Outsourcing Strategies For Maximizing Drug Exclusivity

By John Serio and Christopher Head

It is extremely important when outsourcing projects to a CDMO that contractual agreements clearly spell out ownership of discoveries and data uncovered during the outsourced development process.

From an IP perspective, an overarching theme common throughout the use of these organizations is the importance of capturing and protecting all points of novelty associated with a drug’s chemistry, manufacturing, and controls (CMC). Frequently, during the CMC development period, novel compositions, processes, and conditions may be discovered that may be used to extend the product’s life cycle.