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A supplementary protection certificate, or SPC, extends patent protection beyond the normal 20 year term for certain regulated products, most often medicines and plant protection products. It exists to compensate for the years of patent life lost while a product waits for regulatory approval.
Because for some products the patent clock and the approval clock run at the same time.
A pharmaceutical patent is usually filed early in development. Clinical trials and regulatory approval can then take a decade, all of it inside the patent term. By the time the product can legally be sold, much of the protection has already been used up. An SPC restores part of that lost period.
Two things must be true. The product must be covered by a patent still in force, and it must have received marketing authorisation from the relevant regulator.
The certificate attaches to a specific product and its authorisation, not to the whole patent. It is applied for separately, per jurisdiction, and within a defined window after authorisation.
It is calculated from the delay between filing the patent and receiving marketing authorisation, and it is capped. In the EU the certificate may not exceed five years from the date it takes effect, with a further six months where the paediatric regulation applies. That cap is set by Article 13 of Regulation (EC) No 469/2009.
An SPC also carries its own patent renewal fees. It is a separate right with its own deadlines, not an automatic continuation of the patent, which is why SPCs are one of the easier things to drop from a portfolio by accident.
Not everywhere. They are established in the EU and a number of other jurisdictions, while others provide equivalent relief under a different name, such as patent term extension in the United States.
