Lundbeck: Remedying IP Overprotection through Competition Law Enforcement in the Pharma Sector

By Konstantinos Sidiropoulos

Introduction

On 8 September 2016, the General Court (‘GC’) handed down a seminal judgment for the pharmaceutical sector in the Lundbeck case. The judgment is of particular importance, because it is the very first ruling of the EU Courts affirming that pharma pay-for-delay agreements (or reverse payment settlement agreements) may be subject to competition law scrutiny. Pay-for-delay (‘PFD’) agreements are agreements that are intended to delay the market entry of generic manufacturers with generic drugs in exchange for payments made by original pharmaceutical producers (i.e., holders of patents for an original branded drug). The GC, upholding the European Commission’s (‘Commission’) decision of 19 June 2013, held that Lundbeck and four generic producers had infringed EU competition law by entering into such agreements.

The Commission has lately been particularly active in this area. Indeed, PFD agreements were first regarded as potential targets for scrutiny under competition law in the EU as a result of the Commission’s Pharmaceutical Sector Inquiry, leading to the publication of its Pharmaceutical Sector Inquiry Final Report in July 2009. Since then, the Commission has been continuously monitoring patent settlements between originator and generic companies, publishing six reports on this matter – the latest of those being published in December 2015. Continue reading

Neues aus dem Elfenbeinturm: November 2016

Call for papers : The Cambridge International and European Law Conference 2017 «Transforming Institutions»

University of Cambridge, 23-24 March 2017. Deadline for abstract submission : 25 November 2016.

Call for submissions : European Journal of Legal Studies New Voices Prize

Deadline for paper submissions : 15 December 2016.

Call for papers : 6th Conference of the Postgraduate and Early Professionals/Academics Network of the Society of International Economic Law

Tilburg University, 20-21 April 2017. Deadline for abstract submissions : 30 November 2016.

Call for papers : Conference « Post-Conflict Justice in Ukraine »

Kyiv, 26-27 May 2017. Deadline for abstract submissions : 15 December 2016.

The Extraterritorial Reach of EU Animal Welfare Rules (Again): Case C-592/14 European Federation for Cosmetic Ingredients

By Jessica Lawrence

What is the scope of the marketing ban on cosmetics containing ingredients that were tested on animals? Does it include cosmetics that were tested on animals because of the requirements of a third country’s laws? This was the question the CJEU addressed in its decision in the European Federation for Cosmetic Ingredients case. The Court’s 21 September 2016 judgment goes some way toward resolving the lack of clarity of the animal testing provisions of the Cosmetics Regulation (which Advocate General Bobek’s Opinion referred to as ‘not well drafted’ and ‘not a paragon of clarity’ (AG’s Opinion paras 74 & 24)). But it also continues a recent line of cases in which the Court approves of EU rules with important extraterritorial effects. Continue reading

ISDS in EU FTIAs. Yes, No, Maybe? A Domestic Enforcement Perspective

by  Szilárd Gáspár-Szilágyi

I. SETTING THE STAGE

In recent years ISDS has been on the lips of many politicians, academics, NGOs and even laymen, some of whom have recently ‘discovered’ that there is a mechanism through which foreign investors (often large multinationals, but not always) can bring claims against host-states before an international arbitral tribunal. The arguments in favour and against ISDS are plentiful, but one always catches my eyes. According to this argument (page 3), the EU does not need ISDS in its new free trade and investment agreements (FTIAs) with developed states, because the original rationale of this mechanism was to protect foreign investors from host‑state jurisdictions where basic tenets of the rule of law were not observed. However, trading partners such as the US or Canada have well‑functioning judicial systems that protect foreign investors; therefore, ISDS is not needed.

As a novice to the field of EU investment law, I must confess I am not yet fully convinced by the benefits of ISDS. Nevertheless, the afore-mentioned argument resonates with my previous field of research, concerned with the domestic enforcement of EU and US international agreements, and once again illustrates that there is often a disconnect between the international and the domestic enforcement of treaties.

I will not advocate for the ‘greater’ protection of foreign investors. Instead, I want to shed some critical light on the argument according to which foreign investors already enjoy high levels of protection in advanced domestic judicial systems. I will argue that the domestic protection of foreign investors is more complex. On the one hand, foreign investors can bring a claim before a domestic court against the host-state, invoking domestic standards of protection. On the other hand, they could also potentially bring a claim before the same domestic courts, relying on international standards of investment protection. As I will illustrate, the international and domestic levels of enforcement should not be treated as worlds apart and the interplay between the two can shape the strategies of the treaty negotiators and of the investors. Continue reading

Referring Brexit to the Court of Justice of the European Union: Why Revoking an Article 50 Notice Should be Left to the United Kingdom

By Oliver Garner

An Encore to (R)Miller from the Court of Justice?
There is a potential European encore to the constitutional drama of the UK High Court decision in R(Miller) v Secretary of State for Exiting the European Union. The judgment found that the UK government cannot trigger Article 50 TEU without Parliament’s involvement. The government has already indicated its intention to appeal directly to the UK Supreme Court (UKSC). Certain commentators in the media have picked up on the possibility that the Supreme Court could refer (certain aspects of) the case to the Court of Justice of the European Union (CJEU). This has been referred to as ‘the constitutional equivalent of breaking the space-time continuum’.

Of course, as the reaction to the judgment in (R)Miller has shown, the UK media are not afraid of exaggeration. The first and most important thing to reiterate is that the CJEU could not act as the final constitutional arbiter of the question in the case of whether the UK government may use the royal prerogative to give notice under Article 50 TEU. The EU law clause is clear that the condition for the decision to withdraw is ‘accordance with [the] constitutional requirements’ of the Member State. Therefore, the final decision on the substance of whether these requirements have been fulfilled will always be for that Member State’s highest judicial authority. Instead, the possibility of a referral to the Court of Justice in the case concerns one specific aspect of the withdrawal clause: whether the notification to the European Council of an intention to withdraw under Article 50(2) is revocable. The silence of the clause can be seen to constitute a ‘gap’ in the law.

However, this post will argue that it is not necessary for the Court of Justice to prove an authoritative determination on this question of EU law in order for the UK Supreme Court to decide the specific question of UK constitutional law in the (R)Miller adjudication. Therefore – in the specific case of (R)Miller  – the UK court is under no obligation under Article 267 TFEU to refer the question to the Court of Justice of the European Union. The post will go on to consider the hypothetical situations in which there may be such an obligation to refer, and will suggest how the Court of Justice should determine the question in such a scenario. Continue reading

Investment Court System in CETA to be judged by the ECJ

By Laurens Ankersmit

Last Thursday, the leaders of the Belgian federal government and the regional and community governments reached a compromise deal  over the EU-Canada Comprehensive Economic and Trade Agreement (CETA). One of the key outcomes is that the Belgian federal government will seek the Opinion of the European Court of Justice on the compatibility of the Investment Court System (ICS) in Chapter Eight of CETA with the Treaties. As soon as the Belgian federal government makes the request for an Opinion, the Court will be able to express itself on this contentious legal issue. In this post, I will provide some background on the origins of the Walloon request before explaining why ICS could potentially pose a legal problem for the EU.


Wallonia’s longstanding resistance against CETA and the resolution of 25 April of 2016

To insiders, the resistance put up by Wallonia in particular should have been no surprise. Over the past few years, the Walloon and Brussels parliaments have had extensive debates on the merits of CETA and have been increasingly critical of the deal. One of the main and more principled sources of opposition was the inclusion of ICS in CETA, a judicial mechanism that allows foreign investors to sue governments over a breach of investor rights contained in the agreement. Continue reading

Opinion 1/15: AG Mengozzi looking for a new balance in data protection (part II)

By Maxime Lassalle

The AG’s proportionality test

After these general considerations, the AG starts his proportionality test. In the opinion nine points are considered separately (para. 210). From this analysis, three main elements deserve to be emphasized. Continue reading

Opinion 1/15: AG Mengozzi looking for a new balance in data protection (part I)

By Maxime Lassalle

On 8 September 2016, Advocate General (AG) Mengozzi delivered his much awaited opinion on the agreement between Canada and the European Union on the transfer and processing of Passenger Name Record (PNR). It follows the European Parliament’s resolution seeking an Opinion from the Court of Justice of the European Union (CJEU) on the compatibility of the agreement with the Treaties. Even though the opinion concludes that the agreement has many loopholes, it could disappoint those who were expecting a strong condemnation of PNR schemes as such.

This blogpost intends to present the context of this procedure and the main elements of the AG’s opinion before analysing them. The question of the appropriate legal basis for the agreement, also raised by the Parliament, will not be addressed. However, before turning to the AG’s opinion, we need to briefly sketch the background of the proposed agreement. Continue reading

Neues aus dem Elfenbeinturm: October 2016

Conference « New Instruments to Promote the Correct Application of the EU Charter of Fundamental Rights »

Florence, 28 October 2016. Deadline for (free) registration : 18 October 2016.

Colloquium « Les religions et le droit du travail »

Université de Rouen, 20-21 Octobre 2016. Free access.

Conference « Computers, Privacy & Data Protection : The Age of Intelligent Machines »

Brussels, 25-27 January 2017. Deadline for submissions : 22 October 2016.

Call for Papers: ESIL Conference “The Role of the European Parliament in the Conclusion and Implementation of International Agreements on International Economic Law Issues

European Parliament, Brussels, 9 December 2016. Deadline for abstract submissions: 7 November 2016.

Call for papers : One Day Symposium on Transnational and International Environmental Crime – Synergies, Priorities and Challenges

University of Lincoln, 15 February 2017. Deadline for abstract submissions : 18 November 2016.

Call for submissions Comparative Constitutional Law and Comparative Law Quarterly

Deadline for submissions : 27 November 2016.

Housing Law Research Network 3rd Annual Housing Law Symposium: Human Rights, Housing and Dispute Resolution

Malmö University, 23-24 March 2017. Deadline for abstract submissions : 1 January 2017.

 

 

May’s March towards Brexit: some comments on the potential legal implications of the UK’s ‘Great Repeal Bill’

By Oliver Garner

‘Brexit means Brexit’ means March

We have learned two important things about what ‘Brexit means Brexit’ means from the Conservative party conference last week: (1) Theresa May’s government will trigger Article 50 TEU in March 2017 at the latest; and (2) a ‘Great Repeal Bill’ will be proposed in the next Queen’s speech which will repeal the European Communities Act 1972 and enshrine all EU law into domestic law (at least for the time being). This post will focus on some potential legal implications of the ‘Great Repeal’ of EU law in the United Kingdom. It will consider how exactly EU Directives and Regulations will be implemented into UK law, before considering the substantive issue of whether such implementation means that EU citizens in the UK will retain their ‘acquired rights’ to residence. The argument will be that enacting the ‘Great Reform Bill’ will be a far more difficult task for the UK government and Parliament than its announcement suggests. Furthermore, without extensive amendments, such wholesale transposition could undermine the effectiveness of the withdrawal from the Union legal order.

The announcement of a March Article 50 notification does not provide answers to all the vagaries of the legal procedure of Article 50 (including exactly how notification will be sent, and which government minister will be responsible). However, it does provide political certainty as to the timeframe of Brexit, barring the notification being blocked by the outcome of the upcoming constitutional challenge to the government’s authority to trigger Article 50 without the consent of Parliament. Under Article 50(3), if a withdrawal treaty is not concluded, and if there is no unanimous agreement to extend the time-frame of negotiations, the United Kingdom will cease to be a Member State of the European Union by March 2019. Continue reading

“In the Light of the Guidelines”: Brexit and the European Council

By Darren Harvey

During her speech at the Conservative Party conference on Sunday, Prime Minister Theresa May stated that the UK would be notifying the European Council of its intention to withdraw from the EU in accordance with Article 50(1) TEU by the end of March 2017 at the latest.

Earlier that day, during an interview on the BBC with Andrew Marr, the Prime Minister was asked what will happen immediately after the notification to leave the EU has been made.

The Prime Minister responded:

“Well, it’s for the European Union, the remaining members of the EU have to decide what the process of negotiation is. I hope, and I’ll be saying to them, that now that they know what our timing is going to be, it’s not an exact date but they know it’ll be in the first quarter of next year, that we’ll be able to have some preparatory work, so that once the trigger comes we have a smoother process of negotiation.”

Shortly after this announcement, European Council President Donald Tusk took to Twitter, stating that once Article 50 had been triggered, the remaining 27 EU Member States would “engage to safeguard [their] interests” – thus suggesting that no preliminary negotiations shall be conducted prior to such notification.

This exchange raises a fundamental question about the Article 50 TEU withdrawal process that has not yet been fully considered; namely, what role will the European Council play in this process? Continue reading

News from Minimum Harmonisation: How the Tobacco Advertising Cases Shape the Law of the Internal Market

By Josef Weinzierl and Jonas Weissenmayer

Minimum harmonisation has always been in the toolbox of the EU legislature as one way of regulating the internal market, and its normative virtues are hotly debated in the literature. The concept also raises a quirky and often neglected constitutional issue: are minimum harmonising Directives compatible with the re-regulatory aim of Article 114 TFEU, despite the fact that they allow for varying national standards that go beyond the common floor of the Directive, hence failing to eliminate all obstacles to trade? The CJEU’s answer to this question given in the recent Philip Morris judgment, emerged from the latest round of challenges by the tobacco industry against Directive 2014/40/EU, seems to be ‘no’. This post offers some reflections on the controversial regulatory structure of Directive 2014/40, as well as on the reasoning of the Court. Continue reading

CJEU sheds light on liability for operators of open Wi-Fi networks (Case C-484/14 Mc Fadden v Sony Music)

By Bernd Justin Jütte

One week after the Court of Justice (CJEU) handed down its Judgment in GS Media (see for a comment here), it has ruled on another important copyright case. In Mc Fadden v Sony Music the Court followed the Opinion of AG Szpunar (see for comment on this blog here) to a large extent while disagreeing on two crucial points. It decided that the operator of an open wireless network provides an ‘information society service’ (ISS) within the meaning of Article 14 E-Commerce Directive if he provides access to the network as part of his economic activities. This means he can avail himself of the liability exemption laid down in that provision. However, the operator of a wireless network can be required to protect the network with a password in order to deter users from infringing the rights of copyright holders. The Court further decided that the right holder can claim from network operators the costs related to an injunction (e.g. to prevent future infringements), but not the costs related to claims for primary infringements of copyrights by the users of the Wi-Fi network. Continue reading

Hungary’s Referendum on the Migrant Quota: a ‘no’ sought to do what?

By Márk Némedi

“Do you want the European Union to be able to prescribe the mandatory settlement of non-Hungarian nationals to Hungary even in lack of the consent of the National Assembly?”[i] – this is the question Hungarian voters will be asked to respond to on 2 October 2016. Speculations and verbal sparring have been strengthening about what may lie ahead, and not without reason. It appears that the possible legal and political implications of a valid vote could be broader than usual. At the least, referenda should pose concrete questions which invite an answer giving political institutions a well-circumscribed mandate. They should not give national governments a blanket authorisation and a political salvus conductus to freely choose what the will of the people requires. This contribution will look at how these principles fare in the upcoming referendum on the migrant quota and what the broader implications may be for both Hungary and the Union. Continue reading

Saving the Internet or linking limbo? CJEU clarifies legality of hyperlinking (C-160/15, GS Media v Sanoma)

By Bernd Justin Jütte

In a much awaited decision, the CJEU has ruled that linking to freely-available copyrighted content that has been uploaded without the consent of the right holder is, in principle, legal. However, it qualified that such a reference could infringe the right to communication to the public under Article 3(1) of the Information Society Directive (Directive 2001/29/EC) if certain elements were present. After AG Wathelet had provided his Opinion in early April (see post on this Blog here), the CJEU rendered its Judgement on 8 September 2016. Continue reading

Neues aus dem Elfenbeinturm: September 2016

Call for Papers: Regional Human Rights Systems in Crisis

Wisconsin International Law Journal Annual Forum, University of Wisconsin, 31 March 2017. Deadline for abstract submission: 23 September 2016.

Call for Papers: EUSA Conference “Uncertain Destinations: The European Union at 60”

Miami, 4-6 May 2017. Deadline for abstract submission: 30 September 2016.

Call for Papers: Workshop on the legislative choice between delegated and implementing rule-making

German Research Institute for Public Administration, Speyer, 20 March 2017. Deadline for abstract submission: 10 October 2016.

Conference: An Administrative Procedure Act for the EU?

Lund University, 24 November 2016. Deadline for (free) registration: 10 November 2016.

Brexit: A Tale of Two Agreements?

By Hugo Flavier and Sébastien Platon

There seems to be a common assumption (see, among many others, here 3.6, here or here at 14:00) that there is a distinction between two kinds of « post-Brexit agreements », i.e. the withdrawal agreement (the divorce settlement) and the agreement regarding the future relationship between the United Kingdom (UK) and the European Union (EU). However, this distinction is, in fact, not very clear. It raises, in particular, several questions related to the legal basis and the nature (exclusive or not) of the withdrawal agreement. This contribution aims to clarify the distinction between these two agreements and identify the legal difficulties arising from their articulation. It will be argued that, due to some legal uncertainties, the negotiators of these agreements should be careful of their respective contents. Continue reading

Brexit, Europhobia and Xenophobia

By Christopher Harding

One of the most worrying aspects of the recent campaigning in the UK ahead of the referendum on UK membership of the EU, and the subsequent outcome of the referendum, was the opportunity provided to express more openly and forcibly feelings which appeared to be Eurosceptic or even more deeply Europhobic or xenophobic. On the one hand, public opinion in the UK has long been considered insular and Eurosceptic, but the referendum seemed to trigger the more open and confident expression of xenophobic views and suggests a polarisation of opinion on Britain’s international and European roles. On the other hand, Britain also has a reputation as a welcoming and tolerant society in its general attitude towards those from other countries. This contribution is a reflection on the reality of tolerance and intolerance in contemporary British society and how recent events in the UK fit into the wider European legal and cultural landscape of human mobility across frontiers. Continue reading

Pirates of the Gulf of Aden: the Sequel, or how the CJEU further embeds the CFSP into the EU legal order

By Thomas Verellen

The Court of Justice of the EU (CJEU) recently added a new chapter to the long-running chain-novel on the relationship between the Common Foreign and Security Policy (CFSP) and other areas of EU external action. In its judgment of 14 June 2016, the Court’s Grand Chamber answered questions on the choice of legal basis (CFSP versus AFSJ) of a Council decision concluding a transfer agreement between the EU and Tanzania, and on the meaning of Article 218(10) TFEU on the sharing of information by the Council with the Parliament as it pertains to treaty-making in the CFSP.

The ruling is interesting, as it is perhaps indicative of a relaxed, rather pragmatic, approach to the politically thorny question of the CFSP’s scope, as well as revealing of a principled effort by the Court to further embed the CFSP into the EU legal order. In this sense, the Court’s approach in Somali Pirates II is structurally similar to the one undertaken in the recent case of H v Council on the scope of the CJEU’s jurisdiction in CFSP-disputes.

In the following post, I briefly develop both aspects of this equation – pragmatism with regard to the scope of the CFSP versus principle with regard to the reach of EU constitutional principles into the CFSP – and I conclude with a brief reflection on the normative issue of whether the Court stays within its role as a judicial body, where I suggest the CJEU’s approach fits squarely within its duty to say what the law is. Before proceeding any further, however, a few words of background are in order. Continue reading

Neues aus dem Elfenbeinturm: August 2016

PhD Forum “Law and Governance in a Crisis-Ridden Union

Netherlands Institute for Law and Governance, Vrije Universiteit Amsterdam, 17 November 2016. Deadline for abstract submissions : 4 September 2016.

Call for papers “The Migration Crisis as a Challenge for Democracy

Centre for Direct Democracy Studies, University of Białystok. Deadline for abstract submissions : 10 September 2016.