About the author:
Kate Hickinson is a partner and patent attorney in our Manchester office. Kate handles all types of chemical subject matter and has considerable experience and expertise in the pharmaceutical area having worked in-house at AstraZeneca for several years. Kate is experienced in working with clients to help them to identify the best ways to protect their inventions.
In the pharmaceutical area, Kate has experience filing and prosecuting patent applications directed to new chemical entities, chemical processes, formulations, solid forms and combination therapies, as well as experience of SPCs and data exclusivity.
What are Supplementary Protection Certificates (SPCs)?
Supplementary Protection Certificates (SPCs) are national rights that apply to certain pharmaceutical and plant protection products that have been authorized for use by the regulatory authorities. Regulatory approval is necessary in order to bring these products to market but can be a lengthy process which results in a loss of useful patent term for the patentee. SPCs are intended to compensate a patent owner for this loss of useful patent term and can extend the term of the patent for a maximum of five years. A six-month additional extension is available if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP). The extension compensates for the additional clinical trials and testing that a PIP requires.
Currently SPCs based on European patents must be applied for nationally in each member state in which the patent is in force. This can result in variations in the grant procedure and the duration of SPCs across the EU.
How does the Unified Patent Court (UPC) affect SPCs?
When the Unified Patent Court (UPC) opens its doors ( currently anticipated to be on 1 June 2023 – see https://www.appleyardlees.com/upc/), the court will have jurisdiction over actions relating to SPCs based on nationally validated European patents and SPCs based on European patents with unitary effect (i.e. Unitary Patents/UPs). The UPC will not have jurisdiction over SPCs based on national patents, just as it will not have jurisdiction over national patents granted by national Patent Offices. The UPC also will not hear actions relating to a Patent Office decision to refuse an SPC, which actions will still be dealt with by national courts.
SPCs and the opt out
If a SPC owner wishes to avoid the jurisdiction of the UPC, it will be possible, during a transition period, to opt a SPC out of the UPC system, provided that the SPC is based on a nationally validated European patent. It will not be possible to opt out SPCs that are based on a European patent with unitary effect.
Opt outs of SPCs will follow the opt out of the European patent upon which it is based, such that any opt out of the patent shall extend to any SPC based on it. In other words, if the European patent is opted out, then the SPC must also be opted out. If the European patent has expired, the expired patent can still be opted out so as to enable the opt out the SPC. When a SPC is granted subsequent to applying for an opt out, the opt out shall take effect automatically upon grant of the SPC. Thus, neither the patent nor the SPC may be removed from the jurisdiction of the UPC independently of each other.
The holder of a SPC may be different to the proprietor of the European patent on which the SPC is based. In this case, the holder of the SPC and the patent proprietor must apply for the opt out together.
It is possible to withdraw an opt-out request in order to opt back into the jurisdiction of the UPC. As for opt outs, withdrawal of an opt out for a SPC must follow withdrawal of the opt out for the patent upon which the SPC is based.
SPCs having unitary effect
The UP/UPC system does not provide for a SPC having unitary effect. However, it seems that the introduction of a Unitary SPC may be a logical extension of the UP. The European Commission is now proposing to introduce legislation to introduce a Unitary SPC system, so as to facilitate the grant of SPCs across the EU. It is hoped that this would reduce the administrative burden and costs associated with applying for SPCs and would provide more certainty for SPC holders. Details of how such a system would function are yet to be decided. For example, it is not clear whether this would be a Unitary SPC to extend the protection of Unitary patents or perhaps a unified procedure for granting a bundle of SPCs covering multiple states, along the same lines as the procedure for obtaining a European patent.
The views of stakeholders was requested recently by the European commission and we will await further news in this regard with interest. Of course, any new Unitary SPC system would have to run alongside the current national route to a certain extent, with non-EU countries and some EU countries (Spain and Poland) not being part of the UP/UPC system.