SPCs AND REGULATORY

Maximising your market opportunity

Our specialist team can help you with all aspects of Supplementary Protection Certificates (SPCs), patent term extensions (PTEs) and regulatory exclusivities. We know the scale of resources required to bring a medicinal or plant protection product to market and why these rights have such a valuable commercial role to play in protecting your investment.

Expert in the interplay between patents, SPCs/PTEs and regulatory exclusivities, we will help you navigate a clear path through these complex and interrelated legal frameworks. Our attorneys closely monitor evolving case law in this area to ensure our clients remain in the strongest position to maximise the global market opportunity for their innovation.

As one of Europe’s largest life sciences IP teams, with expertise spanning pharmaceuticals, biologics, and agrochemicals, you can be assured that we have the technical knowledge and experience to exhaust every available route to achieving your objectives. You’ll be in good company working with us as we have successfully secured SPCs for products such as: Abstral®, Brintellix®, Cervarix®, Edluar®, Fasenra®, Feraccru®, Gardasil®, Jetrea®, Idelvion®, Nimenrix®, PecFent®, Synflorix®, Xerava®, Xospata ®

SPC filing strategies: From selecting the most appropriate patent on which to base an SPC filing to devising the optimal product definition, our attorneys are adept at identifying the most favourable approach for our clients, incorporating the latest developments in this evolving field to maximise exclusivity.

Filing and co-ordinating prosecution of SPCs/PTEs: We can support you in filing and co-ordinating SPC and patent term extension prosecution anywhere in the world. Operating from our offices across Europe and working in partnership with our trusted network of attorneys worldwide, you can be assured of the highest standards and meticulous attention to detail in every jurisdiction, including US, Europe and beyond.

We also understand the administrative pressure that SPC/PTE filings can place on in-house legal teams, with the need to constantly chase and keep an eye on deadlines. Our experts are here to ease this burden, and provide regular and concise updates to keep you fully informed every step of the way.
From large pharmaceutical companies with established SPC portfolios to high growth SMEs, as well as generics manufacturers looking to gain a foothold, we understand this crowded and technically complex arena. It is the combined legal and technical expertise of our IP solicitors, patent attorney litigators and patent attorneys working side-by-side that makes the biggest difference to our ability to litigate SPC rights for our clients, in Europe and beyond. With all the expertise you need in one team, you can be confident of a singular focus on your commercial objectives.
Following the significant investment you will have made to obtain a marketing authorisation, and patent and SPC rights, we can help you to maximise your exclusivity via a paediatric extension. We also appreciate that timescales may be tight, and you will need us to be able to work quickly and meticulously to secure a favourable outcome. Our experienced team is well-versed in the requirements for a paediatric extension and can work with you to acquire necessary documentation from regulatory bodies such as the European Medicines Agency to ensure that we meet the relevant deadlines.
We know the difference that market exclusivity and effective protection of clinical trial data can make in safeguarding your investment. With the requisite knowledge and understanding of the regulatory processes, our attorneys are well-placed to advise on the effects and interplay of these advantageous rights within an overall strategy to protect your innovation.
The new Unified Patent Court (UPC) will have competence to hear actions relating to SPCs based on nationally validated European Patents and SPCs based on a new European Patent with unitary effect (Unitary Patent or UP). SPCs based on national patents will not be part of the UPC system. Moreover, before an SPC is granted, its application is not part of the UPC system and hence any appeals against a Patent Office decision to refuse an SPC are still dealt with by national courts.

During a transition period, a nationally validated European Patent and its SPCs can be opted out of the UPC system. There does not appear to be any provision for opting out an SPC independently of the European Patent on which it is based. Any new SPCs that are granted after an opt-out is in place are automatically opted out. It is also possible to withdraw an opt-out request later (i.e. to opt back in to the UPC).

Please visit our dedicated pages here for more information on the UPC and the opt out process.