This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission's approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.

A Law on Administrative Procedure (LAP) is an essential institutional feature of democratic and effective governments. It is a general law on executive law-making, setting out how laws and regulations should be made. The need for a LAP at EU-level is growing – to counter the EU's legitimacy deficit and to make the regulatory process more predictable and robust. At the same time, the EU regulatory “machine” faces new challenges and pressures, as it seeks to implement highly complex (risk management) regulation. Greater regulatory effectiveness depends on more transparency, evidence quality standards and participation. As such, an EU LAP appears to be the natural culmination of the EU Smart Regulation agenda. Since the European Parliament in 2013 called for the Commission to adopt a LAP-related legislative proposal, the debate has gained in visibility and political salience. This article makes the case for an EU LAP for the EU institutions, citizens and businesses – provided the Law enshrines the four key principles of good administration (transparency and consistency; public participation; public record; and accountability); it establishes clear and legally binding procedural standards; and it covers as a principle also rule-making and adjudication decisions by all EU institutions and bodies involved in the preparation, adoption, implementation and repeal of secondary legislation.

Joined Cases C-358/13 and C-181/14, Markus D. and G.

Substances which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health do not fall within the scope of the definition of a “medicinal product” in the Directive 2001/83 (official headnote).

Consumer safety and medicines control legislation is not suitable to penalise the introduction of new psychoactive substances on European markets (author's headnote).

Art 1(2)(b) Directive 2001/83

This report provides an overview of the potential impact of the draft Trans–Pacific Partnership Agreement on public health and access to medicines, in light of a recent analysis conducted by UNITAID. The international organization observed that the increased intellectual property protection endorsed in the draft agreement,which calls for the adoption of TRIPSplus standards, is likely to severely impact generic competition, affecting the availability of medicines in developing countries, and reducing the ability of governments to set the appropriate balance between the protection of innovation and the safeguard of public health

Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.

Case C350/12 P Council of the European Union v. Sophie in't Veld Judgment of the Court (First Chamber) of 3 July 2014

This report discusses a proposal fromthe Center for International Environmental Law(CIEL), ClientEarth and Friends of the Earth Germany (Bund) on the regulation of nanomaterials in the European Union. It discusses in particular, the proposal for a horizontal regulation on nanomaterials (also referred to as a nano-patch for existing legislation) that would fill in the regulatory gap on nanomaterials. The proposal goes beyond a review of the REACH text and encompasses all EU legislation relevant to nanomaterials. The proposed instrument would amend the REACH text with delimitation in scope to all areas relevant to nanomaterials (on the model of Regulation 1272/2008 on the classification, labelling and packaging of chemicals). The main aim of the regulation is to ensure that hazard, risk and exposure assessments for all forms and uses of such materials are adequately carried out and taken into consideration.

In U.S. patent cases, a factor for demonstrating that an invention is non–obvious is the commercial success of the product embodying that invention. There must also be a nexus or connection between the patented characteristics of the claimed product and its commercial success. One may presume that a nexus exists if the characteristics of a product that is shown to have commercial success are covered by the patent claims at issue. In Europe, “commercial success alone is not to be regarded as indicative of inventive step. The following requirements must first be met: a long–felt need must have been fulfilled, and the commercial success must derive from the technical features of the invention and not fro mother influences (e.g. selling techniques or advertising).” Based on my understanding of U.S. and European patent law relevant to the issue of commercial success, this paper addresses some of the economic issues and associated data to consider in assessing whether a patented pharmaceutical product is a commercial success.