EU & Germany: Denial of absolute product protection for DNA-patents (CJ decision in Monsanto v Cefetra, C- 428/08) – a German perspective
Anna Wolters, Dusseldorf

The Court of Justice of the European Communities just recently denied absolute product protection of patent claims directed to DNA sequences in the case Monsanto v Cefetra and others, C- 428/08. 

EU & UK: Recent English case law on Supplementary Protection Certificates and an overview of the pending references before the CJEU
Trevor Cook, London

In our Life Sciences Update for April 2010 we discussed, from a French perspective, the vexed question of protection for combination products under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (the "SPC Regulation").  This is an area that has also occupied a number of other courts in EU Member States in recent years, including the English Patents Court. 

And with the reference to the CJEU in Medeva's SPC Applications there are now several pending references to the Court of Justice of the EU (CJEU) under the SPC Regulation.
 

Return to top

Regulatory

EU: Public consultation regarding the revision of Directive 98/79/EC on in vitro diagnostic medical devices
Marc Martens, Brussels

On 29 June 2010, the European Commission launched a public consultation on specific issues relating to in vitro diagnostics.  The two other medical devices Directives (Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices) were revised by Directive 2007/47/EC, and the need to revise Directive 98/79/EC was revealed by the public consultation that launched in 2008. Directive 98/79/EC has not been substantially amended since its adoption in 1998.

EU: Access to medicinal product dossier's documents
Mauro Turrini, Milan

On 7 July 2010, the European Ombudsman  published its Draft Recommendation of his inquiry into complaint 2560/2007/BEH against the European Medicines Agency ("EMA") concerning the refusal to disclose clinical study reports and corresponding trial protocols concerning certain anti-obesity medicinal products which were submitted by two pharmaceutical companies to the EMA with a view to obtaining marketing authorisations.

Germany: Medicinal Products: to be or not to be?
Jarste Akkermann, Frankfurt

The German Federal Court of Justice has given a key decision in its judgment of 14 January 2010 (Case I ZR 138/07) relating to the differentiation of foodstuffs and medicinal products in borderline cases. The question was whether cinnamon capsules constituted a foodstuff having a nutritive effect or a medicinal product by function having a pharmacological effect. The judgment follows the "Garlic Capsules" decision of the European Court of Justice (Case C-319/05). The German Federal Court of Justice has reiterated its reasons in a parallel court proceeding concerning another cinnamon containing product (Case I ZR 67/07) as well.

Italy: The new Italian CME discipline
Mauro Turrini, Milan

In Italy a new practice involving continuing medical education (CME) courses has been recently introduced which further strengthens the obligations and duties of both providers and sponsors. In particular, the recent Agreement between State and Regions (i.e. "accordo Stato-Regioni") of 5 November 2009 on CME, which was followed by a number implementing regulations dated 13 January 2010, introduced important new rules, in particular, on: (i) credits to healthcare professionals issued directly by (private) authorised providers (and not, as previously, provided by the experts committee of the Ministry of Health); (ii) more stringent rules on conflicts of interests of said providers; and (iii) more stringent rules on sponsors' permitted activities.

Return to top

EU: Free movement of medical devices bearing CE marking
Alain Gorny and Laure Dusart, Paris

The CJEU recently interpreted Article 4 of Directive 93/42/CEE on medical devices in response to a preliminary reference laid before it. A Swedish company manufacturing an alloy destined for use in dental amalgams containing mercury was refused an exemption by the Kemikalieinspektionen (Chemical Products Inspectorate) due to the prohibition under Swedish law against exporting mercury for professional purposes both within the EU and beyond.

Sweden: Clarification of obligation to perform clinical evaluations
Catrin Agerhall & Helena Siljestrom, Stockholm

New rules and regulations concerning medical devices entered into force in Sweden on 21 March 2010. The changes are based on the EU directive 2007/47/EC amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.
 

Finland: New legislation on medical devices passed in Finland
Ella Mikkola, Helsinki

The Finnish Parliament has passed new legislation on medical devices in Finland. Most sections of the new legislation entered into force on 1 July 2010.

Czech Republic: Amendment of the Act on Medical Devices
Vojtech Chloupek, Prague

New legislation on medical devices entered into force in the Czech Republic on 16 June 2010. The amendment partially implements the EU Directive 2007/47/EC of 5 September 2007 and relates to, in particular, conditions for the use of medical devices, clinical trials, prescription, release, purchase, warehousing and sale of medical devices, notification duties; state control and fines.
 

Return to top

Industry

EU: European General Court upholds findings of abuse of dominant position by AstraZeneca for misusing the SPC and marketing authorising systems
Richard Eccles, London

The European General Court issued its judgment on 1 July 2010 on AstraZeneca's appeal against the European Commission's decision adopted on 15 June 2005 fining AstraZeneca ("AZ") €60 million for abuse of dominant position through misuse of the patent system to obtain supplementary protection certificates (SPCs) and misuse of the pharmaceutical regulatory system by selective withdrawal of certain marketing authorisations.  The Court reduced the total fines from €60 million to €52.5 million due to the fact that the Commission had failed to prove certain aspects related to the second abuse.  However the Court confirmed the overall gravity of the infringements, pointing out that the abuses had lasted several years and related to the best-selling medicinal product in the world at the time, AZ's blockbuster drug Losec.

EU: European Commission Reports on the Monitoring of Patent Settlement Agreements
Richard Eccles, London

In the European Commission's pharmaceutical sector enquiry report of July 2009, the Commission drew attention to patent settlement agreements between originator and generic companies, indicating that these can raise competition law issues in particular where there is a value transfer from the originator, patent owning company to the generic company in return for delayed market entry or limits on market entry on the part of the generic company.  Since the time of the pharmaceutical sector report, the Commission has opened proceedings apparently relating to patent settlement agreements, concerning Les Laboratoires Servier. 

Return to top