Patenting a drug repurposing program as a shield for staying in control

Drug repurposing programs embody the potential to extend therapeutic application of an existing drug molecule to a novel indication, to aid patients with an unmet medical need. Developing an existing drug for a new indication may be a faster route to the clinic. This may likely be a less cost-intensive approach, too, due to potentially suitability of existing clinical trial data in the registration process. Here, regularly faster development and at lower cost compared to the R&D program for a new medicinal molecule. A series of aspects is relevant for designing a successful repurposed drug program with a viable business case in mind, which aspects are necessary to keep in mind in order to increase the odds of indeed finally making the drug available for patients in need thereof. Topics requiring attention are amongst others: (i) clinical trial design; (ii) pricing and reimbursement; (iii) registration requirements; (iv) key features making a drug repurposing program an attractive business model for investment; and (v) the benefits that patenting can provide for a drug repurposing program regarding staying in control when a pricing- and reimbursement scheme for example is established.

In this presentation, this latter aspect, the role of patenting in drug repurposing programs, will be addressed. The embedded role that a well-designed patenting strategy can play in a drug repurposing program, will be highlighted. With special emphasize on the interconnections between IP protection and the other listed aspects. Some details will be shared on which aspects of a drug repurposing program are eligible for patent protection.

Some examples of patentable subject matter commonly apparent while developing a repurposed drug are:

(1) The known drug molecule, now used in the treatment of a new indication;

(2) The known drug, now used in a new formulation for the new indication;

(3) The known drug, now used at a different dose or in a different dosing regimen;

(4) The known drug, now administered to the new patient group in a new manner.