

In a much-anticipated decision, the High Court (Phillips J.) has delivered judgment in Sainsbury’s Supermarkets Ltd v. (1) Visa Europe Services LLC and ors. The Court dismissed Sainsbury’s Claim. This case follows two earlier conflicting decisions of the High Court and Competition Appeals Tribunal in respect of the same subject-matter: Asda Stores Ltd v. Mastercard Inc [2017] 4 C.M.L.R. 32 and Sainsbury’s v. MasterCard [2016] CAT 11.

To read the full case note please click here.

Simple Interest is an Adequate Remedy for Overpaid VAT

Littlewoods Limited & others v Commissioners for Her Majesty’s Revenue and Customs [2017] UKSC 70

The Supreme Court has decisively and unanimously concluded that s78 Value Added Tax Act 1994 (“VATA 1994”) provides complete and adequate compensation for being kept out of the money by providing for simple interest on overpaid VAT.   The words “if and to the extent that they would not be entitled to do so apart from this section”  in s78(1) did not preserve common law rights to compound interest alongside s78, otherwise s78 “would effectively become a dead letter”.  Those words only preserve other statutory rights to interest.  Further, s78 does not violate EU law by denying taxpayers “an adequate indemnity”.

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The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

Balmoral Tanks v CMA – a Moral Tale

The Competition Appeal Tribunal’s decision in Balmoral Tanks v CMA  could almost have been conceived as a case study. It contrasts an old fashioned cartel, involving organised price fixing and customer allocation, with “loose pricing talk” among competitors, and reminds us that modern competition law is well equipped to deal with both. The decision also takes a robust approach to the calculation of fines, declining to interfere with the CMA’s calculations, despite some apparently anomalous results.

Rob Williams and James Bourke acted for CMA.

Please click here to read the case note.

The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

Zero Rating of Construction Works on Existing Buildings

This case note was first featured in the August 2017 issue of De Voil.

The Upper Tribunal’s decision in Revenue and Customs Commissioners v J3 Building Solutions Ltd [2017] UKUT 253 (TCC) (“J3 BS”) perhaps belatedly seeks to clarify the law in relation to the zero rating of construction works to existing buildings although relevant statutory provisions changed in 1995.  Rather than clarifying the law, it exposes a conflict in authorities which needs resolving.

Please click here to read the case note.

The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

Gender Reassignment – the legal saga continues

Secretary of State for Work and Pensions v HY (RP) [2017] UKUT 303 (AAC) (“HY”)

Alexandra Littlewood, Pupil Barrister, Monckton Chambers

Summary

In the latest round of judicial scrutiny of the legislation governing gender reassignment, the Upper Tribunal (“UT”) has held that the Gender Recognition Act 2004 is compatible with EU anti-discrimination law. Next up, the Court of Justice of the European Union (“CJEU”) will consider a similar question on a reference from the Supreme Court in MB v Secretary of State for Work and Pensions [2016] UKSC 53.

HY concerned the rights of male-to-female transgender people to claim a state retirement pension at the lower pensionable age applicable to women. The UT held that the UK legislative scheme, which requires a male-to-female transgender person to hold a gender recognition certificate before claiming retirement pension on the basis that they are a woman, was compatible with EU law. Its conclusions turned on its interpretation of the equal treatment principle in Council Directive 79/7/EEC on equal treatment for men and women in matters of social security, and on the CJEU’s seminal judgment in Case C-423/04 Richards v Secretary of State of Work and Pensions.

Ben Lask was instructed by the Government Legal Department for the Secretary of State for Work and Pensions. Brendan McGurk was instructed by Arnold & Porter Kaye Scholer LLP for the claimants.

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Lone parents deliver successful blow to the ‘Benefit Cap’

R (DA and others) v Secretary of State for Work and Pensions

Shelter intervening

References to paragraph numbers are references to the DA judgment.

Overview

On 22 June 2017, the High Court (Collins J) ruled that the application of the ‘Benefit Cap’ to lone parents with children under two years old is unlawful because it discriminates, without justification, against both those parents and their children.

Ian Wise QC and Michael Armitage were instructed (along with Caoilfhionn Gallagher QC of Doughty Street Chambers) by Hopkin Murray Beskine for the Claimants.

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The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.

The (Fast-Track) Trial of Socrates

Hot on the heels of its first decision under the new collective proceedings regime, the Competition Appeal Tribunal has just handed down judgment following the first trial held under the “fast-track” procedure introduced as part of the Competition Appeal Tribunal Rules 2015: Socrates Training Limited –v- The Law Society of England and Wales [2017] CAT 10. Whereas, in 399 BC, the City of Athens found the philosopher guilty of “failing to acknowledge the gods that the city acknowledges”, the Tribunal in this case held that the Law Society had, for part of the period covered by the claim, offended against the twin deities of UK competition law -the Chapter I and Chapter II prohibitions – by requiring law firms to purchase certain training courses exclusively from the Law Society, as a condition of membership of an accreditation scheme.

The Judgment will be of interest to all competition law practitioners, but especially to those advising SMEs. And not a hemlock in sight…

Please click here view the full case note.

Socrates was represented by Philip Woolfe and The Law Society was represented by Kassie Smith QC and Imogen Proud.