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The CMA issued an infringement decision today fining GlaxoSmithKline (“GSK”) and two other pharmaceutical companies a total of £45 million for delaying market entry of generic versions of GSK’s blockbuster anti-depressant Seroxat (paroxetine) in the UK.
Continue Reading CMA Fines GlaxoSmithKline and Several Generic Companies £45 million for Delaying Market Entry of Generic Paroxetine in the UK

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), concluding that “the number of settlements that might attract competition law scrutiny remains at a low level”.  In fact, 88% of the settlements analysed fell into categories that the Commission considered prima facie do not require competition law scrutiny (para. 51).
Continue Reading European Commission Publishes its 6th Report on the Monitoring of Patent Settlements

This article was originally posted on our sister blog Inside Medical Devices

On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the medical devices and IVD framework. The European Commission considers this as “a major step forward towards the adoption of new regulations on medical devices to help guarantee a high level of health and safety protection for EU citizens using these products.”

This agreement is based on the technical work of the Permanent Representatives Committee of EU countries which finalized the Council’s position on the draft Medical Devices and IVD Regulations on September 23, 2015. The core substance of the Council’s position was already agreed in a partial General Approach on the draft EU medical devices package on June 19, 2015 (for details please see our previous post of early September). The final agreement of October 2015 does not deviate from the substance of that partial agreement of June 2015. The main difference is that it includes a general approach on the recitals of the draft Regulations on medical devices and IVD. Preambles of EU legislative instruments do not have a binding effect; however, they are useful in the interpretation of rules and usually consulted by EU and Member State institutions and courts in their application of the law.
Continue Reading EU Agreement on a General Approach on the Medical Devices Package

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 ‘by object’, such that it infringed article 101(1) of the Treaty on the Functioning of the European Union (“TFEU”).

Unlike its subsequent analysis in Servier where the Commission analysed by the ‘object’ and ‘effect’  of the agreements, in Lundbeck the Commission did not analyse the effects of the parties’ conduct.Continue Reading Merck and Generics UK challenge the Commission’s ‘by object’ analysis in Lundbeck

This post was originally published on our sister blog Inside Medical Devices.

On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here).  The General Approach does not yet include the recitals to the new medical devices and IVD regulations.

The Council’s text on the new IVD Regulation significantly amends the Commission’s proposed definition of ‘companion diagnostics’, an evolution relevant to sponsors of both medicinal products and diagnostic devices.  The Council’s definition of companion diagnostics is almost identical to the definition used by the FDA, but significantly different from the European Commission’s proposal and the European Parliament’s suggested amendments.  An overview is set out below.
Continue Reading IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS).  EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need.

The MHRA issued the scientific option to Bristol-Myers Squibb Pharmaceutical Limited for its advanced melanoma product, nivolumab.  Nivolumab represents the second medicine, and also the second anti-PD-L-1 monoclonal antibody, to be approved as part of the EAMS.  In March this year, Merck Sharp & Dohme Limited’s product, pembrolizumab, used to treat advanced melanoma received the first EAMS scientific opinion.  The scientific opinions comprise a public assessment report and three treatment protocols, for patients, healthcare professionals, and on the pharmacovigilance system.  Both opinions describe the risks and benefits of the medicines and the context for their use, supporting the prescriber and patient to make a decision on whether to use either medicine before their licence is granted.Continue Reading MHRA grants second scientific opinion as part of the Early Access to Medicines Scheme

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 Fentanyl decision concerning a co-operation agreement between Sandoz and Janssen Cilag.  It not only looked at whether the settlement agreements between Servier and certain generic companies restricted competition by object, it also analysed their effects.  As a result of its analysis, the Commission found that Servier’s conduct amounted to an abuse of dominance under Article 102 of the Treaty on the Functioning of the European Union (the “TFEU”).

In July 2014, the Commission fined Servier and generic companies Niche/Unichem, Matrix (now Mylan), Teva, Krka and Lupin a total of €428 million for having concluded agreements that delayed market entry of generic versions of Servier’s blockbuster blood pressure medicine, perindopril, and protected it from price competition from generics in the EU.  All these agreements entailed Servier making significant payments (or providing other types of inducements) to the generic companies.  In addition to entering into these settlement agreements, Servier adopted various other practices that the Commission found were part of Servier’s overall strategy to delay or prevent entry of generic versions of perindopril. 
Continue Reading European Commission Published Non-Confidential Version of Servier Decision

On 11 June 2015, the General Court handed down its judgment in Case T-452/14 Laboratoires CTRS v European Commission (the “CTRS Case”) annulling the Commission’s decision to grant Kolbam a marketing authorisation.  The General Court held that references in Kolbam’s SmPC to the efficacy of Kolbam for indications that Orphacol was authorised circumvented Orphacol’s market exclusivity and could encourage off label prescribing.
Continue Reading General Court Confirms Market Exclusivity Rights in CTRS Case

This article was originally published on our sister blog InsidePrivacy

May 2015 saw a number of developments in the EU mHealth sector worthy of a brief mention.  The European Commission announced that it would work on new guidance for mHealth apps, despite the European Data Protection Supervisor and British Standards Institution publishing their own just weeks earlier.  In parallel, the French data protection authority announced a possible crackdown on mHealth app non-compliance with European data protection legislation.  This post briefly summarizes these developments.
Continue Reading May 2015 EU mHealth Round-Up

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

…