The Medicines Patent Pool and Gilead agreed in November 2011 to amend the licences they signed in July 2011 in order to clarify two issues raised in civil society feedback on the agreement.
The first amendment relates to what some groups felt was an ambiguity regarding the covenant not to sue on emtricitabine (FTC) in the event that a licensee terminates the tenofovir (TDF) portion of the licence. The amendment makes clear that even in the event of a TDF termination, the covenant not to sue on TDF/FTC combination survives. This means that licensees that choose to terminate the TDF portion of the licence can continue to manufacture combinations containing TDF and FTC in at least 112 countries without Gilead asserting its patent rights on FTC.
The second amendment clarifies the right of a licensee to supply a country outside the Licensed Territory in the event of a compulsory licence. The previous requirement that Gilead and the licensee be in agreement regarding the existence, scope and content of the compulsory licence has been removed. This clarifies the right of any Pool licensee to supply outside of the licensed territory where a compulsory licence has been issued.
The full, signed text of the amendment is available here [pdf].
This is the second amendment to the Gilead-Pool agreement. The first amendment [pdf] added South Sudan to the Licensed Territory when the Republic was created in July 2011.
The full, updated text of the main licensing agreement between Gilead and the Patent Pool is available here [pdf].