SPC & Regulatory Group

With hundreds of cases across Europe, the complex, fast-moving world of SPC and IP regulation is one of our specialities.

For some products (specifically human and veterinary medicinal, and plant protection), you can apply for an extended monopoly period after your patent expires. This national right is called a Supplementary Protection Certificate (or SPC) and is intended to compensate you for any delays getting your product to market caused by the regulatory review process.

An SPC can give you up to five and a half years’ extra protection for products already being marketed, so they can be hugely important commercially. Unfortunately, the law surrounding them is complex, counterintuitive, and very quick to change.

We’re proud to employ some of the foremost experts in the field, with an unsurpassed understanding based on years of experience taking SPC cases all the way up to the Court of Justice of the EU. In fact, some of our staff have helped to develop case law around SPCs – so you couldn’t hope for a more knowledgeable team.

Our case experience includes:

  • Hundreds of SPC applications across Europe
  • Seeking extension of SPC length based on completion of clinical trials in the paediatric population
  • Handling, up to the Court of Justice of the EU (CJEU), cases involving important questions about interpreting the legislation, including: C-202/05 (Yissum's SPC application); C-422/10 (Georgetown University et al's SPC applications), and C-484/12 (Georgetown University).
  • Authoring numerous influential articles and IP Updates on SPCs (which you can find on the Latest page)
  • Inventing the concept of negative-term SPCs, which has now been validated by the CJEU (see our articles from July 2007 and January 2012)
  • Proposing an interpretation of the law that could lead to longer SPC protection for some human medicinal products (see article)
  • Regularly lecturing about SPCs and paediatric extensions at international conferences

We can also advise you on other forms of intellectual property linked to authorisation of regulated, bioactive products – regulatory data protection (data exclusivity) and orphan medicinal product marketing exclusivity, for example. If you have questions about the validity, scope and duration of protection that you’re entitled to or your competitors have claimed, please get in touch and we’d be happy to advise.