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.
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Where is SPC protection available?
In the member states of the EU. SPCs are also available in the UK, in member states of the European Economic Area (EEA) and in a small number of other countries in Europe, including Switzerland. However, SPC law and practice differs (mostly in subtle ways) between the different countries and regions. -
When is SPC protection available?
In the UK or an EU or EEA member state, SPCs are potentially available for those active ingredients (or combinations of active ingredients) that, upon the day of application in a particular country, are:
(a) protected in that country by a patent that is in force; and
(b) present in a medicinal or plant protection product that is the subject a Marketing Authorisation (MA) that is valid in that country.
The MA mentioned in (b) must be the first in that country for a product containing the (combination of) active ingredient(s) concerned.
There is ongoing debate on the precise conditions under which (a) and (b) above are satisfied, as well as on the question of which substances qualify for SPC protection.
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Who can apply for an SPC?
In the UK and EU or EEA member states, the applicant must be the holder of a patent that protects the (combination of) active ingredient(s) for which supplementary protection is sought. -
Must the patentee also be the proprietor of the MA?
Not under current practice in the UK and EU or EEA member states. However, whether the patentee must have some form of connection with (or permission from) the MA holder is a question upon which courts in the UK, the EU and the EEA have yet to provide a definitive answer. -
How many SPCs can be granted for any one (combination of) active ingredient(s)?
Under current practice in the UK and EU member states, 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, only one patent can be selected for the grant of an SPC directed to the active ingredient(s) in question.
However, in the UK and EU member states, 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.
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What is the deadline for applying for SPC protection?
Whilst the patent upon which the SPC is based is still in force, the deadline in the UK and EU or EEA member states 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 (as discussed below in connection with duration of protection) can, in the UK and EU or EEA member states, 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.
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What scope of protection does an SPC provide?
In the UK and EU or EEA member states, 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 or plant protection product.
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.
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How long does SPC protection endure?
In the UK and EU or EEA member states, 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 earliest MA for the specified (combination of) active ingredient(s) that is granted in, or in respect of, a relevant region; and
(II) 5 years from expiry of the patent upon which the SPC is based.
In EU and EEA member states, the relevant region mentioned in (I) above comprises all of those member states. In some circumstances it may also comprise Switzerland. In the UK, the relevant region is the same, except that it additionally comprises the UK (or any nations thereof). This has the consequence that, in some circumstances, the duration of SPC protection can be shorter in the UK than in either EU or EEA member states.
With respect to (I) above, the period of 15 years commences when the MA becomes valid. In its 2015 decision in case C-471/14, the Court of Justice of the EU (CJEU) concluded that the date upon which a “centralised” MA becomes valid in Europe is the date upon which the applicant is notified of the European Commission's decision to issue the MA, and not the (earlier) date upon which the decision was made. By reaching this conclusion, the CJEU effectively accepted a point first argued by Mike Snodin in an article published in SCRIP Regulatory Affairs in October 2011 (and also in subsequent articles in December 2013 and October 2014).
It is possible to file appeals in order to rectify the duration of an SPC that has been calculated incorrectly (e.g. not in accordance with C-471/14). In its 2017 decision in C-492/16, the CJEU confirmed that such appeals are valid if filed at any time before expiry of the SPC in question.
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 regulatory agency responsible for issuing the MA upon which the SPC relies.
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).
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When is an SPC invalid?
In the UK and EU or EEA member states, 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.
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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 a pending application. This option is also available in many other (but not all) EU and EEA member states.