Over 60 countries worldwide offer the possibility of extensions (PTEs or SPCs) for medicinal product patents. “Supplementary Protection Certificate” (SPC) is the name given to such an extension in many European countries. European SPCs can extend the term of a medicinal or plant protection patent by up to 5 years, with the possibility of a further 6-month extension term in some circumstances. In many other countries worldwide the maximum PTE period is also capped at a maximum of 5 years.
The policy aim with PTEs and SPCs is to “compensate” (to some extent) a patent owner for some of the patent term that is effectively “lost” by having to go through the regulatory trials and approval process. SPCs are national rights that need to be applied for via the national patent office of each country where there is at least one suitable patent to extend.
When must SPC and PTE applications be filed?
Most commonly there is a 6-month deadline, triggered by the Marketing Authorisation, to file an application for an SPC or PTE application, although the deadline is shorter in some countries – at 3 months or even as little as 60 days. If the patent to be extended is not granted until after the Marketing Authorisation is issued, then the filing deadline for the SPC or PTE application is generally calculated from the patent grant date.
For what types of products are SPCs and PTEs available?
An SPC may be granted in respect of a patented active ingredient, or mixture of active ingredients, of a medicinal or plant protection product. Such medicinal products may be for humans or animals.
PTEs are more generally available for human medicinal products, as officially approved in the relevant country.
For combination treatments in particular, there may be a number of patents to consider from an SPC or PTE perspective. As part of the strategy analysis towards selecting a patent for extension, it may be appropriate to consider the extensive case law that has been generated in the relation to combination therapies.
On what type of patent must an SPC or PTE be based?
An SPC may be based on any patent which protects:
a) the active ingredient(s) of the authorised medicinal or plant protection product;
b) a method of producing the active ingredient(s);
c) an application of the active ingredient(s); or
d) a preparation containing the active ingredient(s) (at least in the case of plant protection products).
The patent must be in force, in the country where the SPC is sought, at the time the SPC application is filed.
Similar provisions apply in PTE countries, although there is a degree of variation on a country-by-country basis.
Where are SPCs and PTEs available?
SPCs can be obtained in the UK, all member states of the EU as well as Switzerland, Norway, Iceland and some other European countries. In addition, PTEs for medicinal products are available in some European countries and numerous other commercially important countries worldwide.
Mewburn Ellis have been involved with key aspects of over 1000 SPCs/PTEs for our clients and we’re well-placed to support you in this specialist area of great commercial importance.
This information is simplified and must not be taken as a definitive statement of the law or practice.