Supplementary Protection Certificates: FAQs
The following questions and responses represent generic information and do not constitute specific advice. If you have a specific query relating to Supplementary Protection Certificates, then we strongly recommend that you seek professional advice. In this respect, please contact us if you would like our assistance with your query.
- Where is SPC protection available?
- When is SPC protection available?
- Who can apply for an SPC?
- Must the patentee also be the proprietor of the MA?
- How many SPCs can be granted for any one (combination of) active ingredient(s)?
- What is the deadline for applying for SPC protection?
- What scope of protection does an SPC provide?
- How long does SPC protection endure?
- When is an SPC invalid?
- Who can apply to invalidate an SPC?
1. Where is SPC protection available?
In the member states of the EU or the European Economic Area (EEA), as well as in Switzerland. However, there are subtle differences between SPC law and practice in the EU and that in either the EEA member states or Switzerland.
2. When is SPC protection available?
In a particular country, SPCs are potentially available for those active ingredients (or combinations of active ingredients) that are: (a) protected in that country by a patent that is in force on the day of SPC application; and (b) present in a medicinal product or PPP that is the subject a Marketing Authorisation (MA) that is valid in that country.
Typically, an SPC will be based upon (and its duration will be set by) the first MA in the EEA for a product containing the (combination of) active ingredient(s) concerned. However, there may be circumstances in which SPC protection can be based upon a MA for a new use of a previously authorised (combination of) active ingredient(s).
The precise conditions under which (a) and (b) above are satisfied are currently the subject of much debate, as is the question of which substances qualify for SPC protection.
3. Who can apply for an SPC?
The holder of a patent that protects the (combination of) active ingredient(s) for which supplementary protection is sought.
4. Must the patentee also be the proprietor of the MA?
No. The patentee need not be the proprietor of (or indeed have any connection with) the MA upon which the SPC will also be based.
5. How many SPCs can be granted for any one (combination of) active ingredient(s)?
Typically (but not always), only one SPC can be granted to any one patentee for a particular (combination of) active ingredient(s). This is regardless of whether that patentee has multiple patents that protect the specified active ingredient(s). In such circumstances, the patentee must choose one of his patents to base the SPC upon.
However, there is no limit to the number of different patentees that may each obtain their own SPC for a given (combination of) active ingredient(s). Also, a patentee is free to assign an SPC application to a different legal entity, so that the SPC can be granted in the name of that different entity. This may affect the total number of SPCs that can be granted based upon patents held by a single patentee, but it may also have anti-trust implications.
6. What is the deadline for applying for SPC protection?
Whilst the patent upon which the SPC is based is still in force, the deadline is within 6 months of the later of:
(i) the date of grant of the basic patent (i.e. the patent upon which the SPC is based); and
(ii) the date of grant of the MA that the SPC will rely upon.
In any event, the SPC application must be filed before the patent upon which it is based expires in the territory concerned.
An application for extension of an SPC (see point 8 below) can be submitted either together with the application for a normal (i.e. unextended) SPC or at any time up to 2 years before expiry of normal SPC term.
7. What scope of protection does an SPC provide?
An SPC provides only very narrow, use-limited protection around the specified active ingredient(s). Nevertheless, because it can be capable of protecting all authorised uses of the specified active ingredient(s), an SPC can be a highly effective tool in excluding generic competition for the marketed medicinal product or PPP.
In any event, the scope of SPC protection cannot be any broader than the protection provided by the patent upon which the SPC is based.
8. How long does SPC protection endure?
If (and only if) the patent upon which an SPC is based reaches the end of its full term, the SPC comes into force immediately as the patent expires. The SPC then endures until the earlier of:
(I) 15 years from the first MA in the EEA for the specified (combination of) active ingredient(s); and
(II) 5 years from expiry of the patent upon which the SPC is based.
In relation to (I) above, it is important to note that there are some circumstances where an MA from Switzerland can count as the first in the EEA.
Further, where the first MA in the EEA is a “centralised” authorisation issued by the European Commission, Mike Snodin has argued that SPC term ought to be calculated by reliance upon the Notification Date of the “centralised” MA, as opposed to the (earlier) date upon which the European Commission decides to issue the MA (see Mike’s articles in SCRIP Regulatory Affairs from October 2011, December 2013 and October 2014). The Court of Justice of the EU (CJEU) has now accepted the premise set out in Mike’s articles. Thus, for all pending applications in all EU Member States, SPC term will now be calculated using, where relevant, the date of notification of a “centralised” MA. However, as noted in Mike Snodin’s article in SCRIP Regulatory Affairs from October 2015, correcting the (too short) term of granted SPCs may prove tricky in some territories.
SPCs to active ingredient(s) present in certain human medicinal products may be eligible for a 6-month extension of term, provided that those medicinal products have been the subject of clinical trials in the paediatric population that have been completed in accordance with a plan agreed with the European Medicines Agency.
If extended SPC protection is likely to be sought, then the possibilities for negative (normal) term SPCs should also be contemplated. In this respect, please see, for example, the articles that Mike Snodin has (co-)authored on the topic of zero and negative term SPCs, such as the 2007 RAJ Pharma article and the SCRIP Regulatory Affairs article from January 2012.
The precise date of expiry of an SPC may vary from country to country, for example due to differences in patent expiry dates or the date ascribed to a particular MA. In this respect, an additional day of SPC term may be obtainable in countries with “short” patent term (such as the UK) by reliance upon still further arguments put forward by Mike Snodin (in his SCRIP Regulatory Affairs article from June 2014).
9. When is an SPC invalid?
An SPC can become invalid if the patent upon which it is based:
- lapses before the end of its full term; or
- is revoked at least to the extent that the (combination of) active ingredients defined in relation to the SPC is no longer protected by that patent.
An SPC can also be invalid if it is granted contrary to the provisions of the SPC legislation, including those provisions discussed in connection with Question 2 above.
10. Who can apply to invalidate an SPC?
Any third party. In the UK, an application to invalidate an SPC can be filed at the High Court. Alternatively, it can be filed with the UK Intellectual Property Office (UK IPO) – though any decision by the UK IPO with respect to SPC validity will be appealable to the High Court.
Similarly, it is also possible to apply to invalidate an extension of an SPC – either on the same grounds as are available for unextended SPCs or upon the grounds that the legislative provisions governing extension of SPCs have not been satisfied.
At least in the UK, pending SPC applications cannot be opposed. However, it is possible to file third party observations in connection with pending application. This option is also available in many other (but not all) European territories.