Q&A XI – On Supplementary Protection Certificate – SPC (AL, BA, RS, MK)

February 24, 2022 at 7:53 am

Each month we answer 3-5 questions our clients often have on a specific topic and share it with you.

Q1: When is Supplementary Protection Certificate (SPC) issued?

For patents that protect medication for humans and animals as well as for most agricultural/plant chemicals, issuance of SPC is available – this is due to the fact that patent protection of such inventions is not in itself enough for the owner to be able to commercialize them, as a separate & independent process for a permit to distribute them in the marketplace is necessary.

This aims to give owners of such inventions up to 5 extra years of protections, should they chose to apply for SPC.

Q2: What are the conditions that need to be met?

As stated above, the invention covered by the patent needs to be medication for humans or animals or plant protection/chemical – goods that need separate permits to be put into a marketplace.

Additionally, request for SPC has to be filed with the local IPO within 6 months since such permit has been obtained or up to 6 months from the date of the registration of the patent.

The request is filed by the owner of the patent, not by the licensee or the manufacturer.

Q3: What are the steps?

If all of the above is strictly followed – filing by the responsible person/entity in the foreseen term and there is a right to SPC protection, the IPO will publish it, issue a Certificate and note it in the official Registry.

The SPC protection will last up to 5 years (the exact formula is: time from the filing of the patent application to first permit, minus 5 years; but no longer than 5 years) – and this time starts when the 20 years of the primary patent are finished.

Annuities need to be paid for each year, as for the all other patents.

Note: SPC is not available in Montenegro & Kosovo (ME &KS) – their IP Laws have the necessary articles describing the supplementary certificate, but intend to start using them only once they have joined the EU.

Update: Kosovo has a new law valid from end of February 2022 which no longer ties use of SPC regulation to joining the EU, meaning that SPC is now available in Kosovo.It remains to be seen how the application of SPCs will be conducted in practice.

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