Supplementary protection certificates

All EU countries have SPC regimes and in fact share the same SPC legislation. Iceland, Norway and Switzerland/Liechtenstein also have SPC regimes modelled on the EU system.

The owner of a patent protecting an active ingredient or combination of active ingredients present in an authorised medicine or plant protection product, i.e. a medicine or plant protection product that has been awarded an MA, may be in a position to obtain an SPC for that active ingredient or combination. Whether or not the patent owner is the MA-holder is not relevant. However, if a patent owner has already been awarded an SPC in a given country for an active ingredient or combination of active ingredients of an approved medicine/plant protection product then that owner is precluded from obtaining further SPCs in that country for the same active ingredient or combination.

An SPC comes into force when the basic patent supporting the SPC expires. The duration of the SPC is equal to the period of time that elapses between the patent filing date and the award of marketing authorisation, minus five years. There is, however, a maximum duration cap of five years. In addition, in order to harmonise SPC duration across Europe, the MA selected for the calculation must be the first MA for the active ingredient(s) to have been awarded in Europe (the EU, Iceland, Norway and Switzerland/ Liechtenstein).

• Example 1: Patent filing date = 1st January 2001 | Date of marketing authorisation = 1st January 2009 | Duration of SPC = 3 years

• Example 2: Patent filing date = 1st January 2001 | Date of marketing authorisation = 1st January 2014 | Duration of SPC = 5 years. A further six months’ duration may be available in the case of medicinal product SPCs for which all of the studies required in compliance with an agreed paediatric investigation plan have been completed. A so-called paediatric extension to the SPC may then be sought.

An SPC must be filed by the later of:

• (i) six months from the date of grant of the basic patent; or
• (ii) six months from the date of award of marketing authorisation effective in the territory where the SPC is to be sought

Note that the MA in (ii) must be the first MA for the active ingredient(s) in the territory concerned. In addition, at the date of application for an SPC the basic patent must be in force.

SPCs are applied for on a national basis. SPC applications are submitted to national patent offices and must normally, as a minimum, identify the following:

• (i) the patent on which the SPC is to be based, which can be a national patent or European patent covering the territory in which SPC protection is being sought;
• (ii) the first MA for the active ingredient(s) effective in the territory where SPC protection is being sought; and
• (iii) the first MA for the active ingredient(s) to have been awarded anywhere in the Europe (the EU, Iceland, Norway and Switzerland/ Liechtenstein), if earlier than the MA in (ii). In addition, it is normal to include copies of the official MA documents when filing a new SPC application.

Once granted, a challenge to the validity of an SPC may be made before the national authority responsible for dealing with patent revocation. Generally, this means that the national courts are available for hearing SPC validity challenges.

However, some countries may also have a procedure enabling a challenge to be mounted before the national patent office in the period immediately after SPC grant. In many countries, it is also possible to submit third party observations during the SPC application process. The following are grounds for SPC invalidity:

• (i) the basic patent does not protect the active ingredient(s) of an approved medicine/plant protection product;
• (ii) there is no valid MA for the active ingredient(s) of the SPC;
• (iii) the patentee has already been awarded an SPC for the same active ingredient or combination of active ingredients;
• (iv) the national MA relied upon in the SPC application was not the first MA for the active ingredient(s) in the country concerned;
• (v) the basic patent lapsed before expiry of its lawful term;
• (vi) the basic patent is revoked or limited to the extent that the active ingredient(s) for which the SPC was granted would no longer be protected by the patent, or after expiry of the basic patent grounds for revocation exist which would have justified such revocation or limitation.

The legislation enacting the SPC manufacturing waiver in the EU (Regulation (EU) 2019/933) has now been completed by the European Parliament and the Council of the European Union.