Extended protection for medicinal products

It is possible to obtain supplementary protection certificates for medicinal products. A supplementary protection certificate may extend patent protection by up to five years. The EU Medicinal Products for Paediatric Use Regulation (1901/2006), which entered into force on 26th January 2007, made it possible to obtain a further extension of six months in order to study the use of a medicinal product among children (defined as people up to the age of 18 years).

Although a six-month extension of the protection period may not sound like much time, consider, for example, the Merck drug Cancidas for the treatment of serious fungal infections. In accordance with the regulation, Cancidas was the first drug to be recommended for use among children by the European Medicines Agency. In the third quarter of 2008, Merck’s turnover for Cancidas was $148 million worldwide. It is estimated that a further six-month extension of the protection period would result in further earnings in Europe of $60 million.

Such an extension would not be costly to the manufacturers of medicinal products, as the costs involved in paediatric studies are often insignificant compared to the potential additional earnings. It also helps society as at present, in Europe, more than 50% of the drugs used in the treatment of children have not been tested or approved for such use. Therefore, extended protection periods will help to improve children’s quality of life and wellbeing.

In October 2008 the first application for extension of a supplementary protection certificate pursuant to the EU regulation was filed in Denmark. The filing took place before the Danish Patent and Trademark Office had even issued a request form and formal guidelines regarding supplementary protection for medicinal products for paediatric use, but it was still in accordance with the amended patent regulations that entered into force on 1st May 2008. In addition, the filing took place before the Danish Agency for Governmental Management had approved the official fee for such types of application.

For further information on extension certificates, please contact [email protected] or [email protected]