If your company is developing a small-molecule drug, protecting the compound itself may not be enough.
The treatment that reaches the market may be a specific combination. If that combination is not properly supported in the patent application, part of the product’s future value may be left unprotected.
The FDA’s recent approval of iberdomide for multiple myeloma provides a good example. Iberdomide was approved in a treatment regimen with daratumumab and dexamethasone.
Where the clinical rationale and data support it, a combination patent can protect the regimen that competitors may ultimately want to market. It can therefore be a valuable addition to the protection for the compound itself.
The relevance may also extend beyond the patent term.
In Joined Cases C-119/22 and C-149/22, the CJEU confirmed that an earlier SPC for one active ingredient does not automatically prevent an SPC for a combination.
Simply naming both active ingredients in the claims is not enough, though. The combination must itself fall under the invention covered by the patent.
For biotech and pharmaceutical companies, the likely treatment regimen should therefore become part of the patent strategy well before market approval.
The question is not only which compound you are developing, but also which combination may ultimately become the product.
