Supplementary protection certificates (SPCs) compensate for delay to market entry for products (medicinal or plant protection) in the European Union (EU) and some European Economic Area (EEA) states by providing up to an additional five years of protection beyond patent expiry.
For medicinal products, a further six months of protection is available through a ‘paediatric extension’ of the SPC as a reward for carrying out studies under an agreed Paediatric Investigation Plan (PIP), bringing the SPC to a maximum of 5 ½ years of additional protection.
Indeed, in some cases, an SPC alone would not confer any additional protection (a so-called ‘negative term SPC’, due to the timing of the marketing authorisation (MA) relative to the 20-year patent term) but the addition of a paediatric extension passes the threshold and confers up to six months protection at what is often the most valuable period of the lifetime of a patented pharmaceutical product.
PAEDIATRIC EXTENSIONS IN THE EUROPEAN UNION
In order to obtain a paediatric extension under the EU’s Paediatric Regulation (No 1901/2006):
- All studies detailed in the agreed PIP must be carried out;
- The results of the studies performed according to the agreed PIP must form part of the application for an MA, either as part of the initial application for the MA or as a subsequent submission (i.e. in the event that a deferral or waiver was initially granted, or in the situation where a paediatric indication is being added to an existing MA);
- Providing that the studies are in conformity with the agreed PIP (whether positive or negative) and the results are reflected in the summary of product characteristics, the national/European regulatory authority adds a Statement of Compliance to the MA;
- An application for a paediatric extension must be made individually in each member state where the applicant wishes to extend its national SPC, and must be filed no later than two years before expiry of the SPC.
According to an exception given in the Paediatric Regulation, SPCs for medicinal products designated as orphan medicinal products are not eligible for paediatric extension, but instead the period of market exclusivity as an orphan medicinal product will be extended from 10 years to 12 years.
PAEDIATRIC EXTENSIONS AND PAEDIATRIC CERTIFICATES IN SWITZERLAND
Even though Switzerland had adopted their own version of SPCs, until recently paediatric extensions were not available. As of 1 January 2019, paediatric extension of Swiss SPCs is now available, as are stand-alone ‘paediatric certificates’ that extend Swiss patents for which no SPC has been granted. Both new provisions extend protection for six months.
The procedure for obtaining a paediatric extension in Switzerland is comparable to the procedure in the EU:
- The application for a Swiss MA (or an application to update the Swiss MA) for the medicinal product must include the results of the studies performed according to the agreed PIP;
- Providing the studies are in conformity with the agreed PIP, Swissmedic adds an attestation (i.e. a Statement of Compliance) to the MA;
- An application for a paediatric extension (containing the Swiss MA with its attestation) must be made to the Swiss Patent Office.
During the five-year transitional period from 1 January 2019 to 31 December 2023, an application for a paediatric extension in Switzerland may be filed no later than six months before expiry of the SPC (and a paediatric certificate may be filed no later than six months before expiry of the basic patent). From 1 January 2024 these periods will become no later than two years before expiry of the SPC (or patent, respectively), matching the time frame in the EU.
Further, the application for a Swiss MA (or an application to update the Swiss MA) for the medicinal product must be filed no later than six months after the first application for a corresponding MA in the European Economic Area (EEA) containing the results of the studies performed according to the agreed PIP. However, this requirement does not come into force until 1 July 2019, and so until 30 June 2019 applicants have time to apply to update their Swiss MAs with the PIP results even though the first application for a corresponding EEA MA was made more than six months ago.
Where a PIP has been completed, we recommend that holders/applicants of Swiss SPCs that have not yet reached the final six months of the SPC term consider (i) updating their Swiss MAs with the PIP results by 30 June 2019 and (ii) once conformity is authorised, applying for Swiss paediatric extensions before the deadline of six months before SPC expiry. Even if there is no Swiss SPC, it still may be possible to extend the patent in Switzerland by six months through a paediatric certificate.
If you are interested in filing or challenging SPCs, extending your SPCs by a paediatric extension, or simply require any further information or advice in this area, please contact Joel Beevers or Michael Pears of our SPC and Regulatory group.