Monckton counsel have successfully defended the Environment Agency’s decision not to renew water abstraction licences near to Catfield Fen in Norfolk.  The applications were to allow the continued use of groundwater for agricultural purposes from existing abstraction sites near to a Special Area of Conservation protected by the EU Habitats Directive.  Catfield Fen contains calcareous fen (a priority habitat under the Habitats Directive) as well as a large population of the rare fen orchid and protected water beetles.

The decision of the Environment Agency to refuse the licences was considered at a three week planning inquiry held in Norwich in Spring 2016.  At the inquiry the Environment Agency, supported by Natural England and the RSPB, presented evidence of rapid ecological change on site suggestive of deteriorating water chemistry which was potentially a result of the water abstractions. By contrast the appellant contended that, applying the test under the Habitats Directive, it was beyond reasonable scientific doubt that the water abstractions were not responsible for any ecological change.

Having considered detailed expert evidence on fen ecology, hydrogeology and water chemistry, Elizabeth Hill BSc(Hons), BPhil, MRTPI, the Inspector appointed by the Secretary of State for Environment, Food and Rural Affairs, dismissed the appeals, finding: ‘it cannot be concluded beyond reasonable scientific doubt that abstraction under the licences would not have an adverse effect on the integrity of sites protected by European law, namely, the Broads SAC.’ She also rejected arguments that the licences should be granted in any event due to “imperative reasons of overriding public interest”, namely the impact of refusing the licences on the economy.

The Planning Inspector’s decision can be read here.

The Environment Agency was represented by Gerry Facenna QC, Daisy Mackersie and David Gregory.

The General Court of the EU yesterday dismissed appeals by Lundbeck, the leading pharmaceutical company, and a number of manufacturers of generic products, against a Commission decision finding that they were party to agreements that infringed EU competition rules and imposing fines.

The case concerned citalopram, a widely-used treatment for mental health conditions.  The agreements were entered into at a time when various generic manufacturers had been taking steps to start supplying citalopram, but Lundbeck had also launched, or was threatening to launch, patent infringement proceedings against those manufacturers in the UK and EEA.  Under the agreements, the generic manufacturers received payment from Lundbeck and also agreed not to supply citalopram for a period of time.

The General Court dismissed the companies’ claim that, because of the position in relation to patents, the generic manufacturers could not be regarded as potential competitors of Lundbeck.  It also rejected the companies’ argument that, because Lundbeck had a patent claim, an agreement not to sell citalopram in potential breach of that claimed patent could not be regarded as an ‘object restriction’ for the purposes of Article 101(1) of the Treaty on the Functioning of the EU.  It agreed with the Commission that, despite the patent claims: (i) the generic companies should be regarded as potential entrants, and (ii) the agreement was a restriction by object.

The case is the first judgment by the European Courts on the “pay for delay” issue, and is a very important decision for the pharmaceutical sector, as well as being the latest word on the category of object restrictions.

A link to the judgments is here.

Please click here to view the full case note.

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; 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.

Stephen Cragg QC and Nikolaus Grubeck, instructed by Kate Harrison at Harrison Grant, acted for Labour Party members excluded from an automatic right to vote in the forthcoming leadership election, on the basis that they have not been members of the Party for more than six months (Evangelou and others v The Labour Party).

In the High Court of Justice on the 4th August Mr Justice Hickinbottom decided that, under the Labour Party rules, the Labour Party’s National Executive Committee does not have the power to disenfranchise 150,000 members, including the claimants.

This means that all members who joined the party before 12th July 2016 have equal rights to vote in the leadership election.

Imogen Proud was instructed for hand down and consequentials.

A copy of the judgment is available here.

See The Guardian website.

The High Court has determined a series of preliminary issues arising out of claims brought by three individuals whose family members were murdered by unknown third parties in the immediate aftermath of the withdrawal of Slobodan Milosovic’s forces from Kosovo in June 1999. Milosovic’s withdrawal followed Nato operations to which the UK contributed. Following the promulgation of UN Security Council Resolution 1244, the UK provided forces to the Kosovo Force (or KFOR) which was given various security taskings. The murders took place within the area for which UK forces had lead responsibility. The Claimants brought (i) claims under the Human Rights Act and (ii) tort claims under local Kosovan law in the Queen’s Bench Division. They were seeking, amongst other things, the establishment of a public enquiry in relation to the alleged breach of the investigative obligations alleged to have arisen under Articles 2 and 3 ECHR, and damages. Preliminary issues were heard on, amongst other issues, (i) whether the alleged acts or omissions of UK forces were to be attributed to the UK or the UN; (ii) whether the claimants where within the jurisdiction of the UK for the purposes of Article 1 of the ECHR; (iii) whether an investigative obligation arose or continued under Articles 2 or 3 of the ECHR; and (iv) whether the UK could avail of any operative immunity in relation to such claims. In a long and detailed judgment, Irwin J determined all of the preliminary issues in favour of the MoD. The Claims will therefore be dismissed.

Brendan McGurk was led by James Eadie QC. The judgment, whose neutral citation is [2016] EWHC 2034 (QB), can be found here.

Case T-66/14 Bredenkamp & Ors v Council, 21st July 2016

The General Court of the CJEU has rejected an application for damages brought by Zimbabwean businessman John Bredenkamp, and 3 companies owned by him, for damages for loss caused by their listing on the EU’s Zimbabwe sanctions list.

The court held that the applicants’ listing was not unlawful wherefore the applicants were not entitled to the damages claimed, so that the Court did not go on to consider the arguments on causation and loss. The Court found that listing a businessman on the basis of strong ties to the Government was a sufficiently clear statement of reasons, with a valid legal basis. Although the Council had not communicated the evidence forming the basis for the designation, the applicants had been given the bulk of the evidence justifying their listing, albeit by way of obtaining them in national proceedings against the UK government and the Court found that this would not therefore have made any difference to the applicants’ rights of defence.

A link to the judgment is here.

Philip Moser QC acted for Mr Bredenkamp and his companies

In a judgment handed down today, Mrs Justice Whipple rejected an attempt by Napp to assert a period of data exclusivity for “bridging data” provided by it in support of its application for a marketing authorisation (MA) for its product BuTrans®/Norspan® under the “hybrid-abridged” procedure laid down in Article 10(3) of the Medicines Directive (Directive 2001/83).

The “hybrid-abridged” procedure can be used where a manufacturer seeks to obtain an MA for a product that differs in certain respects, such as in the route of administration or therapeutic indication, from another manufacturer’s product that already has an MA (known as the “reference medicinal product” or “RMP”). The RMP in this case was an analgesic developed by another manufacturer in the form of a pill placed under the tongue: Napp then developed BuTrans®, which used the same analgesic in the form of a skin patch. Under the hybrid-abridged procedure, which requires the provision of “appropriate” pre-clinical tests and trials, it could and did obtain an MA by relying on the original documentation for the RMP combined with “bridging data” in the form of test results showing that the skin patch method was safe and effective.

Some 11 years later, Sandoz applied for MAs in a number of EU countries, including the UK, for its own analgesic skin patch. In its application, it referred to the RMP, the bridging data provided by Napp for BuTrans® and to its own studies demonstrating bioequivalence between its product and BuTrans®.

The UK Medical and Healthcare Products Regulatory Agency (“MHRA”), along with the equivalent authorities in other EU Member States, granted Sandoz an MA on that basis. Napp sought judicial review of the MHRA’s grant of an MA to Sandoz, claiming that the Medicines Directive did not permit the MHRA, in assessing Sandoz’s application for MAs, to allow it to rely on the “bridging data” provided by Napp. Napp also brought equivalent proceedings in other EU countries. At the hearing, Napp sought a reference for a preliminary ruling to the Court of Justice of the EU, arguing that there was a “lacuna” in the Directive to the extent that it did not lay down a period of exclusivity for “bridging data”: it pointed out that Article 10(1) provided for a period of exclusivity for the manufacturer of the RMP so as to prevent generic manufacturers relying on those data to secure an MA for their own product.

Whipple J observed that, as a matter of language, the reference in Article 10(3) to “appropriate” pre-clinical tests or clinical trials did not preclude the MHRA from accepting as “appropriate“ the data provided by Sandoz, namely the bridging data originally provided by Napp for BuTrans® together with Sandoz’s own studies demonstrating bioequivalence between its product and BuTrans®. That approach did not conflict with the purpose of the Directive of ensuring that medicines were safe and effective. Moreover, the Court of Justice’s case-law had refused to allow periods of exclusivity where the company in Napp’s position also held the MA for the RMP – had Napp also held the MA for the RMP in this case, BuTrans® would, under Article 6(1), have been held to be a “line extension” of the RMP and would not have had any additional period of exclusivity beyond that granted in relation to the RMP under Article 10(1): but there could be no reason for distinguishing the case where Napp held the MA for the RMP from the actual case, where it did not. She further noted that the Commission had expressed the same view in its Notice to Applicants. So she dismissed Napp’s challenge, holding that the MHRA had been correct to grant the MA, and refused to make a reference to the Court of Justice.

George Peretz QC acted for the MHRA.

To read the judgment, please click here.