The extent to which one NCA can depart from an MA that has been previouslygranted by another Member State raises rather dry and technical questions ofEuropean law. However, it has huge commercial significance for the entitiesinvolved, ie the actual or would be holder of the MA, on the one hand, andgeneric manufacturers on the other that would like to market and sell theirequivalent medicines based on the original relevant medicinal product.

The enforcement of the competing rights given to innovators and genericmanufacturers has become increasingly adversarial, either with genericsseeking multiple authorisations in different Member States or challenging theinitial MA that had been granted in favour of the MA holder or the innovator MA holder seeking to protect its rights conferred in terms data exclusivity.

Astellas was one example of such a case. Astellas challengeda generic MA that had been granted by the Finish NCA and the Supreme Administrative Courtreferred two questions for preliminary ruling to the CJEU. The first question waswhether a concerned Member State under the decentralised procedure wascompetent to determine the time at which the data exclusivity period startedto run. The second question was, assuming it was not, whether the nationalcourts could determine the period of data exclusivity and whether the principleof effective legal protection under Article 47 of the Charter required the nationalcourt to scrutinise the original MA granted in another Member State and/ordepart from it in order to give effect to the MA holder’s rights.

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George Peretz QC acted for the United Kingdom Government.

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.

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.

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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.

 

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.

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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.

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.

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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.

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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.