Over 60 countries worldwide offer the possibility of Patent Term 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 patent or plant protection patent by up to 5 years, with the possibility of a further 6-month extension of term in some circumstances. In many countries worldwide the PTE period is 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.
Most commonly there is a 6-month deadline, triggered by the Marketing Authorisation, to file an SPC application. PTE filing deadlines can be 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 a filing deadline for an SPC or PTE application is (in many cases) calculated from the patent's grant date.
An SPC may be granted in respect of a patented active ingredient, or combination 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 is often appropriate to consider the ever-evolving case law and law change proposals, to determine the best way forward.
An SPC may be based on any patent which protects:
a) the active ingredient(s) of the approved product (including substance patents, salt patents, polymorph patents);
b) a method of producing the active ingredient(s) i.e. process patents;
c) a use of the active ingredient(s) e.g for particular disease or symptom, or a commercially relevant dosage regime; or
d) a preparation containing the active ingredient(s) – i.e. a formulation patent
Similar provisions apply in PTE countries, although there is a degree of variation on a country-by-country basis.
SPCs can be obtained in the UK, all member states of the EU as well as Switzerland, Norway, Iceland and some other non-EU European countries. In addition, PTEs for medicinal products are available in numerous other commercially important countries worldwide.
Mewburn Ellis have been involved with key aspects of almost 1500 SPCs/PTEs for our clients and we’re well-placed to support you in this specialist area which is of great commercial importance to innovative drug products (and sometimes: to plant protection products too).
For more information please see our Specialty Pharma spotlight page.
This information is simplified and must not be taken as a definitive statement of the law or practice.
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