Permitting supply of patented products beyond the agreed licensing territory

GSK boosts the geographic scope of the dolutegravir (Tivicay®) licence beyond the stated territory by more than 30 middle-income countries.

Summary  

  • What: GSK achieves a comparatively broad geographic scope in its licensing agreement for dolutegravir (Tivicay®), negotiated via the Medicines Patent Pool (MPP).
  • Details: It permits generic manufacturers to also supply to countries outside the agreed territory, to countries where patents are not in force, regardless of whether a patent is in place in the country of manufacture.
  • Objective: Competition amongst generic manufacturers to supply this product in the markets influenced in the licensing agreement helps to improve affordability and supply of this product.
  • Impact: This results in over 30 additional middle-income countries being able to benefit from the procurement of generics.

Looking closer

In its licence for Tivicay®, negotiated via the MPP, GSK permits supply outside of the agreed territory to wherever patents are not in force, including in countries of manufacture. This enables manufacturers based in India, a key manufacturing country, to boost access to Tivicay® to more than 30 additional middle income countries not mentioned in the licence, meaning the effective licence territory is far broader than it would otherwise be.

It is distinguished from other similar licensing practices by the inclusion of countries of manufacture within this exception, rather than limiting it to supply to countries where patents are not in force. Competition amongst generic manufacturers to supply this product in the markets included in the licensing agreement helps to improve affordability and supply of this product.

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