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Miranda Cole

Miranda Cole is a partner based in the firm’s Brussels office.  She practices competition and communications law and policy, and has more than 15 years of experience in the field.  Ms. Cole’s competition law expertise encompasses merger control, actions under Articles 101 and 102 TFEU, advisory work and actions before the European courts in Luxembourg.

She has particular expertise in advising companies active in the technology and communications sectors in complex and strategic regulatory and policy matters, with particular expertise regarding the impact of evolving regulatory frameworks on new technologies and services.  In the communications sector she has extensive experience advising in connection with all aspects of European and international regulation, policy and competition law, and counselling in connection with the impact of regulation on transactions.

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AG’s Opinion – Licensed and Unlicensed Medicines May Fall Within the Same Relevant Product Market

By Miranda Cole on Posted in Competition, Medicinal Products, Pharmaceutical companies
Yesterday’s Opinion from Advocate General Saugmandsgaard Øe (AG) in Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato takes the position that licensed and unlicensed pharmaceutical products used for the same indication may fall within the same relevant product market. The Italian Council of State (ICS) referred a number of questions to the EU … Continue Reading

UK CMA Imposes Record Fine on Pfizer

By Miranda Cole on Posted in Competition, Medicinal Products, Pharmaceutical companies
The UK’s Competition and Markets Authority (the “CMA”) imposed a £84.2 million (€99.7 million) fine on Pfizer yesterday. In addition, the CMA also fined distributor Flynn Pharma £5.2 million (€6.1 million).  The CMA found that Pfizer and Flynn Pharma abused their dominant positions by charging excessive and unfair prices for phenytoin sodium capsules, drugs used … Continue Reading

French Supreme Court upholds Sanofi’s generic denigration fine

By Miranda Cole on Posted in Competition, Food & Drug Regulatory, Medicinal Products, Pharmaceutical companies
In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art. 102 of the Treaty on … Continue Reading

Italy’s AGCM Fines Aspen EUR 5 Million for Excessive Pricing

By Miranda Cole on Posted in Competition, Food & Drug Regulatory, Medicinal Products, Pharmaceutical companies
The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine (thioguanine) … Continue Reading

Court of Justice Rules That Genentech Must Pay Royalties to Sanofi

By Miranda Cole on Posted in Competition, Food & Drug Regulatory, Intellectual Property, Pharmaceutical companies
In its 7 July 2016 Genentech judgment (Case C-567/14), the European Court of Justice (“ECJ”) ruled that Genentech had to pay royalties to Sanofi-Aventis Deutschland under its licence agreement. The Paris Court of Appeal requested a preliminary ruling on whether the provisions of Article 101 of the Treaty on the Functioning of the European Union … Continue Reading

European Commission Publishes its 6th Report on the Monitoring of Patent Settlements

By Miranda Cole on Posted in Competition
Since its in-depth inquiry into the pharmaceutical industry in 2008-2009, the European Commission (the “Commission”) has monitored patent settlement agreements. In its 2014 report published on 2 December 2015, the Commission revealed the results of its analysis of 76 patent settlement agreements between originators and generics  (a number “far below” the figures of previous years), … Continue Reading

Merck and Generics UK challenge the Commission’s ‘by object’ analysis in Lundbeck

By Miranda Cole on Posted in Competition, Pharmaceutical companies
On Thursday the General Court (the “GC”) held the first two hearings  in the Lundbeck case. Generics UK, now part of the Mylan group, and its former parent Merck KGaA (“Merck”) challenged the European Commission’s (the “Commission”) analysis, arguing that the Commission had wrongfully concluded that Generics UK’s settlement agreement with Danish originator Lundbeck restricted competition … Continue Reading

European Commission Published Non-Confidential Version of Servier Decision

By Miranda Cole on Posted in Competition, Pharmaceutical companies
On 14 July 2015, the European Commission (the “Commission”) published the preliminary non-confidential version of its decision in the Servier case, one year after the decision was issued.  This is the second key Commission decision, after Lundbeck, on reverse payment patent settlement agreements. In Servier, the Commission went further than in Lundbeck and in its … Continue Reading

The Italian Competition Authority launches a sector inquiry in relation to vaccines for human use

By Miranda Cole and Andrea Zulli on Posted in Competition, Pharmaceutical companies
On 27 May 2015, the Italian Competition Authority (ICA) issued a decision launching a sector inquiry into the supply of vaccines for human use. The ICA has stated that it has launched the sector inquiry because of: the importance of vaccines in terms of health care costs borne by the Italian National Health Service (over … Continue Reading

EU Commission Publishes Fifth Report On Patent Settlements In the Pharmaceutical Sector

By Miranda Cole on Posted in Intellectual Property
The European Commission published its Fifth Monitoring Report of Patent Settlements today. Patent settlements enable patent-related disputes to be resolved without having to litigate issues such as patent validity or patent infringement.  The Commission takes the view that patent settlements can infringe competition law when they prompt generic suppliers to delay entry in return for … Continue Reading

European Commission Consults On Revised Competition Regime For Technology Transfer Agreements

By Miranda Cole on Posted in Competition
Originally published as Covington E-Alert on February 26, 2013 On  20  February  2013,  the  European  Commission  published  for  consultation  its  proposal  for revisions to the EU technology transfer competition regime.  The consultation period runs until 17 May 2013.  The new regime will be adopted before April 2014.  The EU’s approach to the application of competition … Continue Reading

Key Considerations for European M&A in the Life Sciences Sector

By Daniel Pavin, James Halstead, Robin Blaney, Chris Bracebridge, Miranda Cole, Guy Dingley and Morag Peberdy on Posted in Anti-Corruption, Competition, Corporate, Employment
Article originally published in PLC Life Sciences Handbook 2012 M&A in the life sciences sector has remained robust, driven by factors such as: „„ The need to replenish shrinking product pipelines. „„ The need to maintain revenues as patents on top-selling products expire. „„ The strategic diversification of business lines. „„ Expansion into emerging markets. … Continue Reading

European Commission Revises Distribution Rules

By Miranda Cole and Jetty Tielemans on Posted in Competition
Originally published as Covington E-Alert on April 27, 2010  On 20 April 2010, the European Commission published new rules governing so-called “vertical” agreements, such as distribution and supply agreements. The new rules are set out in the Vertical Restraints Block Exemption Regulation and the related Guidelines (see DG Competition’s website). They will become effective as … Continue Reading
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