First Pharma Pay-for-Delay Cases: General Court upholds the Commission’s Lundbeck decision

On 8 September 2016, the General Court handed down a series of six much-anticipated judgments upholding the Commission’s 2013 Lundbeck decision, ruling for the first time that pharmaceutical pay-for-delay agreements breach EU competition law (cases T-472/13, T-460/13, T-467/13, T-469/13, T-470/13 and T-471/13).  So-called “pay for delay” agreements typically involve a patent settlement agreement including a payment by the patentee to the generics in exchange for a cessation of patent infringement proceedings and an agreement by the generic companies to stay out of the market for a period of time.

George Peretz QC acted for the European Commission in T-467/13 Arrow v Commission.

Ben Rayment acted for the European Commission in T-471/13 Xellia and Alpharma v Commission.

Ronit Kreisberger and Ligia Osepciu acted for Merck in T-470/13 Merck KGaA v Commission and are acting for Merck in the Paroxetine Appeal in the CAT.

James Bourke acted for the European Commission in Case T-472/13 Lundbeck v Commission, Case T-469/13 Generics (UK) v Commission and Case T-470/13 Merck KGaA v Commission.

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The Comment 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.

NO EXCLUSIVITY FOR BRIDGING DATA UNDER ARTICLE 10(3) OF THE MEDICINES DIRECTIVE: R (Napp Pharmaceuticals v The Secretary of State for Health acting as The Licensing Authority) [2016] EWHC 1982

Ronit Kreisberger is a leading senior junior who has acted for a number of leading pharmaceutical companies including: Merck, Teva, Roche and Pfizer and is currently acting in the Lundbeck and paroxetine “pay for delay” cases in the UK and Luxembourg.

The Administrative Court has rejected Napp’s claim that bridging data submitted to the MHRA for its analgesic skin patch benefits from a period of data exclusivity under the Article 10(3) hybrid-abridged procedure.

Facts

This is a case about the interpretation of Article 10(3) of the Medicines Directive 2001/83/EC which provides that:

In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.

George Peretz QC acted for the MHRA.

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The Comment 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.

There’s a Process for excluding low Bids – use it properly or don’t do it! Another successful Challenge against Award of a substantial Government Project

Mr Justice Colton, sitting in the High Court in Belfast, concluded last week that the Department for Regional Development was in breach of the Public Contracts Regulations 2006 in respect of the award of a contract to design and construct the A8 dual carriageway between Belfast and Larne. In short, he found that the Defendant’s decision to treat the tender submitted by the Plaintiff, FP McCann Ltd (and its JV partner Balfour Beatty), as an abnormally low tender was flawed, though not necessarily manifestly unreasonable. He held that an award of damages on the basis of loss of a chance was however the appropriate remedy for the breaches of Regulation 30 and has invited the parties to make further submissions as to quantum.

Michael Bowsher QC of Monckton Chambers led David Scoffield QC of the NI Bar Library for the Plaintiff, FP McCann Ltd.

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The Comment 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.

 

HMRC v SAE Education Ltd [2016] UKUT 193 (TCC)

The Upper Tribunal (“UT”) overturned the First-Tier Tribunal’s (“FtT”) decision that SAE Education Ltd (“SEL”) was an eligible body for the purposes of Note(1)(b) to Item 1 of Group 6 of Schedule 9 to the Value Added Tax Act 1994 (“VATA”).  In my view, it is strongly arguable that the UT erred in doing so.  The UT construed Note (1)(b) strictly.  That provision should have been construed purposively, as SEL argued.

Melanie Hall QC and Elizabeth Kelsey represented SAE Education Limited instructed by Gordon Dadds LLP.

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This case note was written by Tarlochan Lall and first published in De Voil.

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.

 

Privacy International and Greennet & Others v The Secretary of State for Foreign and Commonwealth Affairs and The Government Communications Headquarters (“GCHQ”) [2016] UKIP Trib 14_85-CH

Following revelations by American whistleblower Edward Snowden (the former NSA employee and CIA contractor) regarding the extent of surveillance carried out by national authorities, Privacy International and seven Internet Service Providers (“ISPs”) launched a legal challenge against GCHQ’s alleged use of Computer Network Exploitation (“CNE”) and so-called “thematic” warrants under the Intelligence Services Act 1994 (“the ISA 1994”).

Daniel Beard QC was instructed for the Respondents.

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The judgment is available here.

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

Streetmap.EU Limited v Google Inc., Google Ireland Limited and Google UK Limited [2016] EWHC 253 (Ch)

In a judgment handed down on 12 February 2016, the High Court dismissed a claim for abuse of dominance brought against Google Inc., Google Ireland Limited and Google UK Limited (“Google”) by online map provider Streetmap.EU. In doing so, the High Court held that where a pro-competitive innovation by a dominant company is alleged to have harmed competition on a related market, the effect on competition in that market must be serious or appreciable in order to constitute an abuse of dominance.

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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.

An education in fiscal neutrality? The Court of Appeal upholds the terms of the UK’s education exemption

Article 132(1)(i) of the PVD requires the following supplies to be exempt from VAT:

the provision of children’s or young people’s education, school or university education, vocational training or retraining, including the supply of services and of goods closely related thereto, by bodies governed by public law having such as their aim or by other organisations recognised by the Member State concerned as having similar objects.

This case note was written by George Peretz QC and first published in De Voil.

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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.

R v Secretary of State for the Home Department ex p David Davis MP, Tom Watson MP, Peter Brice and Geoffrey Lewis [2015] EWCA Civ 1185

Imogen Proud, pupil barrister

The Court of Appeal recently handed down judgment in an appeal concerning the Data Retention and Investigatory Powers Act 2014 (“DRIPA”). This piece of coalition government emergency legislation, which received royal assent on 17 July 2014, was challenged by MPs David Davis and Tom Watson, represented by Liberty. The judicial review concerned the Home Secretary’s powers to order the retention of communications data under section 1 of the Act. The Home Secretary appealed against the judgment of the Divisional Court ([2015] EWHC 2092 (Admin)), which found section 1 of DRIPA to be contrary to the CJEU’s judgment in Joined Cases C/293/12 and C/594/12 Digital Rights Ireland Ltd and Seitlinger and Others (“Digital Rights Ireland”). The Divisional Court’s order disapplied section 1 with effect from March 2016. The Court of Appeal accepted, on a provisional basis, the Home Secretary’s argument that Digital Rights Ireland did not lay down mandatory requirements applicable to all Member States’ domestic data retention regimes, contrary to the Divisional Court’s interpretation. The Court of Appeal has decided to refer questions to the CJEU concerning the meaning of the Digital Rights Ireland judgment.

Daniel Beard QC and Gerry Facenna acted for the Secretary of State for the Home Department. Azeem Suterwalla (instructed by Bhatia Best Solicitors) acted for the Respondents Brice and Lewis.

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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.

 

R (Western Sahara Campaign UK) v The Commissioners for HMRC and the Secretary of State for the Environment, Food and Rural Affairs [2015] EWHC 2898 (Admin)

Article 3(5) of the Treaty on European Union (TEU) binds the Union to contribute ‘to the strict observance and the development of international law, including respect for the principles of the United Nations Charter‘. Does this provision have teeth and can it be used to support the rights of those outside the Union who are affected by EU acts? In an action brought before the UK courts, the Claimants seek to challenge the validity of two EU agreements with Morocco.

Conor McCarthy, led by Kieron Beal QC, is acting for the Claimant in this matter. They were instructed by Leigh Day.

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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.

 

Ryanair Holdings plc v Competition and Markets Authority

James Bourke

In the most recent episode of Ryanair’s epic campaign to guard its territorial interests in Aer Lingus, the Competition Appeal Tribunal has ruled that there has been no “material change of circumstances” since the Competition Commission’s final report of 28 August 2013. The judgment provides insight into the meaning of “material change of circumstances” and makes it clear that, absent such a change, the competition authority does not need to carry out a fresh proportionality review of its remedy decision when taking a decision implementing the remedy under Section 41 of the Enterprise Act 2002.

The CMA was represented by Daniel Beard QC, Rob Williams and Alison Berridge.

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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.