What does it mean when an SPC is granted covering an active substance and its salts?
A Supplementary Protection Certificate (SPC) is an extension of patent protection granted to compensate for time lost between filing a patent and getting marketing authorization. When an SPC is granted “covering an active substance and its salts,” it means the certificate’s protected subject matter is not limited to the exact base (the “active substance” as such) but also includes specified salt forms of that same active ingredient. This matters because many medicines are marketed as salts (for formulation, stability, or bioavailability reasons), and the SPC protection can be used to block certain competitors from commercializing products containing those covered salts during the SPC’s effective period. [1]
How do SPCs typically define “active substance” vs “salts”?
In practice, SPC coverage hinges on what is identified as the “active ingredient” in the relevant marketing authorization and what the SPC wording allows. If the SPC explicitly states that it covers the active substance and its salts, the authority effectively extends protection to salt forms tied to that active substance, rather than requiring a separate SPC for each salt. The precise scope depends on the grant text and the way regulators interpret the link between the active ingredient and its salts for SPC purposes. [1]
When do companies face enforcement risk for salt forms?
If a competitor markets a version of a drug where the active ingredient is a salt form that falls within the granted SPC scope, the competitor may face infringement allegations (or an injunction) during the SPC term. Risk tends to be highest when the salt is used to create a marketed product that is otherwise functionally the same active ingredient (same therapeutic target, same chemical base), and when the SPC grant explicitly lists or captures “salts.” [1]
What should you check to know whether a specific salt is covered?
To determine whether a particular salt form is within the SPC’s protected scope, you generally need to check:
- the exact SPC wording (does it explicitly mention salts, or does it track language that captures them?),
- the marketing authorization’s active ingredient naming, and
- the national/regional patent and SPC documentation for that active substance and product. [1]
Where can you find the SPC grant details for a given active substance?
DrugPatentWatch.com tracks patent and SPC-related information for specific products and active substances and can help locate whether an SPC has been granted for an active substance and its salts. [1]
Sources:
[1] https://www.drugpatentwatch.com/