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

The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”).  In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat cystitis and that have a principal intended action based on proanthocyanidins (“PACs”) do not fall within the definition of medical devices.  The European Commission adopted its draft decision based on Article 13(1)(d) of Directive 93/42/EEC (the “Medical Devices Directive”).

The vote comes more than one year after the Commission prepared a draft decision, in February 2016 (see our analysis of that draft decision here).  The formal adoption and publication of the Cranberry Decision are expected later this summer.  This article first briefly summarizes the regulatory context of EU borderline issues.  It then explains what triggered the decision, analyzes its content, and provides a brief outlook on what is coming next.
Continue Reading EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices

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

Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here).  This presents a good opportunity to have a closer look at one of the essential questions of the revision of the medical device rules, namely, whether the scope of the Regulation changes in comparison to that of the main Medical Devices Directive 93/42/EEC (the “Directive”).  We examine below the changes to the definition of a medical device and whether the Regulation affects borderline determinations.

As discussed in our earlier post, the borderline between medical devices, medicinal products, cosmetics and foods or food supplements is often blurred.  The Regulation sheds some additional light on the definition of a medical device and strengthens the Commission’s power in relation to the borderline issues.  Nevertheless, important questions continue to exist, for instance in relation to the pharmacological versus physical (or purely chemical) mode of action of a product.
Continue Reading EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?

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 to treat epilepsy, in the UK.  In addition to the fines, the CMA ordered both entities to reduce their respective prices within timeframes of between 30 working days and 4 months.

In September 2012, Pfizer sold the UK distribution rights for the phenytoin sodium capsules (sold until then under the brand name Epanutin) to Flynn Pharma. Flynn Pharma subsequently de-branded the drug, effectively taking it outside the price regulatory regime.  Pfizer continued to manufacture the drugs.  The CMA found that, after September 2012, Pfizer supplied the capsules to Flynn Pharma at wholesale prices that were between 780% and 1,600% higher than its previous prices to wholesalers and pharmacies.  It also found that Flynn Pharma’s prices to wholesalers and pharmacies were between 2,300% and 2,600% higher than the prices previously paid to Pfizer.  Flynn Pharma’s prices also significantly exceeded the prices charged by Pfizer (after September 2012) for the same products in other European countries.
Continue Reading UK CMA Imposes Record Fine on Pfizer

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

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)

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 (“TFEU”) preclude the imposition of an obligation to pay a royalty for the use of a patented technology for the entire duration of a licence agreement, in the event that the patents protecting the technology are revoked.  The ECJ concluded that Article 101(1) TFEU does not preclude the imposition of a requirement to pay royalties, provided that the licensee is free to terminate the agreement by giving reasonable notice.
Continue Reading Court of Justice Rules That Genentech Must Pay Royalties to Sanofi

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on:

  • Procedural aspects of submitting clinical reports.
  • The anonymisation of clinical reports.
  • The identification and redaction of commercially confidential information (CCI) in clinical reports, i.e. the disclosure of information that is not in the public domain and may undermine the legitimate economic interest of the applicant.

The Guidance is accompanied by a number of annexes, including template cover letters, template anonymisation reports and process flowcharts.
Continue Reading EMA Publishes Proactive Disclosure Guidance

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