Regulatory exclusivity as a primary intellectual property and commercial asset
How can a company take advantage of regulatory exclusivity to launch an open science drug discovery program? Max Morgan et al explain in their paper Ideation and implementation of an open science drug discovery business model – M4K Pharma published in Welcome Open Research this month.
Comparing protection against competition for a new drug sponsor under an average effective patent term in the US with protection against competition under prospective M4K regulatory exclusivity periods in the US, EU, Canada, and Japan, using a new drug targeting DIPG as the exemplar. [Figure from: Morgan MR, Roberts OG and Edwards AM. Ideation and implementation of an open science drug discovery business model – M4K Pharma [version 1; peer review: 2 approved, 1 approved with reservations]. Wellcome Open Res 2018, 3:154 (https://doi.org/10.12688/wellcomeopenres.14947.1)]