Patents and SPCs

Italy: a marketing authorisation as patent or SPC infringement?
Fulvio Mellucci, Milan

By means of Legislative Decree No. 131/ 2010 which came into force on 2 September 2010, the Italian Government  amended the Italian IP Code (IPC).

One of these amendments directly affects the problem of the possible interference between the administrative procedure for the granting of a Market Authorisation (MA) and a third party's patent or Supplementary Protection Certificate. This has been a much debated problem in Italy in recent years, especially between originators and manufacturers of generics. Indeed, according to some originators the mere filing of an MA application would amount to a patent infringement, being an act not covered by the so-called experimental use exception.

Return to top

Regulatory

EU: Guidance from the Court of Justice of the EU on the scope for Member States to provide for compulsory data sharing in the context of authorisations for plant protection products
Trevor Cook, London

The Plant Protection Products Directive 91/414, which currently governs the regulatory framework for agricultural chemicals in the EU, will be replaced as from June 2011 by Regulation 1107/2009.  One of the many areas in which the new Regulation differs from the current Directive is in mandating, in Article 62, a derogation from the general principles of regulatory data protection which will, in effect, oblige the first applicant for an authorisation to share with subsequent applicants' data as to tests and studies involving vertebrate animals.  As observed in Recital 13 to the Regulation, there should be no deliberate human testing and, by Recital 40, animal testing for the purposes of the Regulation should be minimised and tests on vertebrates should be undertaken as a last resort.  In pursuance of this aim Article 62 provides that where the regulator has relied on such data, as it is entitled to do, the first applicant, absent any agreement on cost-sharing, which is to be determined in a fair, transparent and non-discriminatory way, has a claim, enforceable nationally, against the second applicant for a fair share of such costs. 

France: Competence of the Member States to regulate nutrient content in food supplements
Diane Bandon-Tourret, Paris

In its decision of 29 April 2010 in, Solgar et al (C-446/08), the Court of Justice of the European Union took the opportunity to specify the extent of the Member States' competence regarding the regulation of the manufacture of food supplements  in respect of certain areas not yet regulated by the Commission.

France: Therapeutic Education – HPST law and its implementing provisions
Alain Gorny and Laure Dusart, Paris

Law n 2009-879 of 21 July 2009 is known as the "HPST Law" [relating to Hospitals, Patients, Health and Territories] and was partially implemented by Orders of 2 and 31 August 2010 (specifically relating to therapeutic education and to training programmes).  The HPST Law modifies Le Code de la Sant Publique, creating Articles L.1161-1 et seq. which concern 'therapeutic education'.

The Netherlands: Policy on use patents for the registration of generic medicinal products

Colette Mulder, The Hague
Marketing authorisation holders of generic medicinal products sometimes remove information from the summary of product characteristics and the patient information leaflet to prevent the potential infringement of a use patent.

Spain: reductions in the price of medicinal products and medical devices: new Royal Decree-Law 8/2010

Raquel Ballesteros Pomar and Lola Canalejo, Madrid
In order to comply with the so-called Excessive Deficit Procedure (also known as the corrective arm) established by the European Union pursuant to Article 126 of the Treaty on the Functioning of the European Union, Spain established in its agenda to reduce its government deficit to 3% of gross domestic product by 2013. For this reason, the Spanish Government has enacted various urgent measures to cut public spending.

Finland: New administrative orders on medical devices issued in Finland
Ella Mikkola, Helsinki

In Finland, Valvira (the National Supervisory Authority for Welfare and Health) has issued four administrative orders regulating the procedure to be followed in connection with incident reporting, registration and clinical trials regarding medical devices.

Return to top

UK: NICE provisionally recommends Alzheimer's drugs for early and moderate stage treatment
Ewan Grist, London

Sweden – One year after de-monopolisation
Mathilda Nordmark and Richard Lewinson, Stockholm

Return to top