Medicines for children gain extended patent protection
With the introduction of the Paediatric Regulation in Norway, the pharmaceutical industry is given the right to a further six months' extension to the period of validity of supplementary protection certificates for patented medicines. This is intended to boost the development and testing of medicines for children.
The new rules ensure that medicines for children have better documentary evidence of quality, safety and efficacy, and contribute to improving the availability of medicines intended specially for children.
Implementation of the Paediatric Regulation in Norwegian law necessitates amendments to the Medicines Act and the Patents Act. Amendments will also be made to the Medicines Regulations, the Patent Regulations and the Regulation on Fees.
The amendments in Norwegian law resulting from the Paediatric Regulation will enter into force in Norway on 1 September 2017.
Time limits and transitional rules
Under general rules, an application for a six months' extension to the period of validity for a supplementary protection certificate must be submitted not later than two years prior to expiry of the certificate. Special transitional rules have been set in consideration of holders of certificates that expire in the first few years after the Paediatric Regulation enters into force in Norway.
Under the transitional rules, applications for extension of the period of validity for a supplementary protection certificate in Norway, up to 1 September 2022, must be submitted not later than six months before the certificate expires. Thereafter, the general time limit of not later than two years before the certificate expires, will apply.
Further transitional rules have been set for certificates expiring close in time to 1 September 2017. Under these rules, only holders of certificates expiring after 1 March 2017 will be able to have the period of validity extended. This is related to the requirement for the extension to represent a direct continuation of the period of validity of the certificate, and means that holders of certificates expiring before 1 March 2017 cannot obtain any extension of the period of validity of the certificate.
- If the certificate expires after 1 March 2017, an extension can be obtained, but only with effect for that part of the six-month period, counting from date of expiry of the certificate, remaining at 1 September 2017. Nor does the extension take effect until the application for extension has been published.
- If the certificate does not expire until after 1 September 2017, on the other hand, it will be possible to obtain a six-month extension that represents a direct continuation of the period of validity of the certificate.
- If the certificate expires before 1 April 2018, the deadline for applying for an extended period of validity will be 1 October 2017.
You can apply for an extended period of validity from 1 August 2017
Even if the certificate expires before 1 September 2017, it will therefore not be necessary to apply for an extension before the rules have entered into force.
As the extension can only take effect after the application has been published, it may nevertheless be worthwhile applying earlier.
A special provision has therefore been set in the Regulations that applications for extended period of validity may be submitted from 1 August 2017, and the applications have to be published in Norsk patenttidende (Norwegian Patents Gazette) without undue delay.
Special application form
The Norwegian Industrial Property Office has drawn up a special application form in connection with the implementation of the Paediatric Regulation in Norwegian law.
This application form should be used in submitting applications for extended period of validity. As a supplement to the application form, guidance notes have also been prepared providing further details about the information and documentary evidence that must be submitted at the same time as the application.
It is important to note that the Norwegian Industrial Property Office will require documentary evidence to be submitted showing that there is a valid marketing authorisation for all EEA Member States (with the exception of Liechtenstein), including a declaration that paediatric studies have been performed in accordance with an approved, implemented paediatric trial protocol. This means that where marketing authorisations with declarations on performed paediatric studies have been issued by competent authorities in the individual EEA Member State, copies of these must be attached to the application for extended period of validity. Where a marketing authorisation has been issued centrally, it is sufficient for the applicant to submit a copy of the European Commission's decision, as well as a copy of a declaration on performed paediatric studies issued by EMA.
Guide in Norwegian: Veiledning til søknad om forlengelse av supplerende beskyttelsessertifikat for legemidler (PDF-format).
The fee for extension of supplementary protection certificate (SPC) is NOK 2000.